GASTROENTEROLOGY-UROLOGY DEVICES

• Citation: 21 CFR Part 876
• Sections: 101

§ 876.1 Scope.

(a) This part sets forth the classification of gastroenterology-urology devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

(c) To avoid duplicative listings, a gastroenterology-urology device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

§ 876.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

§ 876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(9) For near patient testing (point of care).

§ 876.1050 Endoscopic transhepatic venous access needle.

(a) Identification. An endoscopic transhepatic venous access needle is inserted through the liver into the patient's portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(3) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.

(4) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.

(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested:

(i) Needle crumple testing;

(ii) Tensile testing;

(iii) Dimensional verification for all components; and

(iv) Simulated use testing.

(6) Labeling must include the following:

(i) Instructions for use, including specific instructions regarding device preparation;

(ii) The recommended training for safe use of the device; and

(iii) A shelf life for any sterile components.

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a) Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.1080 Gastroenterology-urology accessories to a biopsy instrument.

(a) Identification. A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.

(a) Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.

(b) Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”

§ 876.1310 Magnetically maneuvered capsule endoscopy system.

(a) Identification. A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing with the device under anticipated conditions of use must evaluate visualization of the intended region and document the adverse event profile.

(2) Non-clinical testing data must demonstrate the optical, mechanical, and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested, and detailed protocols must be provided for each test:

(i) A bite test must be performed to ensure that the capsule can withstand extreme cases of biting;

(ii) A pH resistance test must be performed to evaluate integrity of the capsule when exposed to a physiological relevant range of pH values;

(iii) A battery life test must be performed to demonstrate that the capsule's operating time is not constrained by the battery capacity;

(iv) A shelf life test must be performed to demonstrate that the device performs as intended at the proposed shelf life date;

(v) Optical testing must be performed to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, geometric distortion, signal to noise ratio, dynamic range, and image intensity uniformity;

(vi) A color performance test must be performed to compare the color differences between the input scene and output image;

(vii) A photobiological safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided;

(viii) Performance testing must demonstrate that the viewing software clearly presents the current frame rate, which is either adjustable manually by the user or automatically by the device. Testing must demonstrate that the viewing software alerts the user when the video quality is reduced from nominal due to imaging data communication or computation problems;

(ix) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the receiver. This test must include controlled signal attenuation for simulating a non-ideal environment; and

(x) Magnetic field strength testing characterization must be performed to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects.

(3) Software validation, verification, and hazard analysis must be provided.

(4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Performance data must validate the reprocessing instructions for the reusable components of the device.

(7) Performance data must demonstrate the sterility of any device components labeled sterile.

(8) Human factors testing must demonstrate that the intended users can safely and correctly use the device, based solely on reading the instructions for use.

(9) Clinician labeling must include:

(i) Specific instructions and the clinical and technical expertise needed for the safe use of the device;

(ii) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications;

(iii) The patient preparation procedure;

(iv) A detailed summary of the device technical parameters;

(v) Magnetic field safe zones;

(vi) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet;

(vii) Reprocessing instructions for reusable components;

(viii) Shelf life for single use components; and

(ix) Use life for reusable components.

(10) Patient labeling must include:

(i) An explanation of the device and the mechanism of operation;

(ii) The patient preparation procedure;

(iii) A brief summary of the clinical study; and

(iv) A summary of the device- and procedure-related complications pertinent to use of the device.

§ 876.1330 Colon capsule endoscopy system.

(a) Identification. A prescription, single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the colon for the detection of polyps. It is intended for use only in patients who had an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The capsule must be demonstrated to be biocompatible.

(2) Non-clinical testing data must demonstrate the mechanical and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested and detailed protocols must be provided for each test:

(i) Bite test to ensure that the capsule can withstand extreme cases of biting.

(ii) pH resistance test to evaluate integrity of the capsule when exposed to a range of pH values.

(iii) Battery life test to demonstrate that the capsule's operating time is not constrained by the battery capacity.

(iv) Shelf-life testing to demonstrate that the device performs as intended at the proposed shelf-life date.

(v) Optical testing to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, distortion, signal-to-noise ratio, uniformity, and image artifacts. A test must be performed to evaluate the potential of scratches, caused by travelling through the gastrointestinal tract, on the transparent window of the capsule and their impact on the optical and color performance.

(vi) An optical safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided.

(vii) A color performance test must be provided to compare the color differences between the input scene and output image.

(viii) The video viewer must clearly present the temporal or spatial relationship between any two frames as a real-time lapse or a travel distance. The video viewer must alert the user when the specific video interval is captured at a frame rate lower than the nominal one due to communication errors.

(ix) A performance test evaluating the latency caused by any adaptive algorithm such as adjustable frame rate must be provided.

(x) If the capsule includes a localization module, a localization performance test must be performed to verify the accuracy and precision of locating the capsule position within the colon.

(xi) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the recorder. Controlled signal attenuation should be included for simulating a non-ideal environment.

(xii) Software validation, verification, and hazards analysis must be provided.

(xiii) Electrical equipment safety, including thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed. If the environments of intended use include locations outside of hospitals and clinics, appropriate higher immunity test levels must be used. Labeling must include appropriate EMC information.

(xiv) Information demonstrating immunity from wireless hazards.

(3) The clinical performance characteristics of the device for the detection of colon polyps must be established. Demonstration of the performance characteristics must include assessment of positive percent agreement and negative percent agreement compared to a clinically acceptable alternative structural imaging method.

(4) Clinician labeling must include:

(i) Specific instructions and the clinical and technical expertise needed for the safe use of the device.

(ii) A detailed summary of the clinical testing pertinent to use of the device, including the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method.

(iii) The colon cleansing procedure.

(iv) A detailed summary of the device technical parameters.

(v) A detailed summary of the device- and procedure-related complications pertinent to use of the device.

(vi) An expiration date/shelf life.

(5) Patient labeling must include:

(i) An explanation of the device and the mechanism of operation.

(ii) Patient preparation procedure.

(iii) A brief summary of the clinical study. The summary should not only include the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method.

(iv) A summary of the device- and procedure-related complications pertinent to use of the device.

§ 876.1390 Ingestible gastrointestinal blood detection capsule.

(a) Identification. An ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must evaluate:

(i) Detection of presence or absence of blood when compared to endoscopic procedures used to detect upper gastrointestinal bleeding;

(ii) Capsule excretion and recovery; and

(iii) All adverse events.

(2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Dimensional testing must verify device dimensions;

(ii) Performance testing must verify functional aspects of the device design;

(iii) Battery life testing must be performed to demonstrate the capsule's operating time is not constrained by the battery capacity;

(iv) Leak testing must verify device integrity under worst-case clinical conditions;

(v) Bite testing must demonstrate that the device can withstand bite forces;

(vi) pH resistance testing must evaluate integrity of the capsule when exposed to a physiological relevant range of pH values;

(vii) Control and monitoring of capsule bioburden must demonstrate the device does not pose an infection risk; and

(viii) Blood detection testing must demonstrate that the device can detect different forms of blood seen under anticipated conditions of use.

(3) Software validation, verification, and hazard analysis must be performed.

(4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed.

(5) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(6) The patient-contacting components of the device must be demonstrated to be biocompatible.

(7) Performance testing must support the shelf life of the device by demonstrating continued package integrity and device functionality over the identified shelf life.

(8) Physician labeling must include:

(i) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications;

(ii) Warning that the device is not a standalone diagnostic device and does not replace clinical decision making; and

(iii) A shelf life.

(9) Patient labeling must include:

(i) An explanation of the device and the mechanism of operation;

(ii) The patient preparation procedure;

(iii) A brief summary of the clinical study; and

(iv) A summary of the device- and procedure-related complications pertinent to use of the device.

§ 876.1400 Stomach pH electrode.

(a) Identification. A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

§ 876.1450 Esophageal tissue characterization system.

(a) Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) All patient contacting components of the device must be demonstrated to be biocompatible.

(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.

(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.

(6) Performance data must validate the reprocessing instructions for any reusable components of the device.

(7) Labeling must include:

(i) Specific instructions regarding the proper placement and use of the device;

(ii) Instructions for reprocessing of any reusable components; and

(iii) An expiration date for single use components.

§ 876.1500 Endoscope and accessories.

(a) Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

(b) Classification —(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

§ 876.1510 Anchored esophageal sheath.

(a) Identification. An anchored esophageal sheath is a device used to provide an endoluminal pathway to facilitate insertion of an endoscope or other compatible device into the upper gastrointestinal tract. A distal anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other compatible device.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:

(i) Testing must verify all dimensions;

(ii) Testing must demonstrate that insertion and removal of any device from the anchored esophageal sheath does not damage the shaft wall or exert force that would cause tissue injury;

(iii) Testing must demonstrate that the anchoring component can be reliably actuated;

(iv) Testing must demonstrate compatibility with any other device that the anchored esophageal sheath is intended to be used with; and

(v) Testing must demonstrate device integrity and functionality in simulated gastric conditions under clinically anticipated forces.

(3) Simulated use testing using an anatomically accurate gastrointestinal model must demonstrate that:

(i) The device can be inserted and removed safely;

(ii) The device remains anchored in place;

(iii) The device can be safely withdrawn after releasing the anchor; and

(iv) The device location and anchoring status can be observed by the intended user.

(4) Performance data must demonstrate continued device functionality over the identified shelf life.

(5) Labeling must include:

(i) Information as to whether the device can be used for foreign body removal or with instruments alongside the endoscope;

(ii) Steps needed to prevent injury to the esophagus or gastroesophageal junction (GEJ) during placement, anchoring, and use of the device;

(iii) Any visualization steps required to confirm the device's placement prior to and after actuating the anchoring component at the GEJ;

(iv) A precaution to avoid excessive force during insertion;

(v) Identification of any endoscopes or other devices that have been validated for use with the anchored esophageal sheath; and

(vi) An expiration date or shelf life.

§ 876.1520 Gastrointestinal lesion software detection system.

(a) Identification. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:

(i) Standalone algorithm performance testing;

(ii) Pixel-level comparison of degradation of image quality due to the device;

(iii) Assessment of video delay due to marker annotation; and

(iv) Assessment of real-time endoscopic video delay due to the device.

(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(4) Performance data must demonstrate electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety testing for any hardware components of the device.

(5) Software verification, validation, and hazard analysis must be provided. Software description must include a detailed, technical description including the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, the associated inputs and outputs, mapping of the software architecture, and a description of the video signal pipeline.

(6) Labeling must include:

(i) Instructions for use, including a detailed description of the device and compatibility information;

(ii) Warnings to avoid overreliance on the device, that the device is not intended to be used for diagnosis or characterization of lesions, and that the device does not replace clinical decision making;

(iii) A summary of the clinical performance testing conducted with the device, including detailed definitions of the study endpoints and statistical confidence intervals; and

(iv) A summary of the standalone performance testing and associated statistical analysis.

§ 876.1530 Endoscopic light-projecting measuring device.

(a) Identification. An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate:

(i) Visualization during the procedure;

(ii) Ease of procedure as reported by the intended user; and

(iii) User acceptability of imaging time.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Accuracy validation;

(ii) Endoscope compatibility testing;

(iii) Battery life testing;

(iv) Durability testing; and

(v) Light safety testing.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Electrical, thermal, and mechanical safety testing must be performed.

(6) Performance testing must demonstrate electromagnetic compatibility of the device in the intended use environment.

(7) Methods and instructions for reprocessing reusable components must be validated.

(8) Labeling must include:

(i) Device technical parameters, including a description of the accuracy of the device;

(ii) Information regarding endoscope compatibility;

(iii) Warning for light hazards and protection for patient and operator; and

(iv) Validated reprocessing instructions.

§ 876.1620 Urodynamics measurement system.

(a) Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

§ 876.1725 Gastrointestinal motility monitoring system.

(a) Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.

(b) Classification. Class II (performance standards).

§ 876.1735 Electrogastrography system.

(a) Identification. An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.

(b) Classification. Class II (Special Controls). The special controls are as follows:

(1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(2) The labeling must include specific instructions:

(i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes;

(ii) To describe how background data should be gathered and used to eliminate artifact in the data signal;

(iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and

(iv) To explain how data results may be interpreted.

(3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal.

(4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.

§ 876.1800 Urine flow or volume measuring system.

(a) Identification. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.

(b) Classification. (1) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

§ 876.2040 Enuresis alarm.

(a) Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

§ 876.2050 Prostate lesion documentation system.

(a) Identification. A prostate lesion documentation system is a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image.

(2) Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.

(3) Appropriate software verification, validation, and hazard analysis must be performed.

(4) All elements of the device that may contact the patient must be demonstrated to be biocompatible.

(5) Methods and instructions for reprocessing of any reusable components must be properly validated.

(6) The labeling must include specific information needed to ensure proper use of the device.

§ 876.2100 Pressure ulcer management tool.

(a) Identification. A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user's decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 876.9.

§ 876.3350 Penile inflatable implant.

(a) Identification. A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 11, 2000, for any penile inflatable implant that was in commercial distribution before May 28, 1976, or that has, on or before July 11, 2000, been found to be substantially equivalent to a penile inflatable implant that was in commercial distribution before May 28, 1976. Any other penile inflatable implant shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

§ 876.3500 Penile implant surgical accessories.

(a) Identification. Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.3630 Penile rigidity implant.

(a) Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

(b) Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”

§ 876.3750 Testicular prosthesis.

(a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 5, 1995, for any testicular prosthesis that was in commercial distribution before May 28, 1976, or that has on or before July 5, 1995, been found to be substantially equivalent to a testicular prosthesis that was in commercial distribution before May 28, 1976. Any other testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

§ 876.4020 Fiberoptic light ureteral catheter.

(a) Identification. A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4270 Colostomy rod.

(a) Identification. A colostomy rod is a device used during the loop colostomy procedure. A loop of colon is surgically brought out through the abdominal wall and the stiff colostomy rod is placed through the loop temporarily to keep the colon from slipping back through the surgical opening.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a) Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

(b) Classification. Class II (performance standards).

§ 876.4310 Endoscopic electrosurgical clip cutting system.

(a) Identification. An endoscopic electrosurgical clip cutting system is a prescription device that applies electrical energy to fragment metallic clips, which are devices placed in the digestive tract to close gastrointestinal perforations, hemorrhages, or perform resection. The system includes instruments that are then used to remove the fragmented clips from the digestive tract.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Performance bench testing to evaluate the functionality (including stress, compatibility, usability, and reliability) of the device during use;

(ii) Electrical and thermal safety testing; and

(iii) Electromagnetic compatibility testing.

(2) Animal testing must evaluate tissue damage, including thermal effects, during the clip removal procedure. This testing must also evaluate usability and effectiveness of the device.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.

(5) Performance data must support shelf life by demonstrating continued sterility of the device (or the sterile components), package integrity, and device functionality over the labeled shelf life.

(6) Labeling of the device must include:

(i) Instructions for use, and

(ii) A shelf life for single use components.

§ 876.4330 Endoscopic pancreatic debridement device.

(a) Identification. An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of debridement of walled off pancreatic necrosis and all adverse events.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(4) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.

(5) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.

(6) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Testing of rotational speeds and vacuum pressure;

(ii) Functional testing including testing with all device components and the ability to torque the device; and

(iii) Functional testing in a relevant tissue model to demonstrate the ability to resect and remove tissue.

(7) Performance data must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.

(8) Software verification, validation, and hazard analysis must be performed.

(9) Training must be provided so that upon completion of the training program, the user can resect and remove tissue of interest while preserving non-target tissue.

(10) Labeling must include the following:

(i) A summary of the clinical performance testing conducted with the device;

(ii) Instructions for use, including the creation of a conduit for passage of endoscope and device into a walled off pancreatic necrotic cavity;

(iii) Unless clinical performance data demonstrates that it can be removed or modified, a boxed warning stating that the device should not be used in patients with known or suspected pancreatic cancer;

(iv) The recommended training for safe use of the device; and

(v) A shelf life for any sterile components.

§ 876.4340 High intensity ultrasound system for prostate tissue ablation.

(a) Identification. A high intensity ultrasound system for prostate tissue ablation is a prescription device that transmits high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance. This classification does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate non-prostatic tissues/organs.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Characterization of acoustic pressure and power output at clinically relevant levels;

(ii) Measurement of targeting accuracy and reproducibility of high intensity ultrasound output;

(iii) Ultrasound-induced heating verification testing at target and non-target tissues;

(iv) Electrical safety testing; and

(v) Electromagnetic compatibility testing.

(2) Software verification, validation, and hazard analysis must be performed.

(3) The elements of the device that may contact the patient's mucosal tissue must be demonstrated to be biocompatible.

(4) Performance data must demonstrate the sterility of the device components that contact the patient's mucosal tissue.

(5) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.

(6) Performance data must support the instructions for reprocessing all reusable components.

(7) In vivo testing must demonstrate that the device thermally ablates targeted tissue in a controlled manner without thermal injury to adjacent, non-target tissues.

(8) Clinical testing must document the adverse event profile, provide evidence of prostatic ablation, and demonstrate that the device performs as intended under anticipated conditions of use.

(9) Training must be provided so that upon completion of the training program, the physician can:

(i) Use all safety features of the device;

(ii) Accurately target the high intensity ultrasound energy within the desired region of the prostate; and

(iii) Perform the ablation procedure in a manner that minimizes damage to non-target tissues.

(10) Labeling must include:

(i) A section that summarizes the clinical testing results, including the adverse event profile and evidence of prostate ablation achieved; and

(ii) An expiration date or shelf life for single use components.

§ 876.4350 Fluid jet system for prostate tissue removal.

(a) Identification. A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must evaluate the following:

(i) All adverse events associated with the device, and

(ii) Improvement in lower urinary tract symptoms (LUTS).

(2) Physician training must be provided that includes:

(i) Information on key aspects and use of the device, and

(ii) Information on how to override or stop resection.

(3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.

(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and

(ii) High pressure fluid jet verification testing at target and non-target tissues.

(5) Software verification, validation, and hazard analysis must be performed.

(6) The patient-contacting elements of the device must be demonstrated to be biocompatible.

(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.

(8) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(9) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(10) Performance data must validate the instructions for reprocessing and reliability of reusable components.

(11) Labeling must include the following:

(i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;

(ii) A shelf life for single use components;

(iii) A use life for reusable components; and

(iv) Reprocessing instructions for reusable components.

§ 876.4370 Gastroenterology-urology evacuator.

(a) Identification. A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

(b) Classification. (1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

§ 876.4400 Hemorrhoidal ligator.

(a) Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

(b) Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4410 Endoscopic traction device.

(a) Identification. An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate:

(i) Perforation, bleeding, and mucosal injury;

(ii) Ease of insertion and removal of the device;

(iii) Visualization during the procedure; and

(iv) Ease of procedure as reported by the intended user.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:

(i) Device deployment and detachment;

(ii) Ability to retract tissue;

(iii) Tensile strength;

(iv) Potential for laceration caused by the device or procedure using the device;

(v) Dimensional verification; and

(vi) For devices that contain a magnet, magnet strength verification and safety assessment.

(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(4) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.

(7) Labeling must include:

(i) The recommended training for safe use of the device;

(ii) Anatomical locations and lesion sizes that have been demonstrated to be safe to use with the device; and

(iii) A shelf life.

§ 876.4480 Electrohydraulic lithotriptor.

(a) Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.

(b) Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”

§ 876.4500 Mechanical lithotriptor.

(a) Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.

(b) Classification. Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4530 Gastroenterology-urology fiberoptic retractor.

(a) Identification. A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4560 Ribdam.

(a) Identification. A ribdam is a device that consists of a broad strip of latex with supporting ribs used to drain surgical wounds where copious urine drainage is expected.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4590 Interlocking urethral sound.

(a) Identification. An interlocking urethral sound is a device that consists of two metal sounds (elongated instruments for exploring or sounding body cavities) with interlocking ends, such as with male and female threads or a rounded point and mating socket, used in the repair of a ruptured urethra. The device may include a protective cap to fit over the metal threads.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4620 Ureteral stent.

(a) Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.

(b) Classification. Class II (performance standards).

§ 876.4630 Ureteral stent accessories.

(a) Identification. Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4650 Water jet renal stone dislodger system.

(a) Identification. A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

§ 876.4680 Ureteral stone dislodger.

(a) Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.

(a) Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4770 Urethrotome.

(a) Identification. A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.4890 Urological table and accessories.

(a) Identification. A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.

(b) Classification. (1) Class II (special controls) for the electrically powered urological table and accessories. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

(2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

§ 876.5010 Biliary catheter and accessories.

(a) Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

(b) Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.