CARDIOVASCULAR DEVICES

• Citation: 21 CFR Part 870
• Sections: 167

§ 870.1 Scope.

(a) This part sets forth the classification of cardiovascular 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 cardiovascular 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..

§ 870.3 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.

§ 870.9 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).

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a) Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

(b) Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

§ 870.1100 Blood pressure alarm.

(a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.

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

§ 870.1110 Blood pressure computer.

(a) Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.

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

§ 870.1120 Blood pressure cuff.

(a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

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

§ 870.1130 Noninvasive blood pressure measurement system.

(a) Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

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

§ 870.1140 Venous blood pressure manometer.

(a) Identification. A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.

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

§ 870.1200 Diagnostic intravascular catheter.

(a) Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

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

§ 870.1210 Continuous flush catheter.

(a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

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

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a) Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

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

§ 870.1230 Fiberoptic oximeter catheter.

(a) Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

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

§ 870.1240 Flow-directed catheter.

(a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

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

§ 870.1250 Percutaneous catheter.

(a) Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

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

§ 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.

(a) Identification. This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.

(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) Simulated-use testing in a clinically relevant bench anatomic model to assess the following:

(A) Delivery, deployment, and retrieval, including quantifying deployment and retrieval forces, and procedural time; and

(B) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.

(ii) Tensile strengths of joints and components, tip flexibility, torque strength, torque response, and kink resistance.

(iii) Flow characteristics.

(A) The ability of the filter to not impede blood flow.

(B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.

(iv) Characterization and verification of all dimensions.

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

(i) Delivery, deployment, and retrieval, including quantifying procedural time.

(ii) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.

(iii) Flow characteristics.

(A) The ability of the filter to not impede blood flow.

(B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.

(iv) Gross pathology and histopathology assessing vascular injury and downstream embolization.

(3) All 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 the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(6) Labeling for the device must include:

(i) Instructions for use;

(ii) Compatible transcatheter intracardiac procedure devices;

(iii) A detailed summary of the clinical testing conducted; and

(iv) A shelf life and storage conditions.

(7) Clinical performance testing must demonstrate:

(i) The ability to safely deliver, deploy, and remove the device;

(ii) The ability of the device to filter embolic material while not impeding blood flow;

(iii) Secure positioning and stability of the position throughout the transcatheter intracardiac procedure; and

(iv) Evaluation of all adverse events including death, stroke, and vascular injury.

§ 870.1252 Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.

(a) Identification. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

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

(1) Clinical performance testing must evaluate:

(i) The ability to safely deliver, deploy, and remove the device;

(ii) The ability of the device to create an arteriovenous fistula;

(iii) The ability of the arteriovenous fistula to attain a blood flow rate and diameter suitable for hemodialysis;

(iv) The ability of the fistula to be used for vascular access for hemodialysis;

(v) The patency of the fistula; and

(vi) The rates and types of all adverse events.

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

(i) Delivery, deployment, and retrieval of the device;

(ii) Compatibility with other devices labeled for use with the device;

(iii) Patency of the fistula;

(iv) Characterization of blood flow at the time of the fistula creation procedure and at chronic followup; and

(v) Gross pathology and histopathology assessing vascular injury and downstream embolization.

(3) 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) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, activation, and retrieval of the device;

(ii) Tensile strengths of joints and components;

(iii) Accurate positioning and alignment of the device to achieve fistula creation; and

(iv) Characterization and verification of all dimensions.

(4) Electrical performance, electrical safety, and electromagnetic compatibility (EMC) testing must be performed for devices with electrical components.

(5) Software verification, validation, and hazard analysis must be performed for devices that use software.

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

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

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

(9) Labeling for the device must include:

(i) Instructions for use;

(ii) Identification of system components and compatible devices;

(iii) Expertise needed for the safe use of the device;

(iv) A detailed summary of the clinical testing conducted and the patient population studied; and

(v) A shelf life and storage conditions.

§ 870.1255 Balloon aortic valvuloplasty catheter.

(a) Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.

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

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

(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.

(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.

(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.

(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.

§ 870.1270 Intracavitary phonocatheter system.

(a) Identification. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.

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

§ 870.1280 Steerable catheter.

(a) Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

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

§ 870.1290 Steerable catheter control system.

(a) Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

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

§ 870.1300 Catheter cannula.

(a) Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.

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

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a) Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

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

§ 870.1330 Catheter guide wire.

(a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

(b) Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

§ 870.1340 Catheter introducer.

(a) Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

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

§ 870.1342 Reverse central venous recanalization system.

(a) Identification. A reverse central venous recanalization system is a prescription device for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.

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

(1) Clinical performance testing must fulfill the following:

(i) Demonstrate the ability to safely deliver, deploy, and remove the device; and

(ii) Evaluate all adverse events including death, bleeding, damage to non-target tissue and organs, blood vessel perforation or rupture, and hematoma.

(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) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, and retrieval of the system;

(ii) Compatibility with other devices labeled for use with the device;

(iii) Tensile strengths of joints and components;

(iv) Kink resistance of system components;

(v) Radiopacity of components used to monitor procedure under fluoroscopy;

(vi) Characterization and verification of all dimensions; and

(vii) Leakage of air or fluid.

(3) All 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 the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(6) Labeling for the device must include:

(i) Instructions for use, including a description of compatible devices;

(ii) A detailed summary of the clinical testing conducted and;

(iii) Shelf life and storage conditions.

§ 870.1345 Intravascular bleed monitor.

(a) Identification. An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.

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

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

(i) Device performance characteristics;

(ii) Adverse effects, including gross necropsy and histopathology; and

(iii) Device usability, including device preparation, device handling, and user interface.

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

(i) Tensile testing of joints and materials;

(ii) Mechanical integrity testing;

(iii) Friction testing;

(iv) Flush testing;

(v) Air leakage and liquid leakage testing;

(vi) Latching and unlatching testing;

(vii) Kink and bend testing;

(viii) Insertion force testing;

(ix) Torque testing;

(x) Corrosion testing; and

(xi) Dimensional tolerance testing.

(3) Performance data must support the sterility and pyrogenicity of the device components intended to be provided sterile.

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

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

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

(7) Performance data must demonstrate electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety.

(8) Human factors performance evaluation must demonstrate that the user can correctly use the device, based solely on reading the directions for use.

(9) Labeling must include:

(i) Instructions for use;

(ii) A shelf life and storage conditions;

(iii) Compatible procedures;

(iv) A sizing table; and

(v) Quantification of blood detected.

§ 870.1350 Catheter balloon repair kit.

(a) Identification. A catheter balloon repair kit is a device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to effect the repair or replacement.

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

(c) Date PMA or notice of completion of a 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 December 26, 1996 for any catheter balloon repair kit that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a catheter balloon repair kit that was in commercial distribution before May 28, 1976. Any other catheter balloon repair kit shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

§ 870.1360 Trace microsphere.

(a) Identification. A trace microsphere is a radioactively tagged nonbiodegradable particle that is intended to be injected into an artery or vein and trapped in the capillary bed for the purpose of studying blood flow within or to an organ.

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

(c) Date PMA or notice of completion of a 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 December 26, 1996 for any trace microsphere that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a trace microsphere that was in commercial distribution before May 28, 1976. Any other trace microsphere shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

§ 870.1370 Catheter tip occluder.

(a) Identification. A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.

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

§ 870.1380 Catheter stylet.

(a) Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

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

§ 870.1390 Trocar.

(a) Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

(b) Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

§ 870.1405 Interventional cardiovascular implant simulation software device.

(a) Identification. An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient's cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.

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

(1) Software verification, validation, and hazard analysis, with identification of appropriate mitigations, must be performed, including a full verification and validation of the software according to the predefined software specifications.

(2) Computational modeling verification and validation activities must be performed to establish the predictive capability of the device for its indications for use.

(3) Performance validation testing must be provided to demonstrate the accuracy and clinical relevance of the modeling methods for the intended implantation simulations, including the following:

(i) Computational modeling results must be compared to clinical data supporting the indications for use to demonstrate accuracy and clinical meaningfulness of the simulations;

(ii) Agreement between computational modeling results and clinical data must be assessed and demonstrated across the full intended operating range ( e.g., full range of patient population, implant device sizes and patient anatomic morphologies). Any selection criteria or limitations of the samples must be described and justified;

(iii) Endpoints ( e.g., performance goals) and sample sizes established must be justified as to how they were determined and why they are clinically meaningful; and

(iv) Validation must be performed and controls implemented to characterize and ensure consistency ( i.e., repeatability and reproducibility) of modeling outputs:

(A) Testing must be performed using multiple qualified operators and using the procedure that will be implemented under anticipated conditions of use; and

(B) The factors ( e.g., medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data.

(4) Human factors evaluation must be performed to evaluate the ability of the user interface and labeling to allow for intended users to correctly use the device and interpret the provided information.

(5) Device labeling must be provided that describes the following:

(i) Warnings that identify anatomy and image acquisition factors that may impact simulation results and provide cautionary guidance for interpretation of the provided simulation results;

(ii) Device simulation inputs and outputs, and key assumptions made in the simulation and determination of simulated outputs; and

(iii) The computational modeling performance of the device for presented simulation outputs, and the supporting evidence for this performance.

§ 870.1415 Coronary vascular physiologic simulation software device.

(a) Identification. A coronary vascular physiologic simulation software device is a prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information ( e.g., blood flow, coronary flow reserve, fractional flow reserve, myocardial perfusion). A coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician.

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

(1) Adequate software verification and validation based on comprehensive hazard analysis, with identification of appropriate mitigations, must be performed, including:

(i) Full characterization of the technical parameters of the software, including:

(A) Any proprietary algorithm(s) used to model the vascular anatomy; and

(B) Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications;

(ii) Adequate consideration of privacy and security issues in the system design; and

(iii) Adequate mitigation of the impact of failure of any subsystem components ( e.g., signal detection and analysis, data storage, system communications and cybersecurity) with respect to incorrect patient reports and operator failures.

(2) Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement; and

(3) Clinical data supporting the proposed intended use must be provided, including the following:

(i) Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner;

(ii) Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests ( e.g., from literature analysis);

(iii) Statistical performance of the device within clinical risk strata ( e.g., age, relevant comorbidities, disease stability) must be reported;

(iv) The dataset must be adequately representative of the intended use population for the device ( e.g., patients, range of vessel sizes, imaging device models). Any selection criteria or limitations of the samples must be fully described and justified;

(v) Statistical methods must consider the predefined endpoints:

(A) Estimates of probabilities of incorrect results must be provided for each endpoint,

(B) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification, and

(C) The report must provide appropriate confidence intervals for each performance metric;

(vi) Sensitivity and specificity must be characterized across the range of available measurements;

(vii) Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements;

(viii) Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and

(ix) If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation, and it must be justified as to how it was determined and clinically validated;

(4) Adequate validation must be performed and controls implemented to characterize and ensure consistency ( i.e., repeatability and reproducibility) of measurement outputs:

(i) Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified, and

(ii) Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency ( i.e., repeatability and reproducibility) of the output that is representative of the range of data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment;

(A) Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device, and

(B) The factors ( e.g., medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data;

(5) Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on measurements require significant user intervention; and

(6) Device labeling must be provided that adequately describes the following:

(i) The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended;

(ii) Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements;

(iii) Key assumptions made in the calculation and determination of simulated measurements;

(iv) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data;

(v) A detailed description of the patients studied in the clinical validation ( e.g., age, gender, race or ethnicity, clinical stability, current treatment regimen) as well as procedural details of the clinical study ( e.g., scanner representation, calcium scores, use of beta-blockers or nitrates); and

(vi) Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results.

§ 870.1420 Coronary artery disease risk indicator using acoustic heart signals.

(a) Identification. A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis.

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

(1) Clinical performance testing must fulfill the following:

(i) Testing must include a discussion of the patient population and any statistical techniques used for analyzing the data; and

(ii) Testing must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.

(2) Acoustic performance testing must evaluate microphone sensitivity, sound acquisition bandwidth, and amplitude accuracy. The acoustic sensor specifications and mechanism used to capture heart sounds must be described.

(3) A scientific justification for the validity of the algorithm(s) must be provided. This justification must fulfill the following:

(i) All inputs and outputs of the algorithm must be fully described;

(ii) The procedure for segmenting, characterizing, and classifying the acoustic signal must be fully described; and

(iii) This justification must include verification of the algorithm calculations and validation using an independent data set.

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

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

(6) Human factors/usability testing must demonstrate that the user can correctly use the device, including device placement, based solely on reading the directions for use.

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

(8) Labeling must include the following:

(i) A description of what the device measures and outputs to the user;

(ii) Instructions for proper placement of the device;

(iii) Instructions on care and cleaning of the device;

(iv) Warnings identifying sensor acquisition factors that may impact measurement results and instructions for mitigating these factors; and

(v) The expected performance of the device for all intended use populations and environments.

§ 870.1425 Programmable diagnostic computer.

(a) Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

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

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a) Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

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

§ 870.1450 Densitometer.

(a) Identification. A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

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

§ 870.1650 Angiographic injector and syringe.

(a) Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

(b) Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

§ 870.1660 Indicator injector.

(a) Identification. An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output.

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

§ 870.1670 Syringe actuator for an injector.

(a) Identification. A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal.

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

§ 870.1750 External programmable pacemaker pulse generator.

(a) Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.

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

§ 870.1800 Withdrawal-infusion pump.

(a) Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output.

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

§ 870.1875 Stethoscope.

(a) Manual stethoscope —(1) Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) 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 § 870.9.

(b) Electronic stethoscope —(1) Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

§ 870.1915 Thermodilution probe.

(a) Identification. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.

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

§ 870.2050 Biopotential amplifier and signal conditioner.

(a) Identification. A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.

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

§ 870.2060 Transducer signal amplifier and conditioner.

(a) Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.

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

§ 870.2100 Cardiovascular blood flowmeter.

(a) Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

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

§ 870.2120 Extravascular blood flow probe.

(a) Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

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

§ 870.2200 Adjunctive cardiovascular status indicator.

(a) Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

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

(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:

(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);

(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;

(iii) Specification of acceptable incoming sensor data quality control measures; and

(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.

(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.

(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.

(4) Clinical data must be provided in support of the intended use and include the following:

(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;

(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;

(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and

(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.

(5) Labeling must include the following:

(i) The type of sensor data used, including specification of compatible sensors for data acquisition;

(ii) A description of what the device measures and outputs to the user;

(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;

(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;

(v) Key assumptions made in the calculation and determination of measurements;

(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and

(vii) A detailed description of the patients studied in the clinical validation ( e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.