ANESTHESIOLOGY DEVICES

• Citation: 21 CFR Part 868
• Sections: 150

§ 868.1 Scope.

(a) This part sets forth the classification of anesthesiology 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, an anesthesiology 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.

§ 868.3 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.

§ 868.9 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).

§ 868.1030 Manual algesimeter.

(a) Identification. A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point.

(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 § 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

§ 868.1040 Powered algesimeter.

(a) Identification. A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent.

(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 § 868.9.

§ 868.1075 Argon gas analyzer.

(a) Identification. An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.

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

§ 868.1100 Arterial blood sampling kit.

(a) Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

(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 § 868.9.

§ 868.1120 Indwelling blood oxyhemoglobin concentration analyzer.

(a) Identification. An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.

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

(c) Date PMA or notice of completion of 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 September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

§ 868.1150 Indwelling blood carbon dioxide partial pressure (P 2CO2 ) analyzer.

(a) Identification. An indwelling blood carbon dioxide partial pressure P CO2 analyzer is a device that consists of a catheter-tip P CO2 transducer (e.g., P CO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

§ 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.

(a) Identification. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

§ 868.1200 Indwelling blood oxygen partial pressure (P O2 ) analyzer.

(a) Identification. An indwelling blood oxygen partial pressure (P O2 ) analyzer is a device that consists of a catheter-tip P O2 transducer (e.g., P O2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

§ 868.1400 Carbon dioxide gas analyzer.

(a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

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

§ 868.1430 Carbon monoxide gas analyzer.

(a) Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

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

§ 868.1500 Enflurane gas analyzer.

(a) Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.

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

§ 868.1505 Ventilatory electrical impedance tomograph.

(a) Identification. A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax.

(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, including the following:

(i) Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing;

(ii) Real time evaluation of local impedance variation;

(iii) Plethysmogram accuracy testing; and

(iv) Use life testing of reusable components.

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

(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.

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

(6) Labeling must include the following:

(i) Guidance for interpretation of the images generated;

(ii) A warning that the device should be removed before use of a defibrillator, or defibrillator interaction information based on defibrillator performance testing with the device;

(iii) A use life for any reusable components; and

(iv) Instructions for reprocessing any reusable components.

§ 868.1575 Gas collection vessel.

(a) Identification. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump.

(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 § 868.9.

§ 868.1620 Halothane gas analyzer.

(a) Identification. A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.

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

§ 868.1640 Helium gas analyzer.

(a) Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.

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

§ 868.1670 Neon gas analyzer.

(a) Identification. A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The device may use techniques such as mass spectrometry or thermal conductivity.

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

§ 868.1690 Nitrogen gas analyzer.

(a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.

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

§ 868.1700 Nitrous oxide gas analyzer.

(a) Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.

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

§ 868.1720 Oxygen gas analyzer.

(a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

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

§ 868.1730 Oxygen uptake computer.

(a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.

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

§ 868.1750 Pressure plethysmograph.

(a) Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.

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

§ 868.1760 Volume plethysmograph.

(a) Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.

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

§ 868.1780 Inspiratory airway pressure meter.

(a) Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.

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

§ 868.1800 Rhinoanemometer.

(a) Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.

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

§ 868.1840 Diagnostic spirometer.

(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

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

§ 868.1850 Monitoring spirometer.

(a) Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.

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

§ 868.1860 Peak-flow meter for spirometry.

(a) Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

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

§ 868.1870 Gas volume calibrator.

(a) Identification. A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.

(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 § 868.9.

§ 868.1880 Pulmonary-function data calculator.

(a) Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.

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

§ 868.1890 Predictive pulmonary-function value calculator.

(a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

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

§ 868.1900 Diagnostic pulmonary-function interpretation calculator.

(a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

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

§ 868.1910 Esophageal stethoscope.

(a) Identification. An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.

(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 § 868.9.

§ 868.1920 Esophageal stethoscope with electrical conductors.

(a) Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.

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

§ 868.1930 Stethoscope head.

(a) Identification. A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological sounds.

(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 § 868.9.

§ 868.1965 Switching valve (ploss).

(a) Identification. A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an earpiece. The valve allows the user to eliminate one sound channel and listen only to a patient's heart or korotkoff (blood pressure) sounds through the other channel.

(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 § 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

§ 868.1975 Water vapor analyzer.

(a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.

(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 § 868.9.

§ 868.1980 Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia.

(a) Identification. This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.

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

(1) Clinical performance testing under anticipated conditions of use must evaluate the location accuracy of anatomical landmarks identified by the device.

(2) Human factors testing must demonstrate that the user can correctly use the device to identify anatomical structures, based solely on reading the instructions for use.

(3) Software verification, validation, and hazard analysis must be performed, including demonstrated compatibility with ultrasound devices labeled to be compatible with the device.

(4) Labeling must include:

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

(ii) Pertinent details of the clinical data collected to evaluate the performance of the device; and

(iii) A warning against over-reliance on device output.

§ 868.2025 Ultrasonic air embolism monitor.

(a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.

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

§ 868.2200 Adjunctive pain measurement device for anesthesiology.

(a) Identification. An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient's actual response to painful stimuli and is not intended to independently direct decision-making.

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

(1) Clinical data must be provided to validate the algorithm in support of the intended use and include the following:

(i) Comparison of output measure(s) to a reference method to demonstrate the required accuracy and/or sensitivity and specificity of the output measure(s);

(ii) Demonstration of the consistency of the output and representativeness 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;

(iii) Evaluation of the type of pain ( e.g., nociceptive, somatic, visceral, neuropathic) that is within the scope of the indicated use; and

(iv) For devices using algorithms based on machine learning, the clinical validation must be completed using a dataset that is separate from the training dataset.

(2) Software description, verification, and validation based on comprehensive hazard analysis must be performed. Software documentation must include:

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

(ii) Description of mechanisms for handling of noisy or missing data and poor signal quality under expected conditions of use;

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

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

(v) Justification for the validity of the algorithm(s) ( e.g., clinical relevance of decision threshold).

(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing under anticipated conditions of use must demonstrate the ability of the device software/algorithm to detect adequate input signal quality and handle noisy or missing data and poor signal quality.

(4) Usability assessment must be provided to mitigate the risk of misinterpretation of device output.

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

(6) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of any hardware components of the device.

(7) Labeling must include the following:

(i) A summary of the clinical validation data, including demographics and other relevant characteristics of the clinical study participants (including age, sex, race or ethnicity, and patient condition), the anesthetic regimen (including types ( e.g., morphine, hydromorphone, fentanyl) and doses of pain medication used), a summary of results, and information on subpopulations (age, sex, race, or ethnicity) that may experience disparate performance.

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

(iii) The type of sensor data used, including specification of compatible sensors for data acquisition.

(iv) Warnings identifying sensor signal-acquisition factors that may impact output.

(v) Warnings to identify and avoid specific patient conditions or concomitant medical therapies that could mask pain or negatively impact device performance leading to inaccurate measurements.

(8) Recommendations for clinical interpretation of the output, including warning(s) emphasizing the adjunctive use of the output measure(s).

§ 868.2250 Monitor for opioid induced impairment of oxygenation.

(a) Identification. A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose.

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

(1) Clinical performance data under anticipated conditions of use must demonstrate that the device performs as intended and include the following:

(i) Comparison to a clinically relevant reference method to demonstrate and support the accuracy and level of sensitivity and specificity for detection of opioid induced impairment of oxygenation;

(ii) Demonstration of the consistency of the output and representativeness 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;

(iii) Performance reported in clinically significant and distinct subpopulations and intended use environments;

(iv) For devices using algorithms based on machine learning, the clinical validation must be completed using a dataset that is separate from the training dataset; and

(v) Simulated use testing of hardware and sensors to characterize accuracy and precision across the intended use population.

(2) Software description, verification, and validation based on comprehensive hazard analysis must be performed. Software documentation must include:

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

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

(iii) Justification for the validity of the algorithm(s) ( e.g., clinical relevance/importance of decision threshold).

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

(i) Performance testing of sensor hardware to characterize sensor accuracy and precision; and

(ii) Compatibility testing of sensors with other hardware and software components of the device.

(4) Usability assessment must be provided to demonstrate that intended device users can safely and correctly use the device.

(5) All components of the device that contact the skin must be demonstrated to be biocompatible.

(6) Performance testing must demonstrate the electromagnetic compatibility, wireless coexistence, electrical safety, thermal safety, and mechanical safety of any hardware components and sensors of the device.

(7) Labeling must include the following:

(i) A summary of the clinical validation data, including relevant characteristics of the included subpopulations and use environments in the clinical study, and performance metrics, including sensitivity, specificity, positive predictive value, and negative predictive value for each of the subpopulations, use environments, and opioid types;

(ii) Principles of sensor operation, including warnings for how to avoid interfering with sensor readings;

(iii) Information for preventing an overdose, recognizing signs of an overdose, and treating an overdose;

(iv) Warnings identifying that the device is not designed to differentiate between the target condition ( e.g., opioid-induced respiratory depression) and other conditions that may cause a false reading ( e.g., obstructive sleep apnea);

(v) Warnings against overreliance on the device; and

(vi) A warning regarding the need for supervised use with awareness of effective countermeasures ( e.g., naloxone) in case of an overdose.

§ 868.2300 Bourdon gauge flowmeter.

(a) Identification. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.

(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 § 868.9.

§ 868.2320 Uncompensated thorpe tube flowmeter.

(a) Identification. An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere.

(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 § 868.9.

§ 868.2340 Compensated thorpe tube flowmeter.

(a) Identification. A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.

(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 § 868.9.

§ 868.2350 Gas calibration flowmeter.

(a) Identification. A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.

(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 § 868.9.

§ 868.2375 Breathing frequency monitor.

(a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

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

§ 868.2376 Device for sleep apnea testing based on mandibular movement.

(a) Identification. A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.

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

(1) Clinical data must be provided. This assessment must fulfill the following:

(i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.

(ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.

(iii) The assessment must compare device performance with a clinical comparator device ( e.g., polysomnography).

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

(3) The performance data must be provided to demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.

(4) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:

(i) A full characterization of the software technical parameters, including algorithms;

(ii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications; and

(iii) A description of all mitigations for failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy.

(5) Labeling must include:

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

(ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics ( e.g., conditions affecting the anatomy of the recording site, or subject conditions that may affect mandibular movement) that may impact measurement results;

(iii) Guidance for interpretation of the measurements, including a statement that the device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor; and

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

§ 868.2377 Apnea monitor.

(a) Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”