Collapse to view only § 870.2710 - Ear oximeter.

§ 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.

[82 FR 35067, July 28, 2017]

§ 870.2210 - Adjunctive predictive cardiovascular indicator.

(a) Identification. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. 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) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must be provided, including:

(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;

(iii) A description of sensor data quality control measures;

(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy;

(v) A description of the expected time to patient status or clinical event for all expected outputs, accounting for differences in patient condition and environment; and

(vi) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form.

(2) A scientific justification for the validity of the predictive cardiovascular indicator algorithm(s) must be provided. This justification must include verification of the algorithm calculations and validation using an independent data set.

(3) A human factors and usability engineering assessment must be provided that evaluates the risk of misinterpretation of device output.

(4) A clinical data assessment must be provided. This assessment must fulfill the following:

(i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data.

(ii) 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.

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

(iv) The assessment must evaluate how the device output correlates with the predicted event or status.

(5) Labeling must include:

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

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

(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;

(iv) A specific time or a range of times before the predicted patient status or clinical event occurs, accounting for differences in patient condition and environment;

(v) Key assumptions made during calculation of the output;

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

(vii) The expected performance of the device for all intended use populations and environments; and

(viii) Relevant characteristics of the patients studied in the clinical validation (including age, gender, race or ethnicity, and patient condition) and a summary of validation results.

[87 FR 8191, Feb. 14, 2022]

§ 870.2300 - Cardiac monitor (including cardiotachometer and rate alarm).

(a) Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

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

§ 870.2310 - Apex cardiograph (vibrocardiograph).

(a) Identification. An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer.

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

§ 870.2320 - Ballistocardiograph.

(a) Identification. A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.

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

§ 870.2330 - Echocardiograph.

(a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.

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

§ 870.2340 - Electrocardiograph.

(a) Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

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

§ 870.2345 - Electrocardiograph software for over-the-counter use.

(a) Identification. An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.

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

(1) Clinical performance testing under anticipated conditions of use must demonstrate the following:

(i) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and

(ii) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.

(2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.

(3) Non-clinical performance testing must validate detection algorithm performance using a previously adjudicated data set.

(4) Human factors and usability testing must demonstrate the following:

(i) The user can correctly use the device based solely on reading the device labeling; and

(ii) The user can correctly interpret the device output and understand when to seek medical care.

(5) Labeling must include:

(i) Hardware platform and operating system requirements;

(ii) Situations in which the device may not operate at an expected performance level;

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

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

(v) Guidance on interpretation of any results.

[86 FR 2549, Jan. 18, 2022]

§ 870.2350 - Electrocardiograph lead switching adaptor.

(a) Identification. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.

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

§ 870.2360 - Electrocardiograph electrode.

(a) Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

(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 § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

[45 FR 7907, Feb. 5, 1980, as amended at 76 FR 43585, July 21, 2011]

§ 870.2370 - Electrocardiograph surface electrode tester.

(a) Identification. An electrocardiograph surface electrode tester is a device used to test the function and application of electrocardiograph electrodes.

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

§ 870.2390 - Phonocardiograph.

(a) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart 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 § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

§ 870.2400 - Vectorcardiograph.

(a) Identification. A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.

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

§ 870.2450 - Medical cathode-ray tube display.

(a) Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

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

§ 870.2600 - Signal isolation system.

(a) Identification. A signal isolation system is a device that electrically isolates the patient from equipment connected to the commercial power supply received from a utility company. This isolation may be accomplished, for example, by transformer coupling, acoustic coupling, or optical coupling.

(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 § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

§ 870.2620 - Line isolation monitor.

(a) Identification. A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company.

(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 § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

§ 870.2640 - Portable leakage current alarm.

(a) Identification. A portable leakage current alarm is a device used to measure the electrical leakage current between any two points of an electrical system and to sound an alarm if the current exceeds a certain threshold.

(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 § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

§ 870.2675 - Oscillometer.

(a) Identification. An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.

(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 § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

§ 870.2700 - Oximeter.

(a) Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

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

§ 870.2710 - Ear oximeter.

(a) Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

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

§ 870.2750 - Impedance phlebograph.

(a) Identification. An impedance phlebograph is a device used to provide a visual display of the venous pulse or drainage by measuring electrical impedance changes in a region of the body.

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

§ 870.2770 - Impedance plethysmograph.

(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

§ 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

(a) Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.

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

§ 870.2790 - Photoplethysmograph analysis software for over-the-counter use.

(a) Identification. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

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

(1) Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use.

(2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.

(3) Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmograph signal quality.

(4) Human factors and usability testing must demonstrate the following:

(i) The user can correctly use the device based solely on reading the device labeling; and

(ii) The user can correctly interpret the device output and understand when to seek medical care.

(5) Labeling must include:

(i) Hardware platform and operating system requirements;

(ii) Situations in which the device may not operate at an expected performance level;

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

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

(v) Guidance on interpretation of any results.

[87 FR 6419, Feb. 4, 2022]

§ 870.2800 - Medical magnetic tape recorder.

(a) Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

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

§ 870.2810 - Paper chart recorder.

(a) Identification. A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.

(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 § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

§ 870.2840 - Apex cardiographic transducer.

(a) Identification. An apex cardiographic transducer is a device used to detect motion of the heart (acceleration, velocity, or displacement) by changes in the mechanical or electrical properties of the device.

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

§ 870.2850 - Extravascular blood pressure transducer.

(a) Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

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

§ 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

(a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.

(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See § 870.1 (e) for the availability of this guidance document.

[71 FR 7871, Feb. 15, 2006]

§ 870.2860 - Heart sound transducer.

(a) Identification. A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds.

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

§ 870.2870 - Catheter tip pressure transducer.

(a) Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

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

§ 870.2880 - Ultrasonic transducer.

(a) Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

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

§ 870.2890 - Vessel occlusion transducer.

(a) Identification. A vessel occlusion transducer is a device used to provide an electrical signal corresponding to sounds produced in a partially occluded vessel. This device includes motion, sound, and ultrasonic transducers.

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

§ 870.2900 - Patient transducer and electrode cable (including connector).

(a) Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.

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

§ 870.2910 - Radiofrequency physiological signal transmitter and receiver.

(a) Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

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

§ 870.2920 - Telephone electrocardiograph transmitter and receiver.

(a) Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

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