21 C.F.R. Subpart C—Cardiovascular Monitoring Devices
Title 21 - Food and Drugs
(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). (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). (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). (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). (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). (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). (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). (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). (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). (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). (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 (performance standards). (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). (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 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (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). (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). (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 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (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 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (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 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (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 (performance standards). (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). (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). (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). (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 (performance standards). (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). (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). (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 7907–7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (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). (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). (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] (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). (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). (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). (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). (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). (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). (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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices
§ 870.2050 Biopotential amplifier and signal conditioner.
§ 870.2060 Transducer signal amplifier and conditioner.
§ 870.2100 Cardiovascular blood flowmeter.
§ 870.2120 Extravascular blood flow probe.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
§ 870.2310 Apex cardiograph (vibrocardiograph).
§ 870.2320 Ballistocardiograph.
§ 870.2330 Echocardiograph.
§ 870.2340 Electrocardiograph.
§ 870.2350 Electrocardiograph lead switching adaptor.
§ 870.2360 Electrocardiograph electrode.
§ 870.2370 Electrocardiograph surface electrode tester.
§ 870.2390 Phonocardiograph.
§ 870.2400 Vectorcardiograph.
§ 870.2450 Medical cathode-ray tube display.
§ 870.2600 Signal isolation system.
§ 870.2620 Line isolation monitor.
§ 870.2640 Portable leakage current alarm.
§ 870.2675 Oscillometer.
§ 870.2700 Oximeter.
§ 870.2710 Ear oximeter.
§ 870.2750 Impedance phlebograph.
§ 870.2770 Impedance plethysmograph.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
§ 870.2800 Medical magnetic tape recorder.
§ 870.2810 Paper chart recorder.
§ 870.2840 Apex cardiographic transducer.
§ 870.2850 Extravascular blood pressure transducer.
§ 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
§ 870.2860 Heart sound transducer.
§ 870.2870 Catheter tip pressure transducer.
§ 870.2880 Ultrasonic transducer.
§ 870.2890 Vessel occlusion transducer.
§ 870.2900 Patient transducer and electrode cable (including connector).
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
