(2) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (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 (performance standards). [45 FR 7907-7971, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994] § 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). Subpart C-Cardiovascular § 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). tion procedures in subpart E of part 807 of this chapter. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996] § 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 cathoderay 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. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996] $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). § 870.2860 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). Subpart D-Cardiovascular Prosthetic Devices § 870.3250 Vascular clip. (a) Identification. A vascular clip is an implanted extravascular device designed to occlude, by compression. blood flow in small blood vessels other than intracranial vessels. (b) Classification. Class II (performance standards). (a) Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation. (b) Classification. Class II. The special controls for this device are: (1) "Use of International Standards Organization's ISO 10993 'Biological Evaluation of Medical Devices Part I: Evaluation and Testing,'" and (2) FDA's: (i) "510(k) Sterility Review Guidance and Revision of 2/12/90 (K90–1)" and (ii) "Guidance for Cardiovascular Intravascular Filter 510(k) Submissions." [45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 65 FR 17144, Mar. 31, 2000] $870.3450 Vascular graft prosthesis of less than 6 millimeters diameter. (a) Identification. A vascular graft prosthesis of less than 6 millimeters (mm) diameter is a device used to replace sections of small arteries. This prosthesis is commonly constructed of woven or knitted materials such as polyethylene terephthalate and polytetrafluoroethylene and is not made of materials of animal origin, including human umbilical cords. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 870.3. [45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987] § 870.3460 Vascular graft prosthesis of 6 millimeters and greater diameter. (a) Identification. A vascular graft prosthesis of 6 millimeters (mm) and greater diameter is a device used to replace sections of arteries. This prosthesis is commonly constructed of woven or knitted materials such as polyethylene terephthalate and polytetrafluoroethylene and is not made of materials of animal origin, including human umbilical cords. (b) Classification. Class II. The stainless steel vascular tunneler of single unit construction to be used to place tunnels for vascular grafts, included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. All other devices classified in this section are subject to the premarket notification procedures. [45 FR 7907-7971, Feb. 5, 1980, as amended at 65 FR 11467, Mar. 3, 2000] |