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(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).

vice used with an audiometer in diagnostic hearing evaluations. A SISI adapter provides short periodic sound pulses in specific small decibel increments that are intended to be superimposed on the audiometer's output tone frequency.

(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 8 874.9. (55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000]

[65 FR 2315, Jan. 14, 2000)

Subpart B-Diagnostic Devices

$ 874.1050 Audiometer.

(a) Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

(b) Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6–1996, “Specification for Audiometers," and subject to the limitations in $ 874.9. (51 FR 40389, Nov. 6, 1986, as amended at 64 FR 14831, Mar. 29, 1999]

$ 874.1080 Audiometer calibration set.

(a) Identification. An audiometer calibration set is an electronic reference device that is intended to calibrate an audiometer. It measures the sound frequency and intensity characteristics that emanate from an audiometer earphone. The device consists of an acoustic cavity of known volume, a sound level meter, a microphone with calibration traceable to the National Bureau of Standards, oscillators, frequency counters, microphone amplifiers, and a recorder. The device can measure selected audiometer test frequencies at a given intensity level, and selectable audiometer attenuation settings at a given test frequency.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

(51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996)

8 874.1060 Acoustic chamber for

audiometric testing. (a) Identification. An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996)

$ 874.1090 Auditory impedance tester.

(a) Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup

$874.1070 Short increment sensitivity

index (SISI) adapter. (a) Identification. A short increment sensitivity index (SISI) adapter is a de

treatment for inflammation of the middle ear.

(b) Classification. Class II. $874.1100 Earphone cushion for

audiometric testing. (a) Identification. An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.

(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 874.9. (51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2315, Jan. 14, 2000)

taste sensation. It is used for assessing the sense of taste.

(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 $874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180 of this chapter, with respect to general requirements concerning records, and 8820.198 of this chapter, with respect to complaint files.

(51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000)

8874.1800 Air or water caloric stimu

lator. (a) Identification. An air or water caloric stimulator is device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.

(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 $874.9.

(55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000)

$ 874.1120 Electronic noise generator

for audiometric testing. (a) Identification. An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.

(b) Classification. Class II. 8874.1325 Electroglottograph. (a) Identification.

An electroglottograph is an AC-powered device that employs a pair of electrodes that are placed in contact with the skin on both sides of the larynx and held in place by a collar. It is intended to measure the electrical impedance of the larynx to aid in assessing the degree of closure of the vocal cords, confirm larygeal diagnosis, aid behavioral treatment of voice disorders, and aid research concerning the laryngeal mechanism.

(b) Classification. Class II. $ 874.1500 Gustometer.

(a) Identification. A gustometer is a battery-powered device that consists of two electrodes that are intended to be placed on both sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in

$ 874.1820 Surgical nerve stimulator/lo

cator. (a) Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

(b) Classification. Class II.

8 874.1925 Toynbee diagnostic tube.

(a) Identification. The toynbee diagnostic tube is a listening device intended to determine the degree of openness of the eustachian tube.

(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 874.9. (51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000)

ciated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.

(b) Classification. Class II.

Subpart C [Reserved)

Subpart D-Prosthetic Devices

a

8 874.3300 Hearing Aid.

(a) Identification. A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer († 874.3320), master hearing aid (8874.3330), and tinnitus masker (8874.3400).

(b) Classification. (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $874.9.

(2) Class II for the bone-conduction hearing aid. (51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000)

$ 874.3330 Master hearing aid.

(a) Identification. A master hearing aid is an electronic device intended to simulate hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.

(b) Classification. Class II. $ 874.3375 Battery-powered artificial

larynx. (a) Identification. A battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. When held against the skin in the area of the voicebox, the device generates mechanical vibrations which resonate in the oral and nasal cavities and can be modulated by the tongue and lips in a normal manner, thereby allowing the production of speech.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

8874.3310 Hearing aid calibrator and

analysis system. (a) Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.

(b) Classification. Class II. 8874.3320 Group hearing aid or group

auditory trainer. (a) Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one more listeners having hearing impairment. The device is used with an asso

[51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994)

$ 874.3400 Tinnitus masker.

(a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.

or

(b) Classification. Class II. The special control for this device is patient labeling regarding:

(1) Hearing health care professional diagnosis, fitting of the device, and followup care,

(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and

(5) Specifications. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000)

ethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

(b) Classification. Class II. 8874.3540 Prosthesis modification in.

strument for ossicular replacement

surgery. (a) Identification. A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoam TM punch; wire cutting scissors; and ossicular finger vise.

(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 $874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180 of this chapter, with respect to general requirements concerning records, and 8820.198 of this chapter, with respect to complaint files.

$ 874.3430 Middle ear mold.

(a) Identification. A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. The device permits an ample air-filled cavity to be maintained in the middle ear and promotes regeneration of the mucous membrane lining of the middle ear cavity. A middle ear mold is made of materials such as polyamide, polytetrafluoroethylene, silicone elastomer, or polyethylene, but does not contain porous polyethylene.

(b) Classification. Class II. 8874.3450 Partial ossicular replace

ment prosthesis. (a) Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

(b) Classification. Class II. 8874.3495 Total ossicular replacement

prosthesis. (a) Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoro

(51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000)

8874.3620 Ear, nose, and throat syn.

thetic polymer material. (a) Identific tion. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

(b) Classification. Class II. 8874.3695 Mandibular implant facial

prosthesis. (a) Identification. A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of mandibular deficits. The device is made of materials such as stainless steel, tantalum, titanium, cobalt-chromium based alloy, polytetrafluoroethylene, silicone elastomer, polyethylene, polyurethane, or polytetrafluoroethylene with carbon fibers composite.

(b) Classification. Class II. $ 874.3730 Laryngeal prosthesis (Taub

design). (a) Identification. A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.

(b) Classification. Class II. 8 874.3760 Sacculotomy tack (Cody

tack) (a) Identification. A sacculotomy tack (Cody tack) is a device that consists of a pointed stainless steel tack intended to be implanted to relieve the symptoms of vertigo. The device repetitively ruptures the utricular membrane as the membrane expands under increased endolymphatic pressure.

(b) Classification. Class II.

consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve the symptoms of vertigo. The device directs excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. The function of the pressure-limiting inner ear valve is to impede the flow of endolymph so that a physiologically normal endolymphatic pressure is maintained. The device is made of silicone elastomer and polyamide and contains gold radiopaque markers within the silicone elastomer sheath.

(b) Classification. Class III.

(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 $874.3.

$ 874.3880 Tympanostomy tube.

(a) Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such

polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.

(b) Classification. Class II.

as

8874.3820 Endolymphatic shunt.

(a) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptons of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.

(b) Classification. Class II.

$ 874.3900 Nasal dilator.

(a) Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils

8 874.3850 Endolymphatic shunt tube

with valve. (a) Identification. An endolymphatic shunt tube with valve is a device that

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