Year 2000 Date Problem and Medical Devices

[Code of Federal Regulations]
[Title 21, Volume 8, Parts 800 to 1299]
[Revised as of April 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874]

[Page 323-333]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

PART 874--EAR, NOSE, AND THROAT DEVICES

Subpart A--General Provisions

Sec.
874.1 Scope.
874.3 Effective dates of requirement for premarket approval.
874.9 Limitations of exemptions from section 510(k) of the act.

Subpart B--Diagnostic Devices

874.1050 Audiometer.
874.1060 Acoustic chamber for audiometric testing.
874.1070 Short increment sensitivity index (SISI) adapter.
874.1080 Audiometer calibration set.
874.1090 Auditory impedance tester.
874.1100 Earphone cushion for audiometric testing.
874.1120 Electronic noise generator for audiometric testing.
874.1325 Electroglottograph.
874.1500 Gustometer.
874.1800 Air or water caloric stimulator.
874.1820 Surgical nerve stimulator/locator.
874.1925 Toynbee diagnostic tube.

Subpart C [Reserved]

Subpart D--Prosthetic Devices

874.3300 Hearing aid.
874.3310 Hearing aid calibrator and analysis system.
874.3320 Group hearing aid or group auditory trainer.
874.3330 Master hearing aid.
874.3375 Battery-powered artificial larynx.
874.3400 Tinnitus masker.
874.3430 Middle ear mold.
874.3450 Partial ossicular replacement prosthesis.
874.3495 Total ossicular replacement prosthesis.
874.3540 Prosthesis modification instrument for ossicular replacement
surgery.
874.3620 Ear, nose, and throat synthetic polymer material.
874.3695 Mandibular implant facial prosthesis.
874.3730 Laryngeal prosthesis (Taub design).
874.3760 Sacculotomy tack (Cody tack).
874.3820 Endolymphatic shunt.
874.3850 Endolymphatic shunt tube with valve.
874.3880 Tympanostomy tube.
874.3930 Tympanostomy tube with semipermeable membrane.

Subpart E--Surgical Devices

874.4100 Epistaxis balloon.
874.4140 Ear, nose, and throat bur.
874.4175 Nasopharyngeal catheter.
874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
874.4350 Ear, nose, and throat fiberoptic light source and carrier.
874.4420 Ear, nose, and throat manual surgical instrument.
874.4490 Argon laser for otology, rhinology, and laryngology.
874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.
874.4680 Bronchoscope (flexible or rigid) and accessories.
874.4710 Esophagoscope (flexible or rigid) and accessories.
874.4720 Mediastinoscope and accessories.
874.4750 Laryngostroboscope.
874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
874.4770 Otoscope.

Subpart F--Therapeutic Devices

874.5220 Ear, nose, and throat drug administration device.
874.5300 Ear, nose, and throat examination and treatment unit.
874.5350 Suction antichoke device.
874.5370 Tongs antichoke device.
874.5550 Powered nasal irrigator.
874.5800 External nasal splint.
874.5840 Antistammering device.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

Subpart A--General Provisions

Sec. 874.1 Scope.

(a) This part sets forth the classification of ear, nose, and throat
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 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in

[[Page 324]]

this part, but shall state why the device is substantially equivalent to
other devices, as required by Sec. 807.87.
(c) To avoid duplicative listings, an ear, nose, and throat device
that has two or more types of uses (e.g., used both as a diagnostic
device and as a therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21 unless otherwise noted.

Sec. 874.3 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 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.

Sec. 874.9 Limitations of exemptions from section 510(k) of the act.

FDA's decision to grant an exemption from the requirement of
premarket notification (section 510(k) of the act) for a generic type of
class I device is based upon the existing and reasonably foreseeable
characteristics of commercially distributed devices within that generic
type. Because FDA cannot anticipate every change in intended use or
characteristic that could significantly affect a device's safety or
effectiveness, manufacturers of any commercially distributed class I
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 its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical

[[Page 325]]

purpose, or the device is intended for lay use where the former intended
use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; 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 a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
[52 FR 32111, Aug. 25, 1987]

Subpart B--Diagnostic Devices

Sec. 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.

Sec. 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]

Sec. 874.1070 Short increment sensitivity index (SISI) adapter.

(a) Identification. A short increment sensitivity index (SISI)
adapter is a device 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.
[55 FR 48440, Nov. 20, 1990]

Sec. 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]

Sec. 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
treatment for inflammation of the middle ear.
(b) Classification. Class II.

Sec. 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

[[Page 326]]

connection path) between the audiometer earphone and the patient's ear.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in subpart E of part 807.
[51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52
FR 32111, Aug. 25, 1987]

Sec. 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.

Sec. 874.1325 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.

Sec. 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 taste sensation. It is used for assessing the
sense of taste.
(b) Classification. Class I. If the device is not labeled or
otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in part 820, with the exception of
Sec. 820.180 with respect to general requirements concerning records,
and Sec. 820.198 with respect to complaint files.

Sec. 874.1800 Air or water caloric stimulator.

(a) Identification. An air or water caloric stimulator is a 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.
[55 FR 48440, Nov. 20, 1990]

Sec. 874.1820 Surgical nerve stimulator/locator.

(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.

Sec. 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.

Subpart C [Reserved]

Subpart D--Prosthetic Devices

Sec. 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 (Sec. 874.3320), master hearing aid (Sec. 874.3330),
and tinnitus masker (Sec. 874.3400).
(b) Classification. (1) Class I for the air-conduction hearing aid.
(2) Class II for the bone-conduction hearing aid.

Sec. 874.3310 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

[[Page 327]]

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.

Sec. 874.3320 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 or more listeners having hearing impairment. The device is used
with an associated 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.

Sec. 874.3330 Master hearing aid.

(a) Identification. A master hearing aid is an electronic device
intended to simulate a 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.

Sec. 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 Sec. 820.180, with respect to
general requirements concerning records, and Sec. 820.198, with respect
to complaint files.
[51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994]

Sec. 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.
(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 Sec. 874.3.

Sec. 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.

Sec. 874.3450 Partial ossicular replacement 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.

[[Page 328]]

Sec. 874.3495 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, polytetrafluoroethylene with
vitreous carbon fibers composite, porous polyethylene, or from a
combination of these materials.
(b) Classification. Class II.

Sec. 874.3540 Prosthesis modification instrument 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
<SUP>TM</SUP> punch; wire cutting scissors; and ossicular finger vise.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it is
exempt from the current good manufacturing practice regulations in part
820, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987]

Sec. 874.3620 Ear, nose, and throat synthetic polymer material.

(a) Identification. 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.

Sec. 874.3695 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.

Sec. 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.

Sec. 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.

Sec. 874.3820 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

[[Page 329]]

occurs. This device is made of polytetrafluoroethylene or silicone
elastomer.
(b) Classification. Class II.

Sec. 874.3850 Endolymphatic shunt tube with valve.

(a) Identification. An endolymphatic shunt tube with valve is a
device that 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 Sec. 874.3.

Sec. 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 as polytetrafluoroethylene, polyethylene, silicon
elastomer, or porous polyethylene.
(b) Classification. Class II.

Sec. 874.3930 Tympanostomy tube with semipermeable membrane.

(a) Identification. A tympanostomy tube with a semipermeable
membrane is a device intended to be implanted for ventilation or
drainage of the middle ear and for preventing fluids from entering the
middle ear cavity. The device is inserted through the tympanic membrane
to permit a free exchange of air between the outer ear and middle ear.
The tube portion of the device is made of silicone elastomer or porous
polyethylene, and the membrane portion is made of
polytetrafluoroethylene.
(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 Sec. 874.3.

Subpart E--Surgical Devices

Sec. 874.4100 Epistaxis balloon.

(a) Identification. An epistaxis balloon is a device consisting of
an inflatable balloon intended to control internal nasal bleeding by
exerting pressure against the sphenopalatine artery.
(b) Classification. Class I.

Sec. 874.4140 Ear, nose, and throat bur.

(a) Identification. An ear, nose, and throat bur is a device
consisting of an interchangeable drill bit that is intended for use in
an ear, nose, and throat electric or pneumatic surgical drill
(Sec. 874.4250) for incising or removing bone in the ear, nose, or
throat area. The bur consists of a carbide cutting tip on a metal shank
or a coating of diamond on a metal shank. The device is used in mastoid
surgery, frontal sinus surgery, and surgery of the facial nerves.
(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 1122, Jan. 16, 1996]

Sec. 874.4175 Nasopharyngeal catheter.

(a) Identification. A nasopharyngeal catheter is a device consisting
of a bougie or filiform catheter that is intended for use in probing or
dilating the eustachian tube. This generic type of device includes
eustachian catheters.
(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 1122, Jan. 16, 1996]

[[Page 330]]

Sec. 874.4250 Ear, nose, and throat electric or pneumatic surgical
drill.

(a) Identification. An ear, nose, and throat electric or pneumatic
surgical drill is a rotating drilling device, including the handpiece,
that is intended to drive various accessories, such as an ear, nose, and
throat bur (Sec. 874.4140), for the controlled incision or removal of
bone in the ear, nose, and throat area.
(b) Classification. Class II.

Sec. 874.4350 Ear, nose, and throat fiberoptic light source and
carrier.

(a) Identification. An ear, nose, and throat fiberoptic light source
and carrier is an AC-powered device that generates and transmits light
through glass of plastic fibers and that is intended to provide
illumination at the tip of an ear, nose, or throat endoscope. Endoscopic
devices which utilize fiberoptic light sources and carriers include the
bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-
bronchial telescope, and nasopharyngoscope.
(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 1122, Jan. 16, 1996]

Sec. 874.4420 Ear, nose, and throat manual surgical instrument.

(a) Identification. An ear, nose, and throat manual surgical
instrument is one of a variety of devices intended for use in surgical
procedures to examine or treat the bronchus, esophagus, trachea, larynx,
pharynx, nasal and paranasal sinus, or ear. This generic type of device
includes the esophageal dilator; tracheal bistour (a long, narrow
surgical knife); tracheal dilator; tracheal hook; laryngeal injection
set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy
tube; adenoid curette; adenotome; metal tongue depressor; mouth gag;
oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil
screw; tonsil snare; tonsil suction tub; tonsil suturing hook; antom
reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal
rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus
irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear
scissor, ear snare; ear spoon; ear suction tub; malleous ripper; mastoid
gauge; microsurgical ear chisel; myringotomy tube inserter; ossici
holding clamp; sacculotomy tack inserter; vein press; wire ear loop;
microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and
throat knife; and ear, nose, and throat trocar.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in subpart E of part 807.
[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987]

Sec. 874.4490 Argon laser for otology, rhinology, and laryngology.

(a) Identification. The argon laser device for use in otology,
rhinology, and laryngology is an electro-optical device which produces
coherent, electromagnetic radiation with principal wavelength peaks of
488 and 514 nanometers. In otology, the device is used for the purpose
of coagulating and vaporizing soft and fibrous tissues, including
osseous tissue. In rhinology and laryngology, the device is used to
coagulate and vaporize soft and fibrous tissues, but not including
osseous tissues.
(b) Classification. Class II.
[58 FR 29534, May 21, 1993]

Sec. 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.

(a) Identification. An ear, nose, and throat microsurgical carbon
dioxide laser is a device intended for the surgical excision of tissue
from the ear, nose, and throat area. The device is used, for example, in
microsurgical procedures to excise lesions and tumors of the vocal cords
and adjacent areas.
(b) Classification. Class II.

Sec. 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a) Identification. A bronchoscope (flexible or rigid) and
accessories is a tubular endoscopic device with any of a group of
accessory devices which attach to the bronchoscope and is intended to
examine or treat the larynx

[[Page 331]]

and tracheobronchial tree. It is typically used with a fiberoptic light
source and carrier to provide illumination. The device is made of
materials such as stainless steel or flexible plastic. This generic type
of device includes the rigid ventilating bronchoscope, rigid
nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial
telescope, flexible foreign body claw, bronchoscope tubing, flexible
biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid
biopsy forceps, flexible biopsy curette, and rigid bronchoscope
aspirating tube, but excludes the fiberoptic light source and carrier.
(b) Classification. Class II.

Sec. 874.4710 Esophagoscope (flexible or rigid) and accessories.

(a) Identification. An esophagoscope (flexible or rigid) and
accessories is a tubular endoscopic device with any of a group of
accessory devices which attach to the esophagoscope and is intended to
examine or treat esophageal malfunction symptoms, esophageal or
mediastinal disease, or to remove foreign bodies from the esophagus.
When inserted, the device extends from the area of the hypopharynx to
the stomach. It is typically used with a fiberoptic light source and
carrier to provide illumination. The device is made of materials such as
stainless steel or flexible plastic. This generic type of device
includes the flexible foreign body claw, flexible biopsy forceps, rigid
biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible
biopsy curette, but excludes the fiberoptic light source and carrier.
(b) Classification. Class II.

Sec. 874.4720 Mediastinoscope and accessories.

(a) Identification. A mediastinoscope and accessories is a tubular
tapered electrical endoscopic device with any of a group of accessory
devices which attach to the mediastinoscope and is intended to examine
or treat tissue in the area separating the lungs. The device is inserted
transthoracicly and is used in diagnosis of tumors and lesions and to
determine whether excision of certain organs or tissues is indicated. It
is typically used with a fiberoptic light source and carrier to provide
illumination. The device is made of materials such as stainless steel.
This generic type of device includes the flexible foreign body claw,
flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush,
rigid biopsy forceps, and flexible biopsy curette, but excludes the
fiberoptic light source and carrier.
(b) Classification. Class II.

Sec. 874.4750 Laryngostroboscope.

(a) Identification. A laryngostroboscope is a device that is
intended to allow observation of glottic action during phonation. The
device operates by focusing a stroboscopic light through a lens for
direct or mirror reflected viewing of glottic action. The light and
microphone that amplifies acoustic signals from the glottic area may or
may not contact the patient.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]

Sec. 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a) Identification. A nasopharyngoscope (flexible or rigid) and
accessories is a tubular endoscopic device with any of a group of
accessory devices which attach to the nasopharyngoscope and is intended
to examine or treat the nasal cavity and nasal pharynx. It is typically
used with a fiberoptic light source and carrier to provide illumination.
The device is made of materials such as stainless steel and flexible
plastic. This generic type of device includes the antroscope,
nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope,
rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy
forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy
forceps and flexible biopsy curette, but excludes the fiberoptic light
source and carrier.
(b) Classification. Class II.

Sec. 874.4770 Otoscope.

(a) Identification. An otoscope is a device intended to allow
inspection of the external ear canal and tympanic membrane under
magnification. The device

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provides illumination of the ear canal for observation by using an AC-
or battery-powered light source and an optical magnifying system.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter only
when used in the external ear canal.
[55 FR 48440, Nov. 20, 1990, as amended at 61 FR 1122, Jan. 16, 1996]]

Subpart F--Therapeutic Devices

Sec. 874.5220 Ear, nose, and throat drug administration device.

(a) Identification. An ear, nose, and throat drug administration
device is one of a group of ear, nose, and throat devices intended
specifically to administer medicinal substances to treat ear, nose, and
throat disorders. These instruments include the powder blower, dropper,
ear wick, manual nebulizer pump, and nasal inhaler.
(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 Sec. 820.180, with respect to
general requirements concerning records, and Sec. 820.198, with respect
to complaint files.
[51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994]

Sec. 874.5300 Ear, nose, and throat examination and treatment unit.

(a) Identification. An ear, nose, and throat examination and
treatment unit is an AC-powered device intended to support a patient
during an otologic examination while providing specialized features for
examination and treatment. The unit consists of a patient chair and
table, drawers for equipment, suction and blowing apparatus, and
receptacles for connection of specialized lights and examining
instruments.
(b) Classification. Class I.
[55 FR 48440, Nov. 20, 1990]

Sec. 874.5350 Suction antichoke device.

(a) Identification. A suction antichoke device is a device intended
to be used in an emergency situation to remove, by the application of
suction, foreign objects that obstruct a patient's airway to prevent
asphyxiation to the patient.
(b) Classification. Class III.
(c) Date PMA or notice or completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 874.3.

Sec. 874.5370 Tongs antichoke device.

(a) Identification. A tongs antichoke device is a device that is
intended to be used in an emergency situation to grasp and remove
foreign objects that obstruct a patient's airway to prevent asphyxiation
of the patient. This generic type of device includes a plastic
instrument with serrated ends that is inserted into the airway in a
blind manner to grasp and extract foreign objects, and a stainless steel
forceps with spoon ends that is inserted under tactile guidance to grasp
and extract foreign objects from the airway.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. A No
effective date has been established of the requirement for premarket
approval. See Sec. 874.3.

Sec. 874.5550 Powered nasal irrigator.

(a) Identification. A powered nasal irrigator is an AC-powered
device intended to wash the nasal cavity by means of a pressure-
controlled pulsating stream of water. The device consists of a control
unit and pump connected to a spray tube and nozzle.
(b) Classification. Class I.
[55 FR 48440, Nov. 20, 1990]

Sec. 874.5800 External nasal splint.

(a) Identification. An external nasal splint is a rigid or partially
rigid device intended for use externally for immobilization of parts of
the nose.

[[Page 333]]

(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. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 59
FR 63009, Dec. 7, 1994]

Sec. 874.5840 Antistammering device.

(a) Identification. An antistammering device is a device that
electronically generates a noise when activated or when it senses the
user's speech and that is intended to prevent the user from hearing the
sounds of his or her own voice. The device is used to minimize a user's
involuntary hesitative or repetitive speech.
(b) Classification. Class I.

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