AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER

K983046 · American Electromedics Corp. · ETY · Nov 17, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K983046
• Device Name: AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
• Applicant: American Electromedics Corp.
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: Nov 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1090
• Device Class: Class 2

Intended Use

The device is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Device Story

The American Electromedics Race Car Tympanometer is an impedance tympanometer used to conduct hearing evaluations and assist in diagnosing otologic disorders. The device measures middle ear impedance; it transforms these acoustic measurements into tympanometric data. The device features an integral printer for immediate output of results. It is intended for use by healthcare professionals in clinical settings. The output allows clinicians to assess middle ear function, aiding in the diagnosis of conditions such as otitis media or eustachian tube dysfunction, thereby guiding clinical management and treatment decisions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Impedance tympanometer; includes built-in printer; standalone device; electrical energy source.

Indications for Use

Indicated for use in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders in patients requiring tympanometric assessment.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Predicate Devices

• Race Car Tympanometer, American Electromedics Corporation (K955289)

Submission Summary (Full Text)

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## NOV 17 1998

K983046

## 510(k) SUMMARY

A. Manufacturer: American Electromedics Corporation 13 Columbia Drive Suite 5 Amherst, NH 03031

Submitted By: Ferguson Medical Consultant to American Electromedics Corporation

- B. Contact Information: Phone: [phone] FAX: [phone]
- C. Classification Name: Auditory Impedance Tester

Common/usual Name: Tympanometer

Proprietary Name: American Electromedics Race Car Tympanometer With Integral Printer

- D. Classification Number: 77ETY
- E. Substantial Equivalence: Race Car Tympanometer, American Electromedics Corporation (K955289)
- F. Device Description: The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer.
- G. Intended Use: The device is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
- H . Technological Characteristics: The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer which has a built-in printer.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 1998

American Electromedics Corporation c/o Ferguson Medical Frank Ferguson Official Correspondent 2581 California Park Drive Suite 269 Chico, California 95928

Re:

K983046

American Electromedics Race Car Tympanometer with Integral Printer Dated: August 1, 1998 Received: September 1, 1998 Regulatory class: II 21 CFR 874.1090/Procode: 77 ETY

Dear Mr. Ferguson:

We have reviewed your Section 510%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification i submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, piense note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "https://www.fda.gov/cdrh/dsmadsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (If known):

American Electromedics Race Car Tympanometer Device Name: With Integral Printer

Indications For Use:

The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Clamil G. Sigman
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, F and Radiological I 510(k) Number

Prescription Use
(Per 21 CFR 801.109) -√

Over-The-Counter Use _

(Optional Format 1-2-96)