AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER

K983051 · American Electromedics Corp. · ETY · Nov 18, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K983051
• Device Name: AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
• Applicant: American Electromedics Corp.
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: Nov 18, 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

American Electromedics Race Car Tympanometer/Audiometer is a combination diagnostic device used in clinical settings by healthcare professionals. It functions as both a tympanometer for assessing middle ear function and an audiometer for hearing threshold testing. The device features an integral printer for immediate documentation of test results. Clinicians use the output to evaluate auditory function and assist in diagnosing otologic conditions. The device provides objective data to support clinical decision-making regarding patient hearing health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Combination tympanometer and audiometer; includes integral printer. Device performs acoustic impedance testing and audiometric threshold testing. No specific materials, software architecture, or connectivity standards are detailed in the provided documentation.

Indications for Use

Indicated for patients requiring hearing evaluations and diagnostic assistance for otologic disorders.

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 With Audiometer and Quik Tymp2, and Quik Tymp1, American Electromedics Corporation (K970279)

Submission Summary (Full Text)

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## 510(k) SUMMARY

- American Electromedics Corporation A. Manufacturer: 13 Columbia Drive Suite 5 03031 Amherst, NH
Submitted By: Ferguson Medical Consultant to American Electromedics Corporation

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

Common/usual Name: Tympanometer/Audiometer

Proprietary Name: American Electromedics Race Car Tympanometer/Audiometer With Integral Printer

- D. Classification Number: 77ETY and 77EWO
- E. Substantial Equivalence: Race Car Tympanometer With Audiometer and Quik Tymp2, and Quik Tymp1, American Electromedics Corporation (K970279)
- F. Device Description: The American Electromedics Race Car Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer.
- 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/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

DEPARTMENT OF

NOV 1 8 1998

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

Re: K983051

American Electromedics Race Car Tympanometer /Audiometer with Integral Printer Dated: August 1, 1998 Received: September 1, 1998 Regulatory class: II 21 CFR 874.1090/Procode: 77 ETY 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Ferguson:

We have reviewed your Section 510(k) 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 QS inspections, 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 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 ritm diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please 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 "http://www.fda.gov/cdr/dsmadsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

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

Enclosure

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510(k) Number (If known): バイタ 305 (

American Electromedics Race Car Tympanometer/ Device Name: Audiometer With Integral Printer

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Segerm

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

OR