K 15 AUDIOMETER

K972221 · American Electromedics Corp. · EWO · Sep 8, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972221
• Device Name: K 15 AUDIOMETER
• Applicant: American Electromedics Corp.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The device is used to perform pure tone threshold tests.

Device Story

K-15 Audiometer performs pure tone threshold tests to assess hearing. Device generates specific frequency and intensity tones presented to patient; patient responds to stimuli to determine hearing threshold. Used in clinical settings by audiologists or trained healthcare professionals. Output provides threshold data for clinical evaluation of hearing loss. Benefits include standardized, accurate assessment of auditory function.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Pure tone audiometer; electronic signal generation for threshold testing; standard clinical form factor; Class II device per 21 CFR 874.1050.

Indications for Use

Indicated for patients requiring pure tone threshold testing to assess hearing sensitivity.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michael T. Pieniazek President American Electromedics Corp. 13 Columbia Drive, Suite #18 Amherst, NH 03031

Re: K972221 Model K 15 Audiometer Dated: June 11, 1997 Received: June 13, 1997 Regulatory Class: II 21 CFR 874.1050/Procode: 77 EWO SEP - 8 1997

Dear Mr. Pieniazek:

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, 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 requirement, 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 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 marked 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 yitro 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/cdrh/dsmamain.html".

Sincerely yours,

Sincerely yours,

WJ. Liao Yu

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

Enclosure

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## INDICATION FOR USE

510(K) Number (if known): K972221
Device Name: K-15 Audiometer

Indications For Use:

The device is used to perform pure tone threshold tests.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109

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OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

David h. Bergman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K972221

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