OTO WIZZARD by MEDRX, INC. | FDA 510(k) Summary

This device is an integrated Audiometer, Real Ear Measurement and Hearing Aid Test System. It is used by an industry trained professional to conduct diagnostic hearing evaluate basic hearing function and assist in the diagnosis of otologic disorders. It is also used to evaluate hearing instrument performance while the aid is in the ear or in a test chamber.

Device Description

This device is an integrated Audiometer, Real Ear Measurement and Hearing Aid Test System.

AI/ML Overview

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for a device called "OtoWizzard," an integrated Audiometer, Real Ear Measurement, and Hearing Aid Test System.

This type of document typically confirms that a device is substantially equivalent to a predicate device and can be marketed. It does not include details about:

Acceptance criteria and reported device performance (in a table format).
Sample sizes, data provenance, or ground truth establishment for any studies.
Number and qualifications of experts or adjudication methods.
Results of multi-reader multi-case (MRMC) comparative effectiveness studies.
Results of standalone algorithm performance studies.
Sample size or ground truth methods for training sets.

The letter simply states that the device is cleared for marketing based on substantial equivalence to a pre-existing device. To get the information you asked for, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical submission.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 1998

Jeffrey A. McLaughlin MedRex, Inc. 777131" Street, Suite 6 Seminole, Florida 33776 Re:

K981511 OtoWizzard Dated: April 24, 1998 Received: April 28, 1998 Regulatory Class: II 21 CFR 874.1050/77 EWO

Dear Mr. McLaughlin:

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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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. This response to your premarket notification submission does not affect any obligation you might have under sections 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

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

Image /page/0/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design.

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510(k) Number (if known): K981511

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Condurrence of CDRH, Office of Device Evaluation (ODE),

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number K981511

Prescription Use_ 2 (Per 21 CFR 801 109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.