The Interacoustics Audio Traveller AA222 is intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.

Device Description

The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.

AI/ML Overview

This is a regulatory letter from the FDA, approving the Interacoustics Audiotraveller, Model AA222. The letter does not contain a detailed study report with acceptance criteria and device performance results. Therefore, I cannot provide most of the requested information based solely on the provided text.

Here's what I can infer and what is explicitly stated:

Information from the document:

Trade/Device Name: Audiotraveller, Model AA222
Regulation Number: 21 CFR 874.1090
Regulation Name: Auditory Impedance Tester
Regulatory Class: Class II
Product Code: ETY
Intended Use: For use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The AA222 is a combination of audiometer and tympanometer.

Limitations:

The provided document is an FDA clearance letter based on a 510(k) submission. A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive new clinical trials with detailed acceptance criteria and performance studies as might be seen for a PMA (Premarket Approval) device or for novel technologies.

Therefore, the document does not contain:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
Information on MRMC comparative effectiveness studies or standalone algorithm performance.
Details on the type of ground truth used, training set sample size, or how ground truth was established for the training set.

The FDA's decision is based on a review of the submitter's assertion that the device is substantially equivalent to a predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The specific data supporting such a claim would be in the 510(k) submission itself, not in the FDA's clearance letter.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or fabric.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2002

Interacoustics USA c/o Daniel Eggan Manager of Regulatory Affairs / QA 9675 West 76th Street Eden Prairie, MN 55344

Re: K022728

Trade/Device Name: Audiotraveller, Model AA222 Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: August 1, 2002 Received: August 16, 2002

Dear Mr. Eggan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Daniel Eggan

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section A

Indications for Use Statement

Applicant: Interacoustics A/S, Assens 02 510(k) Number (if known): Device Name: Audio Traveller AA222

Indications for Use

K027280e

Preserintion Use . (Pei 21 Cr R 801.109)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

0(k) Numbe

Regulation Number and Section

§ 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 (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.