REM440 by INTERACOUSTICS A/S, ASSENS

The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing.

Device Description

REM440, (for use with Thor Platform System Products)

AI/ML Overview

The provided text is a 510(k) substantial equivalence letter from the FDA for the Interacoustics REM440 device, a hearing aid analyzer. It does not contain the detailed information necessary to answer the questions about acceptance criteria and study design.

Specifically, the document states:

Device Name: REM440
Regulation Number/Name: 21 CFR 874.3310 / Hearing Aid Analyzer
Indications For Use: "The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing."
Date of Decision: April 29, 2005 (corrected from an earlier letter of the same date).
510(k) Number: K050496

However, it does not contain any information regarding:

Acceptance criteria or reported device performance.
Sample sizes for test sets or data provenance.
Number or qualifications of experts for ground truth.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

The letter is a regulatory document confirming substantial equivalence to a predicate device, which allows the device to be marketed. It does not elaborate on the specific technical or clinical studies that may have been submitted in the original 510(k) application to demonstrate this equivalence. To find that information, one would typically need to review the full 510(k) submission summary or other related technical documentation, which is not provided in the given text.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Interacoustics A/S, Assens c/o Mr. Daniel Eggan Manager of Regulatory Affairs/QA Interacoustics USA 7625 Golden Triangle Drive Eden Prairie, MN 55344

APR 2 9 2005

ﭘﻮ

Re: K050496 Trade/Device Name: REM440 Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing Aid Analyzer Regulatory Class: Class II Product Code: ETW Dated: April 29,2005 Received: April 29,2005

Dear Mr. Eggan:

This letter corrects our substantially equivalent letter of April 29,2005 regarding the regulation number.

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 deyices 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 (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 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 may 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

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Page - Mr. Daniel Eggan

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.aovlcdrWdsma/dsmamain.html

Sincerely yours,

Orenette RBeeus PhD

lavid M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section A

Indications for Use Statement

Applicant: Interacoustics A/S

510(k) Number (if known):

Device Name: REM440, (for use with Thor Platform System Products)

Indications For Use:

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ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

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Con

Evaluation (ODE)

(Per 21 CFR 801.109)

YKL 4/29/05
Prescription Use
(Per 21 CFR 801.109) K050496

MC 4/29/05
(Division Sign-Off)

510(k) Number K050496

Regulation Number and Section

§ 874.3310 Hearing aid calibrator and analysis system.

(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.