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K Number
K050496
Device Name
REM440
Manufacturer
INTERACOUSTICS A/S, ASSENS
Date Cleared
2005-04-29

(60 days)

Product Code
ETW
Regulation Number
874.3310
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

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:

  1. Acceptance criteria or reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance studies.
  7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. 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.

§ 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.