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K Number
K983048
Device Name
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
Manufacturer
AMERICAN ELECTROMEDICS CORP.
Date Cleared
1998-11-17

(77 days)

Product Code
EWO
Regulation Number
874.1050
Type
Traditional
Panel
EN
Reference & Predicate Devices
K970279
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Device Description

The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.

AI/ML Overview

This 510(k) submission for the American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The provided text only includes:

  • Manufacturer and Contact Information: American Electromedics Corporation, Ferguson Medical.
  • Device Classification and Names: Auditory Impedance Tester, Audiometer, Tympanometer/Audiometer. Proprietary Name: American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer.
  • Substantial Equivalence: Refers to predicate devices: Car Tympanometer With Race Audiometer and Quik Tymp2, and Quik Tymp1, American Electromedics Corporation (K970279).
  • Device Description: A combination device functioning as both a tympanometer and an audiometer with a built-in printer.
  • Intended Use: "The device is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders."
  • Technological Characteristics: Reiteration of the device description.
  • FDA Communication: A letter affirming substantial equivalence to pre-amendment devices, outlining regulatory requirements, and permitting marketing.

There is no mention of:

  1. Acceptance criteria table or reported device performance.
  2. Sample size for test set or data provenance.
  3. Number or qualifications of experts used for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study or effect size.
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used (expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This submission is concerned with demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a performance study with specific acceptance criteria that the device unequivocally meets. The FDA's letter confirms substantial equivalence, which implies that the device is as safe and effective as its predicate devices, but it does not detail new performance study results or acceptance criteria for this specific submission.

§ 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.