(59 days)
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Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on measuring acoustic properties, not using AI/ML for analysis or diagnosis.
No.
The device is used for characterization and diagnosis, not for therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended "to assist in diagnosing inner-ear pathologies" and to "evaluate the functional condition of the inner ear," which are diagnostic purposes.
No
The description refers to an "Analyzer" which strongly implies a hardware component is involved in measuring acoustic properties of the inner ear. The summary does not explicitly state it is software-only.
Based on the provided information, the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HearID+TE Function: The HearID+TE system measures acoustic properties of the inner ear directly within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes characterizing inner-ear status and assisting in diagnosing inner-ear pathologies by measuring acoustic properties in vivo.
Therefore, the HearID+TE is a diagnostic device, but it falls under the category of in vivo diagnostic devices rather than in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies.
The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-to-noise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.
Product codes
EWO, GWJ
Device Description
The HearID system comes in two versions for use with different hardware platforms.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
inner-ear
Indicated Patient Age Range
all populations, including newborn infants
Intended User / Care Setting
trained personnel only
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 an eagle or other bird-like figure, represented by three curved lines that suggest wings and a head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 4 2007
Mimosa Acoustics, Inc. c/o Patricia S. Jeng, Ph.D. 60 Hazelwood Drive, Suite #209 Champaign, IL 61820
K063338 Re:
Trade/Device Name: HearID Transient-Evoked Otoacoustic Emission Analyzer (HearID+TE, T2001, and T2K) Regulation Number: CFR 874.1050
Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: October 31, 2006 Received: November 8, 2006
Dear Dr. Jeng:
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 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 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 - Patricia S. Jeng. Ph.D.
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 vour 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M.B. Eichelman, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use 1
Indications for Use
510(k) Number (if known):
Device Name: HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer
Indications for Use:
The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies.
The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-tonoise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.
The HearID system comes in two versions for use with different hardware platforms.
Prescription Use X_ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONPANUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ea. An, mo
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K063338 |
|---|---|
| --------------- | --------- |
(Per 21 CFR 801.109)
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