(85 days)
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No
The summary does not mention AI, ML, or related terms, and the device description focuses on measuring acoustic properties.
No
The device is described as characterizing middle ear status and assisting in diagnosing middle ear pathologies by measuring acoustic properties, which indicates a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to assist in diagnosing middle ear pathologies."
No
The device description explicitly states that the HearID system comes in two versions with variations in the "hardware platform," indicating it is not solely software.
Based on the provided information, the HearID-wbMEPA Middle Ear Power Analyzer is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is to "assist in diagnosing middle ear pathologies." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While the device measures acoustic properties in vivo (within the living body), the purpose of these measurements is to aid in diagnosis, which is a key characteristic of IVDs.
- Diagnostic Purpose: The device measures various acoustic properties to "allow the evaluation of the functional condition of the middle and outer ear" and "assist in diagnosing middle ear pathologies." This directly points to a diagnostic application.
However, it's important to note:
- Lack of "In Vitro" Specimen: The device measures acoustic properties directly from the ear, not from a specimen in vitro (outside the body). This is a point of potential ambiguity. Some regulatory bodies might classify devices that measure physiological parameters in vivo for diagnostic purposes differently than traditional IVDs that analyze biological samples.
- Regulatory Classification: The final determination of whether a device is an IVD rests with the relevant regulatory bodies (e.g., FDA in the US, CE marking in Europe). They have specific definitions and classification criteria.
In summary, while the device doesn't analyze a biological specimen in vitro in the traditional sense, its stated purpose of assisting in diagnosis strongly suggests it falls under the broader category of devices used for diagnostic purposes, which often includes IVDs.
To be absolutely certain, one would need to consult the device's regulatory classification documentation or the relevant regulatory guidelines in the jurisdiction where the device is marketed.
N/A
Intended Use / Indications for Use
The intended use of the HearID-wbMEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies.
The HearID-wbMEPA system measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The devices are suitable for all populations including new-born infants. The devices are to be used by trained personnel only.
The HearID system comes in two versions: HearID_b-wbMEPA, and HearID_e-wbMEPA, where the difference is the variation of the hardware platform.
Product codes
EWO; GWJ
Device Description
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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
middle and outer ear
Indicated Patient Age Range
all populations including new-born infants
Intended User / Care Setting
trained personnel
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
FEB 1 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mimosa Acoustics, Inc. c/o Patricia S. Jeng 60 Hazelwood Drive, Suite #209 Champaign, IL 61820
Re: K053216
Trade/Device Name: HearID Wideband Middle Ear Power Analyzer (HearID-wbMEPA, HearID-MEPA, wb-MEPA, or MEPA) Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO; GWJ Dated: November 11, 2005 Received: November 18, 2005
Dear Ms. 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
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), 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.gov/cdrh/industry/support/index.html.
Sincerely yours,
.b. Eydelhus, m.d.
Malvina B. Eydelman, M.D. Acting Division 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: Wideband Middle Ear Power Analyzer (wbMEPA)
Indications for Use:
The intended use of the HearID-wbMEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies.
The HearID-wbMEPA system measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The devices are suitable for all populations including new-born infants. The devices are to be used by trained personnel only.
The HearID system comes in two versions: HearID_b-wbMEPA, and HearID_e-wbMEPA, where the difference is the variation of the hardware platform.
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-CONTINUE ON ANOTHER PAGE OF NEEDED)
of CDRH, Office of Device Evaluation (ODE)
Srinivas Nandkumar (SZN)
se and I hroat De
510(k) Number
× Prescription Use (Per 21 CFR 801.109)