(87 days)
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No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the presence of AI/ML in this type of device. The description focuses on standard audiometry and hearing aid testing functions.
No.
The device is used to diagnose hearing function and disorders, and to evaluate hearing aid performance; it does not treat a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device is used to "conduct diagnostic hearing evaluate basic hearing function and assist in the diagnosis of otologic disorders."
No
The device description explicitly states it is an "integrated Audiometer, Real Ear Measurement and Hearing Aid Test System," which implies the inclusion of hardware components necessary for these functions (e.g., transducers for audiometry, probes for real ear measurement, test chambers). The summary does not indicate it is solely software controlling external hardware.
Based on the provided information, this device 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.
- Device function: The description clearly states the device is an integrated Audiometer, Real Ear Measurement, and Hearing Aid Test System. These functions involve testing hearing in vivo (within the living body) and evaluating the performance of hearing aids, not analyzing samples taken from the body.
- Intended Use: The intended use is to "conduct diagnostic hearing evaluate basic hearing function and assist in the diagnosis of otologic disorders" and "evaluate hearing instrument performance." This is done by interacting with the patient's ear directly, not by analyzing biological samples.
Therefore, this device falls under the category of a medical device used for diagnosis and evaluation related to hearing, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is an integrated Audiometer, Real Ear Measurement and Hearing Aid Test System. It is used by an industry trained professional to conduct diagnostic hearing evaluate basic hearing function and assist in the diagnosis of otologic disorders. It is also used to evaluate hearing instrument performance while the aid is in the ear or in a test chamber.
Product codes
EWO
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
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Indicated Patient Age Range
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Intended User / Care Setting
industry trained professional
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 1998
Jeffrey A. McLaughlin MedRex, Inc. 777131" Street, Suite 6 Seminole, Florida 33776 Re:
K981511 OtoWizzard Dated: April 24, 1998 Received: April 28, 1998 Regulatory Class: II 21 CFR 874.1050/77 EWO
Dear Mr. McLaughlin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/0/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design.
1
510(k) Number (if known): K981511
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
This device is an integrated Audiometer, Real Ear Measurement and Hearing Aid Test System. It is used by an industry trained professional to conduct diagnostic hearing evaluate basic hearing function and assist in the diagnosis of otologic disorders. It is also used to evaluate hearing instrument performance while the aid is in the ear or in a test chamber.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDER)
Condurrence of CDRH, Office of Device Evaluation (ODE),
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number K981511
Prescription Use_ 2 (Per 21 CFR 801 109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)