(90 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on automation rather than intelligent algorithms.
No
The device is an audiometer used for evaluations, not for treatment or therapy.
Yes
The device is an automated audiometer intended for conducting hearing threshold evaluations, which is a diagnostic function to assess hearing.
Unknown
The summary does not provide enough detail about the device's components to definitively determine if it is software-only. While it describes the function of an automated audiometer, it doesn't explicitly state that it is solely software and doesn't mention any associated hardware.
Based on the provided information, the ASAM device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases or other conditions. They are used outside of the body (in vitro).
- ASAM Device Function: The ASAM device is an automated audiometer used for conducting hearing threshold evaluations. This involves presenting sounds to the subject's ear and measuring their response. This is a functional test performed on the subject's body, not a test on a biological sample.
Therefore, the ASAM device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ASAM device is an automated audiometer intended for use in conducting hearing threshold evaluations, by the subject without intervention of a skilled professional.
Product codes
77 EWO
Device Description
Automatic Self-Operated Screening Audiometer (ASAM) Device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by the subject without intervention of a skilled professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Bar - Advanced Control Systems Ltd. c/o A Stein-Regulatory Affairs Consulting Ahava Stein P.O. Box 454 Ginot Shomron, 44853 ISRAEL
K982566
Re:
Automatic Self-Operated Screening Audiometer Device July 19, 1998 Dated: Received: July 23, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Stein:
We have reviewed your Sections $10(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for usestated 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 II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral 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 QS 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. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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/odrf/dsmaldsmamain.html".
Sincerely yours,
Kilian Yi
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): | K942566 |
---|---|
--------------------------- | --------- |
Device Name: Automatic Self-Operated Screening Audiometer (ASAM) Device
The ASAM device is an automated audiometer intended for use in Indications for use: conducting hearing threshold evaluations, by the subject without intervention of a skilled professional. if
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Urintle. Legman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number