(90 days)
The ASAM device is an automated audiometer intended for use in conducting hearing threshold evaluations, by the subject without intervention of a skilled professional.
Automatic Self-Operated Screening Audiometer (ASAM) Device
This document is a marketing clearance letter from the FDA for an Automatic Self-Operated Screening Audiometer Device (ASAM). It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.
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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
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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
§ 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.