(23 days)
The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
Not Found
This document is an FDA 510(k) clearance letter for an audiometer (Maico MA53) from 1998. It does not contain information about specific acceptance criteria or study results because, for 510(k) clearances, the primary mechanism for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as might be seen for PMA submissions or more recent AI/ML device clearances.
Therefore, I cannot provide the requested information based on this document. The document essentially states that the device is substantially equivalent to devices marketed before 1976 and is cleared for marketing.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness (SSE) for a more recent device, especially one involving AI/ML components, or a PMA (Premarket Approval) document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 22 1998
Scott Savre Engineering Manager Bernafon-Maico, Inc. 9675 West 76th St. Eden Prairie, MN 55344 Re:
K981142 Maico MA53 (Audiometer) Dated: March 25, 1998 Received: March 30, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Savre:
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, 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 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 OS insoccions, 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/odrh/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
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Page 1 of 1
981142 610(k) Number (if known): _
Device Name: Maico MA53
Indications For Use:
The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ……………
ﭘﯿﻨﮯ ﻭﺍ
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symons
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981142
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.