(73 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as an audiometer used for detection and diagnosis of hearing loss, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the audiometer is for the "detection and diagnosis of a suspected hearing loss."
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The intended use describes an audiometer, which typically involves hardware components for generating and presenting sounds. Without a device description, it's impossible to confirm if this specific audiometer is implemented solely in software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "detection and diagnosis of a suspected hearing loss." This involves testing the function of the ear, which is a part of the human body, rather than analyzing samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Using reagents or assays.
- Measuring biomarkers or other substances in a sample.
An audiometer is a device used to measure hearing ability by presenting sounds to the ear and recording the patient's responses. This is a functional test performed directly on the patient, not an in vitro test performed on a sample.
N/A
Intended Use / 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.
Product codes
77 EWO
Device Description
Not Found
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
Not Found
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
Not Found
Key Metrics
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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN -6 1997
Scott Savre Engineering Manager Bernafon-Maico, Inc. 9675 West 76th Street Eden Prairie, MN 55344 Re: K971080 Maico MA52 Dated: March 21, 1997 Received: March 25, 1997 ... 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 ensoment date of the Medical Device Amendances that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmelic 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 and in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 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 in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html".
Sincerely yours,
William
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
1
11111000011
Page 1 of 1 -
510(k) Number (if known): K971080
Device Name:__________________________________________________________________________________________________________________________________________________________________ Maico MA52
Indications For Use:
14
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971080