(183 days)
Not Found
Not Found
No
The summary describes a standard audiometer and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for descriptions of training/test sets and performance studies typically associated with AI/ML devices.
No
Explanation: The device is described as an audiometer used for diagnostic hearing evaluation and assisting in the diagnosis of otologic disorders, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that audiometers are used to "conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders."
No
The description explicitly states the device is an "electroacoustic device" that "produce controlled levels of test tones and signals," which implies the presence of hardware components beyond just software.
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 that this device is an audiometer used for diagnostic hearing evaluation by producing test tones and signals. This is a functional test of the auditory system, not a test performed on a biological sample.
- Lack of Biological Sample Testing: There is no mention of the device analyzing any biological samples.
Therefore, this audiometer falls under the category of a diagnostic medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is an audiometer. Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.
Product codes
77 EWO
Device Description
It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.
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
hearing health professionals
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 1998
Ziad Shwiyat Trutone Ltd. Partnership 3113 S. 115th E. Ave. Tulsa, OK 74146
Re:
Audiometer AC-50D Dated: December 8, 1997 Received: December 17, 1997 Regulatory class: 11 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Shwiyat:
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 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 (Special Controls) or 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. 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/cdrh/dsmaldsmamain.html".
Sincerely yours,
Killian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/0/Picture/16 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
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Pago 1 of
510(k) Number (if known): 15973377
Device Name: Audiometer AC-50
Indications For Use:
This device is an audiometer, Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an cletroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.
(PLB/ SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBOBO)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973377 |
Prescription Use (Per 21 CI R 801 109)
OR
Over-The-Counter Use
(Optional Formal 1-2-90)