(83 days)
Not Found
None
No
The provided 510(k) summary does not contain any mentions of AI, ML, or related concepts, nor does it describe features typically associated with AI/ML in medical devices (like image processing or data analysis beyond standard metrics).
Yes
The device is intended for "treatment and control of tinnitus," which indicates a therapeutic purpose.
No
Explanation: The device is described for "treatment and control of tinnitus," which indicates a therapeutic rather than a diagnostic purpose.
Unknown
The provided 510(k) summary lacks a "Device Description," which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in treatment and control of tinnitus." This describes a therapeutic or management function within the body, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition based on sample analysis.
- Any typical IVD components or processes.
IVDs are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's intended use falls outside of that definition.
N/A
Intended Use / Indications for Use
For use in treatment and control of tinnitus.
Product codes
KLW
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 (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
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.
0
Image /page/0/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2001
ADM Tronics Unlimited, Inc. c/o Tames E. Lenick, Esq. FDA Counsel to ADM Tronics, Inc. P.O. Box 2002 118 Henry Street Morristown, TN 37814
Re: 510(k) Number: K981704 Trade/Device Name: Aurex - 3 Tinnitus Masker Regulation Number: 21 CFR 874.3400 Regulatory Class: Class II Product Code: KLW Dated: June 26, 1998 Received: June 29, 1998
Dear Mr. Lenick:
This letter corrects our substantially equivalent letter of August 5, 1998, regarding the Aurex -3 Tinnitus Masker. The review forms incorrectly noted this device as over-the-counter (OTC) without requiring a prescription for use. However, tinnitus maskers are Class II prescription devices. The intended use statement did not mention OTC, nor was there any reference to OTC in any other part of the 510(k) submission. Also, the listed predicate device was a prescription device.
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 legally marketed predicate 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 (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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation
1
Page 2 - James E. Lenick, Esq.
(QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 continue 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
David M. Whipple
OLA. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): Қ 9 8 / 70 4 ・・
Device Name: AUREX-3
Indications for Use:
.
For use in treatment and control of tinnitus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINE ON ANOTHER PAGE IF NEEDED)
i:
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Perscription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter use | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | K98 1704 |