(35 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is intended for "sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment," which are therapeutic applications.
No
The device is described as being for "sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment," which indicates a therapeutic rather than a diagnostic purpose. It is used in concert with counseling from medical professionals, but its function is treatment.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, the Tranquil TRI-BTE is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for sound therapy for tinnitus treatment. This involves delivering sound to the patient, not analyzing biological samples (like blood, urine, tissue, etc.) outside of the body.
- Device Description: While the description is "Not Found," the intended use clearly points to a device that interacts with the patient's auditory system, not with biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, using reagents, or any other activities typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Tranquil TRI-BTE's function is therapeutic (sound therapy), not diagnostic in the sense of analyzing biological samples.
N/A
Intended Use / Indications for Use
The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.
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
Prescription Use
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/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 30 2006
General Hearing Instruments Inc. c/o Roger P. Juneau President P.O. Box 23748 New Orleans, LA 70183
Re: K061459
Trade/Device Name: Tranquil TRI-BTE Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: May 25, 2006 Received: June 05. 2006
Dear Mr. Juneau.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Roger P. Juneau
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M.B. Egelman, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) number: K061459
Device name: Tranquil TRI-BTE
Indication for Use: The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Brooms of Jan-Sifi
Prescription Use
✓
(Pes 2 . . . . 001.109)
(Division Sign-Off)
Division of Ophthalmic Ear Nose and Throat Devises K 061459
510(k) Number
Page 1 of