(25 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on personalized sound recording, not AI/ML processing.
Yes
The device is intended to provide temporary relief of tinnitus symptoms, which is a therapeutic purpose.
No
The device is intended to provide temporary relief of tinnitus symptoms by delivering personalized sound. It does not mention any function related to diagnosing or identifying a medical condition.
No
The device description explicitly states it consists of a "personalized sound recorded onto a patient treatment device," implying a hardware component (the treatment device) is part of the system, not just software.
Based on the provided information, the Tinnitus Phase-Out is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Tinnitus Phase-Out Function: The Tinnitus Phase-Out is described as a device that provides temporary relief of tinnitus symptoms through personalized sound. It does not involve the analysis of any biological specimens from the patient.
The device's function is based on delivering sound therapy, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Tinnitus Phase-Out's intended use is to provide temporary relief of tinnitus symptoms.
Product codes
KLW
Device Description
The Tinnitus Phase-Out consists of a personalized sound recorded onto a patient treatment device. The recorded sound is equivalent to that generated by the Timitus Rx. Performance testing demonstrating this equivalence is presented in the 510(t).
The treatment regimen for the Phase-Out is identical to that of the Rx. The only difference is the use of a patient treatment device instead of a customized CD.
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)
Bench testing demonstrating audio equivalence has been provided in the 510(k). Additionally, the following have been met:
- . UL electrical certification
- FDA Guidance describing Special 510(k)s: The New 510(k) Paradigm .
- Class II Special Control Guidance, 21 CFR 874.3400(b) .
- Conformance to the EU Medical Device Directive.. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
1 6 2008
Attachment 5
510(k) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes Timitus Control. Inc.'s summary for the Tinnitus Phase-Out.
SUBMITTER'S NAME ADDRESS:
CONTACT PERSON TELEPHONE NUMBER FAX NUMBER: DATE OF SUBMISSION
Tinnitus Control, Inc. 66 East 80th Street, Suite 1 A New York, New York 10021 _ Calvin Yee 212-535-6160 (official number) 212-517-3728 April 20, 2006
1. Identification of device
Proprietary Name: Tinnitus Phase-Out Common Name: Tinnitus Masker Classification Status: Class II per Regulation §874.3400 Product Code: KLW - Tinnitus Masker.
2. Equivalent device
Tinnitus Rx - K030791.
3. Description of the Device
The device description of the Tinnitus Phase-Out is as follows:
The Tinnitus Phase-Out consists of a personalized sound recorded onto a patient treatment device. The recorded sound is equivalent to that generated by the Timitus Rx. Performance testing demonstrating this equivalence is presented in the 510(t).
The treatment regimen for the Phase-Out is identical to that of the Rx. The only difference is the use of a patient treatment device instead of a customized CD.
4. Intended Use
The Tinnitus Phase-Out's intended use is to provide temporary relief of tinnitus symptoms. This is the same intended use as previously cleared for themitis
V.020701 K030791.
1
5. Discussion of Performance Testing
Bench testing demonstrating audio equivalence has been provided in the 510(k). Additionally, the following have been met:
- . UL electrical certification
- FDA Guidance describing Special 510(k)s: The New 510(k) Paradigm .
- Class II Special Control Guidance, 21 CFR 874.3400(b) .
- Conformance to the EU Medical Device Directive.. .
6. Conclusion
In summary, the Tinnitus Phase-Out described in the submission is substantially equivalent to the predicate device, the Tinnitus Rx. The Tinnitus Phase-Out is substantially equivalent to the device already on the market, and presents no new concerns about safety and effectiveness. Additionally, the new device has identical indications to the predicate device, and the labeling is consistent-both with FDA guidance as well as current medical practice.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 16 2005
Tinnitus Control, Inc. c/o Russell P. Pagano, Ph.D. M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002
Re: K061111
Trade/Device Name: Tinnitus Phase-Out Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: April 20, 2006 Received: April 21, 2006
Dear Dr. Pagano:
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. Iisting 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.
3
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 (301) 827-8910. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
M.B. Egelston - 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
4
Attachment 2
Indications for Use Statement
510(k) Number (if known)
406111
Device Name
Tinnitus Phase-Out
Indications The Tinnitus Phase-Out is intended to provide the temporary relief of tinnitus symptoms. For Use
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K061111