(53 days)
Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms. CD#2, CD#3, CD#4, TAPE#2, TAPE#3 and TAPE#4 provide digital tinnitus masking sounds plus relaxation messages, alpha-rhythms (a gentle musical sound generated on electronic musical instruments), music and/or nature sounds, and are indicated for temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus masking process.
Not Found
The provided document is a 510(k) summary for a "Digital Tinnitus Masking System" (DTM-4). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with specific acceptance criteria and detailed performance studies typical for novel devices.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size.
This 510(k) submission primarily defines the device, its indications for use, and an FDA determination of substantial equivalence to a predicate device. It confirms that the device can proceed to market subject to general controls and existing regulations, but it does not include the detailed performance study results that would typically be presented against explicit acceptance criteria.
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OCT 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Michael L. Petroff Petroff Audio Technologies 6520 Platt Ave., #813 West Hills, California 91307
Re: K974501
Trade/Device Name: Digital Tinnitus Masking System Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: II Product Code: 77 KLW Dated: November 24, 1997 Received: January 20, 1998
Dear Mr. Petroff:
This letter corrects our substantially equivalent letter of January 20, 1998.
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 (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 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.
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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. Egdelmin SimD
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
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Page 1 of 1
510(k) Number (if known): 11974501
Device Name: DTM-4
Indications For Use:
Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms. CD#2, CD#3, CD#4, TAPE#2, TAPE#3 and TAPE#4 provide digital tinnitus masking sounds plus relaxation messages, alpha-rhythms (a gentle musical sound generated on electronic musical instruments), music and/or nature sounds, and are indicated for temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus masking process.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974501
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use √
(Optional Format 1- 2-96)
§ 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.