(53 days)
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Not Found
No
The description focuses on pre-recorded digital audio content (masking sounds, relaxation messages, music, nature sounds) played on standard media players. There is no mention of adaptive algorithms, learning, or data processing that would indicate AI/ML.
Yes
The device is indicated for "temporary relief of tinnitus symptoms," which is a claim that addresses a medical condition.
No
The device is described as providing "digital tinnitus masking" for "temporary relief of tinnitus symptoms" and "promotion of relaxation." It does not claim to diagnose tinnitus or any other medical condition. Its function is to alleviate symptoms, not to identify or characterize a disease.
No
The device is described as a set of CDs and tapes, which are physical media containing digital audio. While the audio itself is digital, the device as described includes the physical media (CDs and tapes) and is intended to be played on commercially available CD or tape players, which are hardware. Therefore, it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary relief of tinnitus symptoms" and "promotion of relaxation during the tinnitus masking process." This is a therapeutic or symptomatic relief purpose, not a diagnostic one.
- Mechanism of Action: The device provides "digital tinnitus masking" sounds. This is an external intervention to alleviate symptoms, not a test performed on a biological sample to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
77 KLW
Device Description
DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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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 shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line. The words are black against a white background.
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
1
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)