(224 days)
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No
The provided text does not mention AI, ML, or any related technologies. The description focuses on the intended use and user, not the underlying technology.
Yes
The device is intended to provide relief from subjective tinnitus and requires regular use over several months as part of a tinnitus management program, indicating a therapeutic purpose.
No
Explanation: The device is described as a "Tinnitus Therapy System" intended to provide relief from subjective tinnitus, indicating a therapeutic rather than a diagnostic purpose.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The intended use describes a "system" and "stimulation," which could imply hardware components.
Based on the provided information, the Desyncra™ for Tinnitus Therapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Desyncra™ Function: The description clearly states that the Desyncra™ system is a "patient device for home use" that provides "relief from the disturbance of subjective tinnitus" through "Stimulation." This indicates a therapeutic device that interacts with the patient's body directly, rather than analyzing samples taken from the body.
The intended use and device description point towards a device that delivers some form of therapy (likely auditory stimulation based on the context of tinnitus) to the patient, which is characteristic of a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Desyncra™ for Tinnitus Therapy System is intended to provide relief from the disturbance of subjective tinnitus while using the system. With regular use (over several months) as part of a tinnitus management program it may provide relief to the patient when not using the system.
The Desyncra™ for Tinnitus Therapy System is a patient device for home use.
The Desyncra™ for Tinnitus Therapy System is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.
Stimulation needs to be applied for several hours a day over a period of weeks or months.
The target population is adults over 18 years of age.
Product codes (comma separated list FDA assigned to the subject device)
KLW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The target population is adults over 18 years of age.
Intended User / Care Setting
The Desyncra™ for Tinnitus Therapy System is a patient device for home use. The Desyncra™ for Tinnitus Therapy System is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Neurotherapies Reset Gmbh. % Deborah Sheffield Regulatory Consultant Deborah L. Sheffield Consulting 5672 Flagler Road Nordland, Washington 98358
Re: K151558
Trade/Device Name: Desyncra For Tinnitus Therapy System, Desyncra For Tinnitus Pro System Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: December 22, 2015 Received: December 23, 2015
Dear Ms. Sheffield:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go
to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Srinivas Nandkumar -S
for Malvina 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 (if known) K151558
Device Name
Desyncra™ for Tinnitus Therapy System Desyncra™ for Tinnitus Pro System
Indications for Use (Describe)
The Desyncra™ for Tinnitus Therapy System is intended to provide relief from the disturbance of subjective tinnitus while using the system. With regular use (over several months) as part of a tinnitus management program it may provide relief to the patient when not using the system.
The Desyncra™ for Tinnitus Therapy System is a patient device for home use.
The Desyncra™ for Tinnitus Therapy System is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.
Stimulation needs to be applied for several hours a day over a period of weeks or months.
The target population is adults over 18 years of age.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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