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Snorefree
This document is a letter from the FDA to Dr. Scott E. Feldman regarding the 510(k) premarket notification for a device named "Snorefree." The letter states that the FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976, and therefore, it can be marketed subject to general controls provisions of the Act.
The document does not contain information about:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi reader multi case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This letter is a regulatory approval document based on substantial equivalence, not a study report detailing performance metrics and validation methods. Therefore, I cannot extract the requested information from the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JAN - 4 1996
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scott E. Feldman, D.D.S. Scott Feldman D.D.S. & Norman Shapiro D.D.S. 6319 Desota Avenue, Suite 401 Woodland Hills, California 91367
Re: K925336 Snorefree Trade Name: Regulatory Class: Unclassified Product Code: LRK November 2, 1995 Dated: November 20, 1995 Received:
Dear Dr. Feldman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 320) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2 - Dr. Feldman
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HF2-300) at (301) 594-4639. Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
B. C. Whitmarsh'
Timothy /A. Ulatowski Acting Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”