(72 days)
To reduce or alleviate snoring by maintaining an open airway during sleep.
Not Found
I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Snore-Ezzer." It confirms that the device is substantially equivalent to a pre-amendments device and can be marketed.
While it mentions the "Indication For Use" (to reduce or alleviate snoring by maintaining an open airway during sleep), it does not provide:
- A table of acceptance criteria and reported device performance.
- Details about the sample size, data provenance, number of experts, adjudication method, or ground truth for any test set.
- Information about MRMC studies, standalone algorithm performance, or training set details.
The letter is a regulatory approval document, not a scientific study report or a summary of validation testing. It indicates that the device has met the regulatory requirements for market clearance based on a determination of substantial equivalence, but it does not disclose the specific performance metrics or studies used to demonstrate that functional equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert A. Gall President SNORE-EZZER, LLC 1217 South Grandview Boulevard Waukesha, Wisconsin 53188
FEB 1 2 1998
Re : K974531 Snore-Ezzer Trade Name: Regulatory Class: Unclassified Product Code: LRK Dated: November 25, 1997 December 2, 1997 Received:
Dear Mr. Gall:
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 (for the indications for use stated in the enclosure) 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, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent, determination assumes compliance...with.... .... the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Gall
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K974531/A'
Page 1 of 1
K974531 510(k) Number ( if known )
Snore-Ezzer Device Name:
Indication For Use:
ri
To reduce or alleviate snoring by maintaining an open airway during sleep.
( 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 Dental, Infection Control,
and General Hospital Devices
510(k) Number K97453)
Prescription Use
( Per 21 CFR 801.109)
OR
Over-TheCounter Use
( Optional Format 1-2-96)
§ 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.”