(85 days)
To Alleviate or correct simple snoring by maintaining an open airway during sleep and to prevent bruxing and grinding of teeth.
Not Found
The provided document is a 510(k) clearance letter from the FDA for "Dr. B's Mouthpiece, Model 32129-10002" with the trade name "Snore-Ezzer, LLC". This document states that the device has been found substantially equivalent to a legally marketed predicate device.
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample sized used for the test set and the data provenance: This information is not present in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
- Adjudication method for the test set: This information is not present in the document.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present in the document.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not present in the document.
- The type of ground truth used: This information is not present in the document.
- The sample size for the training set: This information is not present in the document.
- How the ground truth for the training set was established: This information is not present in the document.
The document is a regulatory clearance and details the FDA's decision based on the application, not the technical study results themselves. To find the information you're looking for, you would typically need to refer to the 510(k) Summary or the 510(k) Premarket Notification submission documents, which are separate from this clearance letter.
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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1999
Mr. Robert A. Gall Snore-Ezzer, LLC 1217 South Grandview Boulevard Waukesha, Wisconsin 53188
Re: K991948 Dr. B's Mouthpiece, Model 32129-10002 Trade Name: Requlatory Class: Unclassified Product Code: LRK June 4, 1999 Dated: Received: June 9, 1999
Dear Mr. Gall:
We have reviewed your Section 510(k) notification of intent to we have reviewed joarenced above and we have determined the market the devicetially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in tho 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 regulations 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 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA 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
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Page 2 - Mr. Gall
the Act for devices under the Electronic Product Radiation the Act for devices under the Electronic Froductions.
Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as the FDA This letter will allow you to begin marketing for the FDA
described in your 510(k) premarket notification. The FDA described in your 510 (k) premarket notification. - Ene Flegally
finding of substantial equivalence of your device to a ror your finding of substantial equivalence of your device of a response marketed predicate device results in a crassirsdated by of
device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling
and and and 173 and 201 and additionally 809.10 for in If you desire specific advice for your additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CPR Part 801 and addressat the Office of
vitro diagnostic devices), please contact the Office of yitro diagnostic devices), please contact the original on and Compliance at (301) 594-4692. Additionariy, Los as Contact
the promotion and advertising of your device, please not the promotion and advertising of your device, proad be and and and the office of the Office of the Office of Compliance at (301) 334 reference to the regulation entification" (21 CFR 807.97). Other general
premarket notification" (21 CFR 807.97). Other general premarket notification" (21 CFR 807.97). Sthe Act may be information on your responsibilities ands- turers Assistance
obtained from the Division of Small Manufacturers Assistance obtained from the Division of Smart Manufacturer (101) 443-6557) or at
at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its toll-free number (800) 638-2041 of (302) 113 -0.
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number ( if known )
Device Name:
DR. B'S Mouthpiece
Indication For Use:
To Alleviate or correct simple snoring by maintaining an open airway during sleep and to prevent bruxing and grinding of teeth.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rmoner
Division Sign-Off (Division Sign-On)
Division of Dental, Infection Control, and General Hospital Device 510(k) Number
Prescription Use OR L ( Per 21 CFR 801.109 )
Over-TheCounter Use
( Optional Format 1-2-96 )
510(k) Snore-Ezzer, LLC
22
§ 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.”