(75 days)
To be used for the treatment of simple snoring in both dentate and edentult patientis. Can be used also for the treatment of snoring in patients with periodontically comprised dentitions and likewise patients presenting with Tempero-mandibular Dysfunction (TMD). Cephalometric and videoendoscopy studies have established that tongue protrusion creates a greater, increase in oropharyIngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function.
TONGUE STABILIZING DEVICE
I am sorry, but the provided text is a 510(k) clearance letter for a medical device and does not contain the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. The letter primarily states that the device, a "Tongue Stabilizer Device" for the treatment of simple snoring, is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- Whether a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document explicitly mentions "Cephalometric and videoendoscopy studies have established that tongue protrusion creates a greater, increase in oropharyngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function." However, details about these studies, such as their acceptance criteria, specific results, sample sizes, or ground truth methodology are not provided in this regulatory letter.
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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 1999
Ms. Christina M. LaJoie Sleep Apnea/Snoring Project Manager Great Lakes Orthodontics, LTD 199 Fire Tower Drive P.O. Box 5111 Tonawanda, New York 14151-5111
Re : K993381 Tongue Stabilizer Device Trade Name: Requlatory Class: Unclassified Product Code: LRK September 8, 1999 Dated: Received: October 7, 1999
Dear Ms. LaJoie:
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, 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) requlation (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
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Page 2 - Ms. LaJoie
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 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 leqally 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) 594-4692. 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
Timothy A. Ulatowski 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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1993381 510(k) Number (if known):
TONGUE STABILIZING DEVICE Devide Name:
Indications For Use:
To be used for the treatment of simple snoring in both dentate and edentult Can be used also for the treatment of snoring in patients with patientis. periodontically comprised dentitions and likewise patients presenting with Tempero-mandibular Dysfunction (TMD). Cephalometric and videoendoscopy studies have established that tongue protrusion creates a greater, increase in oropharyIngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Presoription Use (Per 21 CFR 801.108
Susan Swanson
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Dodsion of Dental, Infection Control, and General Hospital Device 510(k) Number
0011:07 / 2007 / 1 200
もらくなり!む E 2006 URP TOE THE SECOL 2007
§ 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.”