(301 days)
The SleepApp™ is intended for the treatment of snoring and mild to moderate obstructive sleep apnea in adults 18 years of age and older.
Not Found
This document is a marketing clearance letter from the FDA for a medical device called "SleepApp™". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The letter does not contain any information about acceptance criteria or performance studies of the device. It is a regulatory approval document based on the submission of a 510(k) premarket notification. Therefore, I cannot provide the requested information.
The sections you've provided, {0}, {1}, and {2}, are standard FDA communication and an "Indications for Use Form." None of these sections detail acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies. These types of details would typically be found in the manufacturer's 510(k) submission itself, which is not provided here.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Richard Moore Dental Director, Regulatory Affairs Sleep Medicine Network, Incorporated 7931 NE Halsey Suite 305 Portland, Oregon 97213
NOV 1 9 2010
Re: K100185
Trade/Device Name: SleepApp™ Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Device for Snoring and Intraoral Device for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: October 28, 2010 Received: October 28, 2010
Dear Mr. Moore:
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.
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Page 2- Mr. Moore
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
| 510(k) Number (if known): | K100185 |
|---|---|
| Device Name: | SLEEP APP ™ |
Indications for Use:
The SleepApp™ is intended for the treatment of snoring and mild to moderate obstructive sleep apnea in adults 18 years of age and older.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
Susan Penner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K00185
Page 1 of 1
§ 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.”