(42 days)
The Snore Guard Advance is intended to be used for the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults.
The Snore Guard Advance consists of a mouthguard worn on the maxilla, connected to an occlusal stop (called an "occlusal ramp"), which contacts the patient's mandibular incisors. Both the maxillary tray and the occlusal ramp are custom fitted using a "boil-and-bite" process.
This 510(k) summary for Ranir's Snore Guard Advance does not provide the requested information about acceptance criteria and a study proving the device meets those criteria. The document is a premarket notification for a Class II medical device, focused on demonstrating substantial equivalence to a predicate device rather than presenting performance study results against specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details based on the provided text.
The summary states:
"The Snore Guard Advance has the same intended use and similar indications, principles of operation, and technological characteristics as Hays & Meade Anti-Snoring Device. The minor differences in the Snore Guard Advance's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Snore Guard Advance is substantially equivalent to its predicate devices."
This indicates that the primary proof was demonstrating equivalence to an already approved device, rather than conducting a new clinical study with predefined acceptance criteria for efficacy and safety.
{0}------------------------------------------------
510(k) Summary
Ranir's Snore Guard Advance
SEP 0 8 2010
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512 Phone: (616) 698-8880 Facsimile: (616) 656-7650
Contact Person: Jeff Fisher
Date Prepared: July 27, 2010
Name of Device
Snore Guard Advance
Common or Usual Name/Classification Name
Intraoral Anti-Snoring Device
Predicate Devices
Hays & Meade Anti-Snoring Device (K882303)
Purpose of Submission
The Snore Guard Advance is a modification to the Hays & Meade Anti-Snoring Device.
Intended Use / Indications for Use
The Snore Guard Advance is intended to be used for the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults.
Technological Characteristics
The Snore Guard Advance consists of a mouthguard worn on the maxilla, connected to an occlusal stop (called an "occlusal ramp"), which contacts the patient's mandibular incisors. Both the maxillary tray and the occlusal ramp are custom fitted using a "boil-and-bite" process.
Substantial Equivalence
The Snore Guard Advance has the same intended use and similar indications, principles of operation, and technological characteristics as Hays & Meade Anti-Snoring Device. The minor differences in the Snore Guard Advance's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Snore Guard Advance is substantially equivalent to its predicate devices.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ranir LLC C/O Mr. Gerard J. Prud'homme Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004
SEP 0 8 2010
Re: K102118
Trade/Device Name: Snore Guard Advance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Sleep Apnea Regulatory Class: II Product Code: LRK Dated: August 24, 2010 Received: August 24, 2010
Dear Mr. Prud'homme:
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.
{2}------------------------------------------------
Page 2- Mr. Prud'homme
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" (21CFR 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,
Nh 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
{3}------------------------------------------------
Indications for Use Statement
510(k) Number (if known):_
Device Name: Snore Guard Advance
Indications for Use:
The Snore Guard Advance is indicated for use in the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults.
Prescription Use × (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Purves
(Division Sign-Off) (Division Sign On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: K102118
SEP 0 8 2010
§ 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.”