SNORE GUARD ADVANCE

K102118 · Ranir, LLC · LRK · Sep 8, 2010 · Dental

Device Facts

• Record ID: K102118
• Device Name: SNORE GUARD ADVANCE
• Applicant: Ranir, LLC
• Product Code: LRK · Dental
• Decision Date: Sep 8, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Snore Guard Advance is an intraoral anti-snoring device. It consists of a maxillary mouthguard with an integrated occlusal stop (occlusal ramp) that contacts the patient's mandibular incisors. The device is custom-fitted by the user via a 'boil-and-bite' process. It functions by positioning the mandible to maintain airway patency during sleep. It is intended for adult use to treat snoring and mild to moderate Obstructive Sleep Apnea.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Intraoral appliance consisting of a maxillary tray and an occlusal ramp. Custom-fitted using a 'boil-and-bite' thermoplastic process. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Hays & Meade Anti-Snoring Device (K882303)

Submission Summary (Full Text)

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K102118

# 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: [phone] Facsimile: [phone]

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.

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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.

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# 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 [phone] or [phone] 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

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K102118

#### 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