SNORE GUARD

K103004 · Ranir, LLC · LRK · Feb 25, 2011 · Dental

Device Facts

• Record ID: K103004
• Device Name: SNORE GUARD
• Applicant: Ranir, LLC
• Product Code: LRK · Dental
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Snore Guard is indicated for use in the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults 18 years of age or older.

Device Story

Snore Guard is an intraoral anti-snoring device; consists of a maxillary mouthguard connected to an occlusal stop (occlusal ramp). Device is custom-fitted by the patient using a boil-and-bite process. The occlusal ramp contacts the patient's mandibular incisors to maintain jaw position during sleep. Used by adults for nighttime snoring and mild to moderate Obstructive Sleep Apnea. Device functions mechanically to reposition the mandible; no electronic or software components.

Clinical Evidence

No clinical data.

Technological Characteristics

Intraoral mouthguard; maxillary tray with occlusal ramp; custom-fitted via boil-and-bite process; mechanical operation; no energy source; no software.

Indications for Use

Indicated for treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults 18 years of age or older.

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

• Snore Guard Advance (K102118)
• SleepRight Original (K100545)

Submission Summary (Full Text)

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FEB 2 5 2011

#### 510(k) Summary

#### Ranir's Snore Guard

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: December 13, 2010

#### Name of Device

Snore Guard

#### Common or Usual Name/Classification Name

Intraoral Anti-Snoring Device

#### Predicate Devices

Snore Guard Advance (K102118) SleepRight Original (K100545)

#### Purpose of Submission

The Snore Guard is a modification to the Snore Guard Advance.

#### Intended Use / Indications for Use

The Snore Guard is indicated for use in the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults 18 years of age or older.

#### Technological Characteristics

The Snore Guard 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 has the same intended use and similar indications, principles of operation, and technological characteristics as Snore Guard. The minor differences in the Snore Guard's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Snore Guard is substantially equivalent to its identified predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

## FEB 25 201

Re: K103004

Trade/Device Name: Snore Guard Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: February 17, 2011 Received: February 17, 2011

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 Eederal 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

\$\int\$

WATOS

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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# K103004

#### Indications for Use Statement

510(k) Number (if known):

Device Name: Snore Guard

Indications for Use:

The Snore Guard is indicated for use in the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults 18 years of age or older.

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 Runner

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103004