SOMNODENT G2

K121340 · Somnomed, Inc. · LRK · May 30, 2012 · Dental

Device Facts

• Record ID: K121340
• Device Name: SOMNODENT G2
• Applicant: Somnomed, Inc.
• Product Code: LRK · Dental
• Decision Date: May 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The SomnoDent G2 is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Device Story

SomnoDent G2 is a custom-fitted, intraoral mandibular repositioning device used to treat nighttime snoring and mild to moderate obstructive sleep apnea (OSA). The device consists of separate upper and lower trays that increase pharyngeal space during sleep, improving airway patency. It features an adjustable coupling mechanism that allows a dentist or physician to set the degree of mandibular advancement (range 6-10mm). The device is worn by the patient at home or in sleep laboratories. By repositioning the lower jaw, the device helps maintain an open airway, potentially reducing snoring and OSA symptoms. It is designed for single-patient, multi-use and is cleaned daily by the patient.

Clinical Evidence

Bench testing only. Testing included mechanical force tests to simulate bruxism and evaluate the advancement mechanism, and bond strength testing on the winglets. Results demonstrated that the device performs as well as or better than the predicate device.

Technological Characteristics

Intraoral mandibular repositioner; custom-fitted trays with soft lining on hard acrylic surface; advancement mechanism constructed of biocompatible, medical-grade polycarbonate; adjustable range 6-10mm; permits mouth breathing; upper and lower trays disengage for removal.

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

• SomnoDent Flex (K073004)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized graphic above the company name. Below the company name, in smaller font, is the text "Dental * Sleep * Medical".

MAY 3 0 2012

### 510(k) Summary (21 CFR 807.92) Page 1 of 3

### 510(k) Number: K121340

| Submission Owner: | SomnoMed, Inc.<br>7460 Warren Parkway<br>Suite 190<br>Frisco, TX 75034<br>Phone: [phone] | |
|-------------------------|-----------------------------------------------------------------------------------------------|--|
| | Fax: [phone] | |
| | Email: [e-mail] | |
| Official Correspondent: | Kathryn A. Jayne | |
| Date Prepared: | February 15, 2012 | |
| Trade Name: | SomnoDent® G2 | |
| Common Name: | Intraoral device for snoring and mild to moderate obstructive<br>sleep apnea (OSA) | |
| Classification Name: | Device, Anti-Snoring | |
| Regulation Number: | 21 CFR 872.5570 | |
| Product Code: | LRK | |
| Class: | II | |
| Panel: | Dental | |
| Predicate Devices: | K073004, SomnoDent Flex | |

#### Description of the device: ~

The SomnoDent G2 device is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is customized for each intient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent G2 is a modification to the SomnoDent Flex (K073004). The SomnoDent G2 is identical to SomnoDent Flex, except for differences in the adjustment mechanism (which is an addition of a material of construction, which is biocompatible), and a change (which to an dadition of a fifterences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

#### Indications for Use:

The SomnoDent G2 is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized graphic above the company name. Below the name, in smaller font, are the words "Dental - Sleep - Medical".

# 510(k) Summary (21 CFR 807.92)

Page 2 of 3

Substantial Equivalence:

Substantial Equivalence Table

| Substantial Equivalence Table | | |
|---------------------------------------------------------------------------------------|--------------|---------------------------|
| | SomnoDent G2 | SomnoDent Flex<br>K073004 |
| Intended Use | | |
| Intended as an intraoral device | Yes | Yes |
| Intended to reduce snoring or help<br>alleviate snoring | Yes | Yes |
| Treatment of mild to moderate<br>obstructive sleep apnea | Yes | Yes |
| Intended for nighttime use | Yes | Yes |
| Indicated for single patient multiuse | Yes | Yes |
| Indicated for use at home or sleep<br>laboratories | Yes | Yes |
| Target population: adults | Yes | Yes |
| Prescription device | Yes | Yes |
| Design | | |
| Customized fit for each patient | Yes | Yes |
| Separate upper and lower tray pieces | Yes | Yes |
| Works by mandibular advancement | Yes | Yes |
| Can be adjusted or refit | Yes | Yes |
| Lower jaw adjustment using supplied<br>components | Yes | Yes |
| Permits patient to breathe through<br>mouth | Yes | Yes |
| Upper and lower trays disengage for<br>easy removal | Yes | Yes |
| Cleaned and inspected daily by patient | Yes | Yes |
| Material | | |
| Trays constructed from a soft lining<br>material adhered to a hard surface<br>acrylic | Yes | Yes |
| Advancement mechanism constructed<br>of surgical grade stainless steel | No | Yes |
| Advancement mechanism constructed<br>of biocompatible, medical grade<br>polycarbonate | Yes | No |

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a black abstract shape above the company name. Below the name, it says "Dental - Sleep - Medical" in a smaller font.

### 510(k) Summary (21 CFR 807.92) Page 3 of 3

#### Substantial equivalence discussion:

The SomnoDent G2 is considered to be substantially equivalent to the SomnoDent Flex device. The SomnoDent G2 and predicate device function as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The devices are customized for each patient and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent G2 is identical to SomnoDent Flex, except for differences in the adjustment mechanism (which is an addition of a material of construction, which is biocompatible), and a change in adjustable range from 6 to 10mm. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

#### Summary of Testing:

To demonstrate substantial equivalence, bench testing was conducted on the advancement mechanism to ensure the device performed as intended and is safe and Testing included a mechanical force test to simulate bruxism, which was effective. determined worst case use, to ensure the wings functioned as designed and withstood appropriate pressures. The results indicated that the subject device performs as well or better than the predicate device. Mechanical testing was conducted on the winglet bond of the subject device. Testing results indicate that the bonds withstand applicable pressures, ensuring the device is safe and effective. In addition, comparative testing around the coupling mechanism was conducted between the subject and predicate The testing concluded that the advancement of the subject device is devices. substantially equivalent to the predicate device with regards to mechanical performance. Testing demonstrates that the subject device, the SomnoDent G2, is as safe, as effective, and performs as well as or better than the predicate device, the SomnoDent Flex.

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

MAY 3 0 2012

Somnomed Inc. C/O Mr. Jeff D. Rongero Responsible Third Party Official Underwriters Laboratories 12 Laboratory Drive Research Triangle, North Carolina 27709

Re: K121340

Trade/Device Name: SomnoDent G2 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: May 21, 2012 Received: May 25, 2012

Dear Mr. Rongero:

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.

{4}------------------------------------------------

#### Page 2 - Mr. Rongero

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 proportive 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,

h 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

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a logo for SomnoMed, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic element above the company name, "SomnoMed," which is written in a bold, sans-serif font. Below the company name, the words "Dental - Sleep - Medical" are written in a smaller, sans-serif font.

## Indications for Use

510(k) Number (if known):

Device Name: SomnoDent G2

Indications for Use:

The SomnoDent G2 is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C) ·

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swan Runner

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

510(k) Number:

CONFIDENTIAL

12334