SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX

K140278 · Somnomed, Inc. · LRK · Jun 20, 2014 · Dental

Device Facts

• Record ID: K140278
• Device Name: SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
• Applicant: Somnomed, Inc.
• Product Code: LRK · Dental
• Decision Date: Jun 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SomnoDent Fusion 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 Fusion is a patient-specific, custom-fitted intraoral mandibular repositioning device. It consists of separate upper and lower trays that increase pharyngeal space during sleep to improve airway exchange. The device features an adjustable coupling mechanism, allowing a dentist or physician to set the degree of mandibular advancement at the time of fitting. It is intended for nighttime use by patients at home or in sleep laboratories. The device allows for mouth breathing and can be easily removed by the patient. It is cleaned and inspected daily by the user. The device benefits patients by reducing snoring and alleviating symptoms of mild to moderate obstructive sleep apnea.

Clinical Evidence

Bench testing only. Mechanical testing was conducted on the advancement and calibration mechanisms to ensure the device withstands applicable pressures and performs as intended. No clinical data was required or provided.

Technological Characteristics

Custom-fitted intraoral device; materials include acrylic or soft-lining material adhered to acrylic; advancement mechanism constructed of surgical grade stainless steel; adjustable coupling mechanism for mandibular advancement; non-powered; mechanical operation.

Indications for Use

Indicated for treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults 18 years or older. Prescription use only.

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 Classic (K050592)
• SomnoDent Flex (K073004)
• SomnoDent G2 (K121340)

Reference Devices

• SomnoDent Herbst (K130558)

Submission Summary (Full Text)

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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 are the words "Dental * Sleep * Medical".

510(k) Summary (21 CFR 807.92)

JUN 2 0 2014

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# 510(k) Number: К | Чб278

| Submission Owner: | SomnoMed, Inc. |
|-------------------------|---------------------------------------------------------------|
| | 7460 Warren Parkway |
| | Suite 190 |
| | Frisco, TX 75034 |
| | Phone: [phone] x106 |
| | Fax: [phone] |
| | Email: [e-mail] |
| Official Correspondent: | Kathryn A. Jayne |
| Date Prepared: | January 31, 2014 |
| Trade Name: | SomnoDent® Fusion |
| Common Name: | Intraoral device for snoring and mild to moderate obstructive |
| | sleep apnea (OSA) |
| Classification Name: | Device, Anti-Snoring |
| Regulation Number: | 21 CFR 872.5570 |
| Product Code: | LRK |
| Class: | II |
| Panel: | Dental |
| Predicate Devices: | K050592, SomnoDent Classic |
| | K073004, SomnoDent Flex |
| | K121340, SomnoDent G2 |

### Description of the device:

The SomnoDent Fusion 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 patient specific (it is customized for each patient) 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 Fusion is a modification to the SomnoDent Classic (K050592), SomnoDent Flex (K073004), SomnoDent G2 (K121340) and SomnoDent Herbst (K130558). The SomnoDent Fusion is identical to SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst except for differences in the adjustment mechanism. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

# Indications for Use:

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

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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, the words "Dental * Sleep * Medical" are printed in a smaller font.

# 510(k) Summary (21 CFR 807.92)

# Substantial Equivalence:

Substantial Equivalence Table

| | SomnoDent<br>Fusion | SomnoDent<br>Classic<br>K050592 | SomnoDent<br>Flex<br>K073004 | SomnoDent<br>G2<br>K121340 | SomnoDent<br>Herbst<br>K130558 |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------------------|------------------------------|------------------------------------------------------|------------------------------------------------------|
| Intended Use | | | | | |
| Intended as an<br>intraoral device | Yes | Yes | Yes | Yes | Yes |
| Intended to<br>reduce snoring<br>or help alleviate<br>snoring | Yes | Yes | Yes | Yes | Yes |
| Treatment of<br>mild to<br>moderate<br>obstructive<br>sleep apnea | Yes | Yes | Yes | Yes | Yes |
| Intended for<br>nighttime use | Yes | Yes | Yes | Yes | Yes |
| Indicated for<br>single patient<br>multiuse | Yes | Yes | Yes | Yes | Yes |
| Indicated for<br>use at home or<br>sleep<br>laboratories | Yes | Yes | Yes | Yes | Yes |
| Target<br>population:<br>adults | Yes | Yes | Yes | Yes | Yes |
| Prescription<br>device | Yes | Yes | Yes | Yes | Yes |
| Design | | | | | |
| Customized fit<br>for each patient<br>(patient<br>specific) | Yes | Yes | Yes | Yes | Yes |
| Separate upper<br>and lower tray<br>pieces | Yes | Yes | Yes | Yes | Yes |
| Works by<br>mandibular<br>advancement | Yes | Yes | Yes | Yes | Yes |
| | SomnoDent<br>Fusion | SomnoDent Classic<br>K050592 | SomnoDent Flex<br>K073004 | SomnoDent G2<br>K121340 | SomnoDent Herbst<br>K130558 |
| Can be<br>adjusted or refit | Yes | Yes | Yes | Yes | Yes |
| Lower jaw<br>adjustment<br>using supplied<br>components | Yes | Yes | Yes | Yes | Yes |
| Permits patient<br>to breathe<br>through mouth | Yes | Yes | Yes | Yes | Yes |
| Upper and<br>lower trays<br>disengage for<br>easy removal | Yes | Yes | Yes | Yes | Yes |
| Cleaned and<br>inspected daily<br>by patient | Yes | Yes | Yes | Yes | Yes |
| Material | | | | | |
| Trays<br>constructed<br>from a soft<br>lining material<br>adhered to a<br>hard surface<br>acrylic | Yes<br>(Flex retention)<br>No<br>(Classic retention) | No | Yes | Yes<br>(Flex retention)<br>No<br>(Classic retention) | Yes<br>(Flex retention)<br>No<br>(Classic retention) |
| Advancement<br>mechanism<br>constructed of<br>surgical grade<br>stainless steel | Yes | Yes | Yes | No | Yes |

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Image /page/2/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized black shape above the name "SomnoMed" in a bold, sans-serif font. Below the name, in a smaller font, are the words "Dental • Sleep • Medical".

# 510(k) Summary (21 CFR 807.92) Page 4 of 4

SomnoMed SomnoDent Fusion 510(k) Submission

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Image /page/3/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized graphic above the company name. Below the name, it says "Dental - Sleep - Medical".

# 510(k) Summary (21 CFR 807.92) Page 4 of 4

### Substantial equivalence discussion:

The SomnoDent Fusion is considered to be substantially equivalent to the SomnoDent Classic, Flex, G2, and Herbst device. The SomnoDent Fusion and predicate devices 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 patient specific (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 Fusion is identical to SomnoDent Classic, Flex, G2, and SomnoDent Herbst except for differences in the adjustment. The SomnoDent Fusion will be available in one of two material types, acrylic (identical to SomnoDent Classic) or soft lining adhered to acrylic (SomnoDent Flex). 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, testing was conducted on the advancement mechanism to ensure the device performed as intended and is safe and effective. Mechanical testing was conducted on the calibration mechanism of the subject device. Testing results indicate that the mechanism withstands applicable pressures, ensuring the device is safe and effective. The testing concluded that the advancement of the subject device is substantially equivalent to the predicate device with regards to mechanical performance. Testing demonstrates that the subject device, the SomnoDent Fusion, is as safe, as effective, and performs as well as or better than the predicate devices, the SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst.

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Public Health Service

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

# June 20, 2014

SomnoMed. Incorporated Ms. Kathryn Jayne Regulatory Affairs/Quality Assurance Manager 7460 Warren Parkway, Suite 190 Frisco, TX 75034

Re: K140278

Trade/Device Name: SomnoDent Fusion Classic, Somnodent Fusion Flex Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Il

Product Code: LRK Dated: June 4, 2014 Received: June 5, 2014

Dear Ms. Jayne:

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 10 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 - Ms. Jayne

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for SomnoMed, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic of two overlapping shapes, one solid black and the other filled with white dots. Below the graphic is the company name, "SomnoMed," in a bold, sans-serif font, with the words "Dental • Sleep • Medical" in a smaller font underneath.

# DEPARTMENT OF KEALTH AND HUMAN SERVICES
Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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610(k) Number (if known)

K140278

Device Name SonnoDent Fusion

Indications for Use (December)

Indications for Use (Decorde)
The Sommonlews Fission is imment of sightines maring and mild to modests obstructive sloep spass in patients 18 years of age or older.

| Type of Use (Select one or both, as applicable) | <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Sheena A. Green -S |
|------------------------------------------------------------------------------|-----------------------------|
| | 2014.06.20 13:21:29 -04'00' |
| FORM FDA 3881 (1/14) | Page 1 of 2 |

CONFIDENTIAL SomnoMed SomnoDent Fusion Special 510(k) Submission

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