SOMNOFIT

K060795 · Strategic Counsel Sarl · LRK · Dec 18, 2006 · Dental

Device Facts

• Record ID: K060795
• Device Name: SOMNOFIT
• Applicant: Strategic Counsel Sarl
• Product Code: LRK · Dental
• Decision Date: Dec 18, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).

Device Story

Mandibular advancement device (MAD) for snoring and mild-to-moderate OSA; consists of upper and lower thermoplastic plates fitted via 'boil and bite' dental impression; plates connected by orthodontic elastic bands via hooks; bands pull lower jaw forward to expand airway and reduce tongue obstruction; user-operated at home nightly; allows lateral/vertical jaw movement; pressure distributed across 18-24 teeth via internal rigid skeleton band; includes thermometer for fitting, ventilated storage box, and elastic bands.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Thermoplastic dental plates with internal rigid 'skeleton' band; mechanical mandibular advancement via orthodontic elastic bands; universal one-size-fits-all design; custom-fitted via hot water immersion; non-powered; manual operation.

Indications for Use

Indicated for adults requiring reduction or alleviation of snoring and mild to moderate obstructive sleep apnea.

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

• Respironics Silencer (K033822)
• SUAD Device (K023836)
• SleepBite (K013808)
• TAP (K962516)
• NorAD (K013049)

Submission Summary (Full Text)

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## STRATEGIC COUNSEL SARL

42754 Edwards Ferry Road Leesburg, Va. 20176

K060795

DEC 1 8 2006

November 27, 2006

Telephone- 703 777 8404 703 777 7971 Fax-

## 510{k) K060795 Non-Confidential Summary of Safety and Effectiveness

Official Contact: Proprietary or Trade Name: Common Name: Descriptive Name: Device Classification Name: Product Code: Classification Reference: Device Class: Intended Use:

John Dennis, Strategic Counsel Sàrl Somnofit Anti-snoring device Mandibular Advancement Device (MAD) Device, Anti-snoring LRK - Anti-Snoring Device 21 CFR 872.5570 Class II To reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).

#### Substantial Equivalence

Substantial equivalence is made with predicate anti-snoring devices, which are fitted over the lower and upper teeth by "boil and bite" or "boil and fit". Once fitted over the lower and upper jaws, these devices advance the lower jaw forward by connecting with a slight pressure the two jaws at an angle thereby pulling the lower jaw slightly forward. These devices are also referred to as "mandibular advancement devices" with the same intended use of reducing snoring and sleep apnea.

The Somnofit device is of a similar design and functions in a similar manner to other comparable predicate devices and the intended uses are the same. The general differences or modifications between this device and predicate devices are minor and do not raise new safety concerns. Specific predicate devices that fall in this category include:

The Respironics Silencer (K033822) SUAD Device (K023836) SleepBite (K013808) TAP (K962516) NorAD (K013049)

### Device Description and intended use

Like these predicate devices, Somnofit is intended as an aid in the alleviation of snoring by positioning the lower jaw slightly forward thereby freeing the air intake and releasing back the tongue thereby decreasing air obstruction and turbulence. The device is normally placed in users' mouth each evening prior to sleeping and removed from the mouth the following morning. The device fits one user, is multi-use and cleaned daily.

The Somnofit anti-snoring device consists of:

- Lower plate fitted over lower teeth .

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- . Upper plate fitted over upper teeth
Hook mechanism, two located on right and left side of upper plate, four hooks on . lower plate, two on left side and two on right side used to connect two bands one on the right upper and right lower plates, the other on the left upper and left lower plates.

- A floating thermometer .
- . A ventilated storage box
- A packet of 100 orthodontic rubber bands .
- . Instructions

The two buccal mouldings (upper and lower) are designed for universal application in adults with the use of one-size-fits all. The dentist or physician takes a dental impression, by immersing each moulding in hot water, as indicated with the included thermometer in order to soften the impressible plastic material then pressing the plates against the user's upper and lower jaws in order to form a fitting to the size dimensions of user's iaws and teeth. Once individually fit the first time, there is no need to reheatiremold the two plates. The upper and lower jaws fittings are linked by way of two orthodontic elastic bands connected by way of hooks located on the right and left front part of the plates. Two sets of hooks are present on both sides of the lower plate to allow the user to choose a looser or tighter tension of the bands. The upper single hook is located in front of the lower two sets of hooks. This way the bands thrust the lower jaw forward a few millimeters in front of the upper jaw. The elastic bands permit full lateral and vertical movement of device as well as some horizontal movement in user's mouth.

#### Table 1: Risk Profile

| Identified risk | Special controls |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intraoral gingival, palatal or dental soreness | |
| Obstruction of oral breathing | The angle of the elastic bands connecting the<br>upper and lower plates ensures a positioning of<br>the lower jaw a few millimeters in front of upper<br>jaw thereby expanding passageway,<br>decreasing air obstruction. |
| Loosening or flaring of lower anterior teeth or<br>General tooth movement | The frames are designed to cover most of the<br>teeth thereby dispersing the pressure from the<br>elastic bands over a wider group of teeth. |

Encompassed inside the outer layer is a "skeleton" band, which is rigid in material but is made of a chain of rectangles with gaps in between. The gaps allow the whole band to optimally fit to the width of each tooth. This provides for a better fit over most of the user's teeth. With the molding pre-fitted to the user's dental morphology, the elastic traction is distributed over the 18- to 24- teeth.

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# Diagrams and Materials Used

Image /page/2/Figure/2 description: The image shows a diagram of the Artoflex system, which is a dental device. The diagram includes three different views of the device, including a top view, a front view, and a side view. The text in the image describes the Artoflex system as having internal tri-directional articulation for perfect adaptation to any dental morphology and optimal and comfortable retention in the mouth.

510(K) Non-Confidential Summary of Safety and Effectiveness – Somnofit - 3 November 2006

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

DEC 1 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OSCIMED SA C/O Mr. John Dennis Strategic Counsel Sarl 42754 Edwards Ferry Road Leesburg, Virginia 20176

Re: K060795 Trade/Device Name: Somnofit Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring Intraoral and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: December 4, 2006 Received: December 11, 2006

Dear Mr. Dennis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Dennis

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runnes
Shin-Ling, Ph.D.

Chiu Lin, Ph.D. 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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# Indications for Use Form

Page 1 of 1

510(k) Number (if known): K060795

Device Name: Somnofit

Indications For Use: To reduce or alleviate snoring and mild to moderate obstructive sleep apnea.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use

Anesthesiology, General Hospital
Infection Control, Dental Devices

Number: K060775