SOMNOMED BFLEX

K073004 · Somnomed, Inc. · LRK · Jan 30, 2008 · Dental

Device Facts

• Record ID: K073004
• Device Name: SOMNOMED BFLEX
• Applicant: Somnomed, Inc.
• Product Code: LRK · Dental
• Decision Date: Jan 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea.

Device Story

SomnoMed MAS Flex "S" is a custom-fitted intra-oral mandibular repositioning device; used for treatment of snoring and mild to moderate obstructive sleep apnea. Device consists of two trays (upper and lower) that fit over teeth; trays engage via adjustable lugs allowing dentist/physician to set mandibular advancement. Device increases pharyngeal space during sleep to improve airflow. Used in home or sleep laboratory environments; fitted under supervision of licensed practitioner. Patient wears device overnight; device permits mouth breathing and allows trays to disengage for removal. Benefits include reduction of snoring and OSA symptoms through mechanical airway support.

Clinical Evidence

Bench testing only. Comparative performance testing was conducted using the previously cleared material Ivocap Elastomer (K896130). Testing established material biocompatibility and product strength for the SMH Flex "S" material.

Technological Characteristics

Intra-oral mandibular repositioning device. Constructed from molded hard acrylic with a soft lining material (SMH Flex "S") for tooth retention. Features adjustable lugs for mandibular advancement. Custom-fitted to patient dentition. Non-powered, mechanical device.

Indications for Use

Indicated for adult patients suffering from snoring or mild to moderate obstructive sleep apnea (OSA).

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

• SomnoMed MAS (K020592)

Reference Devices

• OASYS (K030407)
• TAP 11 (K062951)
• SomnoMed Flex 292 (K050592)
• Ivocap Elastomer (K896130)

Submission Summary (Full Text)

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Premarket Notification - SomnoMed MAS Flex "S"

K073004

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information: SomnoMed Inc

JAN 30 Ok

Date Summary Prepared: 5th October 2007

Contact Persons: Ashley Truitt

Device Name: Trade Name(s): SomnoMed MAS Flex "S" Classification Name: Device, Anti-snoring (21CFR827.5570) Panel: Dental Product Code: LRK

#### Predicate Device Information:

| Device Name<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Manufacturer | 510(k) Reference |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------|
| SomnoMed MAS | SomnoMed Inc | K020592 |

### Device Description:

The Somnomed MAS Flex "S" is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

Intended use - The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea.

Target population – Adult patients who have a problem with snoring or obstructive sleep apnea.

Environment of Use – The device is initially fitted under the supervision of a licensed practitioner (dentist or physician) and is subsequently used in either a home environment or in a sleep laboratory.

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# Comparison to Predicate Device:

K073002
2 of 3

This submission is for a modification to the originally cleared SomnoMed MAS device.

The SomnoMed MAS Flex "S" is substantially equivalent to the SomnoMed MAS with the only exception of a soft lining material (SMH Flex "S") that can be used instead of the stainless steel ball clasps for retention. The difference between the two types of retention are that the soft lining material (SMH Flex "S") is technologically advanced to grip around the tooth creating a good retention which is designed for patient comfort, this negates the need for metal retention such as ball clasps.

| | SomnoMed<br>MAS<br>K050592 | OASYS<br>K030407 | TAP 11<br>K062951 | SomnoMed<br>Flex 292 |
|---------------------------------------------------------------------------------------|----------------------------|------------------|-------------------|----------------------|
| Indications for Use | | | | |
| Treatment of Snoring in Adults | yes | yes | yes | Yes |
| Treatment of mild to moderate obstructive sleep apnea | yes | yes | yes | yes |
| Use | | | | |
| Intra oral device for overnight use | yes | yes | yes | yes |
| Single patient multi use | yes | yes | yes | yes |
| Use at home or at a Sleep Laboratory | yes | yes | yes | yes |
| Prescription Device | yes | yes | yes | yes |
| Action | | | | |
| Works by mandibular advancement | yes | yes | yes | yes |
| Design | | | | |
| Custom fit for each patient | yes | yes | yes | yes |
| Rigid separate upper and lower tray pieces | yes | yes | yes | yes |
| Can be adjusted or refit | yes | yes | yes | yes |
| Lower jaw adjustment using a supplied adjustment key | yes | yes | yes | yes |
| Cleaned and inspected daily | yes | yes | yes | yes |
| Permits patient to breathe through the mouth | yes | yes | yes | yes |
| Upper and lower trays disengage for easy removal from mouth | yes | yes | yes | yes |
| Materials | | | | |
| Trays constructed from molded hard acrylic and ball clasps | yes | no | no | no |
| Trays constructed from a soft lining material adhered to a hard<br>surface acrylic | no | no | no | yes |
| Trays constructed from a heat sensitive impress able material for<br>fitting to teeth | no | yes | yes | no |

The difference between the intended device SomnoMed Flex "S" and the predicate devices are the materials. All of the predicates act as mandibular repositioners for the treatment of Snoring and mild to moderate Obstructive Sleep Apnea. This difference does not have significant effect on the safety or effectiveness of the SomnoMed MAS Flex "S". It is the prescribing physician's choice what material is used for the patients comfort and what is most suitable for the individual patient's dentition.

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K673004
373

Comparative performance testing was carried out with a previously cleared predicate material Ivocap Elastomer K896130 that is used in the Orthodontic field for the fabrication of Tooth Positioners, Mouthguards and Soft Bite Guards.

## Performance Test Data and Conclusions:

Bench testing has established material biocompatibility and product strength with the material SMH Flex "S".

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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 consists of a stylized eagle with three human figures within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 30 2008

Ms. Ashley Truitt SomnoMed Incorporated 3537 Teasley Lane Denton, Texas 76210

Re: K073004

Trade/Device Name: SomnoMed MAS Flex "S" 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, EBI Dated: December 15, 2007

Dear Ms. Truitt:

Received: January 25, 2008

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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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 (OS) 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 vour 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,

Suita y. Michioms

Chiú Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

K073004

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1081

510(k) Number (if known):

Device Name: SomnoMed MAS Flex "S"

Indications for Use:

The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time Snoring and mild to moderate Obstructive Sleep Apnea (OSA).

| Prescription Use | XX |
|-----------------------------|----|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

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)

| | <div align="center"></div> |
|-----------------------------------------------------------------------------------|----------------------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| 510(k) Number: | K073004 |