SOMNOMED MAS RXA

K050592 · Somnomed, Ltd. · LRK · Jul 12, 2005 · Dental

Device Facts

• Record ID: K050592
• Device Name: SOMNOMED MAS RXA
• Applicant: Somnomed, Ltd.
• Product Code: LRK · Dental
• Decision Date: Jul 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SomnoMed MAS RxA is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Device Story

Intraoral mandibular advancement device; custom-fitted trays for upper and lower teeth; adjustable lug and wing mechanism; dentist/physician-adjusted to set mandibular advancement; increases pharyngeal space; improves airway exchange during sleep; reduces snoring and mild-to-moderate OSA; patient-worn during sleep.

Clinical Evidence

No clinical data; substantial equivalence based on design, material, and intended use similarity to predicate.

Technological Characteristics

Custom-fitted dental acrylic trays; adjustable lug and wing mechanism for mandibular advancement; mechanical device; no energy source; non-sterile.

Indications for Use

Indicated for adults with mild to moderate obstructive sleep apnea (OSA) and snoring.

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

• MDSA (K042161)

Submission Summary (Full Text)

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SomnoMed
Limited A.C.N. 003 255 221

K050592

Level 3, 20 Clarke Street Crows Nest, NSW 2065 Australia

[phone] Tel : [phone] Fax :

www.somnomed.com.au

JUL 1 2 2005

# 510(k) Summary

| Contact Person: | Elaine Duncan |
|----------------------|-----------------------------------------------------------|
| | Paladin Medical Inc.<br>PO Box 560<br>Stillwater MN 55082 |
| | Tel: [phone]<br>Fax: [phone] |
| Brand Name: | SOMNOMED MAS RXA |
| Common Name: | Mandibular advancement device |
| Classification Name: | Device, anti-snoring (21CFR872.5570]) |
| Product Code: | LRK |
| Predicate Device: | MDSA K042161 |
| Date Prepared: | 3 March 2005 |

Description Of The Device: The Somnomed MAS RxA is an intraoral device used for treating Snoring and Sleep Apnea. It consists of two custom fitted trays which fit over the treading Ononing and Groop Aprilation of adjustable lugs. The device functions as a upper und lower toon and only-gests the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is custom made for each patient and thas the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

Indications For Use: The SomnoMed MAS RxA is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Summary of Equivalence: The Somnomed MAS RxA is considered to be substantially equivalent to the Bird MDSA device. Both the Somnomed MAS RxA and the MDSA are equivalion to the Bira hade titratable mandibular repositioning devices for the dental treatment of patients suffering snoring and mild to moderate obstructive sleep apnea.

The technical designs and manufacture of the two devices are almost identical, being r he techniour dooghe and mananavars which fit onto the upper and lower teeth and which are positioned in relation to each other by an adjustable mechanism. The only design are poollionou in relation to the adjustable mechanisms in the two devices. The MDSA difference to in the natibular advancement by means of a locking clasp placed at the front centre of the two acrylic trays, whereas the Somnomed RxA uses interlocking lugs and wings placed on the sides of the trays. The dental acrylic, adjustment screws and ball clasps used to manufacture the Somnomed MAS RxA have all been granted prior 510(k) approval for use in manufacture of dental appliances

A risk assessment concluded that there were no new safety concerns raised by the design of the Somnomed MAS RxA.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2005

:

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Somnomed Limited C/O Ms. Elaine Duncan Paladin Medical Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K050592

Trade/Device Name: MAS RxA 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: June 9, 2005 Received: June 15, 2005

Dear Ms. Duncan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your ever letermined the device is substantially equivalent (for the relerenced above and have attermelosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 the rederal 1 00a, Drag, and , You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of 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 If your device is clusified (boo as of lotter and controls. Existing major regulations affecting (1 Mr), it may be such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.

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### Page 2 -- Ms. Duncan

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 modifine and regulations and regulations administered by other Federal agencies. of the Act of ally I oderal but requirements, including, but not limited to: registration r od into compry - 1 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and if the (21 ce read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betronic 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) Print reter wrification. The FDA finding of substantial equivalence of your device to a premaired 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), rf you desite spiece 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 Inay obtain 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.

Anthony O'Connell for

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

510(k) Number (if known): K050592

Device Name: MAS RxA

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Indications For Use:

The SomnoMed MAS RxA is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

______________________________________________________________________________________________________________________________________________________________________________ Prescription Use

Over-The-Counter Use_ AND/OR

(Part 21 CFR 801 Subpart D)

(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)

for MSR

(Division Sign-Off) Division of Anesthesiology, Ge Infection Control, Dental

510(k) Number. K050592