MPOWRX SNORING SOLUTION

K081965 · Mpowrx Health and Wellness Products, Inc. · LRK · Oct 27, 2008 · Dental

Device Facts

• Record ID: K081965
• Device Name: MPOWRX SNORING SOLUTION
• Applicant: Mpowrx Health and Wellness Products, Inc.
• Product Code: LRK · Dental
• Decision Date: Oct 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.

Device Story

MPowRx Snoring Solution is a one-piece, one-size-fits-all oral appliance for mild to moderate snoring. Device fits between lips and teeth; features an aperture with a protrusion. User squeezes protrusion to reduce air volume, creating a vacuum that retains the tongue in a forward position. Forward tongue retention keeps upper respiratory air passages open during sleep. Device is used by patients at home; intended for prescription use.

Clinical Evidence

Bench testing only.

Technological Characteristics

One-piece, one-size-fits-all oral appliance. Fabricated from common oral appliance material. Mechanical retention via vacuum-assisted tongue protrusion. No electronic components or software.

Indications for Use

Indicated for treatment of mild to moderate snoring in patients. 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

• Snor-X Mouth Guard (K954324)
• Tongue Stabilizer Device (K993381)
• Nose Breathe Mouthpiece for Heavy Snorer (K013687)

Submission Summary (Full Text)

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K081965

#### 510(k) Summary (per 21 CFR 807.92(c))

OCT 2 7 2008

### 1. Applicant

Tech Avenue Ventures d/b/a MPowRx Health and Wellness Products Inc. #510 3553-31 St. NW Calgary, Alberta T2L 2K7 Canada

Contact Person: Gijs van Rooijen, PhD, Principal Tel: [phone] Fax: [phone] E-mail: [e-mail] Date Prepared: June 30, 2008

#### 2. Device Name

| Trade Name: | MPowRx™ Snoring Solution |
|----------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Device, Anti-Snoring |
| Classification Name: | Intraoral devices for snoring and intraoral devices for<br>snoring and obstructive sleep apnea |
| Regulation Number: | 872.5570 |
| Product Code: | LRK |
| Classification: | II |
| Panel: | Dental |

#### 3. Predicate Devices

The MPowRx™ Snoring Solution is substantially equivalent to the following devices:

| 510(k)<br>Number | Device | Applicant |
|------------------|------------------------------------------|---------------------|
| K954324 | Snor-X Mouth Guard | Snorex, Inc. |
| K993381 | Tongue Stabilizer Device | University of Otago |
| K013687 | Nose Breathe Mouthpiece for Heavy Snorer | Steven K. Sue |

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#### 4. Intended Use

The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.

#### 5. Description of the Device

The MPowRxTM Snoring Solution is a simple one-piece, one-size-fits-all oral appliance used to prevent mild to moderate snoring. The MPowRx™ Snoring Solution is comfortably retained within the mouth while sleeping.

The MPowRx™ Snoring Solution is fabricated from a common oral appliance material, fits between the lips and teeth, and has an aperture with a protrusion for holding the tongue. Once the protrusion is squeezed to reduce the air volume, a vacuum is formed which keeps the tongue comfortably retained within the protrusion. Forward retention of the tongue helps keep the upper respiratory air passages open to relieve snoring.

#### 6. Safety & Effectiveness

There are no substantial differences between the MPowRx™ Snoring Solution defined in this 510(k) submission and the predicate devices. They have the same indications for use and any differences in technological characteristics do not raise issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 7 2008

MPowRx Health and Wellness Products Incorporated C/O Ms. Jean Asquith Senior Regulatory Affairs Consultant Emergo Group Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

Re: K081965

Trade/Device Name: MPowRxTM Snoring Solution 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: October 10, 2008 Received: October 14, 2008

Dear Ms. Asquith:

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 - Ms. Asquith

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 proctice 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, 1 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 Center for Devices and Radiological Health's (CDRH's) (CDRH's) of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Marmuels-lending for "

Chiu S. Lin. Ph. D Division 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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K081965

# Indications for Use

510(k) Number (if known):

Device Name: MPowRx™ Snoring Solution

Indications for Use:

The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.

Caution: Federal law restricts this device to sale by or on the order of a physician, dentist or other licensed practitioner.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rose

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

510(k) Number: kaf 165