O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)

K060744 · O'Brien Dental Lab, Inc. · LRK · Jun 2, 2006 · Dental

Device Facts

• Record ID: K060744
• Device Name: O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
• Applicant: O'Brien Dental Lab, Inc.
• Product Code: LRK · Dental
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The O'Brien MPA is intended to reduce snoring and to treat mild to moderate obstructive sleep apnea. This individually fabricated, non-sterile prescription device is a single patient, multi-use product for use at home or in a sleep laboratory.

Device Story

O'Brien MPA is an oral appliance fabricated from thermal plastic material. Device fits over upper and lower anterior teeth to maintain mandible in stationary, anterior protrusive position. Mechanical design physically opens airway to reduce snoring and sleep apnea; includes air channels for mouth breathing. Used at home or in sleep laboratory; prescribed by clinician. Patient wears device during sleep. Output is physical airway management; clinical benefit is reduction of snoring and OSA symptoms.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Thermal plastic material (ADA-approved). Form factor: intraoral appliance covering anterior teeth. Mechanism: mechanical mandibular advancement. No energy source, software, or connectivity. Non-sterile.

Indications for Use

Indicated for patients with snoring and mild to moderate obstructive sleep apnea (OSA). Prescription use only; single-patient, multi-use.

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

• SUAD (K023836)
• TAP (K962516)
• OASYS - Oral Airway System (K030440)

Submission Summary (Full Text)

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K060744

## Abbreviated 510(k) Summary

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:

JUN – 2 2006

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| Device Type: | Sleep Apnea/Anti-Snoring Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | O'Brien Dental Lab, Inc. |
| Contact person: | Suzie Downing |
| | Executive Assistant |
| | 541-754-1238 (office) |
| | 541-754-7478 (fax) |
| | [e-mail] |
| MD#: | 6025024-956733 |
| Trade Name: | O'Brien MPA |
| Common Name: | Oral Appliance / Anti-Snoring Device |
| Classification Name: Anti-Snoring Device | |
| Classification Reg .: | Class II (special controls) |
| Panel: | Dental |
| Product Code: | LRK |
| Predicate Devices: | SUAD - K023836 |
| | TAP - K962516 |
| | OASYS - Oral Airway System - K030440 |
| Description: | The O'Brien MPA is made of thermal plastic material (ADA |
| | approved materials). It is a very simple device that fits snugly over<br>the upper and lower anterior teeth in such a way as to keep the |
| | mandible in a stationary, anterior protrusive position. The reason |
| | for this is to physically open the airway and thus potentially reduce |
| | the occurrence of snoring and sleep apnea. (This theory of airway |
| | management is common, standard operating procedures in the |
| | emergency medical field for airway management purposes.) The |
| | device also includes air channels to allow breathing through the |
| | mouth. |
| Intended Use: | The O'Brien MPA is intended to reduce snoring and to treat mild |
| | to moderate obstructive sleep apnea. This individually fabricated, |
| | non-sterile prescription device is a single patient, multi-use product |
| | for use at home or in a sleep laboratory. |

:

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

Ms. Suzie Downing Executive Assistant O' Brien Dental Lab, Incorporated 4311 SW Research Way Corvallis, Oregon 97333

Re: K060744

Trade/Device Name: O'Brien MPA (Mandibular Positioning Appliance) Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: May 19, 2006 Received: May 23, 2006

Dear Ms. Downing:

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. Downing

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 vour 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 vours.

for Susan Runne
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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K060744

## Indications for Use

510(k) Number (if known):_ K060744

Device Name: __ O'Brien MPA (Mandibular Positioning Appliance)

Indications For Use: The O'Brien MPA is intended to reduce snoring and to treat mild to moderate OSA (obstructive sleep apnea). This individually fabricated, non-sterile, prescription device is a single patient, multi-use product for use at home or in a sleep laboratory.

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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Susan Runyer

Size ( 11) n of Anasthesiology, General Hospital, Control, Dental Devices

Number. K060744