OASYS-ORAL AIRWAY SYSTEM

K030440 · Mark Abramson, D.D.S., Inc. · LRK · Aug 26, 2003 · Dental

Device Facts

• Record ID: K030440
• Device Name: OASYS-ORAL AIRWAY SYSTEM
• Applicant: Mark Abramson, D.D.S., Inc.
• Product Code: LRK · Dental
• Decision Date: Aug 26, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OASYS Oral Airway System is intended to reduce or alleviate snoring and obstructive sleep apnea, OSA.

Device Story

Intraoral appliance; custom-fitted to patient teeth; consists of lower tray, upper molded splint, upper shield, and connecting mechanism; features extensions acting as nasal dilators. Used at home or in sleep laboratories; patient-operated. Device repositions mandible to maintain airway patency; nasal dilators provide additional airway support. Reduces snoring and obstructive sleep apnea symptoms; prevents tooth grinding. Non-sterile; heat-sensitive impression material allows custom fit; adjustable.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design comparison, material characteristics, and literature supporting the historical efficacy of mandibular repositioning devices for snoring and sleep apnea.

Technological Characteristics

Intraoral appliance; heat-sensitive impression material for custom fit; rigid tray; non-sterile. Mechanical operation via mandibular repositioning and integrated nasal dilators. No electronic components, software, or energy sources.

Indications for Use

Indicated for adult patients to reduce or alleviate snoring and 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

• Dr. Keith Thorton (K972061)
• Snore-Ezzer, LLC (K963063)
• Marketing Technologies, Inc. (K963616)
• Nellcor Puritan Bennett, Inc. (K962516)

Reference Devices

• Breathe EZ (K022891)
• Dr.'s Mouthpiece (K991948)

Submission Summary (Full Text)

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# Kozouyo

Page 20 of 22

## OASYS-ORAL AIRWAY SYSTEM

## Mark Abramson 35 Renato Court Redwood City, CA 94061

## Non-Confidential Summary of Safety and Effectiveness

### Page 1 of 3

April 16, 2003

Mark Abramson 35 Renato Court Redwood City, CA 94061 Tel-[phone]

Fax-[phone]

Official Contact: Proprietary or Trade Name: Common/Usual Name: Device: Predicate Devices:

Mark Abramson, D.D.S. OASYS -Oral Airway System Oral Appliance - anti-snoring device OASYS -Oral Airway System Dr. Keith Thorton - K972061 Snore-Ezzer, LLC - K963063 Marketing Technologies, Inc. - K963616 Nellcor Puritan Bennett, Inc. - K962516

### Device Description:

The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of:

- Lower tray fitted over the lower teeth. ●
- Upper shield fitting in front of upper anterior teeth. .
- Upper molded splint fitted over upper teeth. ●
- Connecting mechanism joining upper shield and lower tray. .
- Extensions off shield which act as nasal dilators .

### Intended Use:

| Indicated use: | The OASYS Oral Airway System is intended to reduce or alleviate snoring and obstructive sleep apnea, OSA. |
|----------------|-----------------------------------------------------------------------------------------------------------|
|----------------|-----------------------------------------------------------------------------------------------------------|

Target population: Adult patients.

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## Non-Confidential Summary of Safety and Effectiveness (continued) Page 2 of 3 April 16, 2003

## Environment of Use: Home and sleep laboratories

## Comparison to Predicate Devices:

| Attribute | OASYS<br>K030440 | Breathe EZ<br>K022891 | Dr. 's Mouthpiece<br>K991948 | Marketing T.I.<br>k963063 |
|-------------------------------------------------------------------------|------------------|-----------------------|------------------------------|---------------------------|
| Use: | | | | |
| Intended as an<br>intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce or<br>help snoring | Yes | Yes | Yes | Yes |
| Indicated for use with<br>persons who snore | Yes | Yes | Yes | Yes |
| Indicated for single<br>patient<br>Multi-use | Yes | Yes | Yes | Yes |
| Indicated for use at<br>home or sleep<br>laboratories | Yes | Yes | Yes | Yes |
| Design: | | | | |
| Heat sensitive<br>impressible material<br>for fitting to teeth | Yes | Yes | Yes | Yes |
| Custom fit for each<br>user | Yes | Yes | Yes | Yes |
| Can be adjusted or<br>Refit | Yes | Yes | Yes | Yes |
| Placed in users mouth<br>each evening | Yes | Yes | Yes | Yes |
| Cleaned daily | Yes | Yes | Yes | Yes |
| Easily removed from<br>Mouth<br>Permits user to breath<br>Through mouth | Yes | Yes | Yes | Yes |
| Attribute | OASYS | Breathe EZ | Dr. 's Mouthpiece<br>K991948 | Marketing T.I.<br>k963063 |
| Prevents grinding of<br>Teeth | Yes | Yes | Yes | Yes |
| Materials: | | | | |
| Heat sensitive<br>Impression material | Yes | Yes | Yes | Yes |
| Rigid tray | Yes | Yes | Yes | Yes |
| Non-Sterile | Yes | Yes | Yes | Yes |

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## Page 22 of 22

## Non-Confidential Summary of Safety and Effectiveness (continued) Page 3 of 3 April 16, 2003

Difference Between Other Legally Marketed Predicated Devices

The difference between the intended device and predicates is only the design of the device. All of the predicates act as mandibular repositioners. The OASYS has extensions which act as nasal dilators. This difference does not have a significant effect on the safety or effectiveness of the device.

Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare. The caduceus has a staff with two snakes winding around it and a pair of wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2003

Dr. Mark Abramson Mark Abramson, D.D.S. Incorporated 35 Renato Court Redwood City, California 94061

Re: K030440

Trade/Device Name: Oasys Oral Airway System Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK, LWF Dated: July 8, 2003 Received: July 8, 2003

Dear Dr. Abramson:

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 - Dr. Abramson

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/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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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Page 1 of 1

510(k) Number (if known): __ K030440

OASYS Oral Airway System Device Name: __

Indications For Use:

OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.

Susan Runne

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

510(k) Number: KG38446

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use ----

(Cpuoral Format 1-2-96)