THE BREATHE EZ ANTI-SNORING DEVICE

K022891 · D&S Redhage · LRK · Feb 19, 2003 · Dental

Device Facts

• Record ID: K022891
• Device Name: THE BREATHE EZ ANTI-SNORING DEVICE
• Applicant: D&S Redhage
• Product Code: LRK · Dental
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Breath EZ Anti-Snoring Device is intended to reduce or alleviate snoring by maintaining an open air way and to prevent bruxing, clenching and grinding of the teeth while sleeping.

Device Story

The Breathe EZ is an intraoral anti-snoring and anti-bruxing device. It consists of an oval plate positioned between the upper and lower teeth and gums, featuring an integrated port (tube) to facilitate mouth breathing and prevent tongue or lip obstruction. The device is custom-fitted to the user's teeth using heat-sensitive, impressible material. It is intended for use by adults at home or in sleep laboratories. The user places the device in the mouth each evening before sleep and removes it upon waking. The device is cleaned daily. By maintaining an open airway and providing a physical barrier between teeth, it aims to reduce snoring and prevent dental damage from grinding or clenching.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraoral appliance constructed from heat-sensitive, impressible material. Features an oval plate design with an integrated port for airway maintenance. Non-sterile. Custom-fit via heat molding. Mechanical operation; no energy source or software.

Indications for Use

Indicated for adult patients to reduce or alleviate snoring and prevent bruxing, clenching, and grinding of teeth during sleep.

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. B's Mouthpiece (K991948)
• Marketing Technologies, Inc. (K963063)
• Nellcor Puritan Bennett Inc. (K962516)
• Dr. Kieth Thornton (K972061)

Submission Summary (Full Text)

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# THE BREATHE EZ

FEB 1 9 2003

D&S Redhage 5901 Vedder Road. New Haven, MO 63068

## Non-Confidential Summary of Safety and Effectiveness

Page 1 or 3 August 19, 2002

The Breathe EZ 5901 Vedder Road New Haven, MO 63068 Telephone - [phone]

| Official Contact: | Daniel J. Redhage, Designer | | |
|-----------------------------|---------------------------------------|----------------------------------------|------------------------------------------------------------------------|
| Proprietary or Trade Name: | The Breathe EZ | | |
| Common/Usual Name: | Oral Appliance: anti-snoring/grinding | | |
| Device Classification Name: | Anti-snoring device | | |
| Predicated Devices: | Snore-Ezzer, LLC – K991948 | Marketing Technologies, Inc. – K963063 | Nellcor Puritan Bennett Inc. – K962516<br>Dr. Kieth Thornton – K972061 |

### Device Description:

The Breathe EZ Anti-Snoring/Anti-Grinding Device is composed of:

- · An oval plate fitted in front of and between the upper and lower teeth and gums.
- A port to facilitate normal breathing

### Intended Use:

- Indicated Use: The Breathe EZ Anti-Snoring Device is intended to reduce or alleviate snoring and to prevent bruxing, clenching and grinding of the teeth while sleeping.
Target Population: Adult patients

Environment of Use: Home and sleep laboratories

510(k) Package for The Breathe EZ

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## Non-Confidential Summary of Safety and Effectiveness (continued) Page 2 or 3 August 19, 2002

# Comparison to Predicate Devices:

| Attribute | The Breathe EZ | Dr. B's Mouthpiece<br>K991948 | Marketing T. I<br>K963063 | Nellcor P.B.<br>K972061 |
|----------------------------------------------------------------|----------------|-------------------------------|---------------------------|-------------------------|
| Use: | | | | |
| Intended as an<br>intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce or<br>help alleviate snoring | Yes | Yes | Yes | Yes |
| Indicated for use with<br>persons who snore | Yes | Yes | Yes | Yes |
| Indicated for single<br>user<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 | Yes | Yes | Yes | Yes |
| Permits user to breath<br>through mouth | Yes | Yes | Yes | Yes |
| Prevents grinding of<br>teeth | Yes | Yes | Yes | Yes |
| Attribute | The Breathe EZ | Dr. B's Mouthpiece<br>K991948 | Marketing T. I<br>K963063 | Nellcor P.B.<br>K972061 |
| Materials: | | | | |
| Heat sensitive<br>impression material | Yes | Yes | Yes | Yes |
| Non-Sterile | Yes | Yes | Yes | Yes |

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### Non-Confidential Summary of Safety and Effectiveness (continued) Page 3 or 3 August 19, 2002

#### Comparison to Predicate Devices:

### Differences Between Other Legally Marketed Predicated Devices

The difference between the intended device and predicates is only the design of the device. The predicate Dr. B's Mouthpiece is very similar in every aspect except that The Breathe EZ has an anti-tongue and lip obstruction component consisting of one port, (tube) that provides an open airway regardless of the position of the tongue and lips.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, with flowing lines extending from the faces, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

Mr. Daniel J. Redhage President D & S Redhage 5901 Vedder Road New Haven. Missouri 63068

Re: K022891

Trade/Device Name: The Breathe EZ Anti-Snoring Device Regulation Number: 872.5570 Regulation Name: Anti-Snoring Device Regulatory Class: II Product Code: LRK Dated: December 20, 2002 Received: December 27, 2002

Dear Mr. Redhage:

. . . . . . . . . .

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 vour 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 - Mr. Redhage

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__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: The Breathe EZ anti-snoring device

Indications for Use:

The Breath EZ Anti-Snoring Device is intended to reduce or alleviate snoring by maintaining an open air way and to prevent bruxing, clenching and grinding of the teeth while sleeping.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Muling for MSR
(Division Sign-Off)

Division of Dental, Infection Control, And Genereal Hospital Devices

510(k) Number K022891

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)