THE SNORE PEACE

K981923 · The Snore Peace Group · LRK · Aug 24, 1998 · Dental

Device Facts

• Record ID: K981923
• Device Name: THE SNORE PEACE
• Applicant: The Snore Peace Group
• Product Code: LRK · Dental
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for The Snore Peace® is for snore reduction/prevention.

Device Story

The Snore Peace® is a single-piece, custom-fitted oral appliance designed for nighttime use. It is worn over the upper and lower teeth and inner lips. The device functions by mechanically positioning the tongue and lower jaw in a forward protrusion (60-75% of maximum) to maintain airway patency during sleep. It is intended for use under the prescription and custom fitting of a physician to reduce or prevent snoring.

Clinical Evidence

No clinical data provided. Effectiveness is claimed based on the widespread use and historical market presence of similar predicate devices.

Technological Characteristics

Single-piece, custom-fitted oral appliance. Materials are not specified. Mechanical principle of operation involves physical protrusion of the mandible and tongue. No energy source, software, or connectivity.

Indications for Use

Indicated for reduction or alleviation of snoring in patients by holding the tongue and lower jaw in a 60-75% of patient maximum protrusion forward position 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

• Snore-Ezzer (Snore-Ezzer, LLC)
• Snore Tec (Marketing Technologies, Inc)
• Therasnore (Dr. Thomas E. Meade)

Submission Summary (Full Text)

{0}------------------------------------------------

K981923

### Page 10 of 10

# The Snore Peace® Premarket Notification 510(K) Summary

## Submitter:

The Snore Peace® Group 24791 Via San Felipe Mission Viejo, California 92692 Contact Person: David V. Sheehan Phone: [phone] FAX: [phone]

## Date Summary was prepared: June 1, 1998

#### Device Name:

| Trademark: | The Snore Peace® |
|-----------------|---------------------|
| Common Name: | Anti-snoring device |
| Classification: | Unclassified |
| Product Code: | LRK |

#### Description:

The Snore Peace® is a single piece device which is form custom fitted to the users upper and lower teeth and inner lips. It is meant to be worn at night while sleeping.

#### Intended Use:

The intended use for The Snore Peace® is for snore reduction/prevention.

### Substantial Equivalence:

The Snore Peace® is substantially equivalent to many legally marketed devices in The United States including Snore-Ezzer by Snore-Ezzer, LLC: Snore Tec by Marketing Technologies, Inc; and Therasnore by Dr. Thomas E. Meade.

## Safety & Efficacy:

The Snore Peace® works in a similar manner to other comparative predicate devices and the intended use is the same. Any differences between our product and predicate devices are minor in nature and raise no new safety concerns. The effectiveness and suitability to the intended purpose of The Snore Peace® is assured via the widespread use and length of use of the many similar devices on the market. As such, the safe use of The Snore Peace® by many users, under the prescription and custom fitting of a physician is assured.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three human profiles incorporated into the design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Mr. DaviD V. Sheehan Managing Director The Snore Peace® Group 24791 Via San Felipe Mission Viejo, California 92692

Re : K981923 Trade Name: The Snore Peace® Requlatory Class: Unclassified Product Code: LRK Dated: June 1, 1998 Received: June 1, 1998

Dear Mr. Sheehan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{2}------------------------------------------------

Page 2 - Mr. Sheehan

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Butman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

{3}------------------------------------------------

1000

- 1 270

# The Snore Peace® Premarket Notification Statement for Indications of Use

The Snore Peace® Device Name:

Indication For Use: To reduce or alleviate snoring by holding the tongue and lower jaw in a 60-75% of patient maximum protrusion forward position during sleep.

# (PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use_ or (Per 21 CFR 801.109) Argar Ange (Division Sign-Off) ( Division of Dental, Infection Control, and General of Dental, Intection of General Hospital Devices 510(k) Number < 4