THE QUIET SLEEPER

K012142 · Precision Dental Laboratories, Inc. · LRK · Oct 4, 2001 · Dental

Device Facts

• Record ID: K012142
• Device Name: THE QUIET SLEEPER
• Applicant: Precision Dental Laboratories, Inc.
• Product Code: LRK · Dental
• Decision Date: Oct 4, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The "Quiet Sleeper" is intended to reduce the severity of snoring, and mild to moderate obstructive sleep apnea. Several studies have shown the effectiveness of oral appliances that position the mandible forward for the treatment of simple snoring and mild to moderate sleep apnea.

Device Story

The Quiet Sleeper is an oral appliance designed to reduce snoring and mild to moderate obstructive sleep apnea. The device functions by positioning the patient's mandible forward, which helps maintain airway patency during sleep. It is intended for use by patients to manage their condition. By mechanically adjusting the jaw position, the device aims to decrease airway obstruction, thereby reducing snoring severity and improving sleep apnea symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence based on established effectiveness of mandibular advancement oral appliances for snoring and sleep apnea.

Technological Characteristics

Oral appliance; mandibular advancement design. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for patients with snoring and mild to moderate 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.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 4 2001

Ms. Sharon Lamont Executive Coordinator Precision Dental Laboratories, Incorporated 6 Broadway, Suite 200 Fargo, North Dakota 58102

Re: K012142

Trade/Device Name: The Quiet Sleeper Regulation Number: None Regulation Name: Dental Regulatory Class: Unclassified Product Code: LRK Dated: July 2, 2001 Received: July 10, 2001

Dear Ms. Lamont:

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.

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.

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## Page 2 - Ms. Lamont

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

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

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| 510(k) Number (if known): | K012142 |
|---------------------------|-------------------|
| Device Name: | THE QUIET SLEEPER |

Indications For Use:

The "Quiet Sleeper" is intended to reduce the severity of snoring, and mild to moderate obstructive sleep apnea. Several studies have shown the effectiveness of oral appliances that position the mandible forward for the treatment of simple snoring and mild to moderate sleep apnea.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | KC12142 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

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