PASR/QUIETNITE

K093340 · Exact Supplies , Ltd. · LRK · Jun 11, 2010 · Dental

Device Facts

• Record ID: K093340
• Device Name: PASR/QUIETNITE
• Applicant: Exact Supplies , Ltd.
• Product Code: LRK · Dental
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PAsr/QuietNite, a dentist prescribed mandibular repositioning/advancement device is intended for the treatment of nighttime incidents of snoring and/or mild to moderate obstructive sleep apnea in persons 18 years of age or older. These devices are not indicated for the treatment of central apnea or severe obstructive sleep apnea and should only be prescribed by a Dentist after the undertaking of a sleep study.

Device Story

PAsr/QuietNite is a dentist-prescribed, custom-fabricated mandibular repositioning/advancement device. Worn by patients during sleep to reduce snoring and mild to moderate obstructive sleep apnea. Device functions by mechanically repositioning the mandible to maintain airway patency. Used in home or sleep laboratory settings. Dentist manages the fitting and adjustment process. Benefits include reduction of sleep-disordered breathing symptoms. Device is removable and non-sterile.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Custom-fabricated intraoral mandibular repositioning device. Adjustable design. Non-sterile. Materials and construction techniques are identical to the predicate orthodontic appliance.

Indications for Use

Indicated for adults 18+ years old for treatment of snoring and mild to moderate obstructive sleep apnea. Not indicated for central apnea or severe obstructive sleep apnea. Requires prescription by a dentist following a sleep study.

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

• SilentNite (K972424)

Submission Summary (Full Text)

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510(k) Summary

August 23, 2009

exact
PRECISION DENTAL SUPPLIES

1072

Exact Supplies Ltd The Stables Brightwell Baldwin Oxfordshire, OX49 5NP UK

K093340

JUN 1 1 2010

Establishment Registration Number: 510(k) Number:

Contact Person: Telephone: Cell: E-mail: Address:

Jonathan Parkinson [phone] [phone] [e-mail] The Stables Brightwell Baldwin Oxfordshire, OX49 5NP

### Device

Trade Name: Common Name: Classification Name: Product Code: Class: Regulation Number:

PAsr QuietNite I Asi Quick Sleep Apnea Device Device, Anti-Snoring LRK II 872.5570 Approved

European CE mark:

Approved

Granted European Patent: Pending USA Patent:

## Description of Device:

Description of Device:
The PAsr QuietNite, a dentist prescribed mandibular repositioning device, is Dhe PAsr QuietNite, a dentist prescribed manalouiar repositions.
worn during sleep and is indicated for persons 18 years or older, who wish to
worn during sleep and is and is worn during sicep and is indicated for persons 15 years of street, and one of the sleep
reduce the incidence of snoring and/or mild to moderate obstructive sleep work the incidence of snoring and/or mild to modelate of treatment, it
apnea. Before a densis in the time reseive a PAsr QuietNite appliance for treatment, it
a mea. Before a apnea. Before a dentist prescrives a 1 1 123 < is recommended that the peace study diagnosis to
examination including a sleep study diagnosis to examination including a sicep stady andy and

613070 11 0749

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282

K093340

## Intended Use:

The PAsr/QuietNite, a dentist prescribed mandibular The PAsr/QuietNite, a dentist prescribed for the treatment of
repositioning/advancement device is intended for the treatment of
the management of maring and/or mild to modera repositioning/advancement device is intended for the crown.
nighttime incidents of snoring and/or mild to moderate obstructive sleep
of the see of the was of any of any of an nighttime includents of Shoring
18years of age or older.

These devices are not indicated for the treatment of central apnea or
es and should and and should only be prescribed by a De These devices are not indicated for the treatment of central approved and the country
severe obstructive of a close study severe obstructive sloup applied.
after the undertaking of a sleep study.

# Identification of Legally Marketed Device, (predicate) for Substantial Equivalence:

Name: SilentNite K Number: K972424 Date Cleared: 9/18/1997

Technological Characteristics Summary:

Similarities between both devices are the following:

- Indications for use >
- Indications for use
Function Mandibular Repositioning Device >
- Single Patient V
- Multi-Use >
- Prescription Device V
- iption Device
Custom Fabricated (Fit) from Common Orthodontic Appliance .
- Materials/Techniques
- Adjustable .
- - - - Adjustable
> Environment Home/Sleep Laboratories
- Removable ●
- Non Sterile .
- ✓ Identical Materials

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of one.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jonathan Parkinson Exact Supplies Limited The Stables, Brightwell Baldwin Watlington, Oxfordshire United Kingdom OX49 5NP

## JUN 1 1 2010

Re: K093340

Trade/Device Name: PAsr/QuietNite Regulation Number: 21 CFR 872.5570 Regulation Name: 21 OFF of 21207218879
Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: April 20, 2010 Received: June 9, 2010

Dear Mr. Parkinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bother over 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 interstate comments, or to thay 20, 1978, and saified in accordance with the provisions of Amendinches, or to devroes that have of the election of require approval of a premarket the Federal Food, Drug, and Cosment . For crose, enarket the device, subject to the general approval appreadon (1 Mill). I The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirents for unitude roginst misbranding and adulteration. Please note: CDRH does labeling, and promotions against information warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your (I MA), It may be subject to adame Federal Regulations, Title 21, Parts 800 to 898. In device can be lound in the Coud of Peachar regains concerning your device in the Federal Register.

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#### Page 2- Mr. Parkinson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthone O. awate

Anthony D. Watson, B.S., M.S., M.B.A. 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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K093940

187

Indications for Use Form Indications for Use 510(k) Number (if known): _

Device Name: PAsr/QuietNite

Indications for Use:

The PAsr/QuietNite, a dentist prescribed mandibular The FAST/Quictivite) a donotes in intended for the treatment of repositioning/duvancement of and/or mild to moderate obstructive sleep apnea in persons 18years of age or older.

These devices are not indicated for the treatment of central apnea or These devices are not maleated to the should only be prescribed by a Dentist after the undertaking of a sleep study.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

.

Keri Hailey for MSP

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

510(k) Number: K093340

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