ZQUIET MOUTHPIECE

K093407 · Sleeping Well, LLC · LRK · Jun 22, 2010 · Dental

Device Facts

• Record ID: K093407
• Device Name: ZQUIET MOUTHPIECE
• Applicant: Sleeping Well, LLC
• Product Code: LRK · Dental
• Decision Date: Jun 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years are older.

Device Story

ZQuiet is a single-piece mandibular advancement device designed to reduce nighttime snoring. It consists of upper and lower trays connected by a resilient hinge, constructed from a non-toxic thermoplastic elastomer. The device is placed in the user's mouth each evening to move the lower jaw forward, which helps maintain airway patency. It is intended for use at home or in sleep laboratories by adult patients. The device is non-sterile, reusable, and allows for mouth breathing. It is provided as a prescription device, intended to be sold by or on the order of a licensed dentist or physician. Patients clean the device daily and can easily remove it from the mouth.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility studies, including Agar Diffusion (ISO 10993-5), Primary Dermal Irritation (16 CFR 1500.41), Guinea Pig Closed Patch Sensitization (ISO 10993-10), and Oral Mucosal Irritation (ISO 10993-10). All tests passed, confirming the material is non-cytotoxic, non-sensitizing, and acceptable for oral mucosal contact.

Technological Characteristics

Single-piece mandibular advancement device; material: Dynaflex G2701-1000-02 thermoplastic elastomer; design: upper and lower trays with integrated resilient hinge; non-sterile; intraoral; mechanical operation via jaw advancement.

Indications for Use

Indicated for the treatment of nighttime snoring in adults 18 years or older.

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

• ZQuiet Mouthpiece (K090503)

Submission Summary (Full Text)

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K093407

JUN 2 2 2010

## 510(k) Summary

807.92(c)

#### SPONSOR

807.92(a)(1) Sleeping Well, LLC

Company Address

Company Name:

PO Box 1240

Shelburne, VT 05482 .

Telephone: [phone] Fax: [phone]

Contact Person:

Daniel A. Webster

ZQuiet® Mouthpiece

Anti-Snoring Device Device, Anti-snoring

CFR21 872.5570

Summary Preparation Date: May 27, 2010

#### DEVICE NAME

807.92(a)(2)

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

PREDICATE DEVICE

807.92(a)(3)

| Legally Marketed Equivalent Device | | |
|------------------------------------|-------------------|----------|
| Company | Product | 510(k) # |
| Sleeping Well, LLC | ZQuiet Mouthpiece | K090503 |

LRK

Class II

#### DEVICE DESCRIPTION

807.92(a)(4)

The ZQuiet anti-snoring device is a single piece anti-snoring device, which moves the lower jaw forward and helps reduce the likelihood of snoring. This is achieved by covering the upper and lower teeth with a resilient non-toxic thermoplastic elastomer compound. The ZQuiet is easy to wear and simple to use. The single shot manufacturing process incorporates a resilient hinge in the molar area to provide a single piece device.

The anti-snore device comprises an upper member adapted to engage the maxillary dentition of a human and a lower member adapted to engage the mandibular dentition of the human, the upper and lower members being resiliently hinged together.

#### DEVICE INTENDED USE / INDICATION FOR USE 807.92(a)(5)

The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years are older.

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Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed Dentist.

### Target Population: Adult patients

r

## Environment of Use: Home and sleep laboratories

# COMPARISON OF TECHNICAL CHARACTERISTICS

807.92(a)(6)

| K Number | | K090503 |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Classification Name | Device, Anti-Snoring | Device, Anti-Snoring |
| Product Code | LRK | LRK |
| Indications for Use | The ZQuiet Anti-Snoring device is<br>intended for the treatment of<br>nighttime snoring in adults 18<br>years or older. | The ZQuiet Anti-Snoring device is<br>intended for the treatment of<br>nighttime snoring in adults. |
| Intended as an intraoral<br>device | Intended as an intraoral device | Intended as an intraoral device |
| Intended to reduce<br>snoring or help alleviate<br>snoring | Intended to reduce snoring or help<br>alleviate snoring | Intended to reduce snoring or help<br>alleviate snoring |
| Indicated for single<br>patient multi use | Indicated for single patient multi<br>use | Indicated for single patient multi<br>use |
| Indicated for use at home<br>or sleep laboratories | Indicated for use at home or sleep<br>laboratories | Indicated for use at home or sleep<br>laboratories |
| Prescription device | Prescription device | Prescription device |
| | | |
| Non-sterile | Non-sterile | Non-sterile |
| | | |
| Upper and lower trays<br>One piece design | Upper and lower trays<br>One piece design | Upper and lower trays<br>One piece design |
| | | |
| Permits patient to breathe<br>through the mouth | Permits patient to breathe through<br>the mouth | Permits patient to breathe through<br>the mouth |
| Placed in user's mouth<br>each evening | Placed in user's mouth each<br>evening | Placed in user's mouth each<br>evening |
| Cleaned daily | Cleaned daily | Cleaned daily |
| Easily removed from the<br>mouth | Easily removed from the mouth | Easily removed from the mouth |
| | | |
| Device material | Dynaflex G2701-1000-02 | Dynaflex G27-0001 |

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#### NONCLINICAL AND CLINICAL TEST

#### 807.92(b)

ZQuiet® Anti-Snoring Device has been evaluated through in vitro tests and animal safety studies. All data is consistent in indicating that this product is safe for use as an antisnoring device. The materials used in the following studies are identical to the material under review Dynaflex G2701-1000-02. The categories of safety tests and the safety test conclusions are as follows:

| Test Performed | Standard/Methodology | Results |
|-----------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Agar Diffusion Test (ISO | ISO 10993-5: 1999 "Tests for<br>in vitro cytotoxicity | Pass<br>Not considered cytotoxic |
| Primary Dermal Irritation in<br>Rabbits | Federal Hazardous Substances<br>Act Regulations (16 CFR<br>1500.41 | Pass<br>Not a primary dermal irritant |
| Guinea Pig Closed Patch<br>Sensitization Test | ISO 10993-10: 2002 Tests for<br>irritation and delayed type<br>hypersensitivity | Pass<br>No sensitizing properties |
| Oral Mucosal Irritation Study | ISO 10993 – Part 10 – Tests<br>for Irritation and Delayed-<br>Type Hypersensitivity | Under conditions of this study,<br>and based on the Irritation<br>Index the test article was<br>considered to be a minimal<br>irritant. |

#### CONCLUSION

#### 807.92(b)(3)

ZQuiet Anti-Snoring Device is identical to the predicate device in intended use, and design. The material change has been tested according to ISO 10993 and is found safe for the intended use. The ZQuiet Anti-Snoring Device does not raise any new issues concerning safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

1111 . 25 .

JUN 22 2010

Sleeping Well, LLC C/O Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K093407

Trade/Device Name: ZQuiet Mouthpiece Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: June 4, 2010 Received: June 4, 2010

Dear Ms. Smith:

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. Please note: CDRH does not evaluate information related to contract liability 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 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- Ms. Smith

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/ReportaProblem/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,

Susan Russo

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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K.Q93407

## Indications for Use

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

Device Name: . ZQuiet® Mouthpiece

Indications for Use:

The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years or older.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician

Prescription Use X CFR 801 Subpart D)

(Part 21) 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)

Susan Rose

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

510(k) Number: K093407