ZQUIET-SA

K140777 · Sleeping Well, LLC · LRK · Jul 25, 2014 · Dental

Device Facts

• Record ID: K140777
• Device Name: ZQUIET-SA
• Applicant: Sleeping Well, LLC
• Product Code: LRK · Dental
• Decision Date: Jul 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.

Device Story

ZQuiet-SA is an intraoral appliance for snoring and obstructive sleep apnea; consists of upper and lower trays joined by a flexible hinge; engages maxillary and mandibular dentition to maintain anterior mandibular positioning; widens pharyngeal airway to prevent occlusion; available in multiple models allowing dentists to recommend specific degrees of mandibular advancement (0mm, 2mm, 4mm, 6mm) and anterior post configurations; used by adults; intended to reduce airway obstruction during sleep; provides non-invasive treatment alternative.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

One-piece upper and lower tray design joined by a flexible hinge; constructed from clear to light blue thermoplastic elastomer compound; provides adjustable mandibular advancement (0mm, 2mm, 4mm, 6mm) via interchangeable anterior posts; non-powered, mechanical intraoral device.

Indications for Use

Indicated for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.

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 (K093407)
• ZQuiet (K090503)
• SomnoGuard (K061688)

Submission Summary (Full Text)

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# JUL 2 5 2014 K140777

#### 5 510(k) Summary

#### Submission Correspondent and Owner 5.1

- Mr. Daniel Webster Vice President Sleeping Well, LLC P.O. Box 1240 5247 Shelburne, Rd, #204 Shelburne, VT 05482 Phone: [phone] Fax: [phone] Email: [e-mail]
#### 5.2 Date Summary Prepared

March 25, 2014

#### 5.3 Device Trade Name

ZQuiet-SA

#### 5.4 Device common name

Intraoral Device for Snoring and Obstructive Sleep Apnea

#### 5.5 Device classification name

Device, Anti-Snoring, 21 CFR 872.5570, LRK, Class II

### Legally Marketed Device To Which The Device Is 5.6 Substantially Equivalent

Sleeping Well, LLC - ZQuiet - K093407 Sleeping Well, LLC - ZQuiet - K090503 TOMED Dr. Toussaint, GmbH - SomnoGuard - K061688

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#### Description Of The Device 5.7

The ZQuiet-SA oral appliance consists of an upper and lower tray constructed in one piece and joined by a flexible hinge. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. The device is presented in multiple models allowing the dentist to recommend different degrees of mandibular advancement and preference of anterior posts.

#### 5.8 Intended Use

The ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.

#### 5.9 Technological Characteristics

The ZQuiet-SA has identical technical characteristics as the predicate devices. Table 1 contains a description of basic technological characteristics and demonstrates that the proposed and prediate device are identical in terms of how they achieve their intended use.

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| | ical Characteristics | | | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Feature | ZQuiet-SA Proposed Device | ZQuiet Cleared Under K090503 | ZQuiet Cleared Under K093407 | TOMED SomnoGuard - K061688- |
| Basic Design | An upper and lower tray constructed in once piece and joined by a flexible hinge. The device is pre-sented in multiple models which allow for the dentist to recommend the use of anterior posts and different degrees of mandibular advancement. | An upper and lower tray constructed in one piece and joined by a flexible hinge. The device has anterior posts and is presented in one size. | An upper and lower tray constructed in one piece and joined by a flexible hinge. The device has anterior posts and is presented in one size. | One piece design with a "boil and bite" fitting methodology. The SomnoGuard allows the mandible to be advanced 0-5mm. |
| Differential<br>Mandibular<br>Advancement | 0mm, 2mm, 4mm, 6mm | 6mm | 6mm | 0-5mm |
| Materials | Clear to light blue thermoplastic elastomer compound | Light blue thermoplastic elastomer compound | Light blue thermoplastic elastomer compound | Thermoplastic copolymer. |

'able 1: Substantial Equivalence Table Demonstrating Technologi
es Characteriati

17

.

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#### Non-Clinical Testing 5.10

No additional non-clinical testing was performed for this submission. However, a Risk Analysis was conducted to demonstrate that the risks of the product have been identified and appropriately accounted for.

#### 5.11 Biocompatibility

Since the materials and methods of manufacture are identical to the materials and/or the base materials utilized in the K093407 and K090503 predicate devices, no additional biocompatibility testing was conducted.

#### 5.12 Clinical Testing

No clinical testing was performed in association with this submission.

#### 5.13 Conclusions

The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is substantially equivalent to the legally marketed predicate devices.

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Public Health Service

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

July 25, 2014

· Sleeping Well, LLC c/o Mr. William McLain Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540

Re: K140777

Trade/Device Name: ZQuiet-SA 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: April 25, 2014 Received: April 28, 2014

Dear Mr. McLain:

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 - Mr. McLain

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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

MaryFDAner-S

Erin I. Keith. M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510fk) Number (8 known)

K140777

Devica Nama ZQuiet-SA

Indications for Use (Describe)

ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apace in adults.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael E. Artijes 2014.07.25 05:00 00 00 00 00

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