ZQUIET PRO-PLUS

K122475 · Sleeping Well, LLC · LRK · Dec 7, 2012 · Dental

Device Facts

• Record ID: K122475
• Device Name: ZQUIET PRO-PLUS
• Applicant: Sleeping Well, LLC
• Product Code: LRK · Dental
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

Device Story

ZQuiet® Pro-Plus is a custom-fit, intraoral mandibular repositioning device used during sleep to treat snoring and mild-to-moderate obstructive sleep apnea. The device consists of two acrylic orthotics (maxillary and mandibular arches). It employs a buccal cam mechanism—comprising an apposing fin and buttress—to maintain the mandible in an anteriorized position, increasing pharyngeal space and reducing airway collapse/soft palate vibration. It allows for vertical jaw movement and mouth breathing. The device is prescription-based. It benefits patients by mechanically maintaining airway patency during sleep. An optional stainless steel omega loop on the upper tray may be included to relieve palatal stress.

Clinical Evidence

Bench testing only. Biocompatibility, tear resistance, tear strength, tensile strength, elongation yield, and modulus of elasticity were evaluated to ensure performance and safety comparable to the predicate.

Technological Characteristics

Custom-fit intraoral mandibular repositioning device. Materials: dental-grade acrylics; optional stainless steel wire (omega loop). Mechanism: buccal cam (fin and buttress) for mandibular advancement. Features: embedded expansion screws for adjustment; allows vertical jaw movement. Sterilization: not specified (custom dental orthotic).

Indications for Use

Indicated for adult patients 18+ with snoring and/or mild to moderate obstructive sleep apnea (OSA).

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

• SomnoMed MAS RxA (K050592)

Submission Summary (Full Text)

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KIQ2473

Image /page/0/Picture/1 description: The image shows the logo for ZQuiet, a company owned by Sleeping Well, LLC. The logo features the word "ZQuiet" in a stylized font, with a crescent moon above the "i". Below the logo, the text "Sleeping Well, LLC" and "PO Box 1240" are printed in a smaller, simpler font.

Shelburne, VT 05482

510(k) Summary as required by 21 CFR 807.92(c)

1. Submitter's Identification:

Submitter:

Address:

Daniel Webster, Vice President

Sleeping Well, LLC 5247 Shelburne Rd., #204 PO Box 1240 Shelburne, VT 05482

Telephone: Fax:

Email:

Correspondent:

Date of Submission:

[phone] [phone]

[e-mail]

(Same As Submitter)

August 9, 2012

# 2. Device Name & Classification:

Device Trade Name:

Common Name:

Classification Name:

Product Code:

Classification Regulation

Class:

Number:

RR

21 CFR § 872.5570

Device, Anti-snoring

Obstructive Sleep Apnea

Intraoral Devices for Snoring and

LRK

Anti-

ZQuiet® Pro-Plus

LRR

ll

7 2012

DEC

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## 3. Device Description:

The ZQuiet® Pro-Plus is an intra oral device used for treating snoring and sleep apnea. It functions to reposition the mandible to increase the patient's pharyngeal space to increase airflow, reduce the vibrations of the soft palate associated with snoring, and/or prevent the collapse of the airway associated with apneic events. The device consists of two (2) custom orthotics; one for the maxillary arch and one for the mandibular arch, made from acrylics widely used and approved for use in the dental industry. The orthotic employs a buccal cam mechanism, consisting of an apposing fin and buttress, that maintains the orthotics in an anteriorized relationship when worn during sleep.

### 4. Statement of Intended Use:

The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

# 5. Identification of Legally Marketed Predicate Device:

The ZQuiet® Pro-Plus oral appliance is substantially equivalent to other legally marketed devices in the United States, and has the same intended use and technological characteristics as the following predicate device: The SomnoMed MAS RxA (K050592), by SomnoMed Limited.

### 6. Technological Comparison:

The ZQuiet® Pro-Plus oral appliance utilizes the same technological design features as the predicate device to advance the mandible for the intended use of treating snoring and/or mild to moderate obstructive sleep apnea. Both utilize separate, custom fit, upper and lower dental orthotics. The jaw advancement and relative positioning of the trays is maintained by apposing fin and buttress features, and contain embedded expansion screws for adjustment. Both devices allow vertical jaw movement and enable mouth breathing. The proposed device has one optional design difference that has no relation to the technology associated with the intended use. The upper tray can be made with an omeqa loop of stainless steel wire located at the anterior midline to relieve palatal stress.

### 7. Summary of Substantial Equivalence:

The ZQuiet® Pro-Plus oral appliance is substantially equivalent to the SomnoMed MAS RxA. Both devices have the same intended use/indications for use and technology. Both devices are custom made adjustable mandibular repositioning devices fabricated in registered establishments. Both are prescription devices indicated for patients suffering from snoring and/or mild to moderate obstructive sleep apnea. The fundamental scientific technology

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of the device is identical to the referenced predicate device, and furthermore, it has been demonstrated in this 510(k) submission that the differences between the ZQuiet® Pro-Plus oral appliance and the predicate device do not raise any questions regarding their safety and effectiveness.

# 8. Non-Clinical Testing:

Biocompatibility test results are known for this device as well as tests for tear resistance tear strength, tensile strength, elongation yield, and modulus of elasticity.

## 9. Conclusion

The descriptive characteristics of the ZQuiet® Pro-Plus oral appliance are precise enough to ensure comparability with the predicate when manufactured according to specifications. By comparing designs to the predicate device and the materials used it's concluded that the ZQuiet® Pro-Plus is as safe, as effective, and performs as well as the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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 image of an eagle or bird-like figure with three wing-like extensions.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

# December 7, 2012

Mr. Daniel Webster Vice President Sleeping Well, Limited Liability Company 5247 Shelburne Road, Suite 204 Shelburne, Vermont 05482

Re: K122475

Trade/Device Name: ZQuiet® Pro-Plus Appliance 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: November 2, 2012

Received: November 15, 2012

#### Dear Mr. Webster:

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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Teast be advised that 1 Dr 3 130aantes vour device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I cocharter and regulanents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Part 607), laooning (21 OFR 803); good manufacturing practice requirements as set de rice-related duverse orchite) (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 11 you desire operatio aov/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 1 ou may 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.

Kwame O. Ulmer

Anthony D. Watson, B.S. M.S., M.B.A. 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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# Indications for Use

510(k) Number (if known): LLLLLLLL

ZQuiet® Pro-Plus Appliance Device Name:

Indications for Use: .

The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate i nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

2012.12.06 Susan Runner DDS, MA-13:59:00 -05'00'

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(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital Division of Antol. Dental Devices

510(k) Number:

24