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.

AI/ML Overview

The provided 510(k) summary for the ZQuiet-SA device does not contain acceptance criteria or a study proving that the device meets such criteria in the traditional sense of a performance study with defined metrics. This submission relies on demonstrating substantial equivalence to predicate devices. Therefore, the information requested in some categories cannot be extracted or is not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Technological Characteristics Identical to Predicate Devices	The ZQuiet-SA has identical technological characteristics as the predicate devices (ZQuiet K090503, ZQuiet K093407, TOMED SomnoGuard K061688) in terms of basic design (one-piece upper and lower tray, flexible hinge), materials (thermoplastic elastomer compound), and differential mandibular advancement capabilities. The ZQuiet-SA offers more advancement options (0mm, 2mm, 4mm, 6mm) compared to the predicate ZQuiet devices (6mm) and is comparable to SomnoGuard (0-5mm).
Intended Use Identical to Predicate Devices	The ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults, which aligns with the intended use of comparable predicate devices.
Biocompatibility Established by Predicate Devices	Materials and manufacturing methods are identical to predicate devices K093407 and K090503, thus biocompatibility is considered established.
Risk Analysis Conducted	A Risk Analysis was conducted to demonstrate that product risks have been identified and appropriately accounted for. (No specific performance metrics are provided for the risk analysis itself beyond its completion).

Detailed breakdown of requested information:

A table of acceptance criteria and the reported device performance: See table above. It frames "acceptance criteria" as meeting the criteria for substantial equivalence.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No test set (clinical or performance) was used for this submission. The submission relies on substantial equivalence to predicate devices, which means no new clinical or non-clinical performance data was generated for this specific device to demonstrate its safety and effectiveness.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No clinical or performance test set was used that required expert ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The ZQuiet-SA is a medical device (an intraoral appliance), not an AI/imaging diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The ZQuiet-SA is an intraoral appliance; it is not an algorithm and does not operate in a "standalone" or "human-in-the-loop" context in the way AI algorithms do.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No specific ground truth determination was made for this submission, as it relied on substantial equivalence. The "ground truth" for the predicate devices' effectiveness would have been established through clinical trials (e.g., outcomes data related to snoring and AHI reduction), but these studies were not conducted for the ZQuiet-SA as part of this 510(k) submission.
The sample size for the training set:
- Not applicable. No training set was used as this is not an algorithm-based device.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary of the K140777 Submission:

This 510(k) submission for the ZQuiet-SA device is a direct demonstration of substantial equivalence. The manufacturer asserts that the ZQuiet-SA possesses "identical technological characteristics" and "identical materials and methods of manufacture" to its previously cleared ZQuiet devices (K093407 and K090503) and also compares it to another predicate, TOMED SomnoGuard (K061688).

The "study" that proves the device meets the acceptance criteria is the comparison of its technical characteristics and intended use to those of legally marketed predicate devices. The acceptance criteria are, implicitly, that these characteristics and intended use are sufficiently similar to deem it substantially equivalent, thereby implying comparable safety and effectiveness without the need for new clinical data.

Specifically, the document states:

"No additional non-clinical testing was performed for this submission."
"No additional biocompatibility testing was conducted" because materials and manufacturing are identical to predicate devices.
"No clinical testing was performed in association with this submission."

The FDA's letter concurs with the substantial equivalence determination, allowing the device to be marketed.

Summary

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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: (802) 985-3013 Fax: (802) 985-9298 Email: dan@ZQuiet.com

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

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.
DifferentialMandibularAdvancement	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

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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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Image /page/4/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" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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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FOR FDA USE ONLY

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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Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
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.(b)
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.”