The ZQuiet Anti-Snoring device is intended for the treatment of nightime snoring in adults.
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults.

Device Description

The ZQuiet ® Mouthpiece is an Anti-Snoring device consisting of :

Two trayed plates fitted in front and between the upper and lower teeth and gums . and integrated with each other with the same material as the upper and lower plates.
The device is made of Thermoplastic elastomer .
◆ May be used as supplied

AI/ML Overview

Here's an analysis of the provided text regarding the ZQuiet® Mouthpiece, focusing specifically on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary and subsequent FDA clearance letter. It is designed to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or establish novel performance criteria through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will be limited by the nature of this regulatory submission.

Acceptance Criteria and Device Performance

Based on the provided text, specific quantitative acceptance criteria for device performance (e.g., reduction in snoring decibels, AHI improvement) are not explicitly stated or provided in a table format. The submission focuses on demonstrating substantial equivalence to a predicate device (SomnoGuard Series, K061688) based on shared intended use, materials, design, and theory of operation, implying that if the new device is substantially equivalent, it meets the inherent safety and effectiveness standards already established for the predicate.

Implicit Acceptance Criteria (based on substantial equivalence):

Acceptance Criteria Category	Description	Reported Device Performance (ZQuiet® Mouthpiece)
Intended Use	Treatment of nighttime snoring in adults.	Intended for the treatment of nighttime snoring in adults. (Identical to predicate)
Device Type	Mandibular Advancement Device; intraoral device.	Mandibular Advancement Device; intraoral device. (Identical to predicate)
Core Functionality	Reduces or helps alleviate snoring by advancing the lower jaw to open the upper airway.	Functions by advancement of lower jaw to open upper airway. (Identical to predicate)
Material Composition	Made of Thermoplastic elastomer.	Made of Thermoplastic elastomer. (Identical to predicate)
Biocompatibility	Expected to be biocompatible for intraoral use, not raising new safety concerns.	"ZQuiet® Anti-Snoring Device has been evaluated for safety through in vitro tests and animal safety studies." The conclusion states it "does not raise any new issues concerning safety and effectiveness" compared to the predicate device, implying satisfactory biocompatibility.
Design Characteristics	Key design features such as being ready-to-use, having upper and lower trays, a one-piece design, allowing breathing through the mouth, daily placement/removal, and daily cleaning. (Differences noted for "Boil and Bite fitting" and indication for "mild to moderate" sleep apnea are highlighted as not raising new safety/effectiveness issues for this non-Boil & Bite, snoring-only device).	Ready-to-Use; Upper and lower trays; One piece design; Permits patient to breathe through the mouth; Placed in user's mouth each evening; Cleaned daily; Easily removed from the mouth. (All match predicate, with noted differences in fitting method and specific apnea indication that are argued not to raise new issues).
Regulatory Classification	Class II medical device, product code LRK.	Classified as Class II, product code LRK.

Study Details:

Sample Size and Data Provenance for Test Set:
- The submission does not mention a clinical study with a "test set" or a comparison against a "ground truth" to establish the device's efficacy in reducing snoring.
- The "Non-Clinical Performance Data" section only mentions "in vitro tests and animal safety studies" for biocompatibility. No sample sizes are provided for these.
- This is typical for a 510(k) submission where substantial equivalence to a predicate device is the primary argument, rather than a de novo efficacy claim requiring human clinical trials for performance.
Number of Experts and Qualifications for Ground Truth:
- Not applicable. There is no mention of establishing ground truth using experts for performance claims, as no performance study is described. The assessment focuses on the device's technical characteristics and safety relative to a predicate.
Adjudication Method for Test Set:
- Not applicable. No test set or related adjudication process is described for performance evaluation.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No such study was done or is reported. This type of study is common for imaging or diagnostic devices where human interpretation is involved. The ZQuiet® Mouthpiece is a therapeutic device, and the submission does not involve human interpretation of data where MRMC would be relevant.
Standalone Performance Study (Algorithm Only):
- No such study was done or is reported. This device is a physical medical device, not an algorithm or software. Its performance is directly tied to its physical interaction with the user's anatomy.
Type of Ground Truth Used:
- For the non-clinical safety evaluation, the "ground truth" for biocompatibility would be established by standard biological safety testing protocols (e.g., ISO 10993 series), rather than clinical outcomes or expert consensus.
- For the overall regulatory clearance, the "ground truth" is the legally marketed predicate device (SomnoGuard Series K061688), against which the new device is deemed substantially equivalent in terms of intended use, technology, and safety/effectiveness.
Sample Size for Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
How Ground Truth for Training Set was Established:
- Not applicable. As above, no training set is relevant to this type of device and submission.

In summary: The K090503 submission for the ZQuiet® Mouthpiece is a 510(k) premarket notification. Its "study" for acceptance criteria is primarily a comparison to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial designed to prove independent efficacy against quantitative acceptance criteria. The acceptance criteria are implicit: that the device's characteristics (components, materials, intended use, mechanism of action, design) are sufficiently similar to the predicate that it raises no new questions of safety or effectiveness. The only explicit performance data mentioned are non-clinical (in vitro and animal safety studies) to assess biocompatibility, but no details or sample sizes are provided for these.

Summary

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K090503

510(k) Summary 807.92(c)

SPONSOR		807.92(a)(1)
Company Name:	Sleeping Well, LLC
Company Address	PO Box 1240
	Shelburne, VT 05482	MAR 10 2009
Telephone:	802-985-3013
	888-978-4389
Fax:
Contact Person:	Daniel A. Webster
Summary Preparation Date:	January 20, 2009
DEVICE NAME		807.92(a)(2)
Trade Name:	ZQuiet® Mouthpiece
Common/Usual Name:	Anti-Snoring Device/Mandibular Advancement Device
Classification Name:	Device, Anti-snoring
Regulation Number:	CFR21 872.5570
Product Code:	LRK

PREDICATE DEVICE

Device Class:

807.92(a)(3)

Legally Marketed Equivalent Device Company Tomed Dr. Toussaint GmbH.

Product 510(k) # Anti-Snoring/Sleep Apnea Device K061688

DEVICE DESCRIPTION

807.92(a)(4)

The ZQuiet ® Mouthpiece is an Anti-Snoring device consisting of :

Class II

Two trayed plates fitted in front and between the upper and lower teeth and gums . and integrated with each other with the same material as the upper and lower plates.
The device is made of Thermoplastic elastomer .
◆ May be used as supplied

DEVICE INTENDED USE

807.92(a)(5)

The ZQuiet Anti-Snoring device is intended for the treatment of nightime snoring in adults.

92(a)(2)

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Target Population: Adult patients

and the state of the state of the states

..............................................................................................................................................................................

Environment of Use: Home and sleep laboratories

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
Device	Similarities
	New DeviceZQuiet®	Predicate DeviceSomnoGuard Series
K Number		K061688
Classification Name	Device, Anti-Snoring	Device, Anti-Snoring
Product Code	LRK	LRK
INTENDED USE
Mandibular Advancementdevice	Yes	Yes
Intended as an intraoraldevice	Yes	Yes
Intended to reducesnoring or help alleviatesnoring	Yes	Yes
Indicated for singlepatient multi use	Yes	Yes
Indicated for use at homeor sleep laboratories	Yes	Yes
Prescription device	Yes	Yes
MATERIALS
Device material	Thermoplastic elastomer	Thermoplastic elastomer
Non-sterile	Yes	Yes
THEORY OF OPERATION
Advancement of lowerjaw to open upper airway	Yes	Yes
DEVICE DESIGN
Ready-to-Use	Yes	Yes
Upper and lower trays	Yes	Yes
One piece design	Yes	Yes
Ready-to-use device	Yes	Yes
PATIENT USE
Permits patient to breathethrough the mouth	Yes	Yes
Placed in user's moutheach evening	Yes	Yes
Cleaned daily	Yes	Yes
Easily removed from themouth	Yes	Yes
DIFFERENCES
Boil and Bite fitting	No	Yes
Indicated for use withpatients with mild to	No	Yes

And Antiques and Children

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.......

and the consideration of the comments of the comments of

. . . ......

. .

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Substantial Equivalence Discussion

ZQuiet Anti-Snoring Device is similar to the predicate device in intended use, materials and design and does not raise any new issues concerning safety and effectiveness.

NONCLINICAL AND CLINICAL TEST

807.92(b)

SAFETY and EFFECTIVENESS

BIOCOMPATIBILITY

Non-Clinical Performance Data

ZQuiet® Anti-Snoring Device has been evaluated for safety through in vitro tests and animal safety studies.

CONCLUSION

807.92(b)(3)

ZQuiet® Anti-Snoring Device is similar to the predicate device in intended use, materials and design and does not raise any new issues concerning safety and effectiveness.

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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 features a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sleeping Well, LLC C/o Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

MAR 1 0 2009

K090503 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: February 20, 2009 Received: February 25, 2009

Dear Mr. Devine:

Re:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Devine

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Surete by Nicholas.

Ginette Y. Michaud, M.D. Acting 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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Indications for Use

510(k) Number (if known): _ 109.0502

Device Name: ZQuiet® Mouthpiece

Indications for Use:

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

(Part 21 Prescription Use X AND/OR CFR 801 Subpart D)

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 Bunner

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

510(k) Number: K070503

Page 1 of 1

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.”