The ZQuiet Advance is an intraoral appliance designed to reduce snoring by advancing the lower jaw. The principal effect of mandibular advancement devices is the protrusion of the lower jaw, thereby widening the upper airway to decrease air turbulence, a causative factor in snoring. This device combines several essential functions: Separate upper and lower dental trays with thermal impression material to engage the upper and lower dentition, a mechanism to provide the forward positioning of the lower jaw relative to the upper jaw in 3 positions determined by the user's bite providing up to +6 mm of possible advancement. The design allows the maintenance of the forward positioning of the lower jaw while allowing minor sagittal and vertical movement. The ZQuiet Advance is a "Boil-and-Bite" device that uses thermal impression resin for device retention. The upper and lower trays are both constructed out of a rigid plastic outer tray to provide the device structure and attachment points for the connecting semi-rigid straps that provide the adjustability. Both the upper and lower trays are lined with material that is moldable when heated in a water bath and provides the ability to conform the device to the individual's teeth.

AI/ML Overview

The provided text is a 510(k) summary for the ZQuiet Advance intraoral device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing the details of a study with specific acceptance criteria and performance metrics typically found for AI/ML-based medical devices or devices undergoing rigorous clinical trials to prove efficacy.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document. The device in question is a physical intraoral device, not an AI/ML algorithm requiring such detailed performance characteristics.

The document explicitly states:

"No clinical testing was performed in association with this submission." (Page 15, Section 3.13)
The justification for clearance relies on "Substantial Equivalence" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics.

Instead of a study proving the device meets acceptance criteria in the sense of an AI/ML study, the non-clinical testing performed focuses on mechanical properties and human factors:

Non-Clinical Testing (Page 15, Section 3.11):
- Strap compression testing (compared to similar designs).
- Physical properties testing (by material manufacturer).
- Human Factors Evaluation: Concluded that identified risks associated with critical tasks were adequately mitigated.
Biocompatibility (Page 15, Section 3.12):
- Testing conducted by the device manufacturer.
- Met requirements of ISO 10993-1 for mucosal membrane contacting devices with prolonged duration (cytotoxicity, sensitization, irritation).

Conclusion based on the provided text:

This document is a regulatory submission for a physical medical device. It does not provide the type of performance study details requested for an AI/ML-based device. The device's acceptance is based on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and non-clinical testing (mechanical and human factors), rather than a clinical study with specific performance metrics against an established ground truth.

Summary

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June 15, 2022

Sleeping Well, LLC % William McLain President Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, Pennsylvania 17540

Re: K213088

Trade/Device Name: ZQuiet Advance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: May 13, 2022 Received: May 16, 2022

Dear William 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213088

Device Name ZQuiet Advance

Indications for Use (Describe)

ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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3 510(K) Summary - ZQuiet Advance - K213088

3.1 Submission Owner

Mr. Daniel Webster Vice President Sleeping Well, LLC PO Box 1240 Shelburne, VT 05482 Phone: (802) 985-3013 Email: dan@ZQuiet.com

3.2 Submission Correspondent

Mr. William G. McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street Suite 207 Leola, PA 17540 Phone: (717) 656-9656 Email: bill.mclain@keystoneregulatory.com

3.3 Date Summary Prepared

September 23, 2021

Device Trade Name 3.4

ZQuiet Advance

3.5 Device Common Name

Intraoral Device for Snoring

3.6 Device Classification Name

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

3.7 Legally Marketed Device To Which The Device Is Substantially Equivalent

· Predicate Device PureSleep OTC cleared under K190058
· Reference Device ZQuiet OTC cleared under K180124

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3.8 Description Of The Device

3.9 Indication for Use

ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old.

3.10 Technological Characteristics

The proposed ZQuiet Advance has identical technical characteristics to the PureSleep OTC cleared under K190058. Table 1 below summarizes the overall technological characteristics between the proposed, predicate, and reference devices.

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Feature	Proposed - ZQuiet(K213088)	Device Predicate -PureSleep OTC(K190058)	Reference -ZQuiet OTC(K180124)	Device Comments on Sim-ilarities and Differ-ences
Device Proprietary Name	ZQuiet Advance	PureSleep OTC	ZQuiet OTC	Not applicable
Manufacturer	Sleeping Well, LLC	Sleep Science Partners, Inc.	Sleeping Well, LLC	Not applicable
510(k) Number	K213088	K190058	K180124	Not applicable
Classification Regulation	21 CFR 872.5570	21 CFR 872.5570	21 CFR 872.5570	The classification regulation is identical among the proposed, predicate, and reference devices.
Classification Name	Intraoral Device forSnoring and ObstructiveSleep Apena	Intraoral Device forSnoring and ObstructiveSleep Apena	Intraoral Device forSnoring and ObstructiveSleep Apena	The classification name is identical among the proposed, predicate, and reference devices.
Labeling
Indications for Use	Intended as an aid in thereduction of snoring foradults at least 18 yearsold.	Indicated for use foradults 18 years andabove as an aid in thereduction of snoringduring hours of sleep.	Intended as an aid in thereduction of snoring foradults at least 18 yearsold.	There are minor definitions in wording of the indication for use, however, they are all indicated for the reduction of snoring in adults 18 years and above.
Feature	Proposed - ZQuiet(K213088)	Predicate - PureSleep(K190058)	Reference - ZQuiet(K180124)	Comments on Similarities and Differences
Rx or OTC	OTC	OTC	OTC	The proposed, predicate, and reference devices are all indicated for OTC use.
Patient Population	Adults	Adults	Adults	There are no differences among the proposed, predicate, and reference device related to the patient population. They are all indicated for adult use.
Labeling	Language, visuals and structure are based on FDA guidance documents and closely resemble the predicate device labeling for which an HFE/UE study was conducted concluding that the device is clinically safe for OTC use.	Language, visuals and structure are based on FDA guidance documents and designed for OTC use. An HFE/UE study supported the conclusion that the device is clinically safe for OTC use.	Labeling designed for OTC use with the same contraindications and warnings.	The instructions for use are similar among the proposed, predicate, and reference devices in that they all are formatted for OTC use and contain instructions, contraindications, warning, precautions, and instructions for sizing and fitting the device. They differ in the particulars associated with assembly of the respective products.
Feature	ProposedDeviceZQuietAdvance(K213088)	PredicateDevicePureSleepOTC(K190058)	ReferenceDeviceZQuiet(K180124)	Comments on Sim-ilarities and Differ-ences
Clinical Condi-tions ImpactingSafe and Effec-tive Use	Presence of: looserestorations, missing an-terior or posterior teeth,malocclusion, undercuts,limited fine motor skills,central sleep apnea, anysevere respiratory disor-der, history of jaw painor temporomandibulardisorder (TMD), loose,sore or damaged teeth,loose caps, dental im-plants withing the last3 months, orthodontiaor dentures, sore orbleeding gums, advancedperiodontal disease. Useunder 18 years of age.	Presence of: central sleepapnea, chronic asthma,emphysema, COPD orany other serious breath-ing or respiratory disor-der; loose, damaged orweakened teeth, loose ordamaged fillings or caps;abscess, mouth sores,bleeding gums or severegum disease; dental im-plant within the last 3months, braces, full den-tures or sleep using an-other dental appliance;diagnosis of temporo-mandibular joint disor-der (TMD), symptoms ofTMD such as clicking,popping, grating or lock-ing of your jaw or jawpain when you open yourmouth, yawn or chew;jaw or tooth pain fromclenching your jaw orgrinding your teeth. Useunder 18 years of age.	Not included as the ref-erence device is not in-cluded for a labelingcomparison.	Both the proposed andpredicate devices con-tain references to looserestorations, missing an-terior or posterior teeth,malocclusion, undercuts,central sleep apnea, anysevere respiratory disor-der, history of jaw painor temporomandibulardisorder (TMD), loose,sore or damaged teeth,loose caps, dental im-plants withing the last3 months, orthodontiaor dentures, sore orbleeding gums, advancedperiodontal disease. Useunder 18 years of age.The predicate devicedoes not mention thepresence of malocclu-sions, undercuts, orlimited fine motor skills.
Feature	ProposedZQuietAdvance(K213088)	PredicatePureSleepOTC(K190058)	ReferenceZQuietOTC(K180124)	Comments on Similarities and Differences
		Technology
Mode of Action	Mandibular advance-ment to increase pharyn-geal space to alleviatesnoring.	Mandibular advance-ment to increase pharyn-geal space to alleviatesnoring.	Mandibular advance-ment to increase pharyn-geal space to alleviatesnoring.	There are no differenceamong the proposed,predicate, and refer-ence devices related tomode of action. Theyare all mandibularadvancement devices.
Environment	Home use, during sleep.	Home use, during sleep.	Home use, during sleep.	There are no differenceamong the proposed,predicate, and referencedevices related to theenvironment of use.They are all for homeuse during sleep.
Placement ofDevice	In the mouth, on thelower and upper jaw.	In the mouth, on thelower and upper jaw.	In the mouth, on thelower and upper jaw.	There are no differenceamong the proposed,predicate, and referencedevices related to theplacement of the device.They are all placed inthe mouth, on the lowerand upper jaw.