The Vital Sleep Device is designed to pull the mandible forward by an adjustable distance, and keep the mouth slightly open during use and reduce snoring. It consists of an arch fitted over the upper teeth and one fitted over the lower teeth. The arches are connected by a flexible hinge that allows a lateral movement (pulling the mandible forward). The arches and hinges form one injection-molded poly-propylene part. In the manufacturing process the semi rigid substrate is over-molded with softer EVA material.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Vital Sleep Device," an intraoral device intended to aid in the reduction of snoring. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner one might expect for a new AI/ML device or a device requiring significant clinical efficacy data.

Therefore, the information requested in your prompt (acceptance criteria, specific study details like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, etc.) is largely not present in this type of FDA submission for this particular device. This type of device (intraoral device for snoring) typically relies on demonstrating substantial equivalence based on technological characteristics, materials, and intended use, rather than extensive clinical performance studies with quantitative metrics like sensitivity/specificity for a diagnostic AI.

However, I will extract and synthesize the information that is available and clearly state what is missing based on your request.

Device: Vital Sleep Device (Intraoral device for snoring)
K Number: K201719
Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea
Product Code: LRK
Regulatory Class: Class II

1. A table of acceptance criteria and the reported device performance:

This 510(k) submission for the Vital Sleep Device does not present acceptance criteria in the typical format of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the submission relies on demonstrating substantial equivalence to predicate devices by comparing technological characteristics, materials, and intended use. The "performance" is implicitly demonstrated by showing similarity to devices already on the market and compliance with biocompatibility standards.

Here's a table based on the "Substantial Equivalence Comparison Table" (Table 5.0) which serves as the primary "proof" of meeting FDA requirements for this type of submission:

Item	Feature	Vital Sleep (This Submission - K201719)	Vital Sleep (K092942) Reference Predicate	ZQuiet (K180124) Predicate	Equivalency Discussion (Implicit Acceptance)
1	Product Code	LRK	LRK	LRK	Identical
2	Product Classification	II	II	II	Identical
3	Regulation	872.5570	872.5570	872.5570	Identical
4	Technology – Mode of Action	Mandibular advancement to increase pharyngeal space.	Mandibular advancement to increase pharyngeal space.	Mandibular advancement to increase pharyngeal space.	Identical
5	Indications for Use	The Device is intended as an aid in the reduction of snoring for adults at least 18-years old.	The mandibular advancement device is intended for the treatment of nighttime snoring in adults.	The Device is intended as an aid in the reduction of snoring for adults at least 18-years old.	Identical to the predicate
6	Product Design Principles	Device pulls mandible forward by adjustable distance, keeps mouth slightly open. Arches connected by flexible hinge for lateral movement. One injection-molded poly-propylene part over-molded with EVA material.	Device pulls mandible forward by adjustable distance, keeps mouth slightly open. Arches connected by flexible hinge for lateral movement.	Upper and lower tray constructed in one piece and joined by a flexible hinge. Lower tray protrudes the mandible to widen upper airway.	Identical to reference predicate and Similar to the predicate with more granularity in design principles.
7	Prescription Status	OTC	Prescription	OTC	Identical to the predicate (change from reference predicate is due to predicate)
8	Materials	Injection-molded poly-propylene part over-molded with softer EVA material.	Injection-molded black delrin part over-molded with softer EVA material.	Thermoplastic Elastomer with Blue Colorant.	Similar to the predicate & reference predicate. (Materials were changed but demonstrated biocompatibility)
9	Testing Performed	ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation/Sensitization)	ISO 10993-5, ISO 10993-10	ISO 10993-5, ISO 10993-10	Identical to the predicate & reference predicate
10	Width	63mm	64mm	(Not provided for ZQuiet)	Similar to the reference predicate
11	Length	50mm	51mm	(Not provided for ZQuiet)	Similar to the reference predicate
12	Height	29mm	28mm	(Not provided for ZQuiet)	Similar to the reference predicate
13	Air Gap	6mm	6mm	(Not provided for ZQuiet)	Similar to the reference predicate

Implicit Acceptance Criteria: The device must be demonstrably similar to existing legally marketed predicate devices, and any differences (like material changes or change in prescription status) must be shown not to negatively impact safety or effectiveness. For this device, the primary "acceptance criteria" are met by demonstrating this substantial equivalence and passing biocompatibility tests.

2. Sample sized used for the test set and the data provenance:

Test Set Sample Size: Not applicable in the context of clinical performance testing for this device. The "testing" referred to primarily involves biocompatibility testing (ISO 10993 standards). The document states: "Testing was performed at recognized and qualified testing laboratories (Nelson Labs & Toxikon)." No patient or user sample sizes are mentioned for a performance test set.
Data Provenance: Not applicable in the context of clinical performance. The data provenance described is related to lab testing for biocompatibility.

3. 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):

This question is not applicable to this 510(k) submission. No clinical test set with human "ground truth" (e.g., medical image interpretation) was used or required for this device type. The ground truth (or verification) here is based on laboratory standards (ISO 10993) and engineering specifications to ensure that the device functions as intended and is biocompatible.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring expert adjudication was used.

5. 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. This device is an intraoral appliance, not an AI/ML diagnostic tool or software. Therefore, MRMC studies are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this submission is multifaceted and based on:
- Regulatory Standards: Compliance with 21 CFR 872.5570 (regulation for intraoral devices).
- Predicate Device Characteristics: The established design, materials, and performance of the legally marketed predicate devices (K092942 Vital Sleep and K180124 ZQuiet) serve as the "ground truth" for what is considered safe and effective for this product category.
- Biocompatibility Standards: Successful completion of ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation/Sensitization) testing. This is a crucial "ground truth" for material safety.
- Engineering Specifications: Product dimensions (width, length, height, air gap) and functional design (mandibular advancement mechanism) are compared to the reference predicate.

8. The sample size for the training set:

Not applicable. This submission does not involve an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This submission does not involve an AI/ML algorithm requiring a training set.

Summary of what the document proves:

The document primarily proves that the Vital Sleep Device is substantially equivalent to legally marketed predicate devices by demonstrating:

Similar intended use (aid in snoring reduction).
Similar technological characteristics and mode of action (mandibular advancement).
Compliance with relevant regulatory classifications and product codes.
That changes in materials (from the reference predicate) and prescription status (from the reference predicate to align with the predicate) do not negatively impact safety or effectiveness, particularly through successful biocompatibility testing per ISO 10993 standards and alignment with the already OTC cleared predicate.
That physical dimensions are similar to the reference predicate.
That control over materials and manufacturing processes are in place.

This type of 510(k) clearance does not involve clinical trials with patient cohorts or performance studies with diagnostic metrics like sensitivity/specificity.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 14, 2021

The Snore Reliever Company, LLC % Christopher Devine President Devine Guidance International, Inc. 4730 South Fort Apache Road; Suite 300 Las Vegas, Nevada 89147

Re: K201719

Trade/Device Name: Vital Sleep 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: November 30, 2020 Received: December 7, 2020

Dear Christopher Devine:

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 Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental 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) K201719

Device Name Vital Sleep

Indications for Use (Describe)

The Vital Sleep Device 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)

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

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K201719 Section Five (5) - 510(k) Summary

510(k) SUMMARY

[As Required by 21 CFR 807.92(c)]

Submitter's Name & Address:	The Snore Reliever Company, LLCRegistration Number 30085835024201 Tonnelle Avenue, Unit 202North Bergen, NJ 07047
Contact Person:	Christopher J. Devine, Ph.D.Devine Guidance International, Inc.(702) 917-0585 - mobile
Date Summary Prepared:	December 16, 2020
Device Name:	Vital Sleep DeviceClassification Name - 872.5570 – Intraoral devices forsnoring and intraoral devices for snoring and obstructivesleep apnea
Classification:	Class II (special controls)
Special Controls Guidance:	Class II Special Controls Guidance Document: IntraoralDevices for Snoring and/or Obstructive Sleep Apnea -Guidance for Industry and FDA
Product Code:	LRK
Regulation Number:	872.5570
Regulation Name:	Intraoral Devices for Snoring and Intraoral Devices forSnoring and Obstructive Sleep Apnea
Manufacturing Name/Address:	The Snore Reliever Company, LLC4201 Tonnelle Avenue, Unit 202North Bergen, NJ 07047
Telephone Number:	(646) 316-0918
Predicate Device:	K180124 – ZQuiet (Sleeping Well, LLC)
Reference Device(s):	K092942 - Vital Sleep (Snore Reliever Company

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1.0 Device Description

To fit the mouthpiece to an individual user, the mouthpiece which has been configured for use, is submerged in hot water until EVA material is soft and then placed in the user's mouth. The user gently bites down to create impressions of their teeth in the softened EVA plastic.

Image /page/4/Picture/4 description: The image shows a dental device, possibly a mouthguard or a similar oral appliance. It is made of a combination of white and blue materials. The device appears to be designed to fit over the teeth, with a curved shape that conforms to the dental arch.

Figure 1.0 – Fully-Assembled Vital Sleep Device

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2.0 Technological Characteristics

The adjustment mechanism on the right and left of the mouthpiece consists of a #8-32 threaded lug 20 on the lower half and a screw though hole 18. When the mouthpiece is folded for use, screw seat fits within the channel formed by threaded 20. Screw 14 passes through screw seat 18 to thread into Threaded lug 20, additionally acts as a guide channel for screw seat 18. Mouthpiece is folded, and the two screws are installed by rotation clockwise. Once the Screw is threaded through the Lug 20, the snap portion the snap does not allow screws 14 to back out turning counter clockwise if the thread is not engaged.

The buccal sidewall of raised platform 12 has graduation marks, which can be used to gage the travel of indicator mark on the upper half during adjustment. To move the lower half relative to the upper half, a captive Philips head #8-32 screw 14 is rotated clockwise or counterclockwise. The displacement can be gauged by comparing the movement of indicator notches which are molded into the lower half, to blue indicator mark on the upper half of the mouthpiece. The lower arch is adjustable 6 mm forward from the resting position. The customer can adjust to find what offset is most effective for comfort as well as snore reduction (reference Figure 2.0).

Note: There are no accessory medical devices associated with the Vital Sleep Device.

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Image /page/6/Figure/0 description: The image shows a technical drawing of a collar with screws. The collar is made of a hard material and has several holes for screws. The screws are long and thin, and they have a threaded shaft. The numbers 12, 14, 18, and 20 are used to label different parts of the collar and screws.

Figure 2.0 – User Adjustments (Folding, Threaded Lugs, Screws, & Adjustment Markings)

3.0 Indications for Use

The Vital Sleep Device is intended as an aid in the reduction of snoring for adults at least 18-years old.

4.0 Prescriptive Statement

The Vital Sleep Device is intended for over the counter (OTC) utilization; "Over-The-

Counter Use (21 CFR 801 Subpart C)"

5.0 Discussion(s) Regulatory History, Change in Prescription Status & Change in Materials

5.1 Regulatory History

The reference predicate device (Vital Sleep - first generation) was cleared by FDA on 13 Jan 2010 (K092942). This device remains on the market today. The next generation Vital Sleep Device (this abbreviated 510(k) application K201719) has never been submitted for clearance previously. The next generation device is identical to the first generation device with just one change, composition of materials (resins).

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Additionally, a change from prescription to over-the-counter (OTC) use is being requested to align with current products in commercialization.

5.2 Prescription Status

There are essentially two (2) elements driving the need for filing an abbreviated 510(k) for the Vital Sleep Device: (a) a change in the prescription status from prescription required to OTC; and (b) a change in materials used.
. The proposed Vital Sleep device is intended to be sold over-the-counter. Therefore, the product labeling has been revised to reflect the elimination of prescribing information. The warning statements placed into the Vital Sleep User Manual remain consistent with the reference predicate device (Vital Sleep) and the predicate device (ZOuiet).

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

The predicate ZQuiet (K180124) has received clearance for over-the-counter . use. Premised on the design and construction of the Vital Sleep Device coupled with the successful testing of the device in accordance with ISO 10993 requirements and labeling identical to the predicate; the Vital Sleep Device will be safe and effective as an OTC product.

5.3 Change of Materials

Additionally, the change in materials (similar plastics generally accepted as safe in medical device applications) employed in the construction of the Vital Sleep Device will not negatively impact product performance, safety or efficacy. To ensure the materials used do not adversely impact the user, the Snore Reliever Company

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performed applicable ISO 10993 testing. Testing was performed at recognized and qualified testing laboratories (Nelson Labs & Toxikon). The testing results reflected a pass on all tests performed. A detailed summary can be found in Section 15 of the Abbreviated 510(k).

6.0 Substantial Equivalency Discussion

The proposed Vital Sleep Device has identical characteristics to the predicate device (Vital Sleep - K092942) and the identical over-the-counter (OTC) claim as the reference predicate device (ZQuiet – K180124). A comparison of technological characteristics is delineated within Table 5.0 (Substantial Equivalence Comparison Table).

Item	Feature	Vital Sleep(ThisSubmission)	Vital Sleep(K092942)ReferencePredicate	ZQuiet(K180124)Predicate	EquivalencyDiscussion
1	Product Code	LRK	LRK	LRK	Identical
2	ProductClassification	II	II	II	Identical
3	Regulation	872.5570	872.5570	872.5570	Identical
4	Technology –Mode of Action	Mandibularadvancement toincreasepharyngealspace.	Mandibularadvancement toincreasepharyngealspace.	Mandibularadvancement toincreasepharyngeal space.	Identical
5	Indications forUse	The ZQuietDevice isintended as anaid in thereduction ofsnoring foradults at least18-years old.	The Vital Sleepmandibularadvancementdevice isintended for thetreatment ofnighttimesnoring in adults	The ZQuietDevice isintended as an aidin the reductionof snoring foradults at least 18-years old.	Identical to thepredicate
6	Product DesignPrinciples	The device isdesigned to pullthe mandibleforward by anadjustabledistance, andkeep the mouthslightly open	The device isdesigned to pullthe mandibleforward by anadjustabledistance, andkeep the mouthslightly open	An upper andlower trayconstructed inone piece andjoined by aflexible hinge.The lower trayprotrudes the	Identical toreference predictandSimilar to thepredicate with theexception thatSRC employedmore granularity
Item	Feature	Vital Sleep(ThisSubmission)	Vital Sleep(K092942)ReferencePredicate	ZQuiet(K180124)Predicate	EquivalencyDiscussion
		during use andreduce snoring.It consists of anarch fitted over	during use. Itconsists of anarch fitted overthe upper teeth	mandible towiden the upperairway.	in their principlesof design
		the upper teethand one fittedover the lowerteeth. The archesare connected bya flexible hingethat allows a	and one fittedover the lowerteeth. The archesare connected bya flexible hingethat allows alateral
		lateral movement(pulling themandibleforward).	movement(pulling themandibleforward).
7	Prescription	OTC	Prescription	OTC	Identical to thepredicate
8	Materials	The arches andhinges form oneinjection-moldedpoly-propylenepart. During themanufacturingprocess, thesemi- rigidsubstrate is over-molded withsofter EVAmaterial	The arches andhinges form oneinjection-molded blackdelrin part. Inthemanufacturingprocess the semirigid substrate isover-moldedwith softer EVAmaterial	ThermoplasticElastomer withBlue Colorant	Similar to thepredicate &referencepredicate
9	TestingPerformed	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Identical to thepredicate &referencepredicate
10	Width	63mm	64mm		Similar to thereferencepredicate
11	Length	50mm	51mm		Similar to thereferencepredicate
12	Height	29mm	28mm		Similar to thereferencepredicate
13	Air Gap	6mm	6mm		Similar to thereferencepredicate

Table 5.0 – Substantial Equivalence Comparison Table

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7.0 Special Controls

The application of special controls was in accordance with; "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea - Guidance for Industry and FDA." Sections six (6) through eight (8) of the Guidance Document describe the agency's recommendations for complying with the Special Controls requirements. Compliance with Special Controls was achieved through:

. The identification of risk and the risk mitigation activities pursued;
Biocompatibility testing; ●
Labeling in accordance with 21 CFR, Part 801 requirements; and ●
Warning statements placed into the User Manual. .

7.1 Control of Materials

In support of control the quality of finished devices, all procured materials are submitted to receiving inspection, which includes the clear identification of the material received and a copy of the material certification provided by the supplier.

8.0 Conclusion Statement

The documented evidence complied during the inspection of raw materials, ISO 10993 testing, and comparison made versus the predicate and reference predicate devices for design, materials, intended use, and technical properties demonstrate that the Vital Sleep Device is as safe and effective as the legally marketed predicate devices. Product packaging and labeling were created considering 21 CFR, Part 801 and FDA Guidance Document – Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea -Guidance for Industry requirements. Additionally, the product labeling has been revised to

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provide sufficient granularity in support of the over-the-counter use for the Vital Sleep Device. Therefore, the Snore Reliever Company, LLC concludes that the proposed Vital Sleep Device is substantially equivalent to the predicate devices depicted within this summary report.

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.”