The SNOR LOCK is an oral appliance comprised of an upper and lower tray constructed in one piece. 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.

AI/ML Overview

The provided text is a 510(k) summary for the medical device "SNOR LOCK." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for its intended clinical use (reduction of snoring).

Therefore, I cannot create the requested table of acceptance criteria and reported device performance from the provided text. The document describes non-clinical testing performed to ensure safety and basic functionality and compares the device's characteristics to a predicate device, but it does not include a clinical study with defined acceptance criteria for snoring reduction.

Here's why I cannot fulfill all parts of your request based on the provided text, and what information is available:

Information NOT Available in the Provided Text:

A table of acceptance criteria and the reported device performance for snoring reduction: The document does not describe a clinical study measuring the effectiveness of SNOR LOCK in reducing snoring against specific, quantifiable acceptance criteria. It focuses on demonstrating equivalence to a predicate device.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for a clinical effectiveness study: No such clinical effectiveness study is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such clinical effectiveness study is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 anti-snoring intraoral device, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical effectiveness study: Not applicable.
The sample size for the training set, and how the ground truth for the training set was established for a clinical effectiveness study: Not applicable.

Information Available related to "Acceptance Criteria" implicitly for demonstrating device safety and basic functionality:

The document mentions Non-Clinical Testing with "preset test criteria." These are primarily for biocompatibility and material safety, not clinical efficacy in reducing snoring.

1. A table of acceptance criteria and the reported device performance (for non-clinical testing):

Test Article / Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Appearance, Dimension, Weight	Met preset test criteria	All test results met the preset test criteria.
Appearance, pH, Heavy metals, Potassium permanganate reducing substance, Residue on evaporation, Ultraviolet absorption spectrum of extracts	Met preset test criteria	All test results met the preset test criteria.
ISO 10993-5 – Cytotoxicity	Meets ISO 10993-1 for prolonged contact duration mucosal membrane (>24h to 30 days)	Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged contact duration (>24h to 30 days): cytotoxicity tested.
ISO 10993-3 - Genotoxicity (Bacterial Reverse Mutation)	Meets ISO 10993-1 for prolonged contact duration mucosal membrane (>24h to 30 days)	Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged contact duration (>24h to 30 days): genotoxicity tested.
ISO 10993-10 - Guinea Pig Maximization Test for Skin sensitization	Meets ISO 10993-1 for prolonged contact duration mucosal membrane (>24h to 30 days)	Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged contact duration (>24h to 30 days): sensitization tested.
ISO 10993-11 – Subchronic toxicity	Meets ISO 10993-1 for prolonged contact duration mucosal membrane (>24h to 30 days)	Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged contact duration (>24h to 30 days): subchronic toxicity tested.
General Performance (Bench Testing)	All test results met the preset test criteria	All test results met the preset test criteria.

2. Sample sized used for the test set and the data provenance: Not explicitly stated for each non-clinical test, but "test articles" were used. Data provenance generally refers to the testing institution's method for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable for non-clinical lab tests.
4. Adjudication method: Not applicable for non-clinical lab tests.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone performance: The non-clinical tests assess the device's inherent properties and performance against specified standards, which can be seen as "standalone" from human interaction in a clinical setting.
7. The type of ground truth used:
- For Biocompatibility: Established international standards (ISO 10993 series) define the ground truth for toxicity, genotoxicity, sensitization, etc.
- For Physical/Chemical Properties: Internal methods and referenced standards for appearance, dimension, weight, pH, etc.
8. The sample size for the training set: Not applicable; this device does not use an AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a medical device (SNOR LOCK) through non-clinical testing and comparison to a predicate device, rather than a report on a clinical study proving specific performance acceptance criteria for snoring reduction.

Summary

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November 10, 2022

Solbaro Co., Ltd Jinwook Seo Regulatory Affair 4th fl. 137, Janggam-ro Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27603 SOUTH KOREA

Re: K222475

Trade/Device Name: Snor Lock 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: August 8. 2022 Received: August 16, 2022

Dear Jinwook Seo:

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 -S

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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K222475

Device Name SNOR LOCK

Indications for Use (Describe)

SNOR LOCK is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep.

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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510(k) SUMMARY K222475

Date: August 8, 2022

1. SUBMITTER

Solbaro Co., Ltd. 4th fl. 137, Janggam-ro, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do, Republic of Korea TEL : +82-70-8844-2714 FAX : +82-43-881-2875 Contact Name: Jinwook Seo Email: penbedht(@hanmail.net

2. DEVICE

·Trade Name: SNOR LOCK ·Common Name: Antisnoring device ·Classification Name: Device, Anti-Snoring ·Regulation Number 872.5570 ·Class: 2 ·Classification Product Code: LRK

3. PREDICATE DEVICE

PureSleep®(OTC use), Sleep Science Partners, Inc. K190058

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

SNOR LOCK is indicated for use for adults 18 years and above as an aid in the reduction

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of snoring during hours of sleep.

6. NON-CLINICAL TESTING

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

Testing institution's method -Appearance, Dimension, Weight / Appearance, pH, Heavy metals, Potassium premanganate reducing substance, Residue on evaporation, Ultraviolet absorption spectrum of extracts

ISO 10993-5 – Cytotoxicity

ISO 10993-3 - Genotoxicity (Bacterial Reverse Mutation)

ISO 10993-10 - Guinea Pig Maximization Test for Skin sensitization

ISO 10993-11 – Subchronic toxicity

	Proposed Device	Predicate Device	Discuss/Justify theDifferences
510(k) Number	New	K190058	-
Trade Name	SNOR STOP(SNOR LOCK)	PureSleep®(OTC use)	-
Manufacturer	Solbaro Co., Ltd.	Sleep Science Partners, Inc.	-
Common Name	Antisnoring device	Antisnoring device	Equivalent
ClassificationName	Intraoral devices for snoringand obstructive sleep apnea	Intraoral devices for snoring andobstructive sleep apnea	Equivalent
Device Class	2	2	Equivalent
Product Code	LRK	LRK	Equivalent
Device Description	The SNOR LOCK is an oralappliance comprised of anupper and lower partsconstructed in mouthpiece. Themouthpiece engage with themaxillary and mandibulardentition and the device	The PureSleep® device for Over-the-Counter (OTC) use is anintraoral mandibularrepositioning device thatincreases the pharyngeal space toimprove the user's ability toexchange air and to decrease airturbulence, a causative factor insnoring. The device consists oftwo dental trays designed toconform to the shape of the upper	Equivalent

		maintains an anteriorpositioning of the mandiblewhich widens the pharyngealairway to prevent occlusion.	and lower jaws.
Indication for use		SNOR LOCK is indicated foruse for adults 18 years andabove as an aid in the reductionof snoring during hours ofsleep.	PureSleep® (OTC) is indicatedfor use for adults 18 years andabove as an aid in the reductionof snoring during hours of sleep.	Equivalent
Indication for use	Prescription Status	OTC	OTC	Equivalent
	PatientPopulation	Adult persons 18 years of ageor older	Adult persons 18 years of age orolder	Equivalent
Mode of action		Mandibular repositioningdevice (MRD) that advancesthe lower jaw to increasepharyngeal space and alleviatesnoring.	Mandibular repositioning device(MRD) that advances the lowerjaw to increase pharyngeal spaceand alleviate snoring.	Equivalent
Environment		During sleep, at home	During sleep, at home	Equivalent
	Placement of device	In the mouth, on the lower andupper Jaws	In the mouth, on the lower andupper Jaws	Equivalent
	Preparation / Set-up	Connect upper and lower partsper bite type.	Connect upper and lower partsper bite type.	Equivalent
Molding / Fitment		Custom impression to eachindividual's mouth using a"boil and bite" approach andthermal setting (heat sensitive)resins. Molded to the entireupper and lower arch of teeth.	Custom impression to eachindividual's mouth using a "boiland bite" approach and thermalsetting (heat sensitive) resins.Molded to the entire upper andlower arch of teeth.	Equivalent
Design		Image: Snore Lock	Image: PureSleep	DifferencesMandibularadvancement ofproposed device isfixed in 6mm and

	SNOR LOCK is an all-in-one mouthpiece (intraoral device) that is designed to have lower tray anterior to the upper tray. This allows 6mm advancement of mandible and pharyngeal space.	Consists of an upper and lower tray. Outer shell provides with structural support and inner shell is lined with softer material that is heat sensitive and thus allows for custom fitting.	frame is loacated inside mouthpiece.
Adjustments	6 mm of mandibular advancement	Adjustable jaw advancement position. Adjustably positions the mandible forward in three positions, 4mm apart anteriorly, while maintaining a 9mm inferior placement for user comfort	DifferencesMandibular advancement of proposed device is fixed in 6mm
Single use / Reusable	Single patient, multi-use(reusable)	Single patient, multi-use	Equivalent
Cleaning instructions	Clean/rinse daily with toothbrush & toothpaste.Deep clean once per week with commercial denture cleanser(ex. Polident).	Clean/rinse daily with toothbrush and toothpaste or with effervescent oral device cleaning tablets.Deep clean once per week.	Equivalent
Sterile	No	No	Equivalent
Materials	Body : ethylene-vinyl acetate copolymer resinFrame : ethylene propylene copolymer, colorant	Polypropylene homopolymer and ethylene vinyl acetate copolymer	DifferencesSNOR LOCK has additional chemical substances; colorant, ethylene propylene copolymer
Biocompatibility	Meets ISO 10993-1 for a surface device contacting mucosal membrane for a	Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged	Equivalent
	prolonged contact duration(>24h to 30 days): cytotoxicity,sensitization,genotoxicity and subchronictoxicity	contact duration (>24h to 30days): cytotoxicity, sensitizationand irritation

7. SUBSTANITAL EQUIVALENCE

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8. SUBSTANTIAL EQUIVALENCE DISCUSSION

SNOR LOCK has the same Indications for Use and the principle of operations as the predicate device. Even though there is a slight difference in design(mandibular advancement is fixed in 6mm), it does not affect the equivalence and functioning of intended use-reduction of snoring. It has similar physical properties, and demonstrates biocompatibility and performance specifications comparable to the predicate devices.

The chemical compositions might slightly differ from the predicate devices. Additional components are used as frame material and frame colorant. Both devices have used ethylene-vinyl acetate copolymer as base material, which has a major contact with a patient tissue. Additional polymer material used in SNOR LOCK, ethylene propylene copolymer, is a elastomer with established biocompatibility and widely medical use, including surface of infusion bag. Light Brown model(008031) of SNOR LOCK is created by addition of every colorant with the same ratio. By conducting biocompatibility test using this model as a worst case, risk of each product lines with different color are fully assessed. Both SNOR LOCK and predicate deivce are met the requirement of anti-snoring device.

The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that SNOR LOCK is substantially equivalent to the predicate devices.

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.”