EndSnorZ™ Sleep Appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. EndSnorZ™ Sleep Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

Device Description

The EndSnorZ Sleep Appliance is a mandibular advancement device. It holds the mandible in a protrusive position determined by the trained dentist. The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin, and a connector, made of a biocompatible medical-grade synthetic polymer with injection molding technology. The connectors attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 0.5 mm increments. The device is customized to conform to the patient's upper and lower dentition, provided to Prismatik in patient scans. After loading the patient's scan, the splints are designed according to the scan and the clinician's prescription. Prismatik's computer aided design (CAD) software is used for the design phase. The connectors are applied after the splints are manufactured. This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the EndSnorZ™ Sleep Appliance. It asserts substantial equivalence to a predicate device, the Silent Nite sl. The document describes laboratory testing and biocompatibility assessments to support this claim, rather than a clinical study evaluating the device's performance in humans against specific acceptance criteria.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of a clinical trial or performance evaluation with human subjects is not present in the provided text. The document focuses on demonstrating substantial equivalence through comparison to existing devices and laboratory testing of materials and mechanical properties.

However, I can extract information related to the device and the testing performed to support its substantial equivalence, which is a form of "proof" in the regulatory context.

Here's an interpretation based on the provided text, addressing the points where information is available and noting where it is not:

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

The document does not present specific clinical acceptance criteria (e.g., a certain percentage reduction in AHI or snoring events) as it is not a clinical performance study with human outcomes. Instead, the "acceptance criteria" for this 510(k) submission are implied to be the demonstration of substantial equivalence to the predicate device through:

Identical/Similar Indications for Use: The device aims to address the same clinical need as the predicate.
Similar Technological Characteristics: The device functions similarly and is made of biocompatible materials with comparable mechanical properties.
Fulfillment of Biocompatibility and Mechanical Testing Standards: Meeting established safety and performance standards for materials.

Here's a table summarizing the reported device performance in the context of substantial equivalence, based on the comparative testing and characteristics mentioned:

Criterion (Implied for Substantial Equivalence)	Reported Device Performance (EndSnorZ™ Sleep Appliance)
Indications for Use Alignment	Indicated "to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older," worn "to support the lower jaw in a forward position," and "removable by the patient." Identical to predicate.
Mechanism of Action	"Designed so the lower jaw is in an advanced (forward protruding) state during sleep. This forward position improves the flow of air through the patient's pharyngeal space during sleep, repositioning the mandible and thus reducing snoring and mild to moderate OSA." Same as predicate.
Biocompatibility (per ISO 10993)	"All materials meet requirements of ISO 10993." Specifically, Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal Reactivity), Part 10 (Maximization for Delayed-Type Hypersensitivity). GLP Cytotoxicity testing (per ISO 10993, Part 5) performed on connectors. Test results showed materials and manufactured connectors are safe and biocompatible.
Tensile Strength of Connectors (against Predicate)	"compare the following mechanical properties of EndSnorZ Sleep Appliance to the Predicate: tensile strength of the connectors..." Results of all laboratory testing confirmed substantial equivalence. (Specific values not provided, only the conclusion of equivalence).
Dimensional Retention of Connectors (when exposed to artificial saliva, against Predicate)	"compare the following mechanical properties of EndSnorZ Sleep Appliance to the Predicate: ...the dimensional retention of connectors when exposed to artificial saliva." Results of all laboratory testing confirmed substantial equivalence. (Specific values not provided, only the conclusion of equivalence).
Design and Manufacturing Process Validation	Testing performed to "validate the design and process for manufacturing the EndSnorZ Sleep Appliance," "validate the position of the devices on the build platform of the SprintRay 3D printing machine for printing the devices with the Keysplint Soft Resin," and "validate that Prismatik's Wave CAD software accurately designs the sleep appliances and is 21 CFR Part 11 compliant." Implied successful validation as part of substantial equivalence.
Material Composition	Splints/Trays: Methacrylate-based light-cured polymer resin used to additively manufacture splints. (Different from predicate (Polyurethane or PETG) but identical to Reference #1 and similar to Reference #2). Advancement mechanism: Synthetic polymer nylon. (Same material type as predicate, but from different sources; both manufactured by injection molding).
Adjustable Range / Increments	Connector adjustment range: 20.5mm to 26mm (Predicate: 21mm to 26mm). Maximum adjustment: 5.5mm; increments of 0.5 mm (Predicate: 5.0 mm; increments of 1.0mm). Total achievable mandibular advancement: Approximately 10mm (Predicate: Approximately 10mm). Noted as "Similar."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical samples of the device and its components used for laboratory/bench testing. The number of samples for these tests (tensile strength, dimensional retention, biocompatibility) is not explicitly stated, but it would have been conducted under GLP (Good Laboratory Practice) guidelines.
Data Provenance: The testing was performed by Prismatik (the manufacturer) and contracted labs for biocompatibility testing. The location of these labs is not specified, but the submission is to the U.S. FDA. The testing is prospective in the sense that it was conducted for this specific submission to demonstrate equivalence.

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)

Not applicable. The ground truth for this submission is based on laboratory measurements and adherence to engineering/material standards (e.g., ISO 10993) and comparison to the predicate device's established characteristics. No expert clinical review of "ground truth" (e.g., diagnosis of OSA severity or snoring levels) from human patients was required or performed as part of this specific 510(k) submission.

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

Not applicable. This concept pertains to multi-reader studies where disagreements among expert readers need to be resolved. This submission is based on laboratory testing and comparison to a predicate, not human image interpretation or clinical outcomes.

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

No. An MRMC study was not performed. This device is a physical intraoral appliance, not an AI or image analysis tool for diagnosis where human reader performance would be assessed.

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

Not applicable. This device 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 510(k) submission is derived from:
- Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate device (Silent Nite sl).
- Laboratory/Bench Testing Standards: Defined metrics and acceptable ranges for material properties (e.g., tensile strength) and biocompatibility, as per ISO standards and engineering principles.
- Manufacturing Validation Data: Confirmation that the manufacturing process consistently produces the device according to design specifications.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML algorithm for which this information would be relevant.

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

Not applicable. There is no training set mentioned in this context.

Summary

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

Prismatik Dentalcraft, Inc. % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K211069

Trade/Device Name: EndSnorZ™ Sleep Appliance 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: September 28, 2021 Received: October 1, 2021

Dear Patsy Trisler:

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.

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

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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 (OS) 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,

For 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) K211069

Device Name

EndSnorZTM Sleep Appliance

Indications for Use (Describe)

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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510(k) Summary – K211069

Submitter Name:	Prismatik Dentalcraft, Inc.
Submitter Address:	2144 Michelson DriveIrvine, CA 96212
Contact Person:	Herbert CraneVice President, RA/QA
Telephone:	949.222.3531
Date Prepared:	October 21, 2021
Device Trade Name:	EndSnorZ™ Sleep Appliance
Common Name	Anti-Snoring Device
Classification Nameand Number	Intraoral devices for snoring and for obstructive sleep apnea21 CFR 872.5570
Product Code	LRK
Regulatory Class	II
Primary PredicateDevice:	K183270, Silent Nite sl, Prismatik Dentalcraft, Inc.
Reference Devices:	#1: K183598, KeyPrint KeySplint Soft, Keystone Industries(Product Codes: MQC, KMY)#2: K203712, The Slide, Biotex, Inc. (Product codes LQZ, LRK)
Indications for UseStatement:	EndSnorZ™ Sleep Appliance is indicated to reduce snoring andmild to moderate obstructive sleep apnea in patients 18 years ofage or older. EndSnorZ™ Sleep Appliance is worn whilesleeping to support the lower jaw in a forward position prescribedby the dentist. The appliance is removable by the patient.
Device Descriptionand Summary ofTechnologicalCharacteristics	The EndSnorZ Sleep Appliance is a mandibular advancementdevice. It holds the mandible in a protrusive position determinedby the trained dentist.
	The device consists of upper and lower splints (trays), which areadditive manufactured using a biocompatible light curable resin,and a connector, made of a biocompatible medical-gradesynthetic polymer with injection molding technology. Theconnectors attach the upper and lower splints to maintain theforward position of the lower jaw. The device is adjustable in 0.5mm increments.
	The device is customized to conform to the patient's upper andlower dentition, provided to Prismatik in patient scans. Afterloading the patient's scan, the splints are designed according tothe scan and the clinician's prescription. Prismatik's computeraided design (CAD) software is used for the design phase. Theconnectors are applied after the splints are manufactured.

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This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep. Mechanism of Action The EndSnorZ™ Sleep Appliance is designed so the lower jaw is in an advanced (forward protruding) state during sleep. This forward position improves the flow of air through the patient's pharyngeal space during sleep, repositioning the mandible and thus reducing snoring and mild to moderate OSA. Device Testing Laboratory Testing Testing was performed by Prismatik to: . validate the design and process for manufacturing the EndSnorZ Sleep Appliance: validate the position of the devices on the build platform of . the SprintRay 3D printing machine for printing the devices with the Keysplint Soft Resin; validate that Prismatik's Wave CAD software accurately . designs the sleep appliances and is 21 CFR Part 11 compliant: and compare the following mechanical properties of EndSnorZ . Sleep Appliance to the Predicate: tensile strength of the connectors and the dimensional retention of connectors when exposed to artificial saliva. Results of all laboratory testing confirmed substantial equivalence. Biocompatibility The following ISO 10993 testing was performed by the manufacturers of the Reference devices' printer resin and the connector polymer to assess the safety and biocompatibility of the resin and synthetic polymer materials. Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal) Reactivity), Part 10 (Maximization for Delayed-Type Hypersensitivity) Prismatik also contracted for GLP Cytotoxicity testing (per ISO 10993, Part 5) of the injection molded connectors. The test results showed that the materials and the manufactured connectors are safe and biocompatible for the stated intended use. Animal | Human Testing No animal or human testing are required for this product type. The EndSnorZ™ Sleep Appliance as compared to the predicate Comparison to Predicate and Silent Nite sl device: Reference Devices: ■ The intended use is the same. · The mechanisms of action are the same. . The materials used to make the device components are similar to the predicate. Further, the materials and methods for fabricating the splints are the same as the materials and additive manufacturing methods used for Reference #1: The resin is the same KeyPrint KeySplint

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Soft resin used for 3D printing the EndSnorZ sleep appliance splints. And, Reference #2 sleep appliance devices are also fabricated with additive manufacturing workflow and methods using a similar light-cured resin.

The following Substantial Equivalence Comparison table includes key similarities and differences of the EndSnorZ Sleep Appliance compared to the Predicate and both Reference devices.

Based on documentation presented in the 510(k), including Substantial comparative testing between the subject and Predicate devices, Equivalence Conclusion and the presentation of similarities in technological characteristics to the Reference devices, it can be concluded that the differences in the base materials and methods of manufacture do not raise new questions of safety and effectiveness. Thus the EndSnorZ Sleep Appliance is substantially equivalent to the Predicate device.

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EndSnorZ™ Sleep Appliance Premarket Notification: Traditional 510(k)

Substantial Equivalence Comparison Table

Element	New Device	Primary Predicate	Reference Device#1	Reference Device#2	Differences
Device name:	EndSnorZ Sleep Appliance	Silent Nite® sl	KeyPrint® KeySplintSoft ™	The Slide	N/A
510(k) #:	K211069	K183270	K183598	K203712	N/A
Classification	21 CFR 872.5570	21 CFR 872.5570	21 CFR 872.5570	21 CFR 872.5570	New device, Predicate
Product Code:	LRK	LRK	MQC, KMY	LQZ, LRK	and Reference #2: no
Class:	II	II	II	II	differences
Submitter:	Prismatik Dentalcraft, Inc.	Prismatik Dentalcraft, Inc.	KeyStone Industries	Biotex, Inc.	N/A
Indications forUse:	indicated to reducesnoring and mild tomoderate obstructivesleep apnea (OSA) inpatients 18 years of ageor older. EndSnorZSleep Appliance is wornwhile sleeping to supportthe lower jaw in a forwardposition prescribed by thedentist. The appliance isremovable by the patient.	indicated to reducesnoring and mild tomoderate obstructivesleep apnea (OSA) inpatients 18 years of ageor older. Silent Nite® sl isworn while sleeping tosupport the lower jaw in aforward positionprescribed by the dentist.The appliance isremovable by the patient.	indicated for thefabrication oforthodontic anddental appliancessuch asmouthguards,nightguards, splintsand repositioners.	is for use to reducenight-time snoringand mild to moderateobstructive sleepapnea (OSA) inadults.	New device, Predicate,and Reference #2: nodifferences.Reference #1: may beused during sleep, butnot for use to reducesnoring or OSA.
Method of Use:	Single patient user,removable andreusable appliance	Single patient user,removable andreusable appliance	Single patient user,removable andreusable appliance	Single patient user,removable andreusable appliance	None
Rx or OTC	Rx	Rx	Rx	Rx	None
Environment	During sleep at home orin sleep laboratory	During sleep at home orin sleep laboratory	During sleep at home	During sleep at home	As noted
DESIGN:
Rigid Trays	Upper and lower	Upper and lower	Upper and lower	Upper and lower	None
Adjustable	Yes	Yes	Yes	Yes	None
MATERIALS:
Splints/Trays	Methacrylate-based light-cured polymer resin usedto additively manufacturesplints.	Polyurethane or PETGheat-sensitive materialsused to manufacture splints	Methacrylate-basedlight-cured polymerresin used toadditivelymanufacture splints.	Methacrylate-basedlight-cured polymerresin used toadditivelymanufacture splints	Materials & fabricationmethod is differentcompared to predicatebut identical to Ref #1and similar to Ref #2.
Advancementmechanism	Synthetic polymer nylon	Synthetic polymer nylon	N/A	Syntheticpolycarbonate	Compared to Predicatesame material type butfrom difference sources,both are manufacturedby injection moldingmethods.
PHYSICALPROPERTIES:
Connectoradjustment range:	20.5mm to 26mm	21mm to 26mm	N/A	N/A	Similar as noted
Maximumadjustment:	5.5mm; increments of0.5 mm	5.0 mm; increments of1.0mm	N/A	N/A	Similar as noted
Total achievablemandibularadvancement:	Approximately 10mm	Approximately 10mm	N/A	N/A	Similar as noted
STERILITY	Non-sterile	Non-sterile	Non-sterile	Non-sterile	None
BIOCOMPATIBLE	All materials meetrequirements of ISO10993	All materials meetrequirements of ISO 10993	All materials meetrequirements of ISO10993	All materials meetrequirements of ISO10993	None

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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.”