The REST EAZY Appliance is intended for use in adult patients for the reduction of snoring and mild to moderate obstructive sleep apnea. The REST EAZY Appliance is worn while sleeping to support the lower jaw in a forward position as prescribed by the dentist. The appliance is removable by the patient.

Device Description

The proposed REST EAZY Appliance device consists of an upper and lower acrylic splint, custom fabricated to the patient's teeth. The splints are connected to each other via the REST EAZY adjustable Herbst style mechanism that orients the jaw in a predetermined relationship. These devices function as a mandibular repositioner, which increases the pharyngeal space. An enlarged pharyngeal space assists the patient with improved air exchange. The device is custom fit for each patient, as prescribed by the dentist.

AI/ML Overview

The provided text is a 510(k) Summary for the REST EAZY Appliance. It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data as would be found for complex AI/ML-driven devices. Therefore, much of the requested information regarding acceptance criteria, performance metrics, and clinical study details (like sample size for test sets, expert qualifications, and adjudication methods) is not applicable or not available in this specific document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific quantitative acceptance criteria or performance metrics in a table format for the device's efficacy in reducing snoring or treating obstructive sleep apnea. Instead, it relies on demonstrating substantial equivalence to an already cleared predicate device (Specialty Appliance Works, Inc.'s Acrylic Splint Herbst Appliance).

The reported "performance" is implicitly tied to this substantial equivalence; the new device is expected to perform similarly to the predicate.

Acceptance Criteria Category	Acceptance Criteria (from predicate equivalence)	Reported Device Performance (by equivalence)
Intended Use	Reduction of snoring and mild to moderate obstructive sleep apnea in adult patients. Support lower jaw in forward position while sleeping. Removable by patient.	Same as predicate.
Technological Characteristics	Matching fundamental scientific technology, design, and materials of the predicate device.	Device consists of customized maxillary and mandibular form-fitting arches with an adjustable Herbst-style mechanism to support jaw movement. Materials are stainless steel (304 or 316) and dental acrylic (Variflex®).
Biocompatibility	No new materials, materials established as biocompatible for permanent external communicating (mucosa) contact.	Utilizes stainless steel and dental acrylic, identical to predicate. Biocompatibility established for Variflex (K033632).
Physical Properties	Similar physical properties as the Variflex material used in the predicate.	Testing conducted on Variflex (K033632) material for ultimate tensile strength, Young's modulus, hardness (Shore D), water sorption, and water solubility. (Specific values not provided in this summary).
Safety/Risk	Risks are identified and addressed through contraindications, warnings, precautions, and instructions for use, similar to the predicate.	Risk analysis performed; no significant new risks identified beyond those associated with mandibular advancement devices (e.g., TMJ soreness, soft tissue soreness, dentition complications).

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

Not applicable. This submission is based on demonstrating substantial equivalence through comparison of technological characteristics and materials to a predicate device, not through a new clinical performance study. The data provenance mentioned refers to the biocompatibility and physical properties of the materials, which were established through prior testing of a cleared component (Variflex K033632).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new clinical "test set" requiring expert ground truth establishment for diagnostic performance is described in this document.

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

Not applicable. As no clinical test set requiring expert adjudication for ground truth is described.

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 is not an AI-assisted device. The device is a physical intraoral appliance.

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

Not applicable. This is not an algorithmic device.

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

Not applicable. For this type of 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the FDA's prior clearance of the predicate device based on its established safety and effectiveness. The performance of the new device is inferred to be similar due to its substantially equivalent characteristics.

8. The sample size for the training set:

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable. This is not a machine learning device.

Summary

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March 26, 2018

Insert Molding Solutions, Inc. % Felicia Ruley Principal Specialist Regulatory and Quality Solutions, LLC 2790 Mosside Blvd #800 Monroeville, Pennsylvania 15146

Re: K172760

Trade/Device Name: REST EAZY 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: February 14, 2018 Received: February 22, 2018

Dear Felicia Ruley:

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. 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 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 J. Ryan -S

for Tina Kiang, Ph.D. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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) K172760

Device Name REST EAZY 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

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92 on March 20th 2018.

l. Submitter

Submitter's Name:	Insert Molding Solutions, Inc.
Contact Person:	Mr. Paul HendrixsonPresident
Address:	4325 Settingdown Circle, Suite 105Cumming, GA 30028
Telephone:	(678) 965-5334
Fax:	(678) 965-5343
Email:	paul@insertmoldingsolutions.com

II. Application Correspondent

Contact's Name:	Regulatory and Quality Solutions, LLC.
Contact Person:	Ms. Felicia Ruley, RACPrincipal Specialist
Address:	2790 Mosside Blvd #800Monroeville, PA 15146
Telephone:	(877) 652-0830 ext. 161
Email:	fruley@rqteam.com

III. Device

Trade Name:	REST EAZY Appliance
Common/Usual Name:	Intraoral devices for snoring and intraoral devices for snoring andobstructive sleep apnea
Classification Name:	Intraoral devices for snoring and intraoral devices for snoring andobstructive sleep apnea
Product Classification:	Class II, § 872.5570, Product Code LRK

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IV. Predicate Device

. Specialty Appliance Works, Inc.'s Acrylic Splint Herbst Appliance
- K083209 (Specialty Appliance Works, Inc), FDA cleared on 01/27/2009

V. Reference Devices

. Embassy Dental Laboratory's Acrylic Herbst Appliance
- K111009 (Embassy Dental Laboratory), FDA cleared on 04/11/2011 O
. Selane Products Inc.'s SML-OSA2 Appliances
- K162816 (Selane Products Inc.), FDA cleared on 0/27/2017 o
. Great Lakes Orthodontics' Variflex
- K033632 (Great Lakes Orthodontics), FDA cleared on 11/19/2003 o

VI. Device Description

Per 21 CFR 872.5570, intraoral devices for snoring and/or obstructive sleep apnea 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, tonque retaining devices, and mandibular repositioning devices. The proposed REST EAZY Appliance is considered a mandibular repositioning device.

VII. Indications for Use

VIII. Comparison of Technological Characteristics with the Predicate Devices

The proposed REST EAZY Appliance has the same intended use, fundamental scientific technology and materials as the predicate device Specialty Appliance Works, Inc.'s Acrylic Splint Herbst Appliance.

The following table (Table 7-1) provides an overview of general technological characteristics in comparison to the predicate device.

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Table 7-1: General Technological Characteristics Comparison
	Proposed Device	Predicate Device
	Insert Molding Solutions, Inc.	Specialty Appliances Acrylic Splint Herbst
Product Features	REST EAZY Appliance	Appliance (K083209)
	The proposed device consists of 2	The Acrylic Splint Herbst Appliance consists
	customized maxillary and mandibular form-	of an upper and lower acrylic splint custom
	fitting arches (splints). These splints are	fabricated to the teeth. These full arch splints
	produced in a lab using industry standard	are connected to each other by the Herbst
	dental acrylic material. The splints are formed	mechanism, which is a rod and tube type
Device Description	with stainless steel nut flanges to permit the	assembly that orientates the jaws in a
	attachment of the advancement connectors.	predetermined relationship. The Herbst
	The advancement connectors each consist of	mechanism allows the patient vertical and
	a threaded portion with an eyelet and a	lateral range of motion while the jaws are
	receptacle (nut) portion with an eyelet.	orientated in the biting relationship dictated
	Vertical adjustment stops may also be placed	by the positioning of the Herbst mechanism
	on the occlusal aspect of the maxillary base.	as it connects to the respective arch splints.
	The REST EAZY Appliance is intended for	The Acrylic Splint Herbst Appliance is
	use in adult patients for the reduction of	intended for use in patients 18 years of age
	snoring and mild to moderate obstructive	or older for the reduction of snoring and mild
Indications for Use	apnea. The REST EAZY Appliance is worn	to moderate obstructive sleep apnea. The
	while sleeping to support the lower jaw in a	Acrylic Splint Herbst Appliance is worn while
	forward position as prescribed by the dentist.	sleeping to support the lower jaw in a forward
	The appliance is removable by the patient.	position prescribed by the dentist. The
		appliance is removable by the patient.
Class	II	II
Product Code	LRK	LRK
Regulation Number	872.5570	872.5570
Regulation Name	Intraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea	Intraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea
Design	HerbstUpper and lower arches to support jaw	HerbstUpper and lower arches to support jaw
Patient Contact	External communicating (>30 days) Surface-contacting (mucosa)	External communicating (>30 days)Surface-contacting (mucosa)
Sterility	Non-sterile	Non-sterile

	Device is cleaned between uses by thepatient following instructions provided by itsmanufacturer	Device is cleaned between uses by thepatient following instructions provided by itsmanufacturer
Type of Device	Prescription use only.	Prescription use only.
Usage	Removable intraoral device.Single patient multiple use.	Removable intraoral device.Single patient multiple use.
Scientific Principle	Supports forward movement of lowermandible during sleep	Supports forward movement of lowermandible during sleep
Principle of	Positions the lower jaw forward and openvertically causing the mandible to protrudefrom the position of the maxilla.	Positions the lower jaw forward and openvertically from its normal location whichcauses a protrusion of the mandible inrelation to the maxilla.
Operation
	Temporarily repositions the mandible toincrease the pharyngeal space which allowsfor improved air exchange.	This forward repositioning, which istemporary while the appliance is being used,increases the pharyngeal space whichassists the patient with improved airexchange.
Materials	Stainless Steel (304 or 316) and Dental	Stainless Steel (304 or 316) and Dental
	Acrylic (Variflex®)	Acrylic (methyl methacrylate or Variflex®)

Table 7-1: General Technological Characteristics Comparison

IX. Performance Data

The following performance data was considered in support of the substantial equivalence determination.

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Performance Guidelines

The special control for these devices is the FDA quidance document entitled "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA." [67 FR 68512, Nov. 12, 2002]

Biocompatibility

The predicate and subject devices are considered to be external communicating devices of permanent exposure (>30 days) per ISO 7405 and surface-contacting devices (mucosa) of permanent contact (>30 days) per ISO 10993-1. There are no new materials being used in the proposed device. Materials utilized for the REST EAZY Appliance are identical to the primary materials used in the predicate device for the same intended use. Both the predicate and REST EAZY Appliance are made from stainless steel and dental acrylic. Biocompatibility testing has been previously established through biocompatibility testing for the Variflex (K033632) material.

Non-Clinical Testing

The following physical properties testing was conducted on the Variflex (K033632) material.

Ultimate Tensile Strength
. Young's Modulus
. Hardness (Shore D)
Water Sorption
. Water Solubility

Risk Analysis

A risk analysis including an evaluation of the materials of construction and design was performed. The prescribing dentist must recognize the potential for TMJ soreness, soft tissue soreness, and dentition complications (soreness, motion, loosening) when using a mandibular advancement device. The contraindications, warnings, precautions, storage directions, prescription preparation instructions, fitting and adjustment directions are provided to avoid potential problems from arising or persisting with the dentition, tissue, or joints. No significant new risks were identified.

X. Conclusion

The proposed REST EAZY Appliance has the same intended use, fundamental scientific technology and materials as the predicate device Specialty Appliance Works. Inc.'s Acrylic Splint Herbst Appliance; the REST EAZY Appliance is substantially equivalent to the predicate device.

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.”