REST EAZY Appliance

K172760 · Insert Molding Solutions, Inc. · LRK · Mar 26, 2018 · Dental

Device Facts

• Record ID: K172760
• Device Name: REST EAZY Appliance
• Applicant: Insert Molding Solutions, Inc.
• Product Code: LRK · Dental
• Decision Date: Mar 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

REST EAZY Appliance is a custom-fabricated mandibular repositioning device; consists of upper and lower acrylic splints connected by an adjustable Herbst-style mechanism. Device worn during sleep; supports lower jaw in forward position to increase pharyngeal space; improves air exchange; reduces snoring and obstructive sleep apnea. Fabricated in dental labs using industry-standard dental acrylic and stainless steel (304/316). Prescribed by dentists; removable by patients. Clinical benefit derived from temporary mandibular protrusion during sleep to maintain airway patency.

Clinical Evidence

Bench testing only. Biocompatibility established via reference to Variflex (K033632) material. Physical properties testing performed on Variflex material included ultimate tensile strength, Young's modulus, hardness (Shore D), water sorption, and water solubility. No clinical data presented.

Technological Characteristics

Custom-fit intraoral mandibular repositioning device. Materials: Dental acrylic and stainless steel (304 or 316). Design: Herbst-style mechanism with threaded advancement connectors and eyelets. Non-sterile; single-patient multiple-use. Surface-contacting (mucosa) for permanent exposure (>30 days).

Indications for Use

Indicated for adult patients for reduction of snoring and mild to moderate obstructive sleep apnea.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Specialty Appliance Works, Inc.'s Acrylic Splint Herbst Appliance (K083209)

Reference Devices

• Embassy Dental Laboratory's Acrylic Herbst Appliance (K111009)
• Selane Products Inc.'s SML-OSA2 Appliances (K162816)
• Great Lakes Orthodontics' Variflex (K033632)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized human figure. The second logo is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text.

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K172760

Device Name REST EAZY Appliance

Indications for Use (Describe)

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.

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

| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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 Hendrixson<br>President |
| Address: | 4325 Settingdown Circle, Suite 105<br>Cumming, GA 30028 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

### II. Application Correspondent

| Contact's Name: | Regulatory and Quality Solutions, LLC. |
|-----------------|-------------------------------------------------|
| Contact Person: | Ms. Felicia Ruley, RAC<br>Principal Specialist |
| Address: | 2790 Mosside Blvd #800<br>Monroeville, PA 15146 |
| Telephone: | [phone] ext. 161 |
| Email: | [e-mail] |

### III. Device

| Trade Name: | REST EAZY Appliance |
|-------------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Intraoral devices for snoring and intraoral devices for snoring and<br>obstructive sleep apnea |
| Classification Name: | Intraoral devices for snoring and intraoral devices for snoring and<br>obstructive sleep apnea |
| Product Classification: | Class II, § 872.5570, Product Code LRK |

{4}------------------------------------------------

#### 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

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.

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

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.

#### 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.

{5}------------------------------------------------

| 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 intraoral<br>devices for snoring and obstructive sleep<br>apnea | Intraoral devices for snoring and intraoral<br>devices for snoring and obstructive sleep<br>apnea |
| Design | Herbst<br>Upper and lower arches to support jaw | Herbst<br>Upper and lower arches to support jaw |
| Patient Contact | External communicating (>30 days) Surface-<br>contacting (mucosa) | External communicating (>30 days)<br>Surface-contacting (mucosa) |
| Sterility | Non-sterile | Non-sterile |
| | | |
| | Device is cleaned between uses by the<br>patient following instructions provided by its<br>manufacturer | Device is cleaned between uses by the<br>patient following instructions provided by its<br>manufacturer |
| Type of Device | Prescription use only. | Prescription use only. |
| Usage | Removable intraoral device.<br>Single patient multiple use. | Removable intraoral device.<br>Single patient multiple use. |
| Scientific Principle | Supports forward movement of lower<br>mandible during sleep | Supports forward movement of lower<br>mandible during sleep |
| Principle of | Positions the lower jaw forward and open<br>vertically causing the mandible to protrude<br>from the position of the maxilla. | Positions the lower jaw forward and open<br>vertically from its normal location which<br>causes a protrusion of the mandible in<br>relation to the maxilla. |
| Operation | | |
| | Temporarily repositions the mandible to<br>increase the pharyngeal space which allows<br>for improved air exchange. | This forward repositioning, which is<br>temporary while the appliance is being used,<br>increases the pharyngeal space which<br>assists the patient with improved air<br>exchange. |
| 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.

{6}------------------------------------------------

#### 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.