Encore System

K183310 · Siesta Medical, Inc. · ORY · May 9, 2019 · Dental

Device Facts

• Record ID: K183310
• Device Name: Encore System
• Applicant: Siesta Medical, Inc.
• Product Code: ORY · Dental
• Decision Date: May 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and / or snoring.

Device Story

Encore System is a surgical device for anterior tongue base and hyoid suspension. It consists of bone screws, suture passers, suspension lines, and associated tools. During surgery, a physician uses the system to fixate soft tissue of the tongue base and hyoid bone to the mandible. The device uses bone screws to secure suspension sutures, which are then tensioned to advance the tongue base anteriorly. This mechanical suspension aims to reduce airway obstruction in patients with OSA or snoring. The system is used in a clinical/surgical setting by a physician. The device provides a mechanical means to achieve anatomical repositioning, which is intended to reduce the apnea-hypopnea index (AHI) and improve patient outcomes related to sleep-disordered breathing.

Clinical Evidence

Evidence based on a literature review of 16 peer-reviewed clinical studies involving 377 patients with moderate-to-severe or severe OSA. Studies compared the Encore System (n=45) and AIRvance System (n=332). Results showed a weighted average AHI reduction of 61.8% for the Encore System and 57.8% for the AIRvance System. Complication profiles were reported as similar between the subject and predicate devices.

Technological Characteristics

Bone screw system composed of Titanium 6AL-4V screws (2.8 mm x 5.5 mm). Suspension lines include #2 monofilament polypropylene and #2 braided polyester. Tether line is co-braided polyester/PTFE. Sterilization via ethylene oxide (ISO 11135:2014). Biocompatibility per ISO 10993-7:2012. Mechanical fixation principle.

Indications for Use

Indicated for patients with obstructive sleep apnea (OSA) and/or snoring, including those with severe OSA.

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

• Siesta Medical, Inc., Encore System (K133680)

Reference Devices

• Medtronic, Inc., AIRvance System (K122391)

Submission Summary (Full Text)

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May 9, 2019

Siesta Medical, Inc Michael Kolber Vice President, Regulatory Affairs 101 Church Street, Suite 3 Los Gatos, California 95030

Re: K183310

Trade/Device Name: Encore System 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: ORY Dated: April 2, 2019 Received: April 9, 2019

Dear Michael Kolber:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

for Malvina Eydelman, M.D. Director 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 Statement ction 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Not yet known

Device Name

Encore System

Indications for Use (Describe)

The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and / or snoring.

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Siesta Medical. The word "Siesta" is in large, bold, black font, with a blue wave-like line above it. Below "Siesta" is the word "Medical" in a smaller, gray font. The logo is simple and modern, with a focus on the company name.

# 510(k) Summary

510(k) Number: K183310

# Submitter Name and Address

| Name: | Siesta Medical, Inc. |
|----------------|------------------------------------|
| Contact: | Michael Kolber |
| | Vice President, Regulatory Affairs |
| Address: | 101 Church Street, Suite 3 |
| | Los Gatos, CA 95030 |
| Telephone: | 408-320-9424 |
| Fax: | 408-399-7600 |
| Date Prepared: | May 3, 2019 |

# General Device Information

| Product Name: | Encore™ System |
|-----------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Screw System |
| Classification: | 21CFR872.5570, Intraoral devices for snoring and intraoral devices for<br>snoring and obstructive sleep apnea |
| Device Class: | Class II |
| Product Code: | ORY |

# Predicate Devices

| Primary: | Siesta Medical, Inc., Encore System, K133680 |
|------------|----------------------------------------------|
| Reference: | Medtronic, Inc., AIRvance System, K122391 |

# Device Description

The Encore System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone and hyoid bone suspension to the mandible bone using a bone screw and suspension lines. The Encore System consists of 1) an integrated suture passer pre-loaded with size #2-0 braided polyester suture, 2) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, and 4) a threading tool. In addition, the following suspension lines are provided depending on the model number: 1) a #2 monofilament polypropylene suspension line with a radiopaque marker, 2) a size #2 braided polyester suspension line, and 3) a size #2 braided polyester suspension line with a radiopaque marker.

#### Intended Use (Indications)

The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and /or snoring.

The intended use has been modified to broaden the intended use from mild and moderate OSA, to now include severe OSA, similar to the MDT AIRvance System (reference predicate). This change does not raise concerns regarding the new intended use since patients who had severe sleep apnea with the Encore System experienced a

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comparable reduction in their apnea hypopnea index and complications as that observed with the AIRvance System.

## Comparison of Technology

The Encore System (subject device) has a modified intended use compared to the predicate devices. The intended use has been modified to simplify and broaden the indications statement. Also, minor changes have been made compared to the Encore System (primary predicate). These changes include adding a Bone Screw, modifying the Tether Line used to hold the Bone Screw in place on the Inserter Shaft by adding loops to ease threading the Suspension Line through the eyelet of the Bone Screw, and using a co-braided Tether Line to more easily differentiate it from the Suspension Line.

The additional Bone Screw is provided as a convenience to the physician in the event that one screw is accidently dropped and deemed non-sterile. The Looped Tether Line allows the physician to thread the Suspension Line through the Bone Screw using fewer steps and without the need for the Threading Tools. Finally, the co-braided Tether Line enables the physician to more easily differentiate it from the Suspension Line during the surgical procedure.

The availability of a spare Bone Screw and use of a co-braided Looped Tether Line prior to the surgical procedure are not differences in technology that raise concerns of safety or effectiveness. A comparison of the Encore System to the primary and reference predicate devices is provided in Table 1. The mechanism of action, design characteristics, dimensions, materials, and procedural steps are unchanged. This information supports substantial equivalence of the Encore System (subject device) to the Encore System (primary predicate) and AIRvance System (reference predicate).

| Point of<br>Comparison | Characteristic | Siesta Medical<br>Encore System<br>K183310<br>(Subject Device) | Siesta Medical<br>Encore System<br>K133680<br>(Primary Predicate) | Medtronic AIRvance System<br>K122391<br>(Reference Predicate) | Equivalent<br>or Effect<br>of Change | |
|---------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Product<br>Labeling | Indication | The ENCORE System is<br>intended for anterior<br>advancement of the tongue<br>base and hyoid suspension.<br>It is indicated for the<br>treatment of obstructive<br>sleep apnea (OSA) and / or<br>snoring. | | The ENCORE System is<br>intended to be used for<br>anterior advancement of the<br>tongue base. It is also<br>suitable for performing hyoid<br>suspension. It is indicated for<br>the treatment of mild or<br>moderate obstructive sleep<br>apnea (OSA) and /or snoring. |
| | | of obstructive sleep apnea (OSA) and/or snoring. | | | | |
| Surgical<br>Procedure | Anatomical<br>Site | Mandible bone through<br>submental incision and the<br>tongue and hyoid | Mandible bone through<br>submental incision and the<br>tongue and hyoid | Mandible bone through<br>submental incision and the<br>tongue and hyoid | Equivalent | |
| | Bone Screw to<br>Suture<br>Method of<br>Attachment | Surgeon threads both suture<br>ends through bone screw,<br>locks suture in place with<br>lock screw | Surgeon threads both suture<br>ends through bone screw,<br>locks suture in place with<br>lock screw | Suture pre-attached to bone<br>screw | Equivalent | |
| | Components | | | | | |
| | Bone Screw | Purpose | Secures suture in mandible | Secures suture in mandible | Secures suture in mandible | Equivalent |
| | | Material | Titanium 6AL-4V | Titanium 6AL-4V | Titanium 6AL-4V | Equivalent |
| | Diameter X<br>Length | 2.8 mm X 5.5 mm | 2.8 mm X 5.5 mm | 2.8 mm X 5.5 mm | Equivalent | |
| Suspension<br>Line Lock<br>Tool | Purpose | Locking mechanism to<br>attach the Suspension Suture<br>to the Bone Screw | Locking mechanism to attach<br>the Suspension Suture to the<br>Bone Screw | None | Equivalent | |
| Bone Screw<br>Inserter | Purpose | Places the bone screw into<br>the bone (n=3) | Places the bone screw into the<br>bone (n=2) | Places the bone screw into the<br>bone | Equivalent | |
| Threading<br>Tool | Purpose | Threads Suspension Suture<br>through Bone Screw eyelet | Threads Suspension Suture<br>through Bone Screw eyelet | None | Equivalent | |
| Suture Passer | Purpose | Passes suture through the<br>tongue | Passes suture through the<br>tongue | Passes suture through the<br>tongue | Equivalent | |
| Suspension<br>Line | Purpose | Anterior advancement of the<br>tongue and hyoid suspension | Anterior advancement of the<br>tongue and hyoid suspension | Anterior advancement of the<br>tongue and hyoid suspension | Equivalent | |
| | Material | #2 monofilament<br>polypropylene with a<br>radiopaque marker<br>#2 braided polyester<br>#2 braided polyester with a<br>radiopaque marker | #2 monofilament<br>polypropylene with a<br>radiopaque marker<br>#2 braided polyester<br>#2 braided polyester with a<br>radiopaque marker | #1 monofilament<br>polypropylene | Equivalent | |
| Working<br>Suture | Purpose | Pull Suspension Suture<br>through tongue anteriorly | Pull Suspension Suture<br>through tongue anteriorly | Pull Suspension Suture<br>through tongue anteriorly | Equivalent | |
| | Material | #2-0 braided PTFE-coated<br>polyester | #2-0 braided PTFE-coated<br>polyester | #1 polypropylene<br>monofilament | Equivalent | |
| Tether Line | Purpose | Hold Bone Screw on Inserter<br>Shaft | Hold Bone Screw on Inserter<br>Shaft | None | Equivalent | |
| | Material | Co-braided polyester / PTFE<br>coating, with loops | Polyester/PTFE coating, no<br>loops | None | Equivalent | |
| Test Results | | | | | | |
| Biocom-<br>patibility | | Biocompatible, same<br>materials as predicate device | Biocompatibility, same<br>materials as predicate device | Not reported | Equivalent | |
| Bench | Suspension<br>Line<br>Endurance | Pass | Pass | Pass | Equivalent | |
| | Bone Screw-<br>to-Suspension<br>Line Fixation<br>Strength | Pass | Pass | Pass | Equivalent | |
| Clinical | Literature<br>Review | Product similar to the Siesta<br>Encore System (K133680) | Literature review comparing<br>Encore System to AIRvance | Literature review comparing<br>Encore System to AIRvance | Equivalent | |

#### Table 1. Comparison of the Siesta Medical Encore System (Subject Device) to the Encore System (Primary Predicate) and the Medtronic AIRvance System (Reference Predicate).

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Image /page/6/Picture/1 description: The image shows the logo for Siesta Medical. The word "Siesta" is in large, bold, black font, with a blue wave-like line above it. Below "Siesta" is the word "Medical" in a smaller, gray font. The logo is simple and modern, with a focus on the company name.

#### Summary of Non-Clinical Performance Testing Bench Test

Tether Loop Strength Test - Assess Tether Loop strength as Suspension Line is pulled through evelet of Bone Screw

## Risk Assesment/Analysis

A Failure Modes and Effects Analysis (FMEA) was used to assess changes made to the subject Encore System compared to the predicate Encore System. The analysis determined that the Tether Loop strength exceeds the suture loading force, resulting in an acceptable low risk category.

### Referenced Standards

ISO 10993-7: 2012 - Ethylene oxide sterilization residuals ISO 11135: 2014 - Sterilization of health care products – Ethylene oxide: Requirements for development, validation and routine control of a sterilization process for medical devices

### Summary of Clinical Performance Testing

The published clinical experiences utilizing the Siesta Medical Encore System and the Medtronic AIRvance System are presented. Data is presented from 16 peer-reviewed clinical studies which include a total of 377 treated moderate-severe or severe patients (Table 2).

| Treatment<br>Method | Studies<br>(n) | Total Patients<br>(n) | AHI* Reduction<br>(range) | Average AHI Reduction<br>(weighted average) |
|---------------------|----------------|-----------------------|---------------------------|---------------------------------------------|
| Encore System | 2 | 45 | 41.7 - 69.9% | 61.8% |
| AIRvance System | 14 | 332 | 34.7 - 77.4% | 57.8% |
| Total | 16 | 377 | - | - |

#### Table 2. Clinical Studies from the Medical Literature.

* AHI - apnea hypopnea index

Patients with severe sleep apnea were treated with the Encore System and experienced a significant reduction in their apnea hypopnea index (AHI) (61.8%) that was similar to the reduction observed with the AIRvance System (57.8%). In addition, the complications are similar between the subject and predicate devices.

The medical literature supports the safety and efficacy of suture based hyoid and tongue suspension for the proposed intended use. The Medtronic AIRvance System, a device with similar features, is well documented in the medical literature with extensive clinical data supporting its use, as well as regulatory recognition in the form of marketing clearance.

The literature review of published clinical articles demonstrated that the modified intended use does not adversely affect safety and effectiveness.

#### Statement of Equivalence

Based on similarities in indications for use and technological characteristics, as well as nonclinical and clinical performance (medical literature) testing, we believe the Encore System is substantially equivalent to the predicate devices.