Encore System

K201238 · Siesta Medical, Inc. · ORY · Oct 2, 2020 · Dental

Device Facts

• Record ID: K201238
• Device Name: Encore System
• Applicant: Siesta Medical, Inc.
• Product Code: ORY · Dental
• Decision Date: Oct 2, 2020
• Decision: SESE
• Submission Type: Special
• 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; used to treat obstructive sleep apnea and snoring. Device components include an integrated suture passer pre-loaded with #2-0 braided polyester suture, bone screws, bone screw inserters, suspension line lock tool, threading tool, drill bit, and a #2 braided polyethylene suspension line. During surgery, the physician fixes soft tissue of the tongue base to the mandible and suspends the hyoid bone to the mandible using the provided screws and suspension lines. This mechanical advancement aims to reduce airway obstruction. All components are provided sterile for single-use in a clinical/surgical setting.

Clinical Evidence

Bench testing only. Suture tensile strength testing was performed to compare the #2 braided polyethylene suspension line against the existing #2 braided polyester suspension line to ensure sufficient strength to resist breakage.

Technological Characteristics

Surgical suspension system comprising bone screws, suture passer, and braided suspension lines. Materials include braided polyethylene and polyester sutures. Components are provided sterile. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring anterior advancement of the tongue base and hyoid suspension for the treatment of obstructive sleep apnea (OSA) and/or snoring.

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

• Encore System (K183310)

Reference Devices

• Force Fiber Suture (K063778)

Submission Summary (Full Text)

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October 2, 2020

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

Re: K201238/S001

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: August 31, 2020 Received: September 3, 2020

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.

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

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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Image /page/2/Picture/0 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.

# Indications for Use Statement

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)

Device Name

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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# 510(k) Summary

| 510(k) Number | K201238 | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------|
| Submitter Name and Address | | |
| Name | Siesta Medical, Inc. | |
| Contact | Michael Kolber<br>Vice President, Regulatory Affairs | |
| Address | 101 Church Street, Suite 3<br>Los Gatos, CA 95030 | |
| Telephone | 408-505-6626 | |
| Fax | 408-399-7600 | |
| Date Prepared | August 31, 2020 | |
| General Device Information | | |
| Product Name | Encore™ System | |
| Common Name | Intraoral device for snoring and obstructive sleep apnea | |
| Classification | 21CFR872.5570<br>Intraoral devices for snoring and intraoral devices for<br>snoring and obstructive sleep apnea. | |
| Device Class | Class II | |
| Product Code | ORY | |
| | | |
| Primary Predicate Device<br>Manufacturer | Device Name | 510(k) Number |
| Siesta Medical, Inc. | Encore System | K183310 |
| Reference Predicate Device | | |

### Teleflex Medical, Inc Device Description

Manufacturer

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) three (3) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, 4) a threading tool, and 5) a drill bit. In addition, a #2 braided polyethelene suspension line is provided. All components are provided sterile.

Force Fiber Suture

K063778

# 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.

## Comparison to the Predicate Device

The Encore System is now available with #2 braided polyethylene suspension line. It has the same intended use as the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for Siesta Medical. The word "Siesta" is in bold, black font, with a blue wave-like line above it. Below "Siesta" is the word "Medical" in a smaller, light gray font. The logo is simple and modern.

The fundamental scientific technology and technological characteristics of the Encore System are the same as the predicate device including mechanism of action, packaging, biocompatibility, sterilization, and labeling. The Encore System now includes a #2 braided polyethylene suspension line and a drill bit.

# Summary of Non-Clinical Testing

Performance testing was conducted to confirm that the #2 braided polyethelene suspension line has sufficuent strength to suture strength to resist breakage. A Suture Tensile Strength Test was conducted to determine the amount of force applied to the suture until the suture breaks. The results of this test confirmed that the strength of the #2 braided polyethylene suspension is similar to that of the existing #2 braided polyester suspension line.

## Conclusion

Based on the intended use and technological characteristics together with results from the nonclinical performance testing, we believe that the subject device Encore System is substantially equivalent to the predicate device K183310.