ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN

K111179 · Siesta Medical, Inc. · ORY · Jul 1, 2011 · Dental

Device Facts

• Record ID: K111179
• Device Name: ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
• Applicant: Siesta Medical, Inc.
• Product Code: ORY · Dental
• Decision Date: Jul 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Siesta Medical, Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

Device Story

The ENCORE Tongue Suspension System is a surgical device used to treat mild/moderate obstructive sleep apnea and snoring by advancing the tongue base anteriorly. The system comprises a titanium bone screw, an inserter, a suture passer, a bone screw lock tool, a threading tool, and suspension sutures (braided polyester or monofilament polypropylene). During the procedure, a physician uses the bone screw to anchor the suture into the mandible; the suture is then passed submucosally through the tongue base using the suture passer. By tensioning the suture, the tongue base is pulled forward, preventing airway obstruction. The device is used in a clinical/surgical setting. It benefits patients by reducing airway collapse during sleep.

Clinical Evidence

Bench testing only. Performance evaluated via Suture Endurance Test and Bone Screw Fixation Strength Test. Results demonstrated that the suture endured 10.5 million cycles and attachment strengths were comparable to the predicate device.

Technological Characteristics

Materials: Titanium bone screw, braided polyester or monofilament polypropylene sutures. Components: Bone screw, inserter, suture passer, bone screw lock tool, threading tool. Principle: Mechanical suspension via bone-anchored suture. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients with mild or moderate obstructive sleep apnea (OSA) and/or snoring requiring anterior advancement of the tongue base.

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

• PRELUDE III Tongue Suspension System (K110127)

Submission Summary (Full Text)

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510(k) for the Siesta Medical, Inc ENCORE Tongue Suspension System April 26, 2011

#### 510(k) Summary (per 21CFR 807.92) Section 5

JUL - 1 2011

| General Company Information | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------|---------------|
| 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: | April 26, 2011 | |
| General Device Information | | |
| Product Name: | ENCORETM Tongue Suspension System | |
| Common Name: | Bone Screw System | |
| Classification: | 21CFR872.5570<br>Intraoral devices for snoring and intraoral devices for snoring<br>and obstructive sleep apnea. | |
| Device Class: | Class II | |
| Product Code: | ORY | |
| Predicate Device | | |
| Manufacturer | Device Name | 510(k) Number |
| Siesta Medical, Inc. | PRELUDE III Tongue<br>Suspension System | K110127 |

Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - The ENCORE Tongue Suspension System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw and suture. The ENCORE Tongue Suspension System consists of an integrated suture passer pre-loaded with size #2-0 braided polyester suture, a titanium bone screw that is pre-mounted on an inserter, a bone screw lock tool. and a Threading Tool. In addition, one of the following suspension sutures are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension suture, 2) a size #1 monofilament polypropylene suspension suture with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension suture with a radiopaque marker, or 4) a size #2 braided polyester suspension suture.

Similar to the PRELUDE III System, the ENCORE Tongue Suspension System 1) uses a bone screw, 2) uses a bone screw inserter to place a bone screw into the bone, and 3) uses a needle to pass a suspension suture submucosally through the base of the tongue. The ENCORE uses a Suture Passer and working suture loops to pass a suture from the posterior position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension suture. A Threading Tool is provided to ease passage of the suspension suture through the bone screw.

#### Intended Use (Indications) , The Siesta Medical, Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

Substantial Equivalence

This submission supports the position that the Siesta Medical, Inc. ENCORE Tongue Suspension System is substantially equivalent to the PRELUDE III Tongue Suspension System (K110127). The 510(k) notice contains a summary of the Suture Endurance Test and the Bone Screw Fixation

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Strength Test, which were used to evaluate the performance characteristics of the ENCORE Tongue Suspension System. This data demonstrate that the suture was able to endure 10.5 million cycles Suspension System. This the bone screw to suture attachment strengths were no worse than the writtion ordaings and that the performance characteristics of the ENCORE Tongue Suspension System compare favorably to the predicate device.

### Conclusions

Siesta Medical, Inc. believes that the information provided demonstrates that the proposed device is Substantially equivalent to the predicate device and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to the entially. Based the ENCORE Tongue Suspension System has been shown to be substantially equivalent to predicate device as described under the Federal Food, Drug and Cosmetic Act.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

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

JUL - 1 2011

Re: K111179

Trade/Device Name: ENCORETM Tongue Suspension System Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: ORY Dated: June 1, 2011 Received: June 2, 2011 .. . . . . . . . . . . . .

Dear Mr. 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. 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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## Page 2- Mr. Kolber

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 requrements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson

Clostformy D. Only .. Oninton
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Siesta Medical, Inc. ENCORE™ Tongue Suspension System

Indications for Use: The Siesta Medical, Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Venner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

-111179 510(k) Number:

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