ENCORE TONGUE SUSPENSION SYSTEM

K121814 · Siesta Medical, Inc. · ORY · Nov 7, 2012 · Dental

Device Facts

• Record ID: K121814
• Device Name: ENCORE TONGUE SUSPENSION SYSTEM
• Applicant: Siesta Medical, Inc.
• Product Code: ORY · Dental
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Traditional
• 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 for anterior tongue base advancement to treat OSA and snoring. The system comprises a titanium bone screw, an inserter, a suture passer, a bone screw lock tool, a threading tool, and various suspension lines (braided polyester or monofilament polypropylene). During surgery, the physician uses the bone screw to anchor the system into the mandible and the suture passer to route a suspension suture submucosally through the base of the tongue. The suspension line is then secured to the bone screw, pulling the tongue base anteriorly to maintain airway patency. The device is intended for clinical use by physicians. The system provides a mechanical means to stabilize the tongue base, potentially reducing airway obstruction during sleep.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing regarding shelf-life extension.

Technological Characteristics

Materials: Titanium bone screw, braided polyester suture, monofilament polypropylene suspension lines. Principle: Mechanical bone-to-soft-tissue suspension. Components: Bone screw, inserter, suture passer, threading tool. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with mild or moderate 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 Tongue Suspension System (K111179)

Submission Summary (Full Text)

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K121814

#### NOV 7 2012

Image /page/0/Picture/2 description: The image shows the logo for Siesta Medical. The word "Siesta" is in large, bold, black letters with a curved line above it. Below "Siesta" is the word "Medical" in smaller, bold, black letters. The logo is simple and professional.

510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System August 3, 2012

#### Appendix 3: 510(k) Summary

| General Company Information | | |
|-----------------------------|---------------------------------------------------------|---------------|
| Name: | Siesta Medical, Inc. | |
| Contact: | Michael Kolber | |
| | Vice President, Regulatory Affairs | |
| Address: | 101 Church Street, Suite 3 | |
| | Los Gatos, CA 95030 | |
| Telephone: | 408-505-6626 | |
| Fax: | 408-399-7600 | |
| Date Prepared: | July 31, 2012 | |
| General Device Information | | |
| Product Name: | ENCORE™ Tongue Suspension System | |
| Common Name: | Bone Screw System | |
| Classification: | 21CFR872.5570 | |
| | Intraoral devices for snoring and intraoral devices for | |
| | snoring and obstructive sleep apnea. | |
| Device Class: | Class II | |
| Product Code: | ORY | |
| Predicate Device | | |
| Manufacturer | Device Name | 510(k) Number |
| Siesta Medical, Inc. | ENCORE Tongue | K111179 |
| | Suspension System | |

### 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 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, the following suspension lines are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension line, 2) a size #1 monofilament polypropylene suspension line with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension line with a radiopaque marker, and 4) a size #2 braided polyester suspension line.

Similar to the predicate ENCORE System, the modified ENCORE Tongue Suspension System 1) uses a bone screw, 2) a bone screw inserter to place a bone screw into the bone, and 3) 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 to anterior position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension line. A Threading Tool is provided to ease passage of the suspension line through the bone screw.

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Image /page/1/Picture/0 description: The image contains the words "SIESTA MEDICAL" in a bold, sans-serif font. The word "SIESTA" is larger and positioned above the word "MEDICAL". There is a curved line above the word "SIESTA". The text is black against a white background.

510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System August 3, 2012

#### 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

The ENCORE Tongue Suspension System has the following similarities to the previously cleared predicate device: the same intended use, operating principle, technology, and manufacturing process. This submission supports the position that the Siesta Medical, Inc. modified ENCORE Tongue Suspension System is substantially equivalent to the predicate ENCORE Tongue Suspension System (K111179). The 510(k) includes a test report to support extension of the shelf-life to 2 years.

#### Conclusions

Siesta Medical, Inc. believes that the information provided demonstrates that the modified 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 predicate device, the modified 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

### November 7, 2012

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

Re: K121814

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: October 8, 2012

Received: October 9, 2012

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 requirements, 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/ucm115809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for Kwame O. Ulme

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System June 19, 2012

# Indications for Use

510(k) Number (if known): K1218/Y

# 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.

Susan Reenn

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

X | 2 | 8 | 4 510(k) Number:

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)