ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT

K121440 · Siesta Medical, Inc. · ORY · Dec 6, 2012 · Dental

Device Facts

• Record ID: K121440
• Device Name: ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
• Applicant: Siesta Medical, Inc.
• Product Code: ORY · Dental
• Decision Date: Dec 6, 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

ENCORE Tongue Suspension System facilitates anterior tongue base advancement to treat OSA and snoring. System components include integrated suture passer (pre-loaded with #2-0 braided polyester suture), titanium bone screw on inserter, suspension line lock tool, and threading tool. Various suspension lines provided (monofilament polypropylene or braided polyester, with/without radiopaque markers). Physician implants bone screw into mandible; sutures soft tissue of tongue base to screw to achieve suspension. Used in clinical setting. Benefits include mechanical stabilization of tongue base to reduce airway obstruction.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing: suture endurance, bone screw fixation strength, radiographic visibility of markers, and system removability in a chronic porcine model.

Technological Characteristics

Titanium bone screw; #2-0 braided polyester suture; monofilament polypropylene or braided polyester suspension lines. Mechanical fixation system. Non-software 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

• ENCORE Tongue Suspension System (K111179)

Submission Summary (Full Text)

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# Attachment 2: 510(k) Summary (per 21CFR 807.92)

DEC 0 6 2012

| 510(k) Number | K121440 | |
|----------------------------|------------------------------------------------------------------------------------------------------------------|---------------|
| 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: | October 29, 2012 | |
| General Device Information | | |
| Product Name: | ENCORE™ Tongue Suspension System | |
| Common Name: | Bone Screw System | |
| 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 | |
| Predicate Device | | |
| Manufacturer | Device Name | 510(k) Number |
| Siesta Medical, Inc. | ENCORE Tongue Suspension System | K111179 |

#### Device 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 premounted on an inserter, a suspension line 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, 4) a size #2 braided polyester suspension line, and 5) a size #2 braided polyester suspension line with a radiopaque marker.

### 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.

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Image /page/1/Picture/0 description: The image shows the logo for Siesta Medical. The word "Siesta" is in large, bold, sans-serif font, with a curved line above it. Below "Siesta" is the word "Medical" in a smaller, sans-serif font. The logo is black and white.

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#### Comparison to the Predicate Device

The modified ENCORE Tongue Suspension System has the same intended use and fundamental scientifc technology as the predicate device. The technological characteristics of the modified ENCORE Tongue Suspension System are substantially equivalent to the predicate device including packaging, biocompatibility, sterilization, and labeling. Through bench performance testing it was demonstrated that the design modifications do not adversely affect safty and effectiveness.

#### Summary of Non-Clinical and Clinical Testing

The non-clinical test data provided in this submission demonstrated that the ENCORE Tongue Suspension System meets the performance specifications. The submission includes the following test results: Suture Endurance Test, Bone Screw Fixation Strength Test, Radiographic Visibility of Suspension Line Marker, ENCORE System Removability in . Chronic Porcine Model. The non-clinical data test results confirm the design modifications do not adverse affect the safety and effectiveness.

Clinical testing was not provided in this submission.

Statement of Equivalence

The ENCORE Tongue Suspension System has the same indications for use and the same technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device and the predicate device have been shown to be substantially equivalent.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble birds in flight or stylized human figures. The logo is rendered in black and white.

Public Health Service

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

#### December 6, 2012

Mr. Michael Kolber Vice President, Regulatory Affairs Siesta Medical, Incorporated 101 Church Street, Suite 3 LOS GATOS CA 95030

Re: K121440

Trade/Device Name: ENCORE™ 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 29, 2012 Received: November 1, 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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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Kwame ©. Ulmer

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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# Indications for Use

K121440 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)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

2012.12.05 Susan Runner DDS, MA 16:17:34 -05'00'

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

510(k) Number: