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 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.

AI/ML Overview

This document describes the 510(k) submission for the Siesta Medical, Inc. ENCORE™ Tongue Suspension System, emphasizing its substantial equivalence to a predicate device. The information provided focuses on non-clinical testing and explicitly states that no clinical testing was performed for this submission. Therefore, many of the requested details related to clinical studies, human reader performance, and ground truth establishment are not available in this text.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission pertains to a modification of an existing device and relies on showing substantial equivalence through non-clinical testing, specific "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, or improvement in human reader performance) are not detailed. Instead, the focus is on performance specifications met through bench testing.

Test Name	Performance Demonstrated / Reported Result	Acceptance Criteria (Implicit)
Suture Endurance Test	Met performance specifications	Suture should withstand expected forces and duration without failure; details of exact criteria are not provided.
Bone Screw Fixation Strength Test	Met performance specifications	Bone screw should maintain adequate fixation in bone; details of exact criteria are not provided.
Radiographic Visibility of Suspension Line Marker	Met performance specifications	Radiopaque marker should be sufficiently visible under radiography; details of exact criteria are not provided.
ENCORE System Removability in Chronic Porcine Model	Met performance specifications	The system should be removable in a chronic setting; details of exact criteria are not provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of clinical performance evaluation, as no human subject clinical testing was performed. The non-clinical tests would have used specific sample sizes for their materials/components, but these are not disclosed in this summary.
Data Provenance: The non-clinical testing appears to be conducted by Siesta Medical, Inc. (manufacturer). No country of origin is specified for the data, but it's implied to be from the manufacturer's testing. All data is retrospective in the sense that it's from completed tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth based on expert consensus was established as no clinical study involving human assessment was conducted.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted. The device is a surgical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the measurement of physical properties (e.g., tensile strength, fixation force, radiographic density) against predefined engineering specifications. This is distinct from clinical ground truth like pathology, expert consensus, or outcomes data, which are not relevant here.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of this device's evaluation, as it is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set.

Summary

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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 KolberVice President, Regulatory Affairs
Address:	101 Church Street, Suite 3Los 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:	21CFR872.5570Intraoral devices for snoring and intraoral devices forsnoring 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

Intended Use (Indications)

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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

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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 (800) 638-2041 or (301) 796-7100 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)

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

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:

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
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.(b)
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.”