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 Description

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) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, and 4) a threading tool. In addition, the following suspension lines are provided depending on the model number: 1) a #2 monofilament polypropylene suspension line with a radiopaque marker, 2) a size #2 braided polyester suspension line, and 3) a size #2 braided polyester suspension line with a radiopaque marker.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Encore System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	Biocompatible, same materials as predicate device	Biocompatible, same materials as predicate device (Pass)
Bench Testing - Suspension Line Endurance	Pass	Pass
Bench Testing - Bone Screw-to-Suspension Line Fixation Strength	Pass	Pass
Bench Testing - Tether Loop Strength	Exceeds suture loading force	Exceeds suture loading force, resulting in acceptable low risk category (Pass)
Clinical Performance (AHI Reduction)	Significant reduction in Apnea Hypopnea Index (AHI) for severe OSA, comparable to predicate.	61.8% AHI reduction for Encore System (similar to 57.8% for AIRvance System).
Clinical Performance (Complications)	Complications similar to predicate devices.	Complications are similar between the subject and predicate devices.
Safety and Effectiveness	Modified intended use does not adversely affect safety and effectiveness.	Medical literature supports safety and efficacy for proposed intended use.

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

Sample Size: The clinical performance was assessed through a literature review of 377 total patients across 16 studies. For the Encore System specifically, 45 patients from 2 studies were included.
Data Provenance: The data is from a literature review of peer-reviewed clinical studies. The document does not specify the country of origin but implies various clinical settings where these studies were conducted. The data is retrospective, drawn from existing published research.

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

This section is not applicable as the provided text describes a literature review of existing clinical data rather than a study involving a prospectively collected test set with ground truthing by experts. The "ground truth" here is the reported clinical outcomes in the published studies.

4. Adjudication Method for the Test Set

This information is not applicable as the data is from a literature review of already published clinical studies, not a new test set requiring expert adjudication.

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

This information is not applicable. The device described is a medical implant (the Encore System) for treating sleep apnea, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance in the way typically seen in image analysis or diagnostic AI.

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

This information is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical performance assessment was derived from outcomes data reported in peer-reviewed clinical studies, specifically the Apnea Hypopnea Index (AHI) reduction and complication rates. For the bench testing, the ground truth was established by passing specified engineering and materials tests (e.g., "Pass" criteria for endurance and fixation strength).

8. The Sample Size for the Training Set

This information is not applicable. The context is the evaluation of a medical device (implant) and not the training of a machine learning model.

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

This information is not applicable for the same reason as above (not an AI/ML context).

Summary

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May 9, 2019

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

Re: K183310

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: April 2, 2019 Received: April 9, 2019

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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina Eydelman, M.D. Director 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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Indications for Use Statement ction 4

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)

Not yet known

Device Name

Encore System

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: K183310

Submitter Name and Address

Name:	Siesta Medical, Inc.
Contact:	Michael Kolber
	Vice President, Regulatory Affairs
Address:	101 Church Street, Suite 3
	Los Gatos, CA 95030
Telephone:	408-320-9424
Fax:	408-399-7600
Date Prepared:	May 3, 2019

General Device Information

Product Name:	Encore™ System
Common Name:	Bone Screw System
Classification:	21CFR872.5570, Intraoral devices for snoring and intraoral devices forsnoring and obstructive sleep apnea
Device Class:	Class II
Product Code:	ORY

Predicate Devices

Primary:	Siesta Medical, Inc., Encore System, K133680
Reference:	Medtronic, Inc., AIRvance System, K122391

Device Description

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.

The intended use has been modified to broaden the intended use from mild and moderate OSA, to now include severe OSA, similar to the MDT AIRvance System (reference predicate). This change does not raise concerns regarding the new intended use since patients who had severe sleep apnea with the Encore System experienced a

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comparable reduction in their apnea hypopnea index and complications as that observed with the AIRvance System.

Comparison of Technology

The Encore System (subject device) has a modified intended use compared to the predicate devices. The intended use has been modified to simplify and broaden the indications statement. Also, minor changes have been made compared to the Encore System (primary predicate). These changes include adding a Bone Screw, modifying the Tether Line used to hold the Bone Screw in place on the Inserter Shaft by adding loops to ease threading the Suspension Line through the eyelet of the Bone Screw, and using a co-braided Tether Line to more easily differentiate it from the Suspension Line.

The additional Bone Screw is provided as a convenience to the physician in the event that one screw is accidently dropped and deemed non-sterile. The Looped Tether Line allows the physician to thread the Suspension Line through the Bone Screw using fewer steps and without the need for the Threading Tools. Finally, the co-braided Tether Line enables the physician to more easily differentiate it from the Suspension Line during the surgical procedure.

The availability of a spare Bone Screw and use of a co-braided Looped Tether Line prior to the surgical procedure are not differences in technology that raise concerns of safety or effectiveness. A comparison of the Encore System to the primary and reference predicate devices is provided in Table 1. The mechanism of action, design characteristics, dimensions, materials, and procedural steps are unchanged. This information supports substantial equivalence of the Encore System (subject device) to the Encore System (primary predicate) and AIRvance System (reference predicate).

Point ofComparison	Characteristic	Siesta MedicalEncore SystemK183310(Subject Device)	Siesta MedicalEncore SystemK133680(Primary Predicate)	Medtronic AIRvance SystemK122391(Reference Predicate)	Equivalentor Effectof Change
		ProductLabeling	Indication	The ENCORE System isintended for anterioradvancement of the tonguebase and hyoid suspension.It is indicated for thetreatment of obstructivesleep apnea (OSA) and / orsnoring.		The ENCORE System isintended to be used foranterior advancement of thetongue base. It is alsosuitable for performing hyoidsuspension. It is indicated forthe treatment of mild ormoderate obstructive sleepapnea (OSA) and /or snoring.
		of obstructive sleep apnea (OSA) and/or snoring.
SurgicalProcedure	AnatomicalSite	Mandible bone throughsubmental incision and thetongue and hyoid	Mandible bone throughsubmental incision and thetongue and hyoid	Mandible bone throughsubmental incision and thetongue and hyoid	Equivalent
	Bone Screw toSutureMethod ofAttachment	Surgeon threads both sutureends through bone screw,locks suture in place withlock screw	Surgeon threads both sutureends through bone screw,locks suture in place withlock screw	Suture pre-attached to bonescrew	Equivalent
	Components
	Bone Screw	Purpose	Secures suture in mandible	Secures suture in mandible	Secures suture in mandible	Equivalent
		Material	Titanium 6AL-4V	Titanium 6AL-4V	Titanium 6AL-4V	Equivalent
	Diameter XLength	2.8 mm X 5.5 mm	2.8 mm X 5.5 mm	2.8 mm X 5.5 mm	Equivalent
SuspensionLine LockTool	Purpose	Locking mechanism toattach the Suspension Sutureto the Bone Screw	Locking mechanism to attachthe Suspension Suture to theBone Screw	None	Equivalent
Bone ScrewInserter	Purpose	Places the bone screw intothe bone (n=3)	Places the bone screw into thebone (n=2)	Places the bone screw into thebone	Equivalent
ThreadingTool	Purpose	Threads Suspension Suturethrough Bone Screw eyelet	Threads Suspension Suturethrough Bone Screw eyelet	None	Equivalent
Suture Passer	Purpose	Passes suture through thetongue	Passes suture through thetongue	Passes suture through thetongue	Equivalent
SuspensionLine	Purpose	Anterior advancement of thetongue and hyoid suspension	Anterior advancement of thetongue and hyoid suspension	Anterior advancement of thetongue and hyoid suspension	Equivalent
	Material	#2 monofilamentpolypropylene with aradiopaque marker#2 braided polyester#2 braided polyester with aradiopaque marker	#2 monofilamentpolypropylene with aradiopaque marker#2 braided polyester#2 braided polyester with aradiopaque marker	#1 monofilamentpolypropylene	Equivalent
WorkingSuture	Purpose	Pull Suspension Suturethrough tongue anteriorly	Pull Suspension Suturethrough tongue anteriorly	Pull Suspension Suturethrough tongue anteriorly	Equivalent
	Material	#2-0 braided PTFE-coatedpolyester	#2-0 braided PTFE-coatedpolyester	#1 polypropylenemonofilament	Equivalent
Tether Line	Purpose	Hold Bone Screw on InserterShaft	Hold Bone Screw on InserterShaft	None	Equivalent
	Material	Co-braided polyester / PTFEcoating, with loops	Polyester/PTFE coating, noloops	None	Equivalent
Test Results
Biocom-patibility		Biocompatible, samematerials as predicate device	Biocompatibility, samematerials as predicate device	Not reported	Equivalent
Bench	SuspensionLineEndurance	Pass	Pass	Pass	Equivalent
	Bone Screw-to-SuspensionLine FixationStrength	Pass	Pass	Pass	Equivalent
Clinical	LiteratureReview	Product similar to the SiestaEncore System (K133680)	Literature review comparingEncore System to AIRvance	Literature review comparingEncore System to AIRvance	Equivalent

Table 1. Comparison of the Siesta Medical Encore System (Subject Device) to the Encore System (Primary Predicate) and the Medtronic AIRvance System (Reference Predicate).

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Summary of Non-Clinical Performance Testing Bench Test

Tether Loop Strength Test - Assess Tether Loop strength as Suspension Line is pulled through evelet of Bone Screw

Risk Assesment/Analysis

A Failure Modes and Effects Analysis (FMEA) was used to assess changes made to the subject Encore System compared to the predicate Encore System. The analysis determined that the Tether Loop strength exceeds the suture loading force, resulting in an acceptable low risk category.

Referenced Standards

ISO 10993-7: 2012 - Ethylene oxide sterilization residuals ISO 11135: 2014 - Sterilization of health care products – Ethylene oxide: Requirements for development, validation and routine control of a sterilization process for medical devices

Summary of Clinical Performance Testing

The published clinical experiences utilizing the Siesta Medical Encore System and the Medtronic AIRvance System are presented. Data is presented from 16 peer-reviewed clinical studies which include a total of 377 treated moderate-severe or severe patients (Table 2).

TreatmentMethod	Studies(n)	Total Patients(n)	AHI* Reduction(range)	Average AHI Reduction(weighted average)
Encore System	2	45	41.7 - 69.9%	61.8%
AIRvance System	14	332	34.7 - 77.4%	57.8%
Total	16	377	-	-

Table 2. Clinical Studies from the Medical Literature.

AHI - apnea hypopnea index

Patients with severe sleep apnea were treated with the Encore System and experienced a significant reduction in their apnea hypopnea index (AHI) (61.8%) that was similar to the reduction observed with the AIRvance System (57.8%). In addition, the complications are similar between the subject and predicate devices.

The medical literature supports the safety and efficacy of suture based hyoid and tongue suspension for the proposed intended use. The Medtronic AIRvance System, a device with similar features, is well documented in the medical literature with extensive clinical data supporting its use, as well as regulatory recognition in the form of marketing clearance.

The literature review of published clinical articles demonstrated that the modified intended use does not adversely affect safety and effectiveness.

Statement of Equivalence

Based on similarities in indications for use and technological characteristics, as well as nonclinical and clinical performance (medical literature) testing, we believe the Encore System is substantially equivalent to the predicate devices.

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.”