(161 days)
No
The device description and performance studies focus on mechanical components and surgical outcomes, with no mention of AI or ML.
Yes.
The device is intended for the treatment of obstructive sleep apnea (OSA) and/or snoring, which are medical conditions, and clinical studies show its effectiveness in reducing AHI.
No
The Encore System is designed for anterior advancement of the tongue base and hyoid suspension to treat obstructive sleep apnea, not for diagnosing it.
No
The device description clearly outlines multiple hardware components including a suture passer, bone screws, inserters, a suspension line lock tool, a threading tool, and various suspension lines. This is a physical medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior advancement of the tongue base and hyoid suspension" and is indicated for the "treatment of obstructive sleep apnea (OSA) and / or snoring." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details surgical tools and implants (suture passer, bone screws, suspension lines) used in a surgical procedure.
- Anatomical Site: The anatomical sites mentioned are the "Mandible bone through submental incision and the tongue and hyoid," which are parts of the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), performing tests outside of the body, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant and tool used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes
ORY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible bone through submental incision and the tongue and hyoid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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).
Treatment Method: Encore System
Studies (n): 2
Total Patients (n): 45
AHI Reduction (range): 41.7 - 69.9%
Average AHI Reduction (weighted average): 61.8%
Treatment Method: AIRvance System
Studies (n): 14
Total Patients (n): 332
AHI Reduction (range): 34.7 - 77.4%
Average AHI Reduction (weighted average): 57.8%
Total:
Studies (n): 16
Total Patients (n): 377
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.
Key Metrics
AHI Reduction (range): 41.7 - 69.9% (Encore System), 34.7 - 77.4% (AIRvance System)
Average AHI Reduction (weighted average): 61.8% (Encore System), 57.8% (AIRvance System)
Predicate Device(s)
Siesta Medical, Inc., Encore System, K133680
Reference Device(s)
Medtronic, Inc., AIRvance System, K122391
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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.
1
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
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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 for |
| snoring 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
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.
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 of
Comparison | Characteristic | Siesta Medical
Encore System
K183310
(Subject Device) | Siesta Medical
Encore System
K133680
(Primary Predicate) | Medtronic AIRvance System
K122391
(Reference Predicate) | Equivalent
or Effect
of Change | |
|---------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Product
Labeling | Indication | 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 ENCORE System is
intended to be used for
anterior advancement of the
tongue base. It is also
suitable for performing hyoid
suspension. It is indicated for
the treatment of mild or
moderate obstructive sleep
apnea (OSA) and /or snoring. |
| | | of obstructive sleep apnea (OSA) and/or snoring. | | | | |
| Surgical
Procedure | Anatomical
Site | Mandible bone through
submental incision and the
tongue and hyoid | Mandible bone through
submental incision and the
tongue and hyoid | Mandible bone through
submental incision and the
tongue and hyoid | Equivalent | |
| | Bone Screw to
Suture
Method of
Attachment | Surgeon threads both suture
ends through bone screw,
locks suture in place with
lock screw | Surgeon threads both suture
ends through bone screw,
locks suture in place with
lock screw | Suture pre-attached to bone
screw | 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 X
Length | 2.8 mm X 5.5 mm | 2.8 mm X 5.5 mm | 2.8 mm X 5.5 mm | Equivalent | |
| Suspension
Line Lock
Tool | Purpose | Locking mechanism to
attach the Suspension Suture
to the Bone Screw | Locking mechanism to attach
the Suspension Suture to the
Bone Screw | None | Equivalent | |
| Bone Screw
Inserter | Purpose | Places the bone screw into
the bone (n=3) | Places the bone screw into the
bone (n=2) | Places the bone screw into the
bone | Equivalent | |
| Threading
Tool | Purpose | Threads Suspension Suture
through Bone Screw eyelet | Threads Suspension Suture
through Bone Screw eyelet | None | Equivalent | |
| Suture Passer | Purpose | Passes suture through the
tongue | Passes suture through the
tongue | Passes suture through the
tongue | Equivalent | |
| Suspension
Line | Purpose | Anterior advancement of the
tongue and hyoid suspension | Anterior advancement of the
tongue and hyoid suspension | Anterior advancement of the
tongue and hyoid suspension | Equivalent | |
| | Material | #2 monofilament
polypropylene with a
radiopaque marker
#2 braided polyester
#2 braided polyester with a
radiopaque marker | #2 monofilament
polypropylene with a
radiopaque marker
#2 braided polyester
#2 braided polyester with a
radiopaque marker | #1 monofilament
polypropylene | Equivalent | |
| Working
Suture | Purpose | Pull Suspension Suture
through tongue anteriorly | Pull Suspension Suture
through tongue anteriorly | Pull Suspension Suture
through tongue anteriorly | Equivalent | |
| | Material | #2-0 braided PTFE-coated
polyester | #2-0 braided PTFE-coated
polyester | #1 polypropylene
monofilament | Equivalent | |
| Tether Line | Purpose | Hold Bone Screw on Inserter
Shaft | Hold Bone Screw on Inserter
Shaft | None | Equivalent | |
| | Material | Co-braided polyester / PTFE
coating, with loops | Polyester/PTFE coating, no
loops | None | Equivalent | |
| Test Results | | | | | | |
| Biocom-
patibility | | Biocompatible, same
materials as predicate device | Biocompatibility, same
materials as predicate device | Not reported | Equivalent | |
| Bench | Suspension
Line
Endurance | Pass | Pass | Pass | Equivalent | |
| | Bone Screw-
to-Suspension
Line Fixation
Strength | Pass | Pass | Pass | Equivalent | |
| Clinical | Literature
Review | Product similar to the Siesta
Encore System (K133680) | Literature review comparing
Encore System to AIRvance | Literature review comparing
Encore 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).
| Treatment
Method | 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.