(114 days)
Not Found
No
The device description and performance studies focus on mechanical components and surgical outcomes, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning.
Yes
The device is intended for the treatment of mild or moderate obstructive sleep apnea (OSA) and/or snoring, which are medical conditions, and it performs a therapeutic action by physically suspending the tongue base and hyoid bone.
No.
The ENCORE System is described as a treatment device for obstructive sleep apnea and snoring, designed for anterior tongue base suspension and hyoid suspension to physically alleviate the condition, not to diagnose it.
No
The device description explicitly lists multiple hardware components including a suture passer, bone screws, bone screw inserters, a suspension line lock tool, a threading tool, and various suspension lines.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for anterior advancement of the tongue base and hyoid suspension to treat obstructive sleep apnea and snoring. This is a surgical procedure performed directly on the patient's anatomy.
- Device Description: The device consists of surgical tools and implants (suture passer, bone screws, suspension lines, etc.) used during a surgical procedure.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not interact with or analyze biological specimens in this way.
The device is a surgical implant and associated tools used for a therapeutic purpose within the body.
N/A
Intended Use / Indications for Use
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.
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) two (2) bone screws and 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
tongue base, mandible bone, hyoid bone
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 non-clinical test data provided in this submission demonstrated that the ENCORE System meets the performance specifications. The submission includes a Suspension Line Endurance Test and Bone Screw-to-Suspension Line Fixation Strength Test. The non-clinical testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The clinical data provided in this submission includes a summary of eleven (11) clinical studies in 461 patients involving hyoid suspension published in the peerreview literature. There were few complications reports, with six studies reporting no significant intraoperative or post-operative complications.
This submission also includes an analysis of a series of patients treated for OSA using hyoid suspension with the Encore System. This patient series included primarily males, with a mean age of 58.3 years, mean BM1 of 27.9 kg/m², and a baseline AHI/RDI of 45.0. Hyoid suspension was successful in all patients. One patient had a post-operative wound seroma that resolved. Mean follow-up time was 75 days, with a reduction in AHI/RDI from 52.8 to 11.8 (78%, p
§ 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.”
0
510(k) for the Siesta Medical, Inc. ENCORE System March 26, 2014
510(k) Summary
| 510(k) Number | K133680 | |
|---|---|---|
| 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 | 408-505-6626 | |
| Fax | 408-399-7600 | |
| Date Prepared | March 26, 2014 | |
| 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 Device | ||
| Manufacturer | Device Name | 510(k) Number |
| Siesta Medical, Inc. | ENCORE Tongue | |
| Suspension System | K121440 | |
| 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) two (2) bone screws and 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 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
1
snoring.
Comparison to the Predicate Device
The ENCORE System has a modified intended use compared to the predicate devices. The intended use has been modified to include a statement that it is also suitable for the performance of a hyoid suspension procedure.
With regard to the modified intended use, similar to the predicate device, a needle is used to pass a suspension suture around the hyoid bone and a bone screw is used to anchor the suture with the desired amount of tension. The difference between the predicate device and the ENCORE System relates to how the suspension sutures are fixed once the desired level of advancement is achieved. In the predicate device, the suspension sutures are provided pre-attached to the bone anchors, which requires the tails of the suspension sutures to be joined or fixed at the midline of the hyoid bone with a knot once they are passed around the hyoid bone. With the ENCORE System the suspension sutures are passed around the hyoid bone and then attached to the bone anchors without the need to tie a knot.
The fundamental scientific technology and technological characteristics of the ENCORE System are the same as the predicate devices including mechanism of action, packaging, biocompatibility, sterilization, and labeling. The ENCORE System contains the same materials and components as the predicate ENCORE System. Through bench performance and clinical testing it was demonstrated that the modified intended use do not adversely affect safety and effectiveness.
Summary of Non-Clinical and Clinical Testing
The non-clinical test data provided in this submission demonstrated that the ENCORE System meets the performance specifications. The submission includes a Suspension Line Endurance Test and Bone Screw-to-Suspension Line Fixation Strength Test.
The non-clinical testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The clinical data provided in this submission includes a summary of eleven (11) clinical studies in 461 patients involving hyoid suspension published in the peerreview literature. There were few complications reports, with six studies reporting no significant intraoperative or post-operative complications.
This submission also includes an analysis of a series of patients treated for OSA
2
Image /page/2/Picture/0 description: The image shows the logo for Siesta Medical. The word "Siesta" is in a large, bold font, with a curved line above it. Below "Siesta" is the word "Medical" in a smaller font. The logo is simple and clean, with a focus on the company name.
using hyoid suspension with the Encore System. This patient series included primarily males, with a mean age of 58.3 years, mean BM1 of 27.9 kg/m², and a baseline AHI/RDI of 45.0. Hyoid suspension was successful in all patients. One patient had a post-operative wound seroma that resolved. Mean follow-up time was 75 days, with a reduction in AHI/RDI from 52.8 to 11.8 (78%, p