(114 days)
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.
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.
Here's a summary of the acceptance criteria and the study details for the Siesta Medical, Inc. ENCORE System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative "acceptance criteria" in the format one might expect for a clinical trial's primary endpoints (e.g., AHI reduction by a certain percentage with a specific p-value threshold). Instead, it relies on demonstrating substantial equivalence to predicate devices and shows that the device performs at least as well as and is as safe and effective as the predicates.
For the non-clinical testing, the criteria were implicitly that the device met performance specifications for:
- Suspension Line Endurance: Demonstrated to meet specifications (specific values not provided in this summary).
- Bone Screw-to-Suspension Line Fixation Strength: Demonstrated to meet specifications (specific values not provided in this summary).
For the clinical performance, the reported outcomes are compared against the understanding of predicate device performance and general clinical efficacy for hyoid suspension.
| Acceptance Criteria (Implicit from Submission) | Reported Device Performance |
|---|---|
| Non-Clinical: | |
| Meet performance specifications for Suspension Line Endurance. | Demonstrated to meet performance specifications. |
| Meet performance specifications for Bone Screw-to-Suspension Line Fixation Strength. | Demonstrated to meet performance specifications. |
| Clinical: | |
| Be as safe and effective as predicate devices for anterior advancement of the tongue base and hyoid suspension. | Literature Review: 11 clinical studies (461 patients) involving hyoid suspension reported few complications, with six studies reporting no significant intraoperative or post-operative complications. |
| Patient Series: 1 patient series (number of patients not explicitly stated for this series alone, but included from context of a retrospective analysis) showed similar efficacy and safety. | |
| 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.”