(268 days)
The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
The Syntheon LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm. 40mm, 45mm, and 50mm to accommodate different sizes of LAA. The Syntheon LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.
This document describes the Syntheon LAA Exclusion System and its substantial equivalence to a predicate device, focusing on various performance and safety aspects rather than an AI/ML component. Therefore, several of the requested categories for AI/ML device studies are not applicable.
Here's the summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clip Opening | Proximal opening >4 mm for all implant sizes (specifically, "Same as PROV, design verification testing for the Syntheon LAA Exclusion system has demonstrated a proximal opening >4 mm for all implant sizes. The implant functions as intended.") | Met (implied by "All pre-determined acceptance criteria were met.") |
| Mechanical Testing | Not explicitly stated what the specific acceptance criteria were, but the general goal was to ensure the device meets performance specifications and demonstrates substantial equivalence to the predicate device. | Met (implied by "All pre-determined acceptance criteria were met. The data demonstrate that the Syntheon LAA Exclusion System is substantially equivalent to the predicate device.") |
| Packaging Testing | Not explicitly stated. | Met (implied by "All pre-determined acceptance criteria were met.") |
| Shelf-life Testing | Not explicitly stated. | Met (implied by "All pre-determined acceptance criteria were met.") |
| Bench-top Validation Testing | Not explicitly stated. | Met (implied by "All pre-determined acceptance criteria were met.") |
| Animal Validation Testing | Not explicitly stated. | Met (implied by "All pre-determined acceptance criteria were met.") |
| Biocompatibility (various tests) | Met requirements of ISO 10993-1:2018 for implantable devices (>30 days contact) and delivery system ( |
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.