(29 days)
The AtriClip® LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
The AtriClip PRO2 LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.
The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) contains design modifications to the predicate AtriClip LAA Exclusion System (PRO1) intended to eliminate the End Effector Hoop configuration, allow for active articulation via articulation controls, and increase ease of deployment of the clip.
This appears to be a 510(k) summary for the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (PRO2). It's a submission for modifications to a previously cleared device (PRO1) and focuses on demonstrating equivalence rather than establishing new performance criteria against a disease or condition. Therefore, the traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical diagnostic performance are not directly applicable in this context.
Instead, the submission aims to demonstrate that the modified device (PRO2) is substantially equivalent to the predicate device (PRO1) and does not raise new questions of safety or effectiveness. The "acceptance criteria" here, implicitly, are that the modified device's performance is at least as good as, and within acceptable limits of, the predicate device across defined engineering and biocompatibility tests.
Here's an attempt to structure the information based on the provided request, interpreting "acceptance criteria" as the performance benchmarks for demonstrating substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric / Test Category | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate PRO1) | Reported Device Performance (PRO2) |
|---|---|---|
| Mechanical Testing | Equivalent mechanical performance to predicate PRO1. | Demonstrated equivalency in performance. |
| Reliability Testing | Equivalent reliability to predicate PRO1. | Demonstrated equivalency in performance. |
| Magnetic Resonance (MR) Safety and Compatibility | Meets FDA Guidance (Dec 11, 2014) for passive implants. | Testing performed per FDA Guidance. |
| Bench Testing on an Animal Model | Demonstrate intended function and performance in an animal model. | Testing performed. |
| Biocompatibility | Meets ISO 10993-1 for external communicating device, tissue/bone contact, |
§ 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.