(30 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.
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier. 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 available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. This Special 510(k) does not include any changes to the Clip.
The Clip Applier is a disposable device with a handle, shaft, and an end effector which contains the Clip. This Special 510(k) includes modifications to the Clip Applier including both lateral and vertical articulation of the end effector and deployment via pulling a deployment tab at the proximal end of the handle.
The provided text describes a 510(k) submission for a modification to the AtriClip LAA Exclusion System, specifically for the Clip Applier. It is not an AI/ML device, therefore, many of the requested categories are not applicable.
Here's an analysis of the provided information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Modifications do not affect the ability to successfully deploy the Clip on the left atrial appendage (LAA). | Testing determined that the modified Clip Applier was able to successfully deploy the Clip on the LAA. |
| Conformance to design controls and specification (per 21 CFR 820.30 and AtriCure's Quality System). | Testing determined that the modified Clip Applier conformed to design controls and product specifications. |
| All materials in the modified Clip Applier are suitable for their intended use. | All materials in the modified Clip Applier are suitable for their intended use. Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials. |
2. Sample size used for the test set and the data provenance
- Sample Size: The text states "The modified Clip Applier was tested on the cadaver model." It does not specify the number of cadaver models used.
- Data Provenance: The testing was conducted internally by AtriCure, Inc. The data provenance is from cadaver models, which is a retrospective experimental setting for device functionality assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML device that requires human expert review for establishing ground truth. The "ground truth" here is the physical ability of the device to deploy the clip successfully on the cadaver model.
4. Adjudication method for the test set
Not applicable. This is a mechanical device, not an AI/ML system requiring adjudication of results. The testing involved direct observation of clip deployment.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI/ML system, and therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical instrument and, by its nature, requires human intervention for its operation.
7. The type of ground truth used
The ground truth used was the successful physical deployment of the AtriClip on the left atrial appendage of a cadaver model, along with conformance to design controls and product specifications. This is a functional and engineering-based ground truth, not a diagnostic one.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system and does not involve a "training set" in the computational sense. The "training" for such a device would involve engineering design, prototyping, and iterative development based on physical testing.
9. How the ground truth for the training set was established
Not applicable (as it's not an AI/ML device with a training set). For a physical device like this, the "ground truth" during development would be established through engineering specifications, design requirements, and results from various stages of prototyping and bench testing, ensuring the device meets its intended functional performance and safety parameters.
§ 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.