(25 days)
The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
The AtriClip Gillinov Cosgrove LAA Clip is a single use, sterile, self-closing, implantable Clip to be deployed with a Reusable 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.
This Special 510(k) includes modifications to package the Clip individually to be loaded on a Reusable Clip Applier.
This 510(k) summary document describes a modification to an existing device, the AtriClip Gillinov-Cosgrove LAA Clip. The core of the submission is to demonstrate substantial equivalence to the previously cleared device (K093679 and K122276), asserting that the modifications do not affect performance.
Therefore, the submission does not contain a new study that defines and tests against acceptance criteria for device performance as a standalone product. Instead, it relies on the previous clearances and tests demonstrating that the new packaging does not degrade the previously established performance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable in the format of specific functional performance criteria for the device itself.
The acceptance criteria in this specific 510(k) are focused on the impact of packaging modifications.
- Acceptance Criteria: The new individual packaging must adequately protect the device during shipment.
- Reported Device Performance: "The Clip was tested to confirm new packaging of the Clip adequately protects the device during shipment." (The document states testing was done, implying it met the criteria, but doesn't provide specific test results or metrics here).
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for the packaging test.
- Data Provenance: The testing for the packaging modification would have been internal AtriCure, Inc. testing, likely prospective for the new packaging configuration.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for packaging protection is determined by engineering and performance testing (e.g., integrity, sterility, functional checks after simulated shipping), not expert consensus in a clinical sense.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data, which is not described for this packaging modification.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for occlusion of the left atrial appendage, not an AI or imaging diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implantable medical device.
7. The type of ground truth used
For the packaging modification, the "ground truth" would be the successful completion of specified packaging validation tests (e.g., sterile barrier integrity, product integrity after shipping simulation, etc.).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states: "The Clip was tested to confirm new packaging of the Clip adequately protects the device during shipment. Complete Design Control testing for the Clip was previously included in the original 510(k) K093679."
This indicates that:
- A specific test (or series of tests) was conducted to evaluate the individual packaging's ability to protect the device during transit. The details of this test (e.g., specific parameters, number of units tested, acceptance criteria for "adequately protects") are not provided in this summary but would have been part of the full 510(k) submission.
- For the performance of the Clip itself (e.g., sealing, occlusion effectiveness, biocompatibility), the submission relies on the comprehensive design control testing and evaluations performed for the original 510(k) K093679. The current submission asserts "there is no change to indications for use/intended use, the implant Gillinov-Cosgrove Clip, or the basic design of the Clip and Clip Applier configuration," and "The modifications do not affect the ability of the Clip to be successfully deployment on the LAA." Essentially, the previous studies prove the device meets its core acceptance criteria, and this submission demonstrates the change does not compromise those criteria.
§ 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.