(91 days)
SCANLAN® Heifetz Aneurysm Elgiloy® Clip System provides standard clips and appliers used to occlude an intracranial aneurysm to prevent it from bleeding or bursting.
The SCANLAN® Heifetz Aneurysm Elgiloy Clip System is a device used to occlude an intractanial aneurysm (a balloonlike sac formed on a blood vessel) to prevent bleeding or bursting.) The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is sold non-sterile. Descriptions of each clip size and shape are provided in the brochure. Appliers are available in five sizes and are described in the accompanying brochure (See Appendix A. ) A schematic for a representative clip size is provided in Appendix B.
The provided text describes a 510(k) summary for the SCANLAN® Heifetz Aneurysm Elgiloy® Clip System. This document asserts substantial equivalence to a predicate device (Weck Heifetz Aneurysm Clip & Applier System) rather than presenting a study with specific acceptance criteria and performance data for the SCANLAN® device itself. Therefore, many of the requested details are not available in the provided text.
Here's an analysis of the information that is and is not present:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not define specific acceptance criteria (e.g., in terms of mechanical strength, biocompatibility, or clinical outcomes) for the SCANLAN® device, nor does it report quantitative performance metrics against such criteria. The document relies entirely on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance
- Not available. Since no specific study testing the SCANLAN® device against acceptance criteria is described, there is no mention of a test set, its sample size, or data provenance. The assessment is based on the design and materials being substantially equivalent to a known, pre-amendment predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set or ground truth establishment process is described for the SCANLAN® device, as its approval is based on substantial equivalence to a predicate.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication process is described.
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 a physical aneurysm clip system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned for the SCANLAN® device itself, as the submission focuses on substantial equivalence based on materials, design, and intended use to an existing predicate.
8. The sample size for the training set
- Not applicable. As this is a physical device submission based on substantial equivalence, there is no concept of a "training set" as understood in machine learning or clinical trials with new performance claims.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth establishment process is described.
Summary of Device and Approval Approach:
The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is a device designed to occlude intracranial aneurysms. Its approval via the 510(k) pathway is based on a demonstration of substantial equivalence to the Weck Heifetz Aneurysm Clip & Applier System (K790413), which is also noted to include pre-amendment devices.
The key statement regarding "proof" of meeting acceptance criteria (in this context, meaning equivalence for regulatory purposes) is:
"There are no substantial differences in materials, designs or performance, in so far as can be determined, between the Weck brand of Heifetz Aneurysm clips and appliers and the Scanlan International products."
This statement implies that the SCANLAN® device is considered safe and effective because it is essentially the same as a device already legally marketed. The "study" here is effectively a comparative analysis of the device's specifications (materials, design) against the predicate, rather than a clinical trial or performance test of the SCANLAN® device itself. No new performance data or acceptance criteria are presented for the SCANLAN® device in this summary.
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).