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The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

The Vericor Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Vericor Support Catheter will be available in three catheter lengths which are 90 cm, 135 cm and 150 cm. The proposed device is a single-lumen catheter. The hub of the catheter incorporates standard luer adapter to facilitate the attachment of accessories. The outer surface of the distal catheter has a hydrophilic coating. The catheter has three radiopaque markers at the distal end to facilitate fluoroscopic visualization. The device is provided in single use and sterile.

This document, a 510(k) Summary, describes the Vericor Support Catheter and its substantial equivalence to a predicate device. This is a medical device, not an AI/ML product, so the questions regarding AI/ML clinical studies are not applicable.

Here's the breakdown of the acceptance criteria and the study (non-clinical) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) Summary details numerous non-clinical tests. The column "Test Method Summary" indirectly describes the acceptance criteria by outlining what the test aims to demonstrate (e.g., "To demonstrate that the device meets the corrosion resistance"). The "Results and Conclusion" column reports that the device met these criteria.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes for each non-clinical test. It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not applicable in terms of country of origin or retrospective/prospective for these non-clinical, laboratory-based tests. The tests were performed on the Vericor Support Catheter itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable as the studies are non-clinical, laboratory-based performance tests, not studies involving human interpretation or clinical data. Ground truth in this context is established by adherence to specified standards and measurement techniques.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements and adherence to established standards, not expert adjudication of subjective interpretations.

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 is a conventional medical device (support catheter), not an AI/ML diagnostic or assistive device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For these non-clinical tests, the "ground truth" is defined by the objective criteria within the referenced international and national standards (e.g., ISO 10993, ISO 10555-1, ASTM standards, USP). Performance is measured against these established technical specifications and benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not involve a training set.

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