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The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.

The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.

The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered with a working length of 155cm and is compatible with 0.018" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.

This document describes the premarket notification (510(k)) for the Roxwood Medical, Inc. MicroCross Catheter. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and reported performance values for each criterion. It lists several non-clinical tests performed, implying that the device met internal specifications for each. These tests are:

The document states: "All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the MicroCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."

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

The document does not specify the exact sample sizes used for each non-clinical test. The testing is described as "extensive bench testing," and the data provenance is implicitly from laboratory (bench) testing, not human or animal subjects. Details such as country of origin are not applicable as this relates to bench testing.

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

This information is not applicable. The device is a physical medical catheter, and "ground truth" in the context of expert review for medical image analysis or similar diagnostic devices is not relevant here. Performance was assessed via engineering and material testing standards.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical bench testing of a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic performance evaluations, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The MicroCross Catheter is a physical catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.

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

This information is not applicable. The MicroCross Catheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through adherence to recognized engineering and material standards, as well as the specifications required for the device's intended function. For example, for "Dimensional Inspection," the ground truth would be the design specifications, and the device's measured dimensions would be compared against these. For "Tensile Strength," the ground truth would be the specified minimum tensile strength, and the device's tested strength would need to meet or exceed this.

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

This information is not applicable, as there is no training set for this physical medical device.

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