Search Results

The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.

The MultiCross Catheter consists of an inner shaft, outer shaft, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is an expandable and retractable nitinol scaffold, which, when deployed by the physician, expands to the artery wall to aid the user in establishing greater support near the treatment site.

This document describes a 510(k) premarket notification for the MultiCross Catheter, a medical device. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance criteria typically associated with AI/ML-based medical devices.

Therefore, many of the requested categories for AI/ML device acceptance criteria and study details (such as sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance metrics) are not applicable or are not explicitly detailed in this type of FDA submission for a Class II device relying on substantial equivalence to a predicate from manual modifications.

However, I can provide information based on what is available in the document regarding the acceptance criteria and the study that proves the device meets them, understanding that the context is a conventional medical device, not an AI/ML product.

Acceptance Criteria and Device Performance for Roxwood Medical, Inc. MultiCross Catheter (K152957)

This submission relies on demonstrating substantial equivalence of the MultiCross Catheter to its predicate device (MultiCross Catheter K121763) through bench testing rather than clinical study of the device's diagnostic performance (which would be relevant for AI/ML devices). The "acceptance criteria" here refer to meeting established specifications through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Overall Conclusion: "The collective results of the non-clinical testing demonstrate that the MultiCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device." And, "The results of the performance testing confirm that the MultiCross Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular catheter."

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

• Sample Size: The document does not specify the sample size for any of the non-clinical bench tests. It broadly states "Extensive bench testing was conducted."
• Data Provenance: The data is from non-clinical bench testing (simulated environments), not patient data. No country of origin is specified for the data itself, but the applicant is Roxwood Medical, Inc. based in Redwood City, California, USA. The testing would have been conducted by or for the manufacturer. The testing is retrospective in that it was completed prior to submission.

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

• Not Applicable. For a device demonstrating substantial equivalence through bench testing, "ground truth" as it pertains to clinical outcomes or expert consensus on image interpretation is not relevant. The "ground truth" here is meeting engineering and performance specifications. The experts involved would be the engineers and quality control personnel performing and evaluating the bench tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for reconciling discordant expert interpretations in clinical studies. This document reports on bench testing, where performance is measured against predefined specifications, not subjective interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study was not performed, nor is it relevant for this specific type of 510(k) submission focused on mechanical and material performance of a catheter. MRMC studies are typically for evaluating the diagnostic performance of imaging devices or AI algorithms with human readers.

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

• Not Applicable. This is a physical medical device (catheter), not an algorithm or AI product. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to pre-established engineering specifications and performance benchmarks. The device's characteristics (e.g., tensile strength, open/close force, absence of particulate) are measured against these objective, quantifiable standards. There is no clinical or pathological "ground truth" in the sense of patient outcomes or diagnoses.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this 510(k) submission for a non-AI/ML device. The device design and manufacturing processes are refined through engineering development, not machine learning training.

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

• Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device