FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the Renegade™ Fiber Braided Microcatheter, focusing on acceptance criteria and supporting studies.

Important Note: The provided text is a 510(k) summary and FDA clearance letter. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than performing de novo studies to establish new acceptance criteria and prove performance against those criteria in the same way a PMA (Pre-Market Approval) would. Therefore, much of the requested information (like specific performance acceptance criteria, detailed study designs, and ground truth establishment) is typically not found in this type of document because the focus is on comparison, not novel claims.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantifiable acceptance criteria and their corresponding reported device performance values are not explicitly stated in a numerical or metric-based format. The submission focuses on demonstrating substantial equivalence.

Item	Acceptance Criteria (Not Explicitly Stated as Numerical Metrics)	Reported Device Performance
Material Biocompatibility	Device materials should be safe for intended human contact and use.	"The Renegade™ Fiber Braided Microcatheters have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use."
Substantial Equivalence to Predicate Device	The device should be as safe and effective as a legally marketed predicate device, without raising new issues of safety or efficacy.	"The Renegade™ Fiber Braided Microcatheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised."
Functional Equivalence	Implied: ability to be coaxially tracked, access distal vasculature, and infuse materials safely and effectively.	Implied by substantial equivalence to the predicate device in terms of "general intravascular use, including neuro, peripheral and coronary vasculature."

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

Sample Size for Test Set: Not specified in the provided document. The 510(k) summary indicates that the device was "tested and compared to the predicate device," but details about the size of the test set for this comparison are not included.
Data Provenance: Not specified. Typically, such testing would be in-house or contracted by the manufacturer, but the geographical origin or whether it was retrospective/prospective is not mentioned.

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

Number of Experts & Qualifications: Not applicable/not provided. For a 510(k) submission focused on substantial equivalence, the "ground truth" is typically the performance of the legally marketed predicate device, and the comparison involves engineering testing or bench testing, not expert-based clinical performance data requiring ground truth establishment in the traditional sense (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not provided. As the tests are primarily engineering or bench tests for substantial equivalence, clinical adjudication methods are not relevant.

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

MRMC Study: No. The provided text does not describe an MRMC comparative effectiveness study. The submission is for a medical device (microcatheter), not AI software, and the clearance pathway is 510(k), which focuses on substantial equivalence rather than comparative clinical efficacy studies.
Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is not an AI device.

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

Standalone Performance Study: Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

Type of Ground Truth: For the purpose of a 510(k) submission for a physical device, the "ground truth" is largely derived from the established safety and effectiveness profile of the predicate device. The tests conducted are designed to show that the new device performs comparably to that predicate in relevant engineering and biocompatibility parameters.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. As this is a physical medical device submission, there is no "training set" in the context of machine learning or AI.

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

Ground Truth for Training Set: Not applicable, as there is no training set mentioned in the context of this device.

Summary

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).