Search Results

The Segue Infusion Catheter is indicated for the delivery of solutions into the peripheral and coronary vasculature.

The Segue Infusion Catheter is a single lumen, over-the-wire designed to locally deliver solutions into the peripheral and coronary vasculature.

This document describes a medical device, the Segue Infusion Catheter, and its clearance process through the FDA 510(k) pathway. However, it does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-driven device.

The provided text focuses on the physical and biocompatibility testing of a traditional medical device (catheter) and its comparison to a predicate device for substantial equivalence. It elaborates on:

• Physical Testing: Dimensional inspection, deployment and recoil verification, marker band attachment, infusion flow rate, internal pressurization, bond strength, flexural fatigue strength, radial force, and trackability.
• Biocompatibility Testing: Performed on sterile materials used in construction.
• Animal Studies: Assessed effects on vessel wall and thrombogenicity.

Therefore, I cannot fulfill your request for the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information because these details are not present in the provided document.

The information requested is typically found in submissions for AI/ML-enabled devices that rely on algorithms and data for their function, which is not the case for this traditional catheter.

Ask a specific question about this device