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.

Summary

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K964154

Section 2 - Summary & Certification

A. 510(k) Summary

Trade Name:	Segue™ Infusion Catheter
Classification Name:	Continuous Flush Catheter
Classification:	Class II
Submitted By:	Interventional Innovations Corporation2670 Patton RoadSt. Paul, MN 55113(612) 636-6634
Contact:	Karen PetersonDirector of Clinical and Regulatory Affairs
Predicate Device:	Segue™ Infusion CatheterFasTRACKER® Infusion Catheter (Target Therapeutics)

Device Description

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

Intended Use

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

Testing

Physical testing of the product under simulated conditions included: dimensional inspection, deployment and recoil verification, marker band attachment, infusion flow rate, internal pressurization, bond strength, flexural fatigue strength, radial force and trackability. All testing results were within product engineering and marketing specifications.

Biocompatibility testing was performed on the sterile materials used in the construction of this infusion catheter. All materials passed the biocompatibility testing and are suitable for this application.

Animal studies were conducted to assess the effects of the device on the vessel wall as well as thrombogenicity effects of the device. There were no adverse results reported.

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Summary of Substantial Equivalence

The Segue Infusion Catheter is constructed of the same or substantially equivalent materials as found in the predicate device. The sizes and configurations available are comparable as is the packaging methods and materials. The clinical indications for use are substantially equivalent to those of the predicate device. Because of the similarities in materials, construction, indications for use, packaging and testing results, this product does not raise any new safety or effectiveness issues.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).