SEGUE INFUSION CATHETER

K964154 · Interventional Innovations Corp. · KRA · Jan 14, 1997 · Cardiovascular

Device Facts

• Record ID: K964154
• Device Name: SEGUE INFUSION CATHETER
• Applicant: Interventional Innovations Corp.
• Product Code: KRA · Cardiovascular
• Decision Date: Jan 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Single lumen, over-the-wire infusion catheter; designed for local delivery of solutions into peripheral and coronary vasculature. Used by physicians in interventional settings. Device facilitates targeted therapeutic delivery; enables localized treatment within vascular system. Benefits include precise solution administration to specific vascular sites.

Clinical Evidence

Bench testing included dimensional inspection, deployment/recoil, marker band attachment, flow rate, pressurization, bond strength, flexural fatigue, and trackability. Biocompatibility testing passed. Animal studies assessed vessel wall effects and thrombogenicity; no adverse results reported.

Technological Characteristics

Single lumen, over-the-wire infusion catheter. Materials biocompatibility verified. Physical characteristics include marker bands for visualization. Sterilized device.

Indications for Use

Indicated for delivery of solutions into peripheral and coronary vasculature in patients requiring local infusion therapy.

Regulatory Classification

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.

Predicate Devices

• FasTRACKER® Infusion Catheter (Target Therapeutics)

Submission Summary (Full Text)

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1-14-97
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 Corporation
2670 Patton Road
St. Paul, MN 55113
[phone]
**Contact:** Karen Peterson
Director of Clinical and Regulatory Affairs
**Predicate Device:** Segue™ Infusion Catheter
FasTRACKER® Infusion Catheter (Target Therapeutics)

### Device Description

The Segue Infusion Catheter is a single lumen, over-the-wire device 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.

Interventional Innovations Corp.
Segue Infusion Catheter - Expanded Intended Use

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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.

Interventional Innovations Corp.
Segue Infusion Catheter - Expanded Intended Use