VariFuse Adjustable Infusion Catheter

The VariFuse Adjustable Infusion Catheter is a single-use, sterile medical device consisting of coaxial inner and outer catheters with adjustable infusion length (0-50 cm). It is designed for administering fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature. The device includes a Touhy Borst Adapter for length adjustment and a 1 cc Luer Lock Syringe for flushing.

The VariFuse uses a coaxial dual-catheter design with unevenly spaced infusion holes on the inner catheter, a distal valve, and radiopaque markers. It is 5.7F (6F nominal) diameter, 90-140 cm overall length, uses ethylene oxide sterilization, and is composed of biocompatible materials meeting ISO 10993-1. The predicate device (UNI*FUSE+) is a single-lumen 4F-5F catheter with longitudinal slits and an occluding ball wire, demonstrating substantially different mechanical design despite similar intended use.

ISO 10993-1:2018 (biocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 10993-11 (pyrogenicity and acute toxicity), ISO 10993-4 (hemocompatibility), and ASTM hemolysis assays. Performance testing included leak, tensile strength, kink resistance, flow rate, valve performance, radiopacity, torque, and simulated use studies.

Substantial equivalence is based on identical intended use and indications for use (administration of fluids into peripheral and pulmonary artery vasculature), equivalent principle of operation (catheter-directed infusion with circumferential fluid distribution), same sterilization method (ethylene oxide), biocompatible materials meeting ISO 10993-1, and comprehensive in-vitro performance testing demonstrating functional equivalence. The device meets the same regulatory classification (Class II, 21 CFR 870.1210) and product code (KRA) as the predicate.