PuraCath Firefly Needleless Connector IT (9005)

The PuraCath Firefly Needleless Connector IT is a sterile, single-patient-use connector for needleless access to intravenous lines and catheters during IV therapy. It can be used for direct injection, intermittent infusion, continuous infusion, or aspiration of drugs, blood, and fluids.

The subject device has a luer-activated, normally closed elastomeric valve with identical performance to the predicate. Minor design changes include molded locking threads instead of a separate collar, a shorter length (1.2 in vs 1.6 in), and lower weight (2.4 g vs 3.2 g). All performance characteristics—priming volume, flow rates, fluid displacement, and hemolysis—remain identical.

ISO 10993 series (biocompatibility), ISO 11135 and ISO 10993-7 (ethylene oxide sterilization), ASTM F756 (hemolysis), USP 788 and 151 (particulates and pyrogens), ISO 8536-4 (infusion equipment), ISO 80369-7 (small-bore connectors), AAMI TIR28, and FDA Guidance for Intravascular Administration Sets.

The subject device uses identical materials, processes, and components as the predicate except for the distal luer configuration and reduced dimensions. These minor differences do not raise new safety or effectiveness issues; all critical performance characteristics and biocompatibility results are equivalent, and comprehensive testing confirms functionality is identical.