EZ™ IV Administration Set

The EZ™ IV Administration Set is a single-use, disposable intravenous administration set designed to deliver medications and fluids from a container into a patient's vascular system via gravity. It includes a vented bag spike with a 0.1 µm air vent, drip chamber with 5 µm particulate filter, roller clamp, flexible PVC tubing (not made with DEHP), and one to three needle-free valve Y-site connectors, plus a Luer connector and priming cap with 3 µm filter.

Key differences from the predicate (ProSeal™ Closed System Administration Set) include: the subject device uses an integrated bag spike instead of a closed-system injector; it includes a check valve and needleless Y-site connectors not present in the predicate; it has three tubing length options (200, 240, 280 cm) versus one; and different priming volumes (14.6–20.4 mL versus 11.9 mL). Material composition differs slightly, with the subject device using ABS for the bag spike and silicone in the check valve and Y-connectors. Both use identical PVC tubing, drops factor (20 gtt/mL), sterilization (ethylene oxide), and shelf-life (3 years).

ISO 8536-4:2019 (infusion sets for gravity feed), ISO 22413:2021 (transfer sets), ISO 10993-1:2018 and related biocompatibility standards (cytotoxicity, sensitization, hemolysis, pyrogenicity, chemical characterization), ISO 80369-7:2021 and ISO 80369-20:2015 (small-bore connectors), ANSI/AAMI CN27:2021 (Luer-activated valves), ASTM F1980-21 (sterile barrier shelf-life), and FDA guidance on intravascular administration sets.

The subject device performs the same fundamental function as the predicate—gravity-based intravenous fluid delivery—with equivalent indications for use, user population, and regulatory classification (Class II, FPA). Although the subject device differs in physical construction (integrated spike vs. injector) and includes additional features (check valve, multiple Y-sites), comprehensive testing on the subject device (air-inlet, flow rate, leak integrity, tensile strength, drip chamber tests) and leveraged data from the predicate demonstrate that performance meets all applicable ISO standards. Biocompatibility testing confirmed no new safety concerns from material variations. These differences are considered not significant because performance testing validated that the subject device safely and effectively achieves its intended use without raising new questions of safety or effectiveness.