eZSURE™ Empty Fluid Container

The eZSURE™ Empty Fluid Container is a sterile, single-use intravenous bag made from flexible, non-PVC plastic film designed to hold medication admixtures for IV administration to patients. It is filled using aseptic technique and available in two configurations: one with a needle-free valve additive port and one with a ProSeal™ injection site port. This submission introduces a new 1,000 mL capacity option for each existing configuration previously available in 100 mL, 250 mL, and 500 mL sizes.

The subject device shares the same design principles, materials, sterilization process, and operational characteristics as the predicate devices, including identical flexible plastic film body material (Sealed Air Nexcel® M315 polyolefin), thermoplastic elastomer spiking ports, and respective additive port types. The only substantial difference is the introduction of a 1,000 mL capacity versus the predicate's 100–500 mL range, while maintaining identical biocompatibility, shelf-life validation (3 years), and single-use designation.

Testing referenced ISO 10993-1 to -23 (biocompatibility), ISO 15747:2018 (plastic IV containers), ISO 8536-4:2019 (infusion sets), ISO 80369-7:2021 and ISO 80369-20:2015 (small-bore connectors), ISO 22413:2021 (transfer sets), ANSI/AAMI CN27:2021 (Luer-activated valves), ASTM F1980-21 (accelerated aging), ASTM F88/F88M-21 (seal strength), ISO 11135:2014 (EO sterilization), and USP standards for pyrogenicity and particulate matter.

The increased 1,000 mL capacity does not raise new safety or effectiveness questions because functional testing (resistance to temperature, pressure, fluid leakage, dropping, and tensile strength) was conducted on the subject device and met intended-use performance standards. Biocompatibility testing and chemical characterization per ISO 10993-1 classification (externally communicating, blood-path indirect, prolonged contact) demonstrated that the larger volume maintains acceptable biological safety specifications identical to the predicate devices. Sterilization, shelf-life validation, and all design and material characteristics remain unchanged, supporting substantial equivalence.