KabiHelp® Uno; KabiHelp® Advance plus

The KabiHelp® Bag is an empty plastic container designed to be filled with parenteral nutrition components and related medications for intravenous administration to patients. The bag is filled using aseptic technique and used with the KabiHelp Pro Compounding System and transfer sets.

The subject device uses EVA plastic with EVOH, PS, ABS, and dyes, compared to the predicate's EVA, PVC, ABS, PP, SBC, MABS, and thermoplastic elastomer. Both offer three-port configurations (fill, injection, administration ports) and monolayer variants. The subject device uses ethylene oxide sterilization versus the predicate's radiation sterilization, both at SAL 10⁻⁶. Packaging differs: Tyvek for EO versus polyethylene for gamma.

ISO 10993-1:2018 (biocompatibility framework); ISO 10993-5, 10, 11, 23 (cytotoxicity, sensitization, irritation, systemic toxicity); ISO 15747:2018 (plastic containers for IV injection); ISO 11607-1:2019 (packaging integrity); USP <151> (pyrogenicity); USP <788> (particulate matter); ASTM F756:2017 (hemolysis); FDA Human Factors Guidance (February 2016).

The subject device is substantially equivalent to predicate K210749 because both are empty IV containers for solution preparation and administration using aseptic technique, share the same regulation (21 CFR 880.5025) and product code (KPE), and perform identical functions. Material, sterilization method, and packaging differences were analyzed and tested, with biocompatibility and performance data demonstrating no new safety or effectiveness concerns.