Solution Administration Sets

Solution Administration Sets are single-use, sterile, disposable devices used to administer fluids from containers into a patient's vascular system through a vascular access device. The product line includes basic sets, secondary sets, CONTINU-FLO sets, stand-alone stopcocks/manifolds, and chemotherapy sets, which can be used with or without Baxter infusion pumps.

The subject devices include three product codes (FPA, FMG, FPB) compared to the predicate's single code (FPA), adding stopcocks, manifolds, and infusion line filters. Key changes include modification of the distal tip protector (vented to non-vented) and material composition, updates to proximal Luer tip protector design, and dimensional compliance to ISO 80369-7:2021 for male and female Luers. Priming volumes expanded from 6.1–21.2 mL to 0.55–21.2 mL; a 20 DPM vented spike sourced from a different supplier uses ABS, HDPE, and Acrylic instead of the predicate's materials.

ISO 80369-7:2021 (small-bore connectors for intravascular applications), ISO 10993-1 (biocompatibility), ISO 8536-4 (infusion equipment performance), ISO 11137-1 and ISO 11137-2 (sterilization by radiation), ISO 11607-1:2019 (packaging for terminally sterilized devices), USP <788> (particulate matter in injections), and ASTM standards (F1886, F88, F2096-11, D4169-22, F1980-21).

The subject devices perform the same intended function as the predicate (fluid administration into vascular systems) with identical indications for use and regulatory classification. All material differences (stopcocks, manifolds, filters, expanded priming volumes, Luer dimensional updates, tubing variants) have been used in other Baxter-cleared devices with the same or similar intended use and contact duration. All components meet the same performance and biocompatibility standards (ISO 8536-4, ISO 10993-1, ISO 80369-7), and nonclinical testing including bench tests, filter performance, microbial ingress, and biocompatibility testing demonstrate comparable safety and effectiveness profiles with no new clinical concerns.