Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)

Bicarby and Ci-Ca dialysate solutions are sterile, ready-to-use kidney replacement therapy fluids for adult patients in acute care settings. Each solution comes in a 2-compartment bag that is mixed before use to produce 5 liters of dialysate, with calcium-containing formulations designed for heparin anticoagulation and calcium-free formulations designed for regional citrate anticoagulation.

The proposed solutions share identical technological characteristics with the predicate device (pureFLOW 400 series) in chemical composition, packaging configuration, shelf-life, sterilization method, and single-use design. Differences include updated indications from CRRT to broader KRT modalities, new ionic contribution formulations supported by reference devices, and a new white hot-stamp UDI material on the bag.

ISO 10993-1:2018 for biocompatibility evaluation; FDA guidance document 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' (08 September 2023). Testing included chemical characterization, cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, hemocompatibility, and genotoxicity assessments.

The proposed Bicarby and Ci-Ca solutions are substantially equivalent to the pureFLOW 400 predicate device because they maintain identical container closure systems (except for UDI stamp material), identical sterilization and packaging methods, and substantially equivalent indications for use in dialysis therapy. The new ionic formulations are supported by reference devices demonstrating clinical precedent, biocompatibility testing confirms the UDI material is biologically safe, and the functional principle of operation—correcting blood electrolytes and acid-base balance via extracorporeal dialysis—remains unchanged from the predicate.