5008X Hemodialysis System

The 5008X Hemodialysis System is a machine-based renal replacement therapy device for acute and chronic kidney failure in healthcare facilities. It controls and monitors both the dialysate and blood circuits, performing hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration (ISO) for patients weighing over 40 kg. The system includes the 5008X machine, two DIASAFE filters, five bloodline configurations, and CitraSure disinfectant.

The 5008X machine handles up to 600 mL/min blood flow and 1000 mL/min dialysate flow with net fluid removal of 0–4000 mL/hr (±1% UF + 0.15% balanced fluid volume accuracy). Bloodlines are single-use, ethylene oxide sterilized with labeled pressures of −300 to +500 mmHg. Optional CLiC monitoring measures hematocrit and oxygen saturation; optional Twister enables access flow measurement via 180° blood flow reversal. The DIASAFE filter produces ultrapure dialysate from pretreated water (≤200 CFU/mL bacteria, ≤2 EU/mL endotoxin input).

ISO 10993-1:2018 (biocompatibility), ISO 8637-1 and ISO 8637-2:2018 (bloodlines), ISO 23500-5 (dialysate purity), ISO 80369-7:2021 (Luer connectors), IEC 60601-1-2 Edition 4.1 (EMC), AAMI/ANSI/ISO 10993-7:2008 (EO residuals), ANSI/AAMI/ST72:2019 (endotoxin testing), and ASTM hemolysis testing.

The 5008X is substantially equivalent to its predicate (5008X K231534) because it shares the same intended use, indications, design specifications, technological characteristics, principle of operation, and performance requirements. Differences from secondary predicates (2008T BlueStar for CDX/heparin/AFM features; Combiset SMARTECH for heparin and saline lines) are matched by equivalent functionality. Comprehensive performance, biocompatibility, electrical safety, software, and human factors testing demonstrate the differences raise no new safety or efficacy concerns.