2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)

The 2008T BlueStar Hemodialysis Machine is an electromechanical device that performs hemodialysis treatment by pumping blood through an extracorporeal circuit and a dialyzer, while simultaneously managing a separate dialysate circuit with controlled fluid mixing, heating, and degassing. The machine is intended for acute and chronic dialysis therapy in healthcare facilities and includes optional features such as SLED (Sustained Low Efficiency Dialysis), low-volume dialysis, isolated ultrafiltration, and integration with optional accessories like the bibag system and Crit-Line Clip Monitor.

The 2008T BlueStar is substantially equivalent to the predicate device (K231125) in intended use, indications for use, design specifications, technological characteristics, principle of operation, and performance requirements. Both devices are electromechanical hemodialysis systems with software control of fluid flow, mixing, heating, and alarms, and support the same therapy options and accessories. There are no changes to the software, usability, or core functionality between the two versions.

Biocompatibility testing per ISO 10993-1:2018 and FDA guidance on biological evaluation of medical devices (dated 08 September 2023); electromagnetic compatibility (EMC) testing per IEC 60601-1-2 (2020) for medical electrical equipment safety and essential performance.

The 2008T BlueStar demonstrates substantial equivalence because it retains identical intended use, indications for use, design specifications, technological characteristics, operating principles, and performance requirements as the predicate 2008T BlueStar (K231125). No changes were made to software, and the device underwent biocompatibility and EMC testing confirming continued safety and efficacy. The four device configurations (with/without CDX and bibag options) represent cosmetic or configurational variations of the same fundamental hemodialysis system design, not functional modifications that would raise new safety or efficacy concerns.