DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)

The DBB-06 PRO Hemodialysis Delivery System is an electromechanical device that performs hemodialysis treatment for adult patients with acute and chronic renal failure in hospital and dialysis clinic settings. It consists of a hemodialysis machine with software-controlled fluid flow, mixing, heating, and alarms, plus EF-02D endotoxin retentive filters that produce ultrapure dialysate. The system is not intended for pediatric patients or home use.

The DBB-06 PRO retains the same basic design, operating principles, and indications as its predicate (DBB-06), including double-needle dialysis and optional Blood Volume, Blood Pressure, and Dialysis Dose Monitors. Key new features include: D-FAS (Dialysis Fully-Assist System) for automated priming, blood filling, rinse back, and fluid bolus; optional Dialysate Flow Adaptation that automatically sets dialysate flow; Patient Card Reader using NFC technology; a pressurization-type blood pressure monitor; and various software and material changes. Performance characteristics (blood flow rates, dialysis flow rates, temperature control, heparin delivery) remain comparable to predicate specifications.

Device testing followed IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-2-16:2018, ISO 10993-1:2018 (biocompatibility), ISO 81060-2:2018/Amd.1:2020 (blood pressure), ANSI/AAMI ISO 23500 (dialysate purity), and ASTM hemolysis testing. Additional standards include IEC TR 60601-4-2:2016 for electrical safety and FDA guidance documents on device software, off-the-shelf software, and cybersecurity.

The DBB-06 PRO is substantially equivalent because it shares identical indications for use, the same basic system design and operating principles as the DBB-06 predicate, and similar technological characteristics in core safety-critical functions (blood/dialysate flow rates, pressure monitoring, temperature control, filtration). New features (D-FAS, Dialysate Flow Adaptation, Patient Card Reader, pressurization-type BP monitor) represent enhancements to operator workflow or optional monitoring capabilities that do not alter the fundamental therapy or introduce new safety risks. Bench testing, biocompatibility testing, software verification, and electromagnetic compatibility testing confirmed these differences do not raise new or different questions of safety or effectiveness when used as intended.