AK 98 Dialysis Machine (955607)

The AK 98 Dialysis Machine is a hemodialysis delivery system designed for intermittent hemodialysis and isolated ultrafiltration treatment of patients with chronic or acute renal failure or fluid overload. It is intended for use in chronic care dialysis or hospital care environments by trained operators under physician prescription, and is not intended for home or self-care use. The device performs HD treatments on patients weighing 25 kg or more.

The proposed device uses platinum-cured silicone tubing in its fluid path, whereas the predicate used both peroxide-cured and platinum-cured tubing. All other technological features are identical: same treatment modalities (HD DN/SP and HD SN/SP), same conductivity monitoring, ultrafiltration control and supervision, same blood flow rates (20–600 ml/min), dialysate temperature (33–40°C), pressure ranges, and IT connectivity with clinical information systems.

The document cites IEC 60601-2-16, 4th edition, as the standard for ultrafiltration supervision requirements. No other specific ISO, IEC, or ASTM standards are explicitly named.

The core SE argument is that the change from peroxide-cured and platinum-cured silicone tubing to platinum-cured tubing only does not impact device performance or safety. Vantive conducted functional performance testing, biocompatibility testing, and extractables and leachables assessment on the AK 98 with the proposed platinum-cured tubing, demonstrating that this material change maintains the same safety and effectiveness profile as the predicate device while all other design specifications and clinical indications remain unchanged.