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U.S. Department of Health and Human Services

Product Classification

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Device hemodialyzer, high cut-off
Definition Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma.
Physical State The high cut-off technology hemodialyzer is characterized by larger membrane pore sizes resulting in a nominal cut off-point of 100 kilo Daltons (kDa) allowing removal of circulating substances with molecular weights up to a value of approximately 45 kDa. The membrane material used in this device is polyarylethersulfone (PAES) with an effective membrane surface area of 2.1 m².
Technical Method The high cut-off technology hemodialyzer is used on a conventional hemodialysis system with controlled ultrafiltration for the removal of free light chains. During therapy, anticoagulated blood taken from the patient flows via a tubing system through the high cut-off technology hemodialyzer and back into the patient's vascular system. Conventional dialysate solution is circulated in a counter-current direction through the dialysate compartment of the high cut-off hemodialyzer. To compensate for the removed fluid volume, a physiologic and isotonic replacement fluid is infused into the patient at a flow rate equal to or less than the filtrate flow rate.
Target Area External communicating device in contact with circulating blood.
Review Panel Gastroenterology/Urology
Product CodeOVL
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible