| 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 Code | OVL |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Device Class |
HDE
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
