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U.S. Department of Health and Human Services

Product Classification

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Device hemodialyzer with expanded solute removal profile
Definition A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (21 CFR §876.5860), including solutes at the upper end of the “middle” molecular weight range (0.5 kDa to 60 kDa).
Physical State A hemodialyzer with expanded solute removal profile is a device that has a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialyzer (21 CFR 876.5820). This hemodialyzer requires the use of an ultrafiltration controller to regulate the rate of removal of water from the patient’s blood.
Technical Method Blood and dialysate flow in a countercurrent path in their respective compartments. In this process, toxins and fluid are transferred across the semipermeable membrane from the blood to the dialysate compartment.
Target Area Extracorporeal blood.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQAX
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5862
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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