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The capillary dialyzer/filter is intended for use in hemodiafiltration and hemofiltration for the treatments of chronic or acute renal failure.

The Gambro POLYFLUX 140H, 170H and 210H Capillary Dialyzers/Filters labeled for single use have the same design, materials, intended use and function as other hemodialyzers/filters currently marketed in the United States. These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (PES) which is identical to the membrane utilized in the Gambro POLYFLUX 14S, 17S and 21S Hemodialyzers /filters labeled for single use which have been previously cleared for marketing in the United States under 510K Notifications (K982414). Blood enters a blood inlet port where it is distributed to the hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns (hollow fiber internal diameter) and a wall thickness of 50 microns. The number of hollow fibers in each hemodialyzer / filter is 7,500 for the POLYFLUX 140H, 9,300 for the POLYFLUX 170H, and 12,000 for the POLYFLUX 210H. This effective membrane length is 270 mm for the POLYFLUX 140H, 170H and 210H. The effective membrane surface area is 1.4 square meters for the POLYFLUX 140H, 1.7 square meters for the 170H and 2.1 square meters for the 210H. The housing and end caps of this hemodialyzer / filter are made of polycarbonate. The design and incorporation of the silicone header gasket is the same as previously approved for the Gambro GFS Plus Hemodialyzers / Filters(K902481). The fibers used in the Gambro POLYFLUX 140H, 170H and 210H are of the same composition as those previously approved for the Gambro POLYFLUX S Hemodialyzers / Filters labeled for single use (K982414). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician.

In accordance with Section 510(k) of the Food, Drug and Cosmetics Act, Gambro Renal Care Products intends to introduce a modification of the Prisma Continuous Fluid Management System into commercial distribution. The modification creates an accessory sterile extension line that will allow the Prismatherm II Blood Warmer manufactured by Stihler Electronic GmbH (K991159) to be used with the Prisma system during continuous renal replacement therapy. The integration of the Blood Warmer into the Prisma System will provide gentle warming of the treated blood, prior to its return to the patient. No modifications of the Prisma Dialysis Control Unit were made as part of this change. A modification is made to the Prisma Blood Tubing Set that places two luer fittings into the tubing set return line proximal to the air detector. When using the optional Blood Warmer, the user separates the new luer fittings and attaches the new warmer Extension Line. New labeling is created for the Extension Line and the Blood Tubing Set.