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The IDEMSA Hemophan Hollow Fiber Dialyzers are indicated for use whenever a patient is in acute or chronic renal failure and a physician prescribes hemodialysis. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness. The indication statement is essentially the same as the indication statement of the predicate devices. The IDEMSA Hemophan Dialyzer has been designed for use in hemodialysis and associated forms of treatment for chronic or acute kidney failure.

The IDEMSA Hemophan Dialyzers are a family of hollow fiber dialyzers that provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Hemophan which is substantially equivalent to the Hemophan membranes utilized in the Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers (cleared for marketing in the United States under 510(k) # K982337). The Hemophan membranes utilized in both IDEMSA Hemophan dialyzers and Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers are manufactured by Membrana GmbH (formerly Akzo (Enka AG)) of Germany. Hemophan® is a modified cellulose membrane that was developed by ENKA to improve the blood compatibility of the regenerated cellulose membrane Cuprophan®. Cuprophan® membranes utilized in both Cobe CentrySystem 160E dialyzers and Baxter CF25 are also manufactured by the former Akzo (Enka AG). The Terumo Clirans T175 series dialyzers also use a cellulose membrane. Blood enters a blood inlet port where it is distributed to the Hemophan membrane. The fibers used in the proposed device are substantially equivalent in design to the previously cleared Haidylena and Cobe CentrySystem dialyzers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The wall thickness of the Hemophan and Cuprophan fibers in the Haidylena, Cobe CentrySystem 160E, Baxter CF25, and the proposed device is 8 microns. The inner diameter of Hemophan and Cuprophan in the Haidylena, Baxter CF25 dialyzer and the proposed device is 200 microns. Blood is pumped via a roller purno from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers where water waste products pass through the membrane of the dialyzer into the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient.