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The line of APS Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patient with acute or chronic renal failure. The APS Series Dialyzers are intended for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. This is the same intended use as the predicate device - APS Series Dialyzers cleared under K001250. - APS Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. - APS Series Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient. - APS Series Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi APS Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi APS Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly: - The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instruction for use and the instruction of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed. - The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin ® (peroxyacetic acid) in conjunction with the Renatron ® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc. - The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer. - The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

The line of Asahi Polysulfone (APS) Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. The Asahi APS Series Dialyzers are designed for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. They are constructed of reusable, hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene butadiene block polymer and are gamma sterilized prior to shipment. The Asahi APS Series Dialyzers are offered for sale in both a "wet" and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference. Modifications made to the Asahi APS Series Dialyzers subject of this 510(k) include (1) labeling revised to provide additional information concerning pre-cleaning; (2) modification of the dialyzer housing to diffuse the flow water used in pre-cleaning; and, (3) modification of the shipping carton partition materials and mold.

The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.

Asahi AM-R Series Dialyzers cleared under 510(k) K970650 are designed as reusable, hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing of styrene butadiene block polymer.

Asahi AM-BIO Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-BIO Series Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient. Asahi AM-BIO Series-Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-BIO Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi AM-BIO Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly: 1. The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed. 2. The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4" and DPS4"), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc. 3. The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer. 4. The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

The line of Asahi AM-BIO Series Dialyzers is a family of hemodialysis membranes, or hollow fiber dialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The device is intended for use in patients who have chronic renal failure or acute renal failure, for both single or initial use and when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. The membrane fibers are made of modified cellulose (i.e., alkyl ether polymer grafted cellulose), derived from cuprammonium rayon. The cuprammonium rayon is manufactured to have a thin layer of modified cellulose exposed to blood contact surfaces. The modification to the cellulose yields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3, and C5,) when compared to regular cellulose membrane dialyzers. The membranes are housed within a plastic casing of styrene butadiene block polymer. Nonremovable casing end caps are also made of styrene butadiene block polymer. The potting material (sealant) is polyurethane and the port caps (stoppers) are made of hydrogenated styrene butadiene block polymer. The AM-BIO Series Dialyzers will be offered for sale in both a "wet" model and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models are filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference. The fluid in wet dialyzers is made of water containing 600 ppm sodium pyrosulfite and 300 ppm sodium carbonate. All Asahi AM-BIO Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after it is accessed for the initial use.

Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-R Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi AM-R Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended.. Accordingly: - (1) The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of the instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed. - (2) The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin ) in conjunction with the Seratronics Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, manufactured by Renal Systems, Inc. - The instructions provided by the manufacturer of the chosen reprocessing (3) agent must be followed in reprocessing the dialyzer. - The reprocessed dialyzer may be used only on dialysis systems equipped with (4) volumetric ultrafiltration controllers.

The AM-R Series Dialyzers are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The performance of these dialyzers, when new for single or initial (first) use and when reprocessed for reuse, have been documented through laboratory (in vitro) testing and confirmatory clinical testing. Assahi AM-R Series Dialyzers are constructed of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer. Asahi AM-R Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after its sterile package is opened for the initial (first) use.