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The Rockwell Medical CitraPure® Acid Concentrates powders and liguids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

The Rockwell Medical CitraPure® Acid Concentrates for Bicarbonate Dialysis are available in liquid and dry forms and contain salt, sugar, and non-sugar powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These solutions and powders when proportioned and mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as hemodialysis solution. The hemodialysis concentrate solutions and powders presented in this 510(k) Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate solution prepared by mixing bicarbonate, chloride, and sodium concentrate with a specified volume of water is proportioned into the second stream, and purified water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. The CitraPure® series formulas are manufactured using the same validated processes, same packaging, and same USP grade ingredients. The only difference is that the raw material ingredient amounts are varied to create different formulas. This 510(k) notification establishes ranges for each concentrate ingredient, with the intent of creating different formulas by varying ingredient quantities within these established ranges using design control. Use of an approved dialysis concentrate formula range is necessary to permit the physicians flexibility to prescribe appropriate treatment meeting specific patient needs.

The Rockwell Medical Technologies, Inc. CitraPure® Acid Concentrate powders/liquidsfor Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

The Rockwell Medical Technologies, Inc. CitraPure® Acid Concentrate for Bicarbonate Dialysis powders and liguits contain salt, sugar, and non-sugar and powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate/powder. These solutions and powders when proportioned/mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The hemodialysis concentrate solutions and powders presented in this 510K Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution which has been prepared by mixing the powder with a specified volume of water and citric acid is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution.

The Rockwell Medical Technologies, Inc., Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate

The Rockwell Medical Technologies, Inc. Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acctate contain, water, salt, dextrose, and non-sugar electrolytes formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate solution. These concentrate solutions, when proportioned/ mixed in a threestream dialysis machine with pre-treated or purified water meeting AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate presented in this 510K Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. These types of final hemodialysis solutions are commonly referred to as "Bicarbonate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These bicarbonate hemodialysis solutions are separated from the patient's blood by means of a semi-permeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cutoff of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 Daltons for conventional cellulosic membranes), ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the dialyzer, to pass through the semi-permeable membrane into the bicarbonate hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Concentrate Powders for Bicarbonate Dialysis with purified water to produce a bicarbonate concentrate solutions for hemodialysis for use in 3stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Technologies, Inc. Concentrate Powders for Bicarbonate Dialysis which are mixed with water in the Bicarbonate Dialysate Concentrate Mixer™ are indicated for use in acute and chronic hemodialysis.

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Bicarbonate Concentrate Mixes with purified water to produce a bicarbonate concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. Hemodialysis therapy removes blood wastes by diffusion through a dialyzer membrane into a dialysate solution flowing on the opposite side of the dialyzer membrane. Hemodialysis also involves using a differential transmembrane pressure to ultrafilter water from the blood usually resulting in a net patient weight loss during the treatment. The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to be used with The Rockwell Medical Supply, LLC. Dri-Sate™ Bicarbonate Concentrate Hemodialysis Mixes which contain sodium bicarbonate and sodium chloride and in another formulation, only sodium bicarbonate (for Cobe Machines). These Dri-Sate™ Bicarbonate Concentrate Hemodialysis Mixes have been previously cleared by the FDA in 510(k) Number K954527 on March 18, 1996. Copies of the 510(K) clearance letter and samples of the labels/instructions for use for these powders are included in Appendix II of this Notification. These are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and acid concentrate in a three-stream hemodialysis machine. These powders when proportioned/ mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These proportioned hemodialysis solutions are heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These bicarbonate hemodialysis solutions are separated from the patient's blood by means of a semipermeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight

The Rockwell Medical Technologies, Inc., Dri-Sate Dry Acid Concentrates for Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate.

The Rockwell Medical Technologies. Inc. DRI-SATE Dry Acid Concentrates containing sodium diacetate, for bicarbonate dialysis contain salt, sugar, and non-sugar and powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These powders when proportioned/ mixed in a three-stream dialysis machine with pre-treated or purified water meeting or exceeding AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a The hemodialysis powders presented in this 510K Notification are intended to be hemodialysis solution. used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution which has been prepared by mixing the powder with a specified volume of water, is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Bicarbonate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys These bicarbonate hemodialysis solutions are separated from the patient's blood by or hemodialyzers. means of a semi-permeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cutoff of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 Daltons for conventional cellulosic membranes), ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the dialyzer, to pass through the semi-permeable membrane into the bicarbonate hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.

The Rockwell Medical Technologies' Dri-Sate™Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Acid Concentrate Mixes with purified water to produce an acid concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions which are mixed in the Dri-Sate Mixer™ are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate

The Rockwell Medical Technologies' Dri-Sate™Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Acid Concentrate Mixes with purified water to produce an acid concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. Hemodialysis therapy removes blood wastes by diffusion through a dialyzer membrane into a dialysate solution flowing on the opposite side of the dialyzer membrane. Hemodialysis also involves using a differential transmembrane pressure to ultrafilter water from the blood usually resulting in a net patient weight loss during the treatment. The Rockwell Medical Technologies' Dri-Sate™ Mixer is designed to be used with the Rockwell Medical Supply, LLC. Dri-Sate™ Acid Concentrate Hemodialysis Mixes which contain salt, sugar, and non-sugar and water containing solutions and powders. These are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These solutions and powders when proportioned/ mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The Dri-Sate™ Acid hemodialysis Mixes which have been presented in a previously cleared 510K Notification (K981003) are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution which has been prepared by mixing the powder with a specified volume of water and glacial acetic acid is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Bicarbonate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These bicarbonate hemodialysis solutions are separated from the patient's blood by means of a semipermeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cut-off of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 daltons for conventional cellulosic membranes), ionized and non-ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the dialyzer, to pass through the semi-permeable membrane into the bicarbonate hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure. Since different patients have different requirements for the removal rates and quantities of various molecules and toxins (i.e. blood urea nitrogen, creatinine, potassium, phosphate, magnesium, chloride, sodium calcium water, etc.) in acute and chronic renal failure, it necessitates having a variety of different bicarbonate containing hemodialysis solutions to satisfy the needs of all acute and end-stage renal failure patients. In addition, there a number of different types of hemodialysis machines which have different proportioning rates.