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The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a fluid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.

The Acid Concentrate, Bicarbonate Concentrate and Acetic Acid wands are sub-assemblies intended to be used with the concentrate and acetic acid canisters as accessories to the 2008 Series Hemodialysis Machines. The wands allow the 2008 Series Hemodialysis Machines to attach to the canisters and supply bicarbonate (blue wand), acid concentrate (red wand), and acetic acid (white wand). During a dialysis treatment, the blue and red Canister-Wand Assemblies provide connectivity to supply the 2008 Series Hemodialysis Machines with Acid Concentrate and Bicarbonate Concentrate solutions. The Hemodialysis Machine will dilute these solutions with Reverse Osmosis (RO) water to produce the final dialysate solution. The white acetic acid Wand Assembly is used to supply Acetic Acid to the 2008 Series Hemodialysis Machines while running an Acid Cleaning Program as part of regular maintenance procedures. The Acid Clean Program flushes the machine with white distilled vinegar, 5% acetic or 5% citric acid for 10-60 minutes to prevent build of bicarbonate in the hydraulic system after treatment. During the cleaning program, the patient is not connected to the hemodialysis machine.

The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

The Fresenius 2008T Hemodialysis Machine with bibag System is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The 2008T Hemodialysis Machine with bibag System allows operators the option to prepare a saturated sodium bicarbonate solution online through automated mixing of dialysis grade water and dry sodium bicarbonate powder within the bibag source disposable. The bibag System comprises: (1) the sodium bicarbonate concentrate generator (known as the bibag module); (2) the bag of dry sodium bicarbonate concentrate. A specialized bibag connector with a door is used to connect the single-use bibag disposable (650g/900g) filled with USP grade dry sodium bicarbonate powder to the bibag connector. The 2008T Hemodialysis Machine draws dialysis grade water into the bibag to produce a saturated solution of sodium bicarbonate online. This online generation of sodium bicarbonate can only be performed using a specially modified Fresenius 2008T Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution. The bibag cannot be used with non-Fresenius hemodialysis machines capable of using cartridge type dry sodium bicarbonate because of the unique connection between the bibag disposable, the bibag connector, and the hemodialysis machine. Modifications to the previously cleared 2008T Hemodialysis Machine with bibag System include: - Active Pressure Regulation Feature: Increases the maximum acid/bicarbonate . concentrate inlet pressure specification from 2 psi to 10 psi. Provides an integrated process for regulating concentrate supply (inlet) pressures from central delivery systems. - Active Venting Feature: Replaces the existing venting process requiring dialysate . flow bypass. - . In-line Particulate Filter: Addition of an inline particulate filter between the bibag concentrate outlet and bicarbonate pump to eliminate the possibility of particulates from the disposable bag from entering the hydraulics. - . Mute Once Feature: Users may elect to mute all conductivity and temperature audible alarms for up to 6 minutes (maximum) to allow a newly installed bibag disposable to reach operating temperature and conductivity. - Acid Clean/Heat disinfection button: Allows users to initiate the acid/heat disinfect process with a single screen selection. This submission also includes a description of software modifications to implement user interface changes. Modifications include: Heparin/SVS status. Dialysate On/Off button. Configurator, SVS Option and are intended to address user preferences and to provide additional user convenience. These changes were also described in K120505 (submitted 17 February 2012; cleared 6 March 2012). Additionally, this submission includes minor software maintenance changes made to the 2008T Hemodialysis Machine with bibag System since the last clearance (K120017). Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine with bibag System remain identical to those for the unmodified device (K120017): The 2008T Hemodialysis Machine with bibag System is a high permeability hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis. hemofiltration and hemoconcentration. The 2008T will accommodate the use of both low flux and high flux dialyzers.

The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

The Fresenius 2008T Hemodialysis Machine with bibag System is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is a specialized, single-use, sealed bag filled with USP grade dry sodium bicarbonate powder. The bibag attaches to a special connector incorporated into the front of the 2008T Hemodialysis Machine. The hemodialysis machine draws dialysis grade water into the bibag to produce a saturated solution of sodium bicarbonate online. This online generation of sodium bicarbonate can only be prepared using a specially modified Fresenius 2008T Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution. The bibag cannot be used with other non-Fresenius hemodialysis machines capable of using cartridge type dry sodium bicarbonate because of the unique connection between the bibag disposable, the bibag connector, and the hemodialysis machine. Modifications of the previously cleared 2008T Hemodialysis Machine with bibag system includes: 5.4.1 900g bibag Disposable: Addition of an optional disposable 900g bibag which is equivalent to 650g bibag but increased in length to accommodate an additional 250g dry sodium bicarbonate powder. The length of a treatment session is dependent upon pre-treatment set-up time (including potential delays) and physician-prescribed dialysate flow rate and sodium bicarbonate concentration. (For example: The larger bag will provide sufficient USP grade dry sodium bicarbonate powder for 8 hours when running at a dialysate flow rate (Qd) of 500 mL/min and sodium bicarbonate concentration setting of 32 mEq/L). There were no hardware or software changes made to the 2008T Hemodialysis Machine with bibag System to accommodate the 900g bag option. The existing bibag module attached to the machine will be used to connect the new 900g bibag with the same connector used for the 650g bibag. Additionally, this submission includes a minor software maintenance change made to the 2008T Hemodialysis Machine with bibag System since the last clearance (K101715). 5.4.2 Function (Fn) Lock Keyboard The existing fold-down compact keyboard used on the 2008T Hemodialysis Machine (K101715) is located directly below the display screen. The keyboard folds down to allow the operator to enter treatment parameter values, chart with CDX or make selections inside the treatment screen and folds up again to prevent unintentional changes. For added user convenience while navigating their MIS systems, FMCNA added function lock capability to the current 2008T's keyboard. The modification includes repurposing the "Fn" key to a "Fn Lock" key and adding a function lock indicator light to the immediate right of the Caps Lock indicator light. Software and hardware modifications were made to implement this feature is only available in 2008T Hemodialysis Machines with activation of the CDX option. In dialysis mode, the Fn Lock LED will be off and the function lock feature will be off. In addition, the keyboard is now equipped with a new elastomer material with higher tear resistance properties as compared to the standard silicon elastomer of the existing keyboard in the unmodified device (K101715). Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K101715): The 2008T is a high permeability hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemoconcentration. The 2008T will accommodate the use of both low flux and high flux dialyzers.