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The SCIg60 Infusion System is intended for the subcutaneous infusion of indicated fluids in the home or hospital environment for adult or pediatric (2 years and older) that require subcutaneous infusion of fluid medication prescribed by a healthcare professional. The SCIg60 Infusion System is indicated for the subcutaneous infusion of: - · Cuvitru Immune Globulin Infusion (Human) 20%, manufactured by Takeda. - · Gammagard Liquid, Immune Globulin Infusion (Human) 10%, manufactured by Takeda, - · Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring, - · Gamunex-C Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics - · Gammaked Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics - · Xembify Immune Globulin Subcutaneous (Human) 20%, manufactured by Grifols Therapeutics, and - Cutaquig Immune Globulin (Human), 16.5%, manufactured by Octapharma AG The SCIg60 Infuser Pump is intended for single patient, multiple use only, while flow controller and patient administration sets are single-use only.

The EMED SClg60 Infusion System consists of the SClg60 Infuser (Pump), a 50 mL Luer lock syringe, a flow rate influset [fixed rate] flow control infusion set, VersaRate adjustable flow rate infusion set, or VersaRate Plus adjustable flow rate infusion set), and a commercially available subcutaneous (SUB-Q) infusion sets that utilize a standard Luer Lock style connector. The SClg60 Infuser is a reusable mechanicambulatory infusion pump that does not require batteries or any electrical source. The SClg60 Infuser uses a spring as a source of energy to the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The SClg60 Infuser is provided with a carrying case and User Manual. The SCIg60 Infuser enclosure is made of synthetic polymer blend of glass reinforced polystyrene, the spring is made of stainless steel, and the spring enclosure is made of a blend of modified polyphenylene oxide and fibrous glass. The Infuset flow control infusion set is an individually packaged, sterile, single-use device. It is assembled from standard Luer lock components and specified lengths of PVC microbore tubing. The tubing results in fixed flow rates when used with the SCIg60 Infuser, and include side-clamps for stopping and starting the SCIg60 Infusion System User Manual includes information to quide users in the selection of Infuset flow control infusion sets to achieve the desired infusion rates. The VersaRate or VersaRate Plus adjustable flow rate individually packaged, sterile, single-use devices. It is assembled from standard Luer lock components, PVC microbore tubing and a dial made of polycarbonate, styrene-ethylene (VersaRate) or polycarbonate, polyoxymethylene (VersaRate Plus). They may be used with the SCIg60 Infuser to provide convenient control of the flow rate without having to select specific Infusion set. The barrel-shaped dial (VersaRate) or flat dial (VersaRate Plus) can be adjusted by turning a barrel or dial in order to set an appropriate flow rate of immune globulin solution or stop the fluid flow entirely. The SClg60 Infusion System User Manual includes information to guide users in the selection of Infuset, VersaRate Plus settings and SUB-Q infusion sets to achieve the desired infusion rates. The following commercially available syringes not sold or distributed by EMED are compatible with SClg60 Infusion System: - BD 50 mL syringe (model no. 309653) - Hizentra® 50 mL Prefilled Syringe (Model / Carton NDC# 44206-455-25)

The VersaPump Infusion System is intended for the subcutaneous infusion of indicated fluids for patients in the home or hospital environment when administered by an adult according to the indicated fluid's product labeling and with specified models of subcutaneous infusion sets, flow controllers, and syringes. The system is intended for single patient, multiple use only. The VersaPump Infusion System is indicated for adult and pediatric patients (2 years and older) that require subcutaneous infusion of fluid medication prescribed by a healthcare professional. The infusion system must be operated by an adult for use with pediatric patients. The VersaPump Infusion System is indicated for the subcutaneous infusion of: - Cuvitru Immune Globulin Infusion (Human) 20%, manufactured by Takeda. - Gammagard Liquid, Immune Globulin Infusion (Human) 10%, manufactured by Takeda, - Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring, - Gamunex-C Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics - Gammaked Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics - Xembify Immune Globulin Subcutaneous (Human) 20%, manufactured by Grifols Therapeutics, and - Cutaquig Immune Globulin (Human), 16.5%, manufactured by Octapharma AG.

The VersaPump Infusion System consists of the VersaPump Infuser designed to be used as a system with a flow rate controller (Infuset™ fixed flow rate control infusion set or VersaRate Plus™ variable flow rate control infusion set) and SUB-Q administration sets that utilize a standard Luer lock connector. The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal). The Infuset flow rate controller is an individually packaged, sterile, single use device. It is assembled from standard Luer components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in fixed flow rate when used with the VersaPump Infuser and include side-clamps for stopping the flow of fluid. The VersaPump Infusion System User Manual includes information to guide users in the selection of Infuset flow rate controller and SUB-O patient administration sets to achieve the desired infusion flow rate. The VersaRate Plus variable flow rate controller is individually packaged, sterile, single use device. It may be used with the VersaPump Infuser to provide convenient control of the flow rate without having to select specific Infuset flow rate controller. The flat dial of the VersaRate Plus can be adjusted to set an appropriate flow rate of immune globulin solution or stop the fluid flow entirely. The VersaPump Infusion System User Manual includes information to guide users in the selection of the VersaRate Plus settings and SUB-Q patient administration sets to achieve the desired infusion flow rate. The SUB-Q Administration Sets consist of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place while in use. The infusion set has a rigid PVC standard Luer lock at one end and a 90° 304 stainless steel needle mounted by a butterfly stabilizer at the other end. The two ends are connected by medical grade PVC tubing. The main subject of this submission is VersaPump Infuser. The rest of the components of the VersaPump Infusion System are identical to the components used as part of the EMED SCIg60 Infusion System previously cleared by the FDA. Therefore, this submission contains safety and effectiveness data only for the VersaPump Infuser when used as a system utilizing the following commercially available syringes not sold or distributed by EMED: - 20 mL BD syringe (model no. 302830) - 20 mL Hizentra Prefilled Syringe (NDC 44206-458-96) - 30 mL BD syringe (model no. 302832) - 30 mL B. Braun syringe (model no. 4617304F) - 35 mL Monoject syringe (model no. 1183500777 or 8881535762) For the VersaPump to operate as a system, the flow rate controller (Infuset™ fixed flow rate control infusion set or VersaRate Plus ™ variable flow rate control infusion set) is connected to one of the above syringes via the Luer Lock. The patient administration set is then connected via Luer Lock connector to the flow controller. The patient administration set provides one or more needles that can be placed into subcutaneous tissue for the infusion. Depending on the number and gauge of the needle(s), and the selection/setting of the flow controller, the desired flow rate is provided. The VersaPump User Manual provides information on flow rates obtainable with various combinations of the VersaPump, EMED flow rate controllers, subcutaneous administration sets, and biologics.

The SCIg60 Infusion System is intended for the subcutaneous infusion of the following immunoglobulin liquid medications: - · Hizentra, Immune Globulin Subcutaneous (Human) 20% (manufactured by CSL Behring), • Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta). · Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta) - · Gamunex-C Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.), - · Gammaked Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.) - · Xembify Immune Globulin Subcutaneous (Human), 20% (manufactured by Grifols Therapeutics, Inc.), and - · Cutaquig Immune Globulin Subcutaneous (Human), 16.5% (manufactured by Octapharma AG) with the BD 50 ml syringe (model no. 309653) in the home or hospital environment.

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser Pump, a flow rate controller (Infuset fixed rate flow control extension set. VersaRate variable flow rate controller, or VersaRate Plus variable flow rate controller), and can be used with commercially available SUB-Q administration sets that utilize a standard Luer Lock style connector. The SCIg60 Infuser Pump must be used with the BD 50 mL syringe (model no. 309653 manufactured by Becton Dickinson (BD)), which was formerly labeled as a 60 mL syringe. The SCIg60 Infuser pump is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The SCIg60 Infuser Pump uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The SCIg60 Infuser Pump is provided with a carrying case and User Manual. The Infuset flow rate controller is an individually packaged, sterile, single use device. It is assembled from standard Luer components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in fixed flow rates when used with the SCIg60 Infuser Pump, and include side-clamps for stopping the flow of fluid. The SCIg60 Infusion System User Manual includes information to guide users in the selection of Infuset flow rate controller and SUB-Q patient administration sets to achieve the desired infusion rates. The VersaRate or VersaRate Plus variable flow rate controllers are individually packaged, sterile, single use devices. They may be used with the SCIg60 Infuser Pump to provide convenient control of the flow rate without having to select specific Infuset flow rate controller. The barrel-shaped dial (VersaRate) or flat dial (VersaRate Plus) can be adjusted by turning a barrel or dial in order to set an appropriate flow rate of immune globulin solution, or stop the fluid flow entirely. The SCIg60 Infusion System User Manual includes information to guide users in the selection of VersaRate (or VersaRate Plus) settings and SUB-Q patient administration sets to achieve the desired infusion rates.

The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60ml syringe (model no. 309653) To pump fluids from a reservoir into an adult or pediatric patients (2 years and older) in a controlled manner in a home or hospital environment.

The EMED SCIg60 Infusion System consists of: SCIg60 Infuser, fixed-rate Infuset flow control extension set, VersaRate variable-rate flow regulator, SUB-O patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset flow control extension sets, VersaRate flow regulator, and SUB-Q patient administration sets are also manufactured by EMED Technologies. The SCIg60 Infuser is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of indicated human plasma-derived immunoglobulin solutions. The Infuset flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stoping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates. The change proposed in this 510(k) includes the addition of the VersaRate flow regulator. The VersaRate flow regulator consists of a barrel-type regulator component, medium-density PVC standard luer lock connectors. Snap-fit design elements of the regulator halves hold the gasket in place and allow the VersaRate to withstand fluid pressures up to 18 psi. The rotation of the flow regulator component alters internal fluid path dimensions.

The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60 ml syringe (model no. 309653).

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser, the Infuset™ flow control extension set and SUB-Q patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset™ flow control extension sets and SUB-Q patient administration sets are also manufactured by EMED Technologies. The SCIg60 Infuser is a reusable mechanical. non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of indicated human plasma-derived immunoglobulin solutions. The Infuset™ flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stopping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset™ flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates. SCIg60 Infusion System should be used in accordance with its directions for use.

The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring) with the BD 60 ml syringe (model no. 309653).

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser, the Infuset™ flow control extension set and SUB-Q patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset™ flow control extension sets and SUB-Q patient administration sets are also manufactured by EMED Technologies (see K140133 and K140131). The SCIg60 Infuser is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring). The Infuset™ flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stopping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset™ flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates. SCIg60 Infusion System should be used in accordance with its directions for use.