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The FreedomEdge® Syringe Infusion System consists of the following components:

• FreedomEdge® Infusion Pump
• Precision Flow Rate Tubing™
• High-Flo SubQ Needle Sets™

The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302830), BD 30 ml syringe (US Reference number: 302832) and Hizentra® 20 ml prefilled syringe (NDC 44206-458-96).

For Immunoglobulin Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins in the home, hospital, or ambulatory settings when administered according to the FDA approved biologic labeling:

• 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% Liquid (manufactured by CSL Behring®)
• Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid 20ml Single-use pre-filled syringe (manufactured by CSL Behring®)

For EMPAVELI™ (pegcetacoplan) Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling.

For RYSTIGGO® (rozanolixizumab-noli) Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of RYSTIGGO® (rozanolixizumab-noli) when administered according to the approved drug product labeling.

For Intravenous Antibiotic Administration:
The FreedomEdge Infusion Pump and Precision Flow Rate Tubing are specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling:

• Ertapenem, Meropenem, Oxacillin, and Tobramycin

The FreedomEdge Infusion System is a non-electrically powered, mechanical infusion system which is intended for subcutaneous or intravenous administration of drug products in a home, ambulatory, or clinical setting. The infusion system includes the FreedomEdge Infusion Pump, the High-Flo SubQ Needle Sets, and the Precision Flow Rate Tubing Sets. The infusion system is designed to be used with sterile, single use syringes (not manufactured or sold by Koru Medical Systems) as the drug reservoir. There have been no significant changes to the technological features (e.g., material, design, energy source, packaging, sterility, manufacturing method) since the previous clearance.

The fundamental operating principle of the FreedomEdge Infusion System is based on the Hagen-Poiseuille equation. The syringe containing the drug to be infused is connected to the flow rate control tubing and the subcutaneous needle set or venous access device and inserted into the pump. The syringe pusher of the pump applies a constant force to the plunger of the syringe. The infusion sets generate a defined amount of resistance which determines the flow rate. Flow rates are modeled using the Hagen-Poiseuille equation and verified at the boundary conditions for the system.

The design and operating principles of the system and its components have not been significantly modified since the device was first cleared. The same test methods were used as in prior submissions. Acceptance criteria were generated for Rystiggo using the same flow rate prediction model as used in prior submissions.

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