FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

The FreedomEdge Infusion System is a non-electrically powered, mechanical infusion pump designed for subcutaneous or intravenous administration of drugs and biologics in home, ambulatory, or clinical settings. It consists of an infusion pump, High-Flo SubQ needle sets, and precision flow rate tubing that work together to deliver controlled infusion rates by applying constant force to a syringe plunger, with tubing resistance determining the flow rate.

The device uses the Hagen-Poiseuille equation to model flow rates and has no significant changes in materials, design, energy source, packaging, sterilization method (gamma radiation 25-40 kGy), or operating principles compared to the predicate. The only modification is the addition of Rystiggo to the list of compatible drugs; all other technological features remain identical to the predicate FreedomEdge Syringe Infusion System (K214045).

Not stated in this summary. The document references use of established test methods consistent with prior submissions (K214045 and K211206) but does not cite specific ISO, IEC, or ASTM standards by designation.