Infusomat® Space Volumetric Infusion Pump Administration Sets

The Infusomat® Space Volumetric Infusion Pump Administration Sets are sterile, single-use devices designed for adults, pediatrics, and neonates to deliver parenteral and enteral fluids intravenously, intra-arterially, subcutaneously, epidurally, or enterally. They contain a silicone tubing segment that interfaces with a peristaltic pump mechanism, connectors, a line loading guide, and a free flow protection clamp to prevent fluid leakage when the pump door opens.

The subject device differs from the predicate in pump segment tubing length (7.125 inches vs. 6.6 inches), outer diameter (0.152 or 0.1614 inches vs. 0.152 inches), inner diameter (0.108 or 0.118 inches vs. 0.108 inches), and tubing material (70 or 74 durometer PVC vs. 70 durometer PVC). Overall set specifications for length, drop rate, and general design remain unchanged. Both devices use biocompatible materials sterilized by ethylene oxide and manufactured via identical injection molding and solvent bonding processes.

ISO 10993-1:2018 (biocompatibility evaluation); ISO 8536-4 (gravity feed infusion sets); ISO 8536-8 (pressure infusion apparatus); ISO 8536-14 (clamps and flow regulators); USP 788 (particulate matter in injections).

The subject device is substantially equivalent because it maintains identical intended use, indications for use, and target population as the predicate. The tubing dimension changes fall within acceptable engineering tolerances and are supported by biocompatibility testing and comprehensive performance testing (occlusion, pressure resistance, tensile strength, fluid tightness, etc.). All materials are biocompatible and comparable to the predicate. Testing with the associated pump device (sensor compatibility for different tubing dimensions) confirms functional performance. No new safety or effectiveness concerns are raised by the specified modifications.