SMARTeZ™ Elastomeric Infusion Pump (RS series)

The SMARTeZ Elastomeric Infusion Pump (RS series) is a sterile, single-use, non-electronic infusion pump that delivers medications continuously using an elastomeric reservoir as its energy source. It is intended for intravenous, subcutaneous, and intra-arterial infusion of medications including pain management, antibiotics, and chemotherapy.

The subject device shares the same principles of operation, energy source, particle filter pore size, performance specifications, sterile barrier packaging, sterilization process, shelf-life, and labeling as the predicate. Key differences include a hard outer shell (versus soft), and the addition of an inline valve fill port and TPU tube clamp portion, which were validated through additional functional and biocompatibility testing.

ISO 28620:2020 (non-electrically driven portable infusion devices), ISO 80369-7:2021 and ISO 80369-20:2015 (small-bore connectors), ANSI/AAMI CN27:2021 (Luer activated valves), ISO 10993 series (biocompatibility), ISO 11135:2014 (ethylene oxide sterilization), ASTM D4169-16 (shipping), ASTM F1980-21 (accelerated aging), and USP methods for pyrogenicity and particulate matter.

The subject device does not raise new questions of safety or effectiveness because it shares identical intended use, indications, principles of operation, and core design characteristics with the predicate device K151650. Design differences (hard shell and inline fill port) are supported by comprehensive bench testing demonstrating compliance with applicable standards and equivalent functional performance and biocompatibility.