SIGMA Spectrum Infusion Pump with Master Drug Library

The SIGMA Spectrum Infusion Pump with Master Drug Library is a large-volume peristaltic pump designed for controlled delivery of fluids—including pharmaceutical drugs, blood products, and patient therapies—via intravenous, arterial, subcutaneous, or epidural routes. It includes a stand-alone Master Drug Library software application that runs on hospital computing platforms to create facility-specific drug library files with dosing limits and pump configuration settings, intended to reduce operator error through guided programming.

The subject device maintains identical core specifications to the predicate (K230022): linear peristaltic pumping mechanism, continuous and intermittent delivery modes, color LCD interface, same AC power specifications, identical operational and storage temperature ranges, same battery options and capacity, and equivalent alarm systems (air-in-line, occlusion, low battery). Flow rates, dose modes, wireless security protocols, and Master Drug Library capacity (32 care areas, 5000 drugs, 400 advisories, 500 modifiers) are identical.

Not stated in this summary.

The subject device is substantially equivalent because it demonstrates identical intended use (controlled fluid administration through the same routes), identical technological characteristics across all critical parameters (pumping mechanism, delivery modes, user interface, power, alarms, flow rates, and drug library capacity), and non-clinical testing met all acceptance criteria when compared to a prior version (K133081). The submission includes software design and labeling changes to address previous recalls, but these refinements do not introduce new safety or effectiveness questions, and all operational and safety specifications remain unchanged from the predicate K230022.