BD Alaris Infusion System with Guardrails Suite MX

The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion pump and monitoring system for continuous or intermittent delivery of fluids, medications, blood products, and analgesics to adult, pediatric, and neonatal patients via intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes. The system comprises a core PC Unit with attachable pump, syringe, PCA, EtCO2, and Auto-ID modules, plus software for drug library management, interoperability with electronic medical records, and safety guardrails.

The subject device maintains the same principle of operation, programmable flow rates (0.1–999 mL/hr for pump/PCA; 0.01–999 mL/hr for syringe), bolus accuracy, maximum infusion pressures, and service life as the predicate K211218. Key differences include: updated flow rate accuracy reporting restricted to Standard Operating Conditions for the LVP module; removal of certain BD and Monoject compatible administration sets and syringes; and addition of wireless firmware update capability to the PCU via Systems Manager software.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-24, IEC 60601-1-8, ISO 80601-2-55, AAMI TIR 101 (fluid delivery performance), UL 1642, IEC 62133-1, and ANSI/IEEE USEMCSC C63.27. Design validation invoked IEC 62366-1 for usability engineering and FDA guidance on cybersecurity, human factors, and reprocessing validation.

The subject device is substantially equivalent to predicate K211218 because both share identical intended use (modular infusion and monitoring across multiple patient populations and routes), same fundamental operating principles (linear peristaltic pumping, modular electromechanical platform), and equivalent essential performance characteristics including flow rate, bolus, and occlusion detection. Differences in compatibility lists and updated accuracy reporting at SOC represent clarifications of existing performance rather than changes affecting safety or effectiveness; removal of certain syringes was due to manufacturer discontinuation, not functional degradation. The new wireless update feature was performance-tested and confirmed to not raise different safety or effectiveness questions. All safety and EMC testing met applicable standards identical to or harmonized with the predicate.