LifeShield Infusion Safety Software Suite

LifeShield Infusion Safety Software Suite is a cloud-based software platform that facilitates communication between healthcare systems and compatible infusion pumps (Plum Duo and Plum Solo). It enables trained healthcare professionals to manage infusion data through four integrated modules: Drug Library Management (for pharmacists to create drug libraries), Clinical Dashboards & Reports (for viewing infusion data and quality improvement), Data Flow Management (for bi-directional communication and automated programming), and general workflow enhancements. The software does not remotely control pumps or manage alarms in real-time.

The subject device maintains the same indications for use, prescription device status, web-based application type, compatible browsers (Chrome, Microsoft Edge), cloud hosting (AWS), and compatible pumps as the predicate. Key updates include enhanced drug library workflow with improved ruleset copying and UI improvements for managing larger numbers of drug library and pump software updates; ability to archive pumps and report locations from third-party location systems; and enhanced multi-factor authentication with optional enforcement for all users. All core functionality—auto-programming, alarm forwarding, infusion documentation, asset management, and digitally-signed drug libraries—remains equivalent.

Design verification and validation testing per IEC 62304:2015 software development processes; cybersecurity evaluation and testing; risk management per ISO 14971:2019 with Safety Assurance Case per AAMI TIR38:2018 and FDA Total Product Lifecycle of Infusion Pumps guidance (2014); Human Factors studies per IEC 62366-1:2020 and ANSI/AAMI HE75:2009/(R)2018.

The subject device is substantially equivalent because it maintains the same indications for use, intended patient population (adult, pediatric, neonate), core functionality, and compatible pump systems as predicate K242117. All modifications are workflow and user interface enhancements (enhanced drug library copying, pump archiving, third-party location reporting, optional multi-factor authentication enforcement) that do not raise different questions of safety and effectiveness. No clinical study is required. Non-clinical testing confirms the device meets design requirements and is reasonably safe and effective.