LifeShield Infusion Safety Software Suite

LifeShield™ Infusion Safety Software Suite is a cloud-based software platform that enables healthcare professionals to manage infusion pump data and operations for adult, pediatric, and neonatal patients. The suite comprises four integrated software products: Drug Library Management (for pharmacists to create drug libraries), Clinical Dashboards & Reports (for viewing infusion data), Data Flow Management (for bidirectional communication with pumps and hospital systems), and general data management capabilities. The software does not remotely control pumps or manage alarms in real-time.

Key differences from predicate K223606 include: support for additional Plum Solo™ pump alongside Plum Duo™; enhanced drug library settings for pump-specific features (auto-program rejection timeout, air-in-line detection, calculation assist); addition of Intermittent therapy mode; alarm forwarding to hospital information systems; Active Directory integration for user access; time-based one-time password multi-factor authentication (versus SMS); and device log download capability. UI improvements facilitate drug library construction and status viewing.

IEC 62304:2015 (software development lifecycle); ISO 14971:2019 (risk management); AAMI TIR38:2018 (safety assurance case); FDA 2014 guidance on Total Product Lifecycle of Infusion Pumps; 2016 FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices; IEC 62366-1:2020 (human factors); ANSI/AAMI HE75:2009/(R)2018 (human factors).

The subject device maintains identical intended use, indications, and fundamental software architecture as the predicate. All modifications are iterative enhancements to existing features: drug library settings align with configurable pump capabilities already supported by predicate design; new therapy mode and dashboard enhancements provide more comprehensive infusion data; security improvements employ industry-standard authentication methods. Design verification, validation, cybersecurity, risk management per ISO 14971, and human factors testing all confirmed no new safety or effectiveness questions are raised. Existing design mitigations in the predicate effectively address risks from these enhancements.