EndoTool IV Cloud 1.0

EndoTool Cloud 1.0 is a cloud-based software system for glucose management in inpatient hospital and long-term care settings. It assists trained healthcare professionals in managing blood glucose levels in adult and pediatric patients aged 2 years and older weighing at least 12 kg by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous insulin dosing for transition from IV therapy. The software functions as a decision-support tool, not a substitute for clinical judgment, with final dose decisions made by the healthcare provider.

EndoTool Cloud 1.0 is hosted in Amazon Web Services (AWS) cloud environment with managed database services, whereas the predicate EndoTool IV 3.1 System uses Windows hosting on client premises or private virtual networks. Both are web-based software applications with identical core features including Algorithm B for insulin dosing, support for Chrome and Microsoft Edge browsers, data storage and analysis capabilities, graphical user interfaces, and alarm advisories. Both require user inputs for weight, age, and dose titration and calculate infusion rates, carbohydrate intake, and nutritional bolus.

Software verification and validation testing was conducted per IEC 62304 requirements and FDA software validation guidance. The predicate device was also validated using the same IEC 62304 and FDA standards.