EndoTool IV (3.1)

EndoTool IV 3.1 is a glucose management software system used by healthcare professionals in inpatient care settings to recommend intravenous insulin dosing, carbohydrate supplementation, and subcutaneous insulin doses for patients aged 2 years and older weighing 12 kg or more. The software adjusts and maintains patient glucose levels within a clinician-determined target range based on current and cumulative glucose values, though it is positioned as an adjunct to clinical judgment rather than a standalone decision tool.

Both the subject device and predicate device are software-only web-based applications operating in Windows hosting environments. They share equivalent indications for use, identical patient population criteria (2 years, 12 kg minimum), and the same core functional features: patient-specific IV drug infusion profiles, glucose evaluation, dose calculations, carbohydrate intake assessment, infusion rate calculations, data storage, and alarm advisories. The main differences are minor: the subject device supports Microsoft Edge and Google Chrome browsers (versus predicate's Internet Explorer, Edge, Chrome, Firefox), and the subject device now supports both on-line and private virtual network hosting options.

Software verification and validation testing was conducted per IEC 62304 requirements and FDA software validation guidance. No other consensus standards (ASTM, ISO) are cited in this summary.

Substantial equivalence is established through technological equivalence rather than clinical data: the subject device and predicate device (K201619) have identical indications for use with only minor clarifying updates, perform the same core glucose management functions, are both standalone software with equivalent design and operating principles, support equivalent computing environments, and have both undergone software validation to IEC 62304 and FDA standards. The only material changes—browser compatibility updates and expanded hosting options—represent improvements to the same underlying algorithm and do not alter the device's fundamental intended use or safety/effectiveness profile.