Device Dossier
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Device Dossier for Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm (Ambulatory insulin infusion pump, electronic,…
Intended purpose
The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for the continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to provide an automatic adjustment of insulin delivery based on continuous glucose monitoring (CGM) and can suspend the delivery of insulin when the SG value falls below, or is predicted to fall below, predefined threshold values.