MiniMed Flex pump

The MiniMed Flex pump is a screenless, battery-operated insulin infusion pump for subcutaneous delivery of insulin to manage diabetes in persons 7 years and older. It communicates wirelessly via Bluetooth Low Energy with compatible continuous glucose monitors and automated glycemic controllers to receive and execute insulin dosing commands based on glucose readings and healthcare provider recommendations.

The Flex pump is screenless with minimal user interface (two buttons and status light), whereas the predicate 780G has an LCD screen and keypad. The Flex pump includes only an internal lithium-ion rechargeable battery, while the 780G requires both an internal lithium-ion battery and an AA battery. The Flex pump enables wireless bolus control via the MiniMed app; the 780G does not. Both pumps deliver the same insulins, operate in Manual and SmartGuard modes, and communicate via BLE with compatible iCGMs, iAGCs, and CGMs.

ISO 14971:2019 (risk management), IEC 62304:2006/A1:2016 (software lifecycle), IEC 62366-1:2015 (human factors), IEC 60601-1 and IEC 60601-1-2 (electrical safety and electromagnetic compatibility), HE75:2009, and FDA guidance documents on device software, human factors, and interoperable medical devices.

The MiniMed Flex pump has identical indications for use, intended population, regulation, product code, and operating principles as the predicate MiniMed 780G. Bench testing demonstrated equivalent delivery volume accuracy, catheter occlusion detection, and drug stability. The device meets all Special Controls requirements in 21 CFR 880.5730 for ACE infusion pumps. Design differences (screenless interface, wireless app control, battery configuration) do not raise new safety or effectiveness concerns and are supported by comprehensive software verification, human factors validation, and interoperability testing.