MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)

The MiniMed 780G Insulin Pump is an alternate controller enabled (ACE) pump for subcutaneous insulin delivery at set and variable rates to manage diabetes mellitus. It can communicate wirelessly with compatible continuous glucose monitors and automated insulin dosing software to receive and execute commands, and contains an integrated bolus calculator that computes insulin doses based on user-entered data. The device is indicated for individuals 7 years and older and requires a prescription.

The 780G pump operates in Manual Mode or Auto Mode (SmartGuard), delivering basal rates of 0–35 U/hour with 8 delivery profiles and boluses ranging from 0.025 to 25 units at 0.025-unit increments. It communicates via Bluetooth Low Energy with compatible integrated continuous glucose monitors and interoperable automated glycemic controllers, delivers insulin with ±5% accuracy, includes active insulin (IOB) tracking, and provides visible/audible/vibratory alarms. The pump houses a polycarbonate case, electronic circuitry, drive motor, user interface with LCD screen, and medication reservoir.

IEC 62366-1:2015 (human factors), IEC 60601-2-24 (infusion pump safety and performance accuracy), ISO 14971:2019 (risk management), ISO 15197:2013 (blood glucose meter compatibility), and HE75:2009. FDA guidance documents on interoperable medical devices (September 2017) and human factors engineering (February 2016) were also applied.

The subject device is substantially equivalent to the predicate MiniMed 780G (K251032) for Product Code QFG because all technological characteristics, indications for use, operating modes, delivery ranges, accuracy specifications, and interoperability features are identical. Additionally, the bolus calculator component is substantially equivalent to the InPen Dose Calculator (K242775) for Product Code NDC. The device meets all Special Controls requirements for ACE infusion pumps under 21 CFR 880.5730, with performance demonstrated through bench testing, risk management per ISO 14971, cybersecurity assessment, and human factors validation.