MiniMed 780G insulin pump

The MiniMed 780G insulin pump is a battery-operated, ambulatory infusion pump for subcutaneous insulin delivery in people with diabetes aged 7 and older. It operates in manual or auto mode, communicates wirelessly with compatible continuous glucose monitors and automated glycemic controllers, and includes an integrated bolus calculator that computes insulin doses based on user-entered data.

Compared to the Tandem t:slim X2 predicate, the MiniMed 780G has a higher maximum basal rate (35 U/hr vs. 15 U/hr), more insulin delivery profiles (8 vs. 6), finer bolus resolution (0.025 vs. 0.01 units), uses a single AA battery instead of rechargeable lithium-polymer, has a keypad interface rather than touchscreen, and offers greater water immersion protection (IPX8 vs. IPX7). The bolus calculator predicate (InPen) is software on Android/iOS; the MiniMed 780G integrates the calculator into pump firmware.

ISO 14971:2019 (risk management), IEC 62366-1:2015 and HE75:2009 (human factors), ISO 15197:2013 (blood glucose meter compatibility), IEC 60601-2-24 (infusion pump delivery accuracy standards).

The MiniMed 780G meets the same regulatory classification (Class II, ACE pump under 21 CFR 880.5730) and product code as the predicate, with identical intended uses: subcutaneous insulin delivery for diabetes management with secure communication to compatible interoperable devices. Both devices operate in manual and auto modes, deliver basal and bolus insulin, support active insulin tracking, and undergo comparable performance testing (delivery accuracy, occlusion detection, drug stability). Differences in specifications (basal rate range, bolus resolution, battery type, user interface) are design variations that do not alter the fundamental function or safety profile; delivery accuracy testing demonstrates the MiniMed 780G meets the same ±5% accuracy standard, and all ACE special controls requirements (21 CFR 880.5730) are satisfied.