iLet ACE Pump

The iLet ACE Pump is an insulin infusion pump designed to deliver insulin subcutaneously based on continuous glucose monitor (CGM) readings and automated glycemic controller (iAGC) inputs for people 6 years and older with diabetes. It features a color LCD display, a Pause Insulin feature, and is compatible with U-100 rapid-acting insulins including Fiasp. The device is single-person use only and has a wireless rechargeable battery with a designed useful life of at least 4 years.

The primary modifications from the predicate device are a color LCD display (replacing monochromatic), slight dimensional and weight changes (49W × 91L × 16H mm, 95 grams versus 59W × 91L × 15H mm, 110 grams), and addition of a Pause Insulin feature. All other specifications remain identical: operating temperature range, humidity, moisture protection (IPX8), basal rate limits (0–11.5 units/hr), wireless charging, and 3-day cartridge change intervals. No significant changes were made to the technological characteristics of the pumping mechanism itself.

ISO 13485 (Quality Management System) and FDA Quality System Regulation (21 CFR 820) compliance are cited. The document references ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), 8.5.2 (Corrective action), and 8.5.3 (Preventative action). Insulin compatibility testing was performed to support U-100 insulin aspart (Fiasp) use in the stated age group.