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U.S. Department of Health and Human Services

Product Classification

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Device alternate controller enabled insulin infusion pump
Regulation Description Alternate controller enabled infusion pump.
Definition An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.
Physical State This device comprises an ambulatory insulin infusion pump to be worn on the body, including insulin reservoir and tubing components intended to connect to an insulin infusion set. This device is also comprised of software which is capable of interfacing with other digital devices.
Technical Method Pump software controls an electric motor which is designed to pump fluid (insulin) into a patient in a controlled manner. That software is designed to communicate wirelessly with other digital devices and be capable of interfacing with digitally connected devices.
Target Area Not meant to act on a specific part of the body, but can work with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data management software.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQFG
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 880.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible