510(k) DEN180058
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 14, 2019
- Date Received
- October 29, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alternate Controller Enabled Insulin Infusion Pump
- Device Class
- Class II
- Regulation Number
- 880.5730
- Review Panel
- CH
- Submission Type
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.