DEN180058 is an FDA 510(k) submission for the t:slim X2 insulin pump with interoperable technology. This device is classified as a Alternate Controller Enabled Insulin Infusion Pump (Class II - Special Controls, product code QFG).
Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on February 14, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5730. 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..
| 510(k) Number | DEN180058 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 29, 2018 |
| Decision Date | February 14, 2019 |
| Days to Decision | 108 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | QFG — Alternate Controller Enabled Insulin Infusion Pump |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5730 |
| 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. |