OmniPod 5 - Page 340

Appendix
332
Appendix
Performance Characteristics
e Omnipod 5 insulin pump delivers insulin in two ways: basal insulin delivery
(continuous) and bolus insulin delivery. e following accuracy data was
collected on both types of delivery in laboratory studies performed by Insulet.
e Summary of Safety and Clinical Performance (SSCP) is available at
www.omnipod.com/sscp. e SSCP is also available in the European Database
on Medical Devices (EUDAMED) website (https://ec.europa.eu/tools/eudamed)
where it is linked to the Basic UDI-DI. e Basic UDI-DI for Omnipod 5 is
0385083000145W.
Delivery performance characterization
Basal Delivery: In order to assess basal delivery accuracy, 12 Pods were tested
by delivering at low, medium, and high basal rates (0.05, 1.00, and 30.0 U/hr).
Water was used as a substitute for insulin. e water was pumped into a container
on a scale, and the weight of the liquid at various time points was used to assess
pumping accuracy.
e following tables report the typical basal performance (median) observed,
along with the lowest and highest results observed for the low, medium, and high
basal rate settings for all pumps tested with no warm-up period. For each time
period, the tables show the volume of insulin requested in the rst row and the
volume that was delivered as measured by the scale in the second row.
Low Basal Rate Delivery Performance (0.05 U/hr)
Basal Duration
(Number of units
requested)
1 hour
(0.05 U)
6 hours
(0.30 U)
12 hours
(0.60 U)
Amount Delivered 0.049 U 0.30 U 0.59 U
[min, max] [0.00, 0.12] [0.13, 0.57] [0.34, 0.99]
Medium Basal Rate Delivery Performance (1.00 U/hr)
Basal Duration
(Number of units
requested)
1 hour
(1.00 U)
6 hours
(6.00 U)
12 hours
(12.00 U)
Amount Delivered 0.99 U 5.97 U 11.88 U
[min, max] [0.65, 1.55] [5.06, 6.87] [10.53, 13.26]