Omnipod 5 algorithm

The Omnipod 5 algorithm is a software-only automated insulin delivery system that works with compatible continuous glucose monitors and insulin pumps to automatically adjust insulin delivery based on glucose readings and predictions. It is intended for managing type 1 diabetes in patients 2 years and older and type 2 diabetes in patients 18 years and older, and requires a prescription.

The Omnipod 5 algorithm uses Bluetooth Low Energy wireless communication and operates on the Omnipod 5 ACE Pump in either automated (closed-loop) or manual (open-loop) modes. Key differences from the predicate include a lowered target glucose range of 100-150 mg/dL (versus 110-150 mg/dL) and a modified ADR alert that allows users to remain in Automated Mode after acknowledgment. Both devices are algorithmic software intended to automatically adjust insulin delivery based on iCGM readings and predicted glucose values.

Software verification and validation testing was performed in accordance with IEC 62304:2015 and FDA's General Principles of Software Validation guidance (January 11, 2002). Interoperability documentation was provided per FDA's Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices guidance (September 6, 2017). Performance validation was conducted via in silico clinical trial per FDA's Assessing the Credibility of Computational Modeling and Simulation guidance (November 17, 2023).

The Omnipod 5 algorithm has identical intended use, indications for use, device type, principles of operation, and technological characteristics as the predicate SmartAdjust technology (K241777). The software modifications—adding 100 mg/dL target glucose capability and improving the ADR alert—do not raise different safety or effectiveness questions. In silico clinical validation demonstrated that simulated performance with the 100 mg/dL target is non-inferior to real-world predicate performance with 110 mg/dL target, supporting substantial equivalence.