UpDoc

UpDoc is a software-as-a-medical-device (SaMD) that helps patients aged 18 and older with type 2 diabetes manage insulin therapy. Healthcare providers set individualized treatment plans including insulin dosing instructions and safety protocols, which the system uses to provide patients with personalized insulin dose recommendations based on their blood glucose readings, meal intake, medication adherence, and reported symptoms.

UpDoc uses a cloud-based architecture with a patient mobile app and HCP web portal. Key differences from the predicate include voice and chat interfaces for data entry, symptom reporting with system locks for safety, built-in protocols for hypoglycemia and hyperglycemia management, and HCP-configurable adjustment parameters with default ±20% safeguards. Like the predicate, it uses a dose calculator algorithm based on blood glucose readings and fixed target ranges, supports multiple insulin types, and provides dose history records to both patients and providers.

IEC 62304 for software development, FDA guidance on Content of Premarket Submissions for Device Software Functions, FDA guidance on Cybersecurity in Medical Devices: Quality System Considerations, and FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices.

UpDoc is substantially equivalent to the predicate d-Nav System (K181916) because both are software-based insulin dose calculators with the same indications for use, intended patient population, and use environments. Both require HCP prescription and setup, use response-to-dose algorithms based on blood glucose and treatment protocols, support similar insulin types, and provide dose history records. UpDoc's additional features (voice/chat input, symptom tracking, enhanced safety protocols) enhance safety without changing the fundamental function or raising new safety concerns.