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510(k) Data Aggregation

    K Number
    K251779

    Validate with FDA (Live)

    Device Name
    Omnipod 5 algorithm
    Manufacturer
    Insulet Corporation
    Date Cleared
    2025-12-03

    (176 days)

    Product Code
    QJI
    Regulation Number
    862.1356
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    2 - 120
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Omnipod 5 algorithm is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. The Omnipod 5 algorithm is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. The Omnipod 5 algorithm is intended for single patient use and requires a prescription.

    Device Description

    The Omnipod 5 algorithm is a software-only device that enables automated insulin delivery by taking in glucose inputs from a connected iCGM and calculating insulin micro-bolus outputs for delivery by a connected ACE Pump.

    The Omnipod 5 algorithm is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump and the SmartBolus Calculator regulated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator are functionally independent from the Omnipod 5 algorithm. The Omnipod 5 algorithm is intended to be digitally connected to a third party iCGM, the Omnipod 5 ACE Pump, and the SmartBolus Calculator.

    The Omnipod 5 algorithm software is installed on both the Omnipod 5 Pod and Omnipod 5 App (either installed on a compatible smartphone or on the Insulet provided Controller) to comprise the Omnipod 5 System. As all regulated devices are required for the Omnipod 5 System, a prescription for the Omnipod 5 System and Omnipod 5 Pods includes:

    • Omnipod Pods with Omnipod 5 algorithm software and
    • Omnipod 5 Application with Omnipod 5 algorithm and SmartBolus Calculator software provided on Insulet provided Controller and when installed on the user's personal mobile device.

    The Omnipod 5 System is a hybrid closed loop system and therefore can operate in either open loop (Manual Mode; Omnipod 5 algorithm disabled) or closed loop (Automated Mode; Omnipod
    5 algorithm enabled). When Automated Mode is turned on, the Omnipod 5 algorithm (installed on the Pod) controls insulin delivery based on recent CGM values.

    AI/ML Overview

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