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510(k) Data Aggregation

    K Number
    K232382

    Validate with FDA (Live)

    Device Name
    Control-IQ Technology
    Manufacturer
    Tandem Diabetes Care, Inc.
    Date Cleared
    2023-11-03

    (87 days)

    Product Code
    QJI
    Regulation Number
    862.1356
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K200467
    Predicate For
    K243823,K251217
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

    Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater.

    Control IQ technology is intended for single patient use and requires a prescription.

    Device Description

    Control-IQ technology (Control-IQ, the device) is a software-only device intended for the management of type 1 diabetes mellitus. The device controls insulin delivery from a compatible alternate controller enabled insulin pump (ACE pump) based on inputs provided by a compatible integrated continuous glucose monitor (iCGM) and inputs provided the user (e.g., carbohydrate intake, exercise, and sleep schedule). Control-IQ technology is meant to be installed on a compatible ACE pump.

    Control-IQ Technology has three different modes: Normal, Sleep, and Exercise. The glucose targets are not customizable in these modes but can change based on the mode selected. During normal mode, Control-IQ Technology aims to control glucose within a target range of 112.5 – 160 mg/dL. During sleep mode, this range is changed to 112.5-120 mg/dL, and it is changed to 140-160 mg/dL during exercise mode.

    Control-IQ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when the Control-IQ technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.

    Control-IQ technology requires users to input their total daily insulin requirement, which should be established with the help of a health care provider before using the device.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study conducted for the Tandem Diabetes Care Control-IQ Technology (K232382).

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of specific numerical acceptance criteria for the Control-IQ technology. However, it states the primary outcome of the pivotal clinical study. The device's performance is reported in relation to this outcome.

    Acceptance Criteria (Implicit)Reported Device Performance (Primary Outcome)
    Percent time in range 70-180 mg/dLThis was the primary outcome of the study, and the study was successful enough to support the expanded age indication. Specific numerical values for the performance are not provided in this document, but the study conclusion supports the device's efficacy for the expanded age range.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: 102 subjects were enrolled in the pivotal clinical study.
    • Data Provenance: The document does not specify the country of origin. It indicates the study was a prospective, randomized controlled trial.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    This information is not provided in the document. The study's "ground truth" for glucose values would inherently come from the continuous glucose monitors (CGM) used by the subjects in the trial, but the involvement of independent experts to establish a "ground truth" for the test set is not mentioned.

    4. Adjudication Method for the Test Set

    This information is not provided in the document.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance

    A MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is an automated glycemic controller, where the AI (Control-IQ technology) directly controls insulin delivery, rather than assisting human interpretation of data for medical decision making.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Yes, the pivotal clinical study directly evaluated the performance of the Control-IQ technology (algorithm only without human-in-the-loop for basal insulin adjustments and correction boluses based on predictions). Subjects were randomized to either Control-IQ or Standard Care, directly comparing the automated system's performance.

    7. The Type of Ground Truth Used

    The ground truth for the primary outcome (percent time in range 70-180 mg/dL) was based on CGM measured glucose values.

    8. The Sample Size for the Training Set

    The document does not provide information on the sample size used for the training set of the Control-IQ algorithm. The clinical study described is a pivotal trial for evaluation of the device, not necessarily for its training.

    9. How the Ground Truth for the Training Set Was Established

    The document does not provide information on how the ground truth for the training set was established.

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