Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053137
    Manufacturer
    Date Cleared
    2006-06-14

    (217 days)

    Product Code
    Regulation Number
    868.1890
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ENDOTOOL DRUG DOSE CALCULATOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EndoTool™ Drug Dose Calculator is a software support system designed for use by trained healthcare professionals to calculate any individual patient's optimal next dose for insulin administered intravenously to control blood glucose level for critically ill patients without inducing hypoglycemia (low blood glucose levels). EndoTool™ is for use with patients who are receiving a relative constant nutritional intake via intravenous fluids with dextrose, total parental nutrition or continuous gastro-intestinal feedings by any route of delivery.

    Device Description

    EndoTool™ Drug Dose Calculator is software that resides on a Microsoft/Intel platforms to calculate (see Section 9.2, page 20) the drug dose of insulin to control blood glucose levels for critically ill patients on continuous feeding (IV, TBN, or tube feeding).

    AI/ML Overview

    I'm sorry, but relevant sections of this document are either missing or do not contain enough information to generate a comprehensive answer for the requested subsections. The provided text primarily focuses on regulatory information, device description, intended use, and substantial equivalence to a predicate device, rather than detailed study design or performance metrics. Therefore, I cannot provide details on acceptance criteria and study results.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1