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510(k) Data Aggregation

    K Number
    K160673
    Device Name
    Insulin Algorithms System
    Manufacturer
    Date Cleared
    2017-06-07

    (454 days)

    Product Code
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSULIN ALGORITHMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Insulin Algorithms System (IA System) is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. The IA System evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, and gender) and suggests changes (if necessary). The system is designed for use by healthcare professionals. The IA System is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs. The IA System is not intended to be used to provide insulin dosing recommendations to the clinician in order to adjust insulin treatment for patients hospitalized in an acute care setting. Also, the IA System is not intended to be used to provide insulin dosing recommendations for patients on insulin pump therapy or IV insulin therapy. Nor is IA System intended to provide recommendations for mealtime injections of insulin that are based on carb counting. The IA System is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.
    Device Description
    The Insulin Algorithms System (IA System) takes basic biometric information (age, height, weight, gender), insulin dosing information (prescribed insulins, injection times, and amounts), meal information (meal times, before meal glucose targets, after meal glucose targets), along with a collection of glucometer readings and processes this information though a custom algorithm to create a recommendation as to what changes to the patient's insulin regimen should be made. The algorithm was developed using the insulin dosing conventions taught and used in The IA System is a software solution. It is comprised of two separate software systems: a server application containing all algorithms and mitigations and a client application that serves as an interface to the server. All data are stored and analyzed on the server application. Each user has an individual identification and password to access the application. The IA System is designed to safeguard the confidentiality, integrity, and availability of electronic health information in conformance with the Health Insurance Portability and Accountability Act (HIPAA).
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