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510(k) Data Aggregation

    K Number
    K991112
    Device Name
    SAGE CONTRAST MANAGEMENT SYSTEM
    Manufacturer
    SAGE LABORATORIES, INC.
    Date Cleared
    1999-09-02

    (154 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sage Contrast Management System is recommended for controlled IV administration of contrast media.

    Device Description

    Sage Contrast Management System

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Sage Contrast Management System. It does not contain the detailed technical information, study design, or results that would allow for a comprehensive description of acceptance criteria and device performance as requested.

    Therefore, I cannot provide the requested information from the provided text. The document primarily states that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number of experts, their qualifications, or adjudication methods for ground truth.
    4. Information about MRMC comparative effectiveness studies or standalone performance.
    5. Details on the type of ground truth used or training set information.
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