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510(k) Data Aggregation

    K Number
    K991520
    Device Name
    FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Date Cleared
    1999-07-30

    (88 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fresenius On Line Clearance Monitor is intended to be used as a module with the Fresenius 2008H hemodialysis machine for determination of dialysis treatment urea clearance and for access flow estimation for those patients undergoing acute or chronic hemodialysis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "On Line Clearance Monitor with the Addition of Access Flow Estimation Capability." It does not contain the detailed information required to answer the questions about acceptance criteria and study design.

    Specifically, the document focuses on regulatory approval (substantial equivalence to a predicate device) rather than clinical performance data or study specifics. It does not provide:

    • A table of acceptance criteria or reported device performance.
    • Sample sizes, data provenance, or details about the test set.
    • Information about experts, adjudication methods, or ground truth establishment.
    • Details about MRMC studies, standalone algorithm performance, or training set specifics.

    Therefore, I cannot fulfill the request based on the provided text.

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