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510(k) Data Aggregation

    K Number
    K050415
    Device Name
    IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS
    Manufacturer
    IMPEDIMED PTY LTD.
    Date Cleared
    2007-03-30

    (770 days)

    Product Code
    OBH
    Regulation Number
    870.2770
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS

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

    (1) Imp XCA – A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity.

    (2) Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.

    Device Description

    The Imp XCA is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate extracellular fluid (ECF) allowing for the clinical assessment of unilateral Lymphedema of the arm.

    AI/ML Overview

    The provided document is a 510(k) Summary for the ImpediMed Imp XCA ExtraCellular Fluid Analysis device, which focuses on device description, intended use, and substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot populate the table or answer most of the questions as the requested information is not present in the provided text.

    Here's what I can extract from the provided text:

    • Device Name: ImpediMed Imp XCA ExtraCellular Fluid Analysis with Lymphoedema Analysis PC Software
    • Intended Use: "A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity."

    Without further documentation detailing clinical studies or performance testing with specific statistical endpoints, I cannot fulfill the request.

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