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510(k) Data Aggregation

    K Number
    K173650
    Device Name
    AquaShield System CO2- Fujifilm
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2018-01-05

    (38 days)

    Product Code
    FEQ,FEO
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the "AquaShield System CO2- Fujifilm." This letter indicates that the device has been cleared for marketing based on substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, a specific study proving those criteria, or details regarding performance metrics for a diagnostic or AI-driven device.

    The AquaShield System CO2- Fujifilm is described as a system "intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures." This suggests it is an accessory for endoscopy procedures, likely for irrigation or insufflation, rather than a diagnostic device with performance metrics typically associated with AI or imaging analyses.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are relevant for AI/ML-driven diagnostic devices, but not for the type of device described in this 510(k) clearance.

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