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510(k) Data Aggregation

    K Number
    K192035
    Device Name
    EvaQMax Smoke Evacuation System
    Manufacturer
    Bio Protech, Inc.
    Date Cleared
    2019-08-29

    (30 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EvaQMax Smoke Evacuation System

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

    To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance for an AI/ML medical device.

    The document is a 510(k) clearance letter from the FDA for a device named EvaQMax Smoke Evacuation System, product code FYD. This is a physical device used to remove and filter smoke and aerosols from a surgical site, not an AI/ML-driven device.

    Therefore, I cannot provide details on:

    • Acceptance criteria and reported device performance for an AI/ML device.
    • Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies related to AI/ML device validation.

    The document discusses regulatory information for a non-AI/ML medical device, including its classification, regulations, and reporting requirements.

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