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510(k) Data Aggregation

    K Number
    K030271
    Device Name
    VENTLAB BACTERIAL FILTER, MODEL BF100
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2003-07-07

    (161 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VENTLAB BACTERIAL FILTER, MODEL BF100

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

    The BF100 Disposable Bacterial/Viral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is broading of single patient use for up to 24 hours, and is not intended for reuse.

    Device Description

    Ventlab Bacterial Filter BF100

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab Bacterial Filter BF 100". It states that the device is substantially equivalent to a predicate device, allowing it to be marketed. However, this document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.

    Therefore, I cannot provide the requested information. The provided text is purely a regulatory approval letter and does not include the technical details of a study or performance evaluation.

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