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    K Number
    K051711
    Device Name
    PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Date Cleared
    2005-11-15

    (141 days)

    Product Code
    PNG
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS

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

    The Denver® Pleurx Peritoncal Catheter Kit (50-8000) is indicated for:

    • Intermittent drainage of symptomatic, recurrent, malignant ascites that does not ● respond to medical management of the underlying disease
    • Palliation of symptoms related to recurrent malignant ascites ●
    • Peritoneal placement only ●

    The Denver® Pleurx Drainage Kits (50-7500 and 50-7510) are indicated for use with either the Pleurx Peritoneal Catheter Kit or the Pleural Catheter Kit.

    Device Description

    The Pleurx Catheter is silicone catheter that can be thought of as containing three zones: the fenestrated zone which is implanted in the body cavity and used to collect fluid; the cuffed zone, which is placed inside a subcutaneous tunnel; and the externalized zone. which includes a valve that remains closed, except when purposefully accessed for a drainage procedure. The Pleurx Drainage Kit includes a vacuum bottle with drainage line that connects to the Pleurx catheter for removing fluid. It also includes a procedure pack. that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance as it relates to an AI/ML device. The document is a 510(k) summary for the Pleurx Peritoneal Catheter Kit and Drainage Kits, which is a medical device, but it is not an AI/ML device. The document focuses on the substantial equivalence of this device to previously marketed devices, rather than on the performance criteria or studies typical for AI/ML products.

    Therefore, I cannot extract information such as:

    1. A table of acceptance criteria and reported device performance (for an AI/ML model)
    2. Sample sizes for test sets, data provenance, and ground truth establishment methods for an AI/ML model
    3. Information about experts, adjudication methods, or MRMC studies for AI/ML performance evaluation
    4. Standalone algorithm performance or training set details for an AI/ML model.
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