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510(k) Data Aggregation

    K Number
    K033389
    Device Name
    POWERPICC CATHETERS, MODELS 3175155, 3175135
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2004-03-19

    (148 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K031129
    Why did this record match?
    Device Name :

    POWERPICC CATHETERS, MODELS 3175155, 3175135

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

    The PowerPICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.

    Device Description

    The PowerPICC Catheters are open-ended radiopaque polyurethane catheters. Catheter size is 5 Fr SL with 50 cm usable length. The catheter has a reverse taper design. Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point. Catheters are provided sterile in basic radiology PICC configurations. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate the PowerPICC from other PICC catheters. The catheter extension leg, junction and clamp ID tag were printed with markings to identify the catheter as Power PICC and to include information to facilitate proper use of the device.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for a medical device (PowerPICC™ Catheters) and does not describe an AI/ML powered device or a study involving such a device. Therefore, I cannot extract the requested information about acceptance criteria and studies related to AI/ML technology from this document.

    The document discusses the substantial equivalence of the PowerPICC™ Catheter to a predicate device, focusing on its intended use, technological characteristics, and conformance to existing medical device regulations and standards. It mentions "verification testing" for performance but does not provide details on specific acceptance criteria, study methodologies, or AI/ML performance metrics.

    For me to provide the requested information, the input text would need to describe a medical device that utilizes AI/ML, along with a study detailing its performance and acceptance criteria.

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