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510(k) Data Aggregation

    K Number
    K040504
    Device Name
    BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2004-05-14

    (77 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS

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

    The Bardex®, Lubri-Sil® and Lubri-Sil® IC Ail-Silicone Foley Catheters are intended for use in the drainage and/or collection and/or measurement of urine.

    The Bardex®, Lubri-Sil® and Lubri-Sil® I.C. All-Silicone Foley Catheters are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.

    Device Description

    The Bard® all-silicone Foley catheter is a two-way all silicone Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer the request as the document does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria.

    Specifically, the document is a 510(k) summary for a Foley catheter, which confirms substantial equivalence to a predicate device based on similar intended use, design, and fundamental scientific technology. While it states that the device was tested for "function and biocompatibility" in accordance with relevant standards, it does not provide any details about:

    • Specific acceptance criteria (e.g., performance metrics, thresholds).
    • Any performance results or data that would allow a table of "reported device performance."
    • Details about a "study" (e.g., type of study, sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance).

    The document is a regulatory submission for premarket notification, not a detailed technical report of performance studies.

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