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510(k) Data Aggregation

    K Number
    K012066
    Device Name
    PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    Manufacturer
    SULZER INTRATHERAPEUTICS, INC.
    Date Cleared
    2001-08-01

    (30 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K003040
    Predicate For
    K014136,K021729
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.

    Device Description

    The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8 and 9 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.

    The modified Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, is substantially equivalent to the currently marketed Protége™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance. A stent retainer feature has been added to enhance the smoothness of deployment and additional ports for enhanced contrast injection.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and an FDA letter confirming substantial equivalence for a medical device (Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology for biliary indications).

    The 510(k) summary states that the modified device "is substantially equivalent to the currently marketed Protége™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance." It does not present specific performance criteria or a study that evaluates them for the modified device. The FDA letter confirms this substantial equivalence based on the provided information, but it also doesn't detail performance studies or criteria.

    Therefore, I cannot provide the requested information in the table or the subsequent numbered points based on the input text.

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