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510(k) Data Aggregation

    K Number
    K972674
    Device Name
    WILSON-COOK NEEDLE KNIFE PAPILLOTOME
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Date Cleared
    1997-08-15

    (30 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K934315
    Why did this record match?
    Device Name :

    WILSON-COOK NEEDLE KNIFE PAPILLOTOME

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

    The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. This device is supplied sterile and is intended for single use only.

    Device Description

    The Wilson-Cook Needle Knife Papillotome consists of a single lumen tubing, 23 gauge needle, and a papillotome handle. This device is designed for insertion through the accessory channel of an endoscope. The catheter is advanced through the accessory channel positioning the needle knife near the papillary orifice. The device is connected to an electrocautery unit via an active cord. The current from the electrocautery unit is passed through the cutting wire to the distal end of the papillotome thus allowing the needle knife to make small incisions in the papilla. Once the appropriate incision has been made the needle knife may be retracted allowing cannulation of the biliary tree.

    AI/ML Overview

    The provided documents describe the Wilson-Cook Needle Knife Papillotome and its 510(k) submission. However, the information available is limited regarding acceptance criteria and a structured study proving the device meets these criteria. Medical device 510(k) submissions, especially from this era (1997), typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with detailed acceptance criteria as one might expect for a novel AI device today.

    Based on the provided text, here's what can be extracted and what is missing:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Implied)Reported Device Performance
    BiocompatibilityEstablished through a history of use in other similar medical devices for patient-contacting materials.
    SterilityValidated EO cycle, following AAMI Overkill Method to SAL 10-6.
    Functional PerformanceFunctional testing conducted per approved protocol. All samples were deemed acceptable, with test specifications met.
    Dimensional SpecificationsSamples subjected to dimensional analysis; all deemed acceptable.
    Visual InspectionSamples subjected to visual inspection; all deemed acceptable.
    Intended UseSubstantially equivalent to the predicate device for accessing the common bile duct when standard cannulation methods have been exhausted.

    Missing Information: Specific quantitative acceptance criteria (e.g., "tensile strength must be > X N," "insertion force must be

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