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510(k) Data Aggregation

    K Number
    K182319
    Device Name
    Glo-Tip Spray Catheter
    Manufacturer
    Wilson-Cook Medical, Inc.
    Date Cleared
    2019-02-01

    (158 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K030765
    Why did this record match?
    Device Name :

    Glo-Tip Spray Catheter

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

    The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.

    Device Description

    The Glo-Tip® Spray Catheter (subject device) is a sterile, single use device compatible with the accessory channel of an endoscope. The device consists of a long, thin polytetrafluoroethylene (PTFE) tube (catheter) with a stylet (metal wire) that together are introduced into the ductal area or elsewhere in the GI tract. Fluid (e.g., water or saline) can be injected through the catheter to spray the tissue that needs cleaning. The Glo-Tip® Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).

    AI/ML Overview

    The provided text describes the Glo-Tip® Spray Catheter and its performance data, but it does not detail a study involving AI or human readers. The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, many of the requested categories related to AI performance, human reader studies, and ground truth establishment in that context are not applicable.

    Here's the information that can be extracted and a note on the unavailable information:

    1. Table of acceptance criteria and the reported device performance:
    RequirementAcceptance Criteria (summary)Reported Device Performance
    Packaging shall maintain functional integrity of the device following EO sterilization and shipping.Meet user requirements and have acceptable visual appearance following two sterilization cycles and simulated shipping conditions.Packages met acceptance criteria.
    Product must perform intended use over labeled shelf life.Same requirements as above, except following two sterilization cycles and aging.Product performed as intended over labeled shelf life.
    Sterile product must be adequately packaged to maintain sterile barrier during expected shipping conditions.Non-opened sterile packaging shall not show any signs of functional damage, such as holes in the pouch and/or voids in the seal area after simulated shipping conditions.No signs of functional damage.
    Package maintains sterile barrier over labeled shelf life.Same requirements as above previous, except following aging.Package has acceptable sterile barrier.
    Device must be a Glo-tip device.Distal tip of device must be fluoroscopically visible.Tip is fluoroscopically visible.
    The product label shall contain accurate dimensional/compatibility information (Catheter outer diameter and length).Catheter outer diameter: 6.9 Fr with acceptable tolerance. Working length: 235 with acceptable tolerance.Device dimensions are in accordance with labeling.
    In accordance with ISO 8600-1:2013, Clause 4.3: The maximum insertion portion width shall not be larger than that stated in the instruction manual.Maximum insertion portion width
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