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510(k) Data Aggregation

    K Number
    K221625
    Device Name
    2-Way 100% Silicone ClearTract Catheter
    Manufacturer
    Silq Technologies Corporation
    Date Cleared
    2022-07-01

    (25 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K192034
    Predicate For
    K222118
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.

    Device Description

    The 2-Way 100% Silicone ClearTract Catheter (previously known as the HDX 100% Silicone 2-Way Foley Catheter) is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection to the urinary bag is a standard non-interconnectable connector.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the "2-Way 100% Silicone ClearTract Catheter." It is not for an AI/ML medical device, and therefore does not contain information about acceptance criteria or studies pertaining to AI/ML device performance.

    The document states:

    • "The renamed 2-Way 100% Silicone ClearTract Catheter has not been modified in any way. It is exactly the same as the HDX 100% Silicone 2-Way Catheter cleared under 510(k) premarket notification K192034."
    • "This special 510(k) premarket notification only proposes an update to the product labeling."
    • "No physical changes or modifications are proposed to the cleared device."

    Instead, it discusses bench testing (friction testing based on ASTM D1894-14) to support the addition of information about a "surface modification that reduces surface friction" to the device's labeling. This is a physical characteristic of the catheter itself, not a performance metric of an AI/ML algorithm.

    Therefore, I cannot provide the requested information about acceptance criteria or studies for an AI/ML device based on this document. The document describes a traditional medical device (a catheter) and a regulatory submission for a labeling change, not an AI/ML product.

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