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510(k) Data Aggregation

    K Number
    K960757
    Device Name
    KARL STORZ URETER RESECTOSCOPE
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-05-01

    (68 days)

    Product Code
    FJL
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K960757
    Why did this record match?
    Reference Devices :

    K960757

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

    The KSEA ureter resectoscope is designed to be used for diagnostic and therapeutic procedures in the transurethral resection of tissue in the ureters and renal pelvis.

    Device Description

    The KSEA ureter resectoscope is a manually operated, reusable surgical device consisting of a straight forward view telescope (0), a working element, a sheath, cutting loops, electrodes, a cold knife and high frequency cables. The instrument is long enough to gain access to the surgical area and is designed to be used as an urological endoscope. The body contact materials are surgical grade stainless steel.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device called the "Karl Storz Ureter Resectoscope." This document is not a study that describes acceptance criteria and device performance in the context of an AI or diagnostic algorithm, but rather a regulatory submission for a traditional surgical instrument.

    Therefore, the requested information elements related to acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not present in this document.

    The document mainly focuses on:

    • Device Identification: Common Name, Trade Name
    • Indication: Diagnostic and therapeutic procedures in transurethral resection of tissue in ureters and renal pelvis.
    • Device Description: Manually operated, reusable surgical device consisting of various components (telescope, working element, sheath, etc.), made of surgical grade stainless steel.
    • Substantial Equivalence: Stating that it is substantially equivalent to predicate devices with similar basic features, design, and intended uses, and that minor dimensional differences do not raise new safety/effectiveness issues.

    To answer your request, I would need a different type of document – specifically, a study report or clinical validation report that details the performance of an AI or diagnostic algorithm.

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