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510(k) Data Aggregation

    K Number
    K040476
    Device Name
    STORZ MODULITH, MODEL SLX-F2
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2004-08-26

    (184 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STORZ MODULITH, MODEL SLX-F2

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

    The Storz Medical MODULITH® Model SLX F2 is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

    Device Description

    The Storz Modulth® Lithotripter Model SLX-F2 is lithotripsy system comprised of a therapy source, an X-ray system, an ultrasound system and a patient table.

    AI/ML Overview

    This document does not contain the specific information required to complete the table and answer the requested questions about acceptance criteria and a study proving device performance. The provided text is a 510(k) summary and an FDA clearance letter for a lithotripter device, the Storz Modulith® Lithotripter Model SLX-F2.

    It states that the device is substantially equivalent to a predicate device (Storz Modulith® Lithotripter Model SLX) and that "The minor differences in design, dimensions and features between the Storz Modulith® Lithotripter Model SLX-F2 and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This suggests that a direct performance study to establish new acceptance criteria was likely not performed for this 510(k) clearance, as the focus was on demonstrating equivalence to an already cleared device.

    Therefore, I cannot provide details on:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for a test set.
    3. Sample size or ground truth establishment for a training set.

    The document only provides:

    • Device Name: Storz Modulith® Lithotripter Model SLX-F2
    • Indication for Use: Noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
    • Device Description: A lithotripsy system comprising a therapy source, an X-ray system, an ultrasound system, and a patient table.
    • Substantial Equivalence Statement: The device is substantially equivalent to the Storz Modulith® Lithotripter Model SLX.
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