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510(k) Data Aggregation

    K Number
    K012925
    Device Name
    DUR-8, MODELS DUR-8
    Manufacturer
    CIRCON VIDEO
    Date Cleared
    2001-11-07

    (68 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DUR-8, MODELS DUR-8

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

    The intended use for this device is for therapeutic and diagnostic procedures in the entire intrarenal collecting system. These devices are marketed as reusable devices. The methods for cleaning, disinfection, and sterilization are presented in "Sterility Information," Section 5 of this document.

    Device Description

    Flexible Ureteropyeloscope

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification FDA letter for a medical device (USA Series™ DUR™ - 8 Flexible Ureteropyeloscope). This document determines the substantial equivalence of the device to legally marketed predicate devices.

    This type of document does not contain any information regarding:

    1. Acceptance criteria and reported device performance.
    2. Sample size or data provenance for a test set.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication method for a test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    Therefore, I cannot fulfill your request based on the provided text. This document is a regulatory approval letter, not a study report or a technical performance specification.

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