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510(k) Data Aggregation

    K Number
    K160241
    Device Name
    Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Date Cleared
    2016-03-02

    (30 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K141991
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This instrument has been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

    Device Description

    The subject device consists of the papillotomy knife for endoscopic sphincterotomy. The subject device consists of a partially open guidewire lumen. The partially open guidewire lumen is called the C-Channel design. The subject device is a variation of the predicate device.

    AI/ML Overview

    The provided document is a 510(k) Summary for a medical device called "Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215". This document describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory approval.

    However, the provided text does not contain the acceptance criteria or a study that proves a device meets specific performance criteria related to an AI/ML algorithm or diagnostic accuracy testing as requested in the prompt. The document is a regulatory submission for a physical medical instrument (a sphincterotome) used in endoscopic procedures, not a software-as-a-medical-device (SaMD) or a device that directly generates or interprets data for diagnostic purposes requiring performance metrics like sensitivity, specificity, or AUC.

    Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study proving device performance in the context of AI/ML or diagnostic accuracy.

    The document mentions "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment," but it does not provide the specific acceptance criteria or the results of these design verification tests. It also mentions a "Shelf-life of three years have been confirmed by accelerated aging test in accordance with ASTM F-1980-07," but no specific acceptance criteria for shelf-life performance are detailed, nor are the full results of this test provided.

    In summary, the document discusses the regulatory approval process for a physical medical device and its non-clinical testing for safety and shelf-life, but not for diagnostic or AI/ML performance.

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