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510(k) Data Aggregation

    K Number
    K052084
    Device Name
    ENDO-EASE ENDOSCOPIC OVERTUBE
    Manufacturer
    SPIRUS MEDICAL, INC.
    Date Cleared
    2005-09-14

    (43 days)

    Product Code
    FED,KOG
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K040048,K973500,K040836
    Predicate For
    K060235,K062805,K092156,K092221
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.

    Device Description

    The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower & I tract.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria using performance metrics. This document is a 510(k) Premarket Notification summary for the Endo-Ease Endoscopic Overtube.

    The document states that substantial equivalence was based on:

    1. design characteristics
    2. comparison to legally marketed predicate devices
    3. performance testing which "consisted of destructive tensile testing of the helix and collars."

    This 510(k) summary focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in efficacy studies.

    Therefore, I cannot fulfill your request for the following information based on the provided text:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set and data provenance.
    • Number of experts used to establish ground truth and their qualifications.
    • Adjudication method for the test set.
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
    • If a standalone (algorithm only) performance study was done.
    • The type of ground truth used.
    • The sample size for the training set.
    • How the ground truth for the training set was established.

    The provided text describes a regulatory submission for a medical device (Endoscopic Overtube) and its clearance, which primarily relies on demonstrating equivalence to existing devices through design and specific engineering performance tests (destructive tensile testing), not clinical or diagnostic accuracy studies.

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