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510(k) Data Aggregation

    K Number
    K060235
    Device Name
    ENDO-EASE ENDOSCOPIC OVERTUBE
    Manufacturer
    SPIRUS MEDICAL, INC.
    Date Cleared
    2006-08-04

    (186 days)

    Product Code
    FDA
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K052084,K040048,K973500,K040836
    Predicate For
    K080050
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper GI endoscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

    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 upper GI tract.

    AI/ML Overview

    The provided text describes a 510(k) summary for a medical device called "Endo-Ease™ Endoscopic Overtube." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a clinical study report that would typically include detailed acceptance criteria and performance data as requested.

    Therefore, the specific information about acceptance criteria, a study proving performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not available in the provided text.

    The document focuses on:

    • Device Description: A sterile, single-use, flexible overtube for use with endoscopes in the upper GI tract.
    • Indications for Use: To aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper GI endoscopy.
    • Safety and Performance: Stated as being based on "design characteristics and comparison to legally marketed predicate devices."
    • Conclusion: The device has been shown to be safe and effective based on indications for use, technological characteristics, performance testing, and predicate device comparison.

    No specific acceptance criteria or study results are detailed in this 510(k) summary. The approval is based on substantial equivalence, implying that its performance is expected to be similar to the predicate devices and that any performance testing conducted would have been to support this equivalence, but the details of such testing are not provided.

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