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510(k) Data Aggregation

    K Number
    K013701
    Device Name
    ENDO-GLIDE
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    2002-02-04

    (88 days)

    Product Code
    GCJ,ITX
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K984562,K780386,K810310
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Lubricate the insertion and passage of imaging devices and surgical instrumentation, such as endoscopes, ultrasound transducers, cransesponias instrumentation, Such as Chaoseoped, catheters and surgical instrumentation.

    Device Description

    Endo-Glide™ is a lubricant that is biocompatible with all hollow viscera, is in vivo biocompatible with tissue and body fluids, is in vivo biodegradable and is recognized as safe for oral administration'. Endo-Glide is an excellent film former, requiring a thin coating to adequately lubricate an instrument, thus using less material. A thin film of Endo-Glide has excellent adherence and will not "snowplow" when inserted into an orifice, which can create dry spots on an instrument, and most particularly on an endoscope. Endo-Glide will be offered in sterile and non-sterile packaging for endoscopic, transurethral and surgical instrumentation lubrication.

    AI/ML Overview

    I am sorry but this document does not contain the information you are requesting. This document is a 510(k) premarket notification for a medical device called "Endo-Glide Lubricant." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting detailed study data or acceptance criteria.

    Therefore, I cannot provide:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used for test sets, data provenance, or the number and qualifications of experts for ground truth establishment.
    • Adjudication methods, MRMC comparative effectiveness study details, or standalone algorithm performance.
    • The type of ground truth used, sample size for the training set, or how its ground truth was established.

    The document states that Endo-Glide is "equivalent in formula" to VivoSonic and "equivalent in use" to K-Y Jelly and Surgilube. This approach, prevalent in 510(k) submissions, relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device without necessarily requiring extensive new clinical studies.

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