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510(k) Data Aggregation

    K Number
    K030174
    Device Name
    GENICON LAPAROSCOPES
    Manufacturer
    GENICON, LC
    Date Cleared
    2003-06-19

    (153 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K070850
    Why did this record match?
    Device Name :

    GENICON LAPAROSCOPES

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

    The GeniCon Laparoscope is available in 3.5mm, 5mm and 10mm diameters with working lengths of 28cm to 44cm. This device has applications in gynecologic, general, thoracic and urology Endoscopic procedures to establish visualization for viewing an interior cavity of the body.

    Device Description

    The GeniCon Platinum Series Laparoscope is a reusable device with a glass rod lens assembly that connects an eyepiece to a viewing lens on the distal end of the scope encompassed within a stainless steel shaft. Surrounding the glass rod assembly and contained with the stainless steel shaft is a series of light fibers that transfer light energy to illumination into the body cavity being viewed.

    AI/ML Overview

    The provided text is a 510(k) Summary for the GeniCon Platinum Series Laparoscope. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and specific performance metrics for the GeniCon device itself.

    Therefore, the document does not contain the information requested in the prompt, such as:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets, training sets, or data provenance.
    • Number and qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness study results.
    • Standalone algorithm performance.
    • Type of ground truth used (e.g., pathology, outcomes data).
    • How ground truth was established for training sets.

    The relevant sections of the document explicitly state:

    • "Performance: The FDA has not adopted performance standards for this product." (Page 0)
    • "Conclusion: Based on the indications for use and technological characteristics, the GeniCon Platinum Series Laparoscope has been shown to be effective for its intended use and substantially equivalent to the predicate device." (Page 0)

    This indicates that the submission relies on substantiating similarity to an already approved device rather than providing new performance data against a set of acceptance criteria.

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