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510(k) Data Aggregation

    K Number
    K080161
    Device Name
    PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
    Manufacturer
    PATTON SURGICAL CORP.
    Date Cleared
    2008-05-29

    (127 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K032676,K992324,K971475
    Predicate For
    K130826
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PassPort® Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

    The PassPort® Vortex Seal functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

    The PassPort® Blunt Tip Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

    The PassPort® Shielded Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

    The PassPort® Cannula Anchor functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

    Device Description

    The Candidate Devices are a single patient device to be utilized as an access port.

    AI/ML Overview

    The provided text is a 510(k) summary for several surgical trocar devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on establishing substantial equivalence to previously cleared predicate devices through device description and indications for use.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance
    2. Sample size and data provenance for a test set
    3. Number and qualifications of experts for ground truth
    4. Adjudication method
    5. Multi-reader multi-case (MRMC) comparative effectiveness study information
    6. Standalone algorithm performance
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established
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