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510(k) Data Aggregation

    K Number
    K965121
    Device Name
    CANNULA
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Date Cleared
    1997-03-20

    (87 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    k913302,k964632,k960936,k924011,k942678
    Why did this record match?
    Reference Devices :

    K913302, K964632, K960936, K924011, K942678

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

    The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.

    The predicate device (Endoscopic Visualization and Space Maintenance Cannula ) has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery including laparoscopy and thoracoscopy.

    The Multi-Port Cannula is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

    Device Description

    The Multi-Port Cannula is a single- use device which consists of two movable working cannulas, seals, a stabilizer, two stationary cannulas, leur fitting, and an insufflation tube. The two movable working cannulas passes completely through the stationary cannulas which are casted to the stabilizer. The seals within the inner wall of the cannulas seal on surgical devices that are inserted through the cannulas. The stabilizer provides a seal against the tissue at the incision site and acts to stabilize the cannulas. Surgical access is achieved via standard incision. The Multi-Port Cannula is assembled and advanced through the incision site. The user may then advance endoscopic tools through the working cannulas or stationary cannulas to perform the procedure. The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) Summary of Safety & Effectiveness for a medical device (Multi-Port Cannula), primarily focusing on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics. It does not detail specific performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth establishment.

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