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510(k) Data Aggregation

    K Number
    K163455
    Device Name
    SurgiCube
    Manufacturer
    SURGICUBE INTERNATIONAL B.V.
    Date Cleared
    2017-09-28

    (293 days)

    Product Code
    ORC
    Regulation Number
    878.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICUBE INTERNATIONAL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiCube® is a stand-alone device that creates a surgical operating environment with a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of < 5 CFU per m³ at the surgical site and instruments. The surgical site of the patient is intended to be placed under the air flow which is directed downwards to the surgical site and/or instruments within 32" (80 cm) in length. Device effectiveness may not be reliably detectable at a distance of 32" (80 cm) from the air flow outlet, and effectiveness depreciates beyond this specified area.
    Device Description
    The SurgiCube® is an apparatus that provides a localized, optimally HEPA filtered, surgical environment to carry out minimally invasive surgery for ophthalmic procedures. It supplies air around the operating surface using uni directional air flow technique. Possible sources of contamination are sidelined. The patient is physically positioned outside the surgical area; just the operating area is in the field. The surgical team can move around the operating surface without interfering with the air. The uni directional flow together with correct surgical draping create a compact and manageable surgical area that will eliminate airborne contamination risks for patients. The SurgiCube® is equipped with a multiple mechanical filter system, including a High Efficiency Particle Air (HEPA) filter with an efficiency of filtering 99,995% of all particles of 0.3um.
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