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510(k) Data Aggregation

    K Number
    K092801
    Device Name
    ABS BLOWER, ABS NOZZLE, MODEL 1001
    Manufacturer
    NIMBIC SYSTEMS, LLC
    Date Cleared
    2011-05-20

    (616 days)

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

    NIMBIC SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel to the direction of airflow, and (3) the incision dimensions are within: 6″ (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.
    Device Description
    The Air Barrier System (ABS) is used in the surgical operating room. The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System. The Filter/Blower is nonsterile and reusable. The Air Delivery System is sterile, single-use. The ABS Filter/Blower captures and filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA) filter. The HEPA filtered air leaves the Filter/Blower via the exit port where it is connected to the Hose portion of the sterile, single-use Air Delivery System. The Hose ends in the Nozzle portion of the Air Delivery System; the Nozzle is gently applied to the incision drape adjacent to a surgical incision. The Nozzle delivers HEPA filtered air directly to the surgical site area to reduce the presence of airborne particulate and microorganisms.
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