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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 and posterior vertebral fusion and laminoplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on an anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel with the direction of air flow, 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.

The ABS device controls the airborne surgical environment at a specific and limited location adjacent to and over surgical incisions by emitting a non-turbulent flow of HEPA filtered air that displaces the presence of airborne colony-forming units and particulate matter within surgical site dimensions of 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable outside of these dimensions and effectiveness depreciates beyond this specified area. The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System. The ABS Filter/Blower filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA) filter. The HEPA filtered air exits the Filter/Blower from an exit port on the top of the unit. The Filter/Blower is nonsterile and reusable. The Air Delivery System, consisting of an Air Supply Hose and Nozzle, is sterile, single-use. The Nozzle portion is applied to the surgery site, on top of the incision drape and adjacent to a surgical incision. The end of the Air Supply Hose is plugged into the Filter/Blower's air exit port. HEPA filtered air then flows through the Air Supply Hose through the Nozzle and directly to the incision site.

Acceptance Criteria and Study Details for the Air Barrier System (ABS)

This document describes the acceptance criteria and the studies that demonstrate the Air Barrier System (ABS) meets these criteria, based on the provided 510(k) summary (K123006).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ABS are primarily defined by its ability to significantly reduce the presence of airborne particulate matter and microorganisms at the surgical site. The reported device performance is based on two clinical studies.

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