(616 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal/Endpoint) | Reported Device Performance (Experiment Group vs. Control/Sham) |
|---|---|
| Microorganism Density Reduction at the surgical site | Mean microorganism density: 1.60 CFU/m³ (experiment group) vs. 10.73 CFU/m³ (outside ABS area of effect, likely representative of control/sham levels) - **Significantly lower (P |
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.