(36 days)
The proposed device is intended for the filtration of contaminants from smoke, generated during laparoacopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria, and viruses).
Pall Laparoscopic Smoke Filtration System
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study that proves a device meets such criteria. The letter acknowledges a device, states its regulatory class, and grants permission to market it, but it does not detail any performance studies.
§ 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.