(329 days)
The Indications for Use of the ViroSafe EY Filter and Buffalo Filter® EY Prefilter are for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, or other smoke plume producing devices. This device is not intended for contact with the patient, It is intended to be used during either open or endoscopic surgical procedures.
Disposable Smoke Evacuation Filter
The provided document is a 510(k) clearance letter from the FDA for a smoke evacuation filter. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.
Therefore, I cannot extract the requested information from the provided text.
§ 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.