(88 days)
This system is intended The SKYVAC is a central smoke evacuation system. to be used by medical personnel for the purpose of removing smoke generated during operating procedures by laser and electro-surgical units.
The SKYVAC is a central smoke evacuation system.
This document is a 510(k) clearance letter for a medical device called "SKYVAC", a central smoke evacuation system. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance for the device based on substantial equivalence to pre-existing devices.
§ 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.