(57 days)
The STERIS Smoke Evacuation System will be used to evacuate the smoke plume created by electrosurgery, laser surgery, or power tool procedures. Locations for use include the OR, Trauma, Endoscopy and Laparoscopy Suites.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to STERIS Corporation regarding their Smoke Evacuation System. It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request using the provided input. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing STERIS to market it, but it does not detail the technical or clinical studies that would contain the information you are asking for.
§ 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.