(90 days)
The EVICEL TM Application Device is intended for the simultaneous topical application of the two biological components of EVICEL TM fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO 2 pressure utilizing the pressure regulator unit) onto the surface.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details. The letter confirms that the device, EVICEL™ Application Device, has been found substantially equivalent to a legally marketed predicate device based on its intended use.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided document.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).