(430 days)
The primary intended use for the Perfect Safety Syringe is for IM/SC use only. The secondary intended use for the Perfect Safety Syringe is for needlestick protection, the device may aid in the reduction of needlestick injuries. In addition, when the syringe user breaks off the plunger, reuse of the syringe is prevented.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the Perfect Safety Syringe to legally marketed predicate devices. It does not contain details about specific performance studies, acceptance criteria, or the methodology of such studies.
§ 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).