(80 days)
General purpose single use piston syringe used to withdraw or inject first into the body. The device is sold as a sold as a sold as a sold and in a sold and is monther is sold device is sold device is not of The device is not intended for use with any specific drugs or biologics. It is sold as a prescription device with needle . attached and ready for use.
RAMY Piston Syringe
I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ramy Syringe). It does not contain information about acceptance criteria for a study, device performance data, sample sizes, expert qualifications, or details about comparative effectiveness studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided. The document primarily discusses regulatory clearance based on substantial equivalence to an existing device.
§ 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).