(349 days)
Tlankang disposable syringes with re-use prevention feature with or without needle is a sterile ,single-use , disposable and non reusable safety syringe which is intended to provide a safe and reliable method for injecting fluid into, or withdrawing fluids from, part of the body below the surface of the skin .
Tiankang disposable syringes with re-use prevention feature with or without needle is a sterile ,single-use , disposable and non reusable safety syringe.
I am sorry, but the provided text is a letter from the FDA to a medical device company regarding the 510(k) premarket notification for disposable syringes. It confirms the substantial equivalence of the device to legally marketed predicate devices.
This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it does not describe a clinical or performance study of the device itself. Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC 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).