(25 days)
The BD Eclipse™ Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
The BD Eclipse™ Bifurcated Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle.
Not Found
I am sorry, but based on the provided documents, there is no information about acceptance criteria or a study that proves the device meets any specific acceptance criteria.
The documents are FDA letters regarding a 510(k) premarket notification for the "BD Eclipse Bifurcated Needle." These letters confirm the device's substantial equivalence to legally marketed predicate devices and reclassify its product code. They do not contain details about performance studies, acceptance criteria, or specific performance metrics.
Therefore, I cannot provide the requested information.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).