(62 days)
The Nipro Hypodermic Needle is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
The subject devices can be classified as single use hypodermic needles as described in 21 CFR 880.5570. Needle sizes include 16-30 Gauge, lengths of ½ to 1 ½ inches, and regular or short bevels.
I'm sorry, but this document does not contain the information requested. The document is a 510(k) premarket notification for Nipro Disposable Needles, and it primarily focuses on establishing substantial equivalence to a predicate device. It does not include details on formal acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies as described in your request.
§ 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).