(278 days)
The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.
The provided text is a 510(k) summary for the VACUETTE® PREMIUM Safety Needle System. This document focuses on establishing substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies.
Therefore, I cannot provide the requested information from the given text. The document acts as a regulatory submission for market clearance, not a clinical or performance study report.
§ 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).