(372 days)
ACACIA'S Flow Eze Blunt Cannula for use with a sterile Acacia 3 riow mac bean medication into a Baxter's Interlink ) Injece meaze Blunt Cannula is single-use only. Split Septum.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device named "Flow-Eze Blunt Cannula." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews that would typically be found in a study summary or a submission to the FDA detailing performance data.
The letter is a regulatory approval notice, not a performance study report. Therefore, I cannot extract the requested information from the provided text. The questions posed pertain to the technical validation of a device's performance, which is not present in this regulatory correspondence.
§ 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).