(68 days)
DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.
Not Found
This document is an FDA 510(k) clearance letter for a medical device: DepotOne™. The letter states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory approval notice, not a detailed 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).