(251 days)
AutoSafe Safety Huber Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implantable vascular ports Additionally, the passine needle safety shield is designed to help prevent needlestick injuries by shielding the needle between steps and after use.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the AutoSafe-Reflex® Safety Huber Infusion Set. This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria as would be found in a performance study report for a diagnostic AI device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval, not a detailed description of device performance and underlying studies that would typically include such data.
§ 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).