(301 days)
The American Medical Manufacturing, Inc. Sharps Collection Container is to be used for collection and disposal of medical sharps in hospitals and doctors' offices.
The American Medical Manufacturing, Inc. Sharps Collection Container is an accessory to a single lumen hypodermic needle. The proposed device functions in the same manner as predicate devices in that they provide safe collection of sharps such as svringes, needles, and blades.
Device Design/Materials Used/Physical Properties: The proposed device is comprised of polypropylene plastic.
The provided text is a 510(k) summary for a Sharps Collection Container. It describes the device, its intended use, and a technological comparison to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot provide the requested table and detailed information as it is not present in the given text.
The document focuses on establishing substantial equivalence to legally marketed predicate devices based on design, materials, and intended function, rather than presenting a performance study with acceptance criteria.
§ 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).