(45 days)
Our Vertical Entry Sharps Container provides a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
The Biodex Sharps Container consists of an injection molded polypropylene container fitted with an injection-molded snap on cover with a connected lid to the cover. The lid snaps onto the cover when the container is filled. The cover and lid are shipped not installed on the container bottom so the containers can be nested to save space. The cover is snapped onto the cover before use. The cover has an oval opening into which the Sharps are dropped vertically into the container.
The provided text is a 510(k) Summary for a Sharps Container. It describes the device, its classification, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert involvement, or AI-related assessments.
The document explicitly states: "The Biodex Sharps Container will be manufactured to the product specifications." but it does not detail what those specifications are beyond general descriptions like being "puncture resistant" and having a "fill line."
Therefore, I cannot fulfill your request as the required information is not present in the provided text. This document is a regulatory submission for a medical device that does not appear to involve AI or require complex performance studies beyond meeting basic safety specifications, which are not itemized here.
§ 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).