(372 days)
Rehrig Healthcare Systems reusable 17 gallon sharps container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.
Sharps Tank Reusable Sharps Container, Device Part Number: MW009. Empty Weight: 9.4 lbs, Color: Red with contrasting Biohazard Symbol, Dimensions: 20.00"L x 12.50"W x 25.8"H. Opening Dimensions: Main lid opening (approximate) - 18.00" x 10.7", Sub-lid opening (approximate) - 8.0" x 6.0". Both the main lid and sub-lid have temporary and final closures. Temporary closures are intended to allow opening and closing of the container by the user and to protect against spillage if toppled. The final closure is designed to secure the container during transport.
The provided text is a 510(k) cleared letter from the FDA for a reusable sharps container. It does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.
The document is a regulatory approval letter, confirming that the "Sharps Tank Reusable Sharps Container" is substantially equivalent to a legally marketed predicate device. It specifies the intended use, physical characteristics of the device, and regulatory information.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets acceptance criteria based on the provided input.
§ 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).