(54 days)
The Sharps Compliance Container is a disposable infectious waste container in 1 gallon, 2 gallon and 3 gallon sizes, intended for use by laypersons or health professionals, in small usage areas in clinical and non-clinical settings, such as: phlebotomy, nursing homes, homes, isolation, doctors office, clinics, labs, or school nurses office. The Sharps Compliance Container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations.
The Sharps Compliance Container is a sharps container (disposable infectious waste container) in 1 gallon, 2 gallon and 3 gallon sizes designed to meet Occupational Safety and Health Administration ("OSHA") regulations on bloodborne pathogens (29 C.F.R. 1910.1030).
The provided text is for a Sharps Compliance Container (K083129), which is a physical medical device (a sharps container). The 510(k) summary and FDA letter clearly indicate that this submission is for a physical product and its intended use, rather than a diagnostic AI/ML device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and comparative effectiveness for an AI/ML device is not applicable to this document.
The submission focuses on demonstrating substantial equivalence to a predicate device (Sage 2 Gallon Alternate Care Sharps Container K973911) based on design and intended use, following guidelines for sharps containers. The device does not involve AI, ML, or any diagnostic algorithms.
§ 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).