(69 days)
This product is intended to be used to collect blood for various blood tests. The EXELINT SecureTouch Vaculet Safety Blood Collection Set aids in the prevention of accidental needle stick injuries.
EXEL Secure Touch Safety Vaculet Blood Collection Set
The provided text is a 510(k) Premarket Notification from the FDA for a blood collection set. It does not contain information about acceptance criteria or a study that proves a device meets those criteria, as typically seen for AI/ML devices or complex diagnostic tools.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, or how training ground truth was established).
This document is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report.
§ 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).