(62 days)
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luce-look syringe. The Needle Guard Will accept any standard disposable syringe without a mechanical safety device and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point of promotion and syringes, into a large sharps container and/or red biohazard bag. Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard. The device is for use by health care professionals in hospitals and private practices research a laboratories, specialized medicines applications, clinics, nursing homes, home care and a laboratories, specialized medically applications, childes, thereases and exchange programs, dental offices, veterinarians, mortuaries.
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luce-look syringe. The Needle Guard Will accept any standard disposable syringe without a mechanical safety device and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point of promotion and syringes, into a large sharps container and/or red biohazard bag. Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard.
I apologize, but the provided text from the FDA 510(k) summary for the "Needle Guard" device does not contain information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
The document primarily focuses on:
- FDA's substantial equivalence determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
- Regulatory classification and requirements: Outlining general controls and referencing relevant CFR parts.
- Indications for Use: Describing what the Needle Guard is designed for, how it works (encapsulating a needle, one-handed operation), compatible syringe sizes, and where it can be used.
Therefore, I cannot provide the requested table or details about a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information based on the given text.
This type of information is typically found in the full 510(k) submission, which includes detailed performance data and testing results, rather than just the FDA's decision letter and the Indications for Use statement.
§ 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).