(15 days)
These devices are intended for the injection of medications into or the withdrawal of body fluids from parts of the body below the surface of the skin.
The devices consist 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.
This document does not describe an AI/ML powered medical device. It details a 510(k) premarket notification for 30 Gauge Monoject® Hypodermic Needles.
Therefore, I cannot provide the information requested regarding acceptance criteria, study details, ground truth, sample sizes, or MRMC studies, as these concepts are specifically relevant to the evaluation and validation of AI/ML algorithms, not hypodermic needles.
The document indicates that the device's substantial equivalence is based on its conformity to recognized safety and performance consensus standards for needles (ISO 7864, ISO 9626, ISO 594-1, ISO 594-2, and ISO 6009) and its similarity in design and intended use to predicate devices.
§ 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).