(72 days)
The bifurcated allergy skin testing needle is indicated for in-vivo diagnostic skin testing using the puncture technique.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a Bifurcated Allergy Skin Testing Needle. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for a typical AI/software device.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance. This type of clearance generally relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different characteristics that do not raise new questions of safety and effectiveness. It does not involve a multi-reader multi-case study, standalone algorithm performance, or detailed ground truth establishment as would be seen for more complex AI-driven medical devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria in the context of an AI-driven device.
§ 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).