(44 days)
The bifurcated vaccinating needle is indicated for use in administering vaccine by the scarification method.
Bifurcated Vaccinating Needle
The provided text is an FDA 510(k) clearance letter for a "Bifurcated Vaccinating Needle." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that you've requested.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the device was cleared because it was found to be "substantially equivalent" to an existing, legally marketed device, not because it underwent a new clinical trial or performance study against specific acceptance criteria. The FDA's 510(k) pathway often relies on demonstrating equivalence rather than requiring a full de novo study with novel acceptance criteria and detailed performance reporting.
Therefore, I cannot extract the requested information from the provided text.
§ 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).