(324 days)
The Zirconia syringe needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
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This document is a 510(k) clearance letter from the FDA for a medical device called "Zirconia Syringe Needle." It states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, this document does not contain information about acceptance criteria or studies proving device performance for an AI/ML powered device.
The provided text is a regulatory clearance for a traditional medical device (a syringe needle), not an AI/ML-powered one. The questions in the prompt are specifically designed to elicit information about the development and validation of AI/ML models. Since this document does not pertain to such a device, the requested information cannot be extracted.
§ 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).