(108 days)
The product is intended to use for injecting fluids intradermally. It is for adult only (greater than 21 years old).
The Sterile Aesthetic Cannula and Hypodermic Needle is a combined medical device, including a blunt needle-cannula and a hypodermic needle. The sharp needle consists of a needle hub, a needle, and a protective cap. The blunt needle-cannula consists of a needle hub, a blunt cannula, and a protective cap. The device is provided for single-used, sterilized, and prescription use only. It offers various model configurations, including multiple needle gauge sizes, lengths, and tips, to fit most usage scenarios.
This document does not contain an AI/ML device. Therefore, the requested information elements related to AI/ML device performance, such as acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable and cannot be extracted.
The document describes a Sterile Aesthetic Cannula and Hypodermic Needle (K223327), which is a conventional medical device. The information provided is primarily about its physical and biological performance testing to demonstrate substantial equivalence to a predicate 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).