(189 days)
The Sterile Safety Hypodermic Needles for Single Use are intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The Sterile Safety Hypodermic Needles for Single Use are composed of a hypodermic needle with a needle safety shield attached to the needle hub, which can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The device is compatible for use with standard luer slip and luer lock syringes. The Sterile Safety Hypodermic Needles for Single Use is for single use only. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
The provided text describes the regulatory clearance of "Sterile Safety Hypodermic Needles for Single Use" (K213535) and does not contain detailed information about a study proving the device meets specific acceptance criteria in the format requested.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (K191644, TK Safety Needle), rather than providing a detailed report of a single study designed to directly prove acceptance criteria.
The "Performance testing" section lists the standards to which the device conforms, implying that testing was conducted to meet the requirements of these standards. However, it does not provide:
- A table of specific acceptance criteria values with corresponding reported device performance values.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets/ground truth for any specific performance study.
Instead, it broadly states that "Performance testing is performed according to the following standards," and that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device."
Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding specific acceptance criteria and a study proving the device meets them. The document asserts compliance with established medical device standards but does not detail the individual test results against specific criteria.
§ 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).