(55 days)
The Non-Coring Needle is used for accessing a subcutaneous port to administer or withdraw fluids.
The Non-Coring Needle is used for accessing a subcutaneous port to administer or withdraw fluids. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Non-Coring Needle is provided by their established history of use in medical product manufacturing.
The provided document is a 510(k) summary for a "Non-Coring Needle" submitted in 1996. It describes the device, its intended use, and its substantial equivalence to predicate devices.
However, the document does not contain any information regarding performance studies, acceptance criteria, or any of the detailed data points requested in your prompt. This 510(k) summary focuses on establishing substantial equivalence based on materials, intended use, and manufacturing processes, typical for devices of this nature and era, rather than providing data from clinical performance studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, study types (MRMC or standalone AI), or training set details because this information is not present in the provided text.
The closest relevant information is:
- Intended Use: "accessing a subcutaneous port to administer or withdraw fluids."
- Predicate Devices: Mentioned as "non-coring needles that are currently marketed, having the same intended use... and being of similar technology, having a stainless steel cannula and Luer hub."
- Substantial Equivalence: Claims similarity in "indications for use, materials and physical construction to predicate devices."
This document does not describe the type of performance study you're asking about, which typically involves quantitative metrics and human-in-the-loop assessments for diagnostic or AI-assisted devices.
§ 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).