(335 days)
The safety needles are intended to be used with a Luer lock syringe for aspiration and injection 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 needle-stick.
The KDL Safety Needle is a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath could be manually activated when the needle is withdrawn from the body before disposal, minimizing the risk of needle sharps injury during disposal. It is activated manually by hand or any solid surface. The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use. The KDL Safety Needle has various colors, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the KDL Safety Needle is sterilized by ethylene oxide and without any pyrogen or latex.
This document is a 510(k) Premarket Notification from the FDA regarding "KDL Safety Needles". It details the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Based on the provided text, the device in question is a hypodermic needle with a safety shield, not an AI/ML-driven device or a diagnostic aid. As such, the typical "acceptance criteria" and "study" framework for AI/ML medical devices (e.g., related to sensitivity, specificity, reader studies, ground truth establishment by experts, etc.) do not apply to this submission.
The document describes the testing performed for this device as non-clinical testing in conformance with various ISO and ASTM standards, which are primarily related to physical performance, sterility, and biocompatibility. There is an explicit statement: "No clinical testing is available for this device."
Therefore, I cannot provide the information requested in the prompt's numbered list, as it pertains to AI/ML device evaluation criteria that are not relevant to this submission.
The "acceptance criteria" for this device are its ability to meet the specified performance standards (e.g., ISO 7864, ISO 9626, ISO 23908), sterility requirements (e.g., ISO 11135), and biocompatibility requirements (e.g., ISO 10993 series). The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted according to these standards, as enumerated in section 8 of the 510(k) summary. These tests demonstrate the device's physical properties, sterility, and biological safety.
§ 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).