(174 days)
The Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, 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 Disposable Medical Safety Hypodermic Needle is composed of a needle hub, a needle tube, a needle cap and a sharp injury protection feature. The sharp injury protection feature is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The sharp injury protection feature is activated with one-hand operation by pressing the sharp injury protection feature either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sharp injury protection feature. The hinge feature(sharp injury protection feature) allows the medical practitioner the flexibility to adjust the sharp injury protection feature to its desired position for use.
This document describes the FDA's 510(k) clearance for the Hantech Medical Device Co., Ltd.'s Disposable Medical Safety Hypodermic Needle. The clearance is based on the device being substantially equivalent to a legally marketed predicate device (TK Safety Needle, K191644).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through adherence to various international ISO standards, indicating it meets the acceptance criteria defined within those standards. The document doesn't provide specific numerical targets for "acceptance criteria" but rather states conformity to the clauses of these standards, which implicitly define the acceptance thresholds.
| Acceptance Criteria (Standard & Clause) | Reported Device Performance (Conformity) | Comments |
|---|---|---|
| Biocompatibility: | ||
| Cytotoxicity (ISO 10993-5: 2009) | Performed in accordance with ISO 10993-1:2018 (body contact: "External communication device - Blood path indirect", |
§ 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).