(30 days)
The 29G x 5/16" Thin Wall K-Pack II Needles being Hypodermic Single Lumen Needles are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.
Acceptance Criteria and Device Performance Study for K-Pack II Needle - 29G x 5/16" Thin Wall
This document describes the acceptance criteria and a summary of verification activities conducted for the K-Pack II Needle - 29G x 5/16" Thin Wall, as presented in the provided 510(k) summary. The study aims to demonstrate substantial equivalence to predicate devices (K-Pack II Needles (K984576) and 29G x 1/2" Thin Wall K-Pack II Needles (K082820)).
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | ACCEPTANCE CRITERIA | REPORTED DEVICE PERFORMANCE |
|---|---|---|
| 1. Visual appearance | Silicon amount on cannula not visible as droplets. | Complies |
| 2. Limits for acidity or alkalinity | $\Delta$ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. | Complies |
| 3. Limits for extractable metals | The extract solution of the 29G K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: $\Sigma Pb, Sn, Zn, Fe \le 5 mg/l$, $Cd |
§ 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).