(50 days)
The 27G x 3/4" Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
The 27G x 3/4" Thin Wall K-Pack II Needles are sterile hypodermic single lumen needles, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
Here's a breakdown of the acceptance criteria and the study information for the K-Pack II Needle - 27G x ¾" Thin Wall, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The device passed all validation activities as indicated by the submission of the 510(k), which implies that the reported device performance met the specified acceptance criteria. The summary states: "All necessary verification and validation tests have been performed by testing the 27G x ½" Thin Wall K-Pack II Needles in accordance with EN ISO 7864 (1995)."
| TEST | ACCEPTANCE CRITERIA | Reported Device Performance (Implied) |
|---|---|---|
| 1. Cleanliness | Inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under x2.5 magnification, the hub socket shall appear free from particles and extraneous matter. | Met Criteria |
| 2. Limits for acidity or alkalinity | Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. | Met Criteria |
| 3. Limits for extractable metals | The extract solution of the 27G Thin Wall K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: | |
| $Σ$ Pb, Sn, Zn, Fe ≤ 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).