(73 days)
The 27G & 30G 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 & 30G 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 ioined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
The provided text describes the 510(k) submission for the K-Pack II Needle - 27G & 30G Thin Wall. This is a medical device for injecting or withdrawing fluids, and the submission aims to demonstrate its substantial equivalence to existing devices. The key information is outlined below:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table of acceptance criteria for various tests conducted according to EN ISO 7864 (1995). The "acceptance criteria" column lists the required standards, and the implication is that the reported device performance met these criteria, as the submission aims to prove safety and effectiveness. However, the document does not explicitly present the quantitative "reported device performance" results against each criterion. It only states that "All necessary verification and validation tests have been performed by testing the 27G & 30G Thin Wall K-Pack II Needles in accordance with EN ISO 7864 (1995)." Therefore, the table below reflects the acceptance criteria as described.
| 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, 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 criterion (implied by submission for clearance). |
| 2. Limits for acidity or alkalinity | Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. | Met criterion (implied by submission for clearance). |
| 3. Limits for extractable metals | The extract solution of the 27G & 30G 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).