(173 days)
The 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 K-Pack II Needle is a sterile hypodermic single lumen needle, 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 or an intravascular administration set.
The provided text describes a 510(k) submission for the K-Pack II Needle, asserting its substantial equivalence to a predicate device. The information focuses on comparison of design, materials, intended use, and performance standards. However, it does not contain information about a study proving specific acceptance criteria, but rather demonstrates compliance with international standards and biocompatibility.
Due to the nature of the document, which is a 510(k) summary for a hypodermic needle seeking substantial equivalence, it does not involve the type of clinical or performance study with acceptance criteria and reported device performance that would be typical for more complex medical devices, especially software or AI-driven ones. The "acceptance criteria" here are primarily compliance with established standards and demonstrated equivalency.
Therefore, many of the requested fields cannot be directly extracted from the provided text for this specific device.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For a hypodermic needle seeking 510(k) clearance, the "acceptance criteria" are generally compliance with relevant international and national standards, and demonstration of substantial equivalence to a predicate device. The performance is assessed against these standards and through direct comparison.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (K-Pack II Needle) |
|---|---|
| Intended Use Equivalence | Both the K-Pack II Needle and the predicate Terumo Disposable Hypodermic Needle 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. |
| Design and Materials Equivalence | Both needles are made of a stainless steel needle tube (sharpened at one end with the same geometry) and a female luer connector (6% luer) made of polypropylene. Components (Cannula, Hub, Glue, Lubricant) are identical to the predicate (Stainless steel, Polypropylene, Epoxy glue, Silicone, respectively). |
| Performance Standard (EN ISO 7864:1995) | Complies with requirements of EN ISO 7864 (1995) Sterile Hypodermic Needles for single use ( = ISO 7864:1993), with the following noted exception/clarification: |
- Section 9.1 Conical fitting: Does not completely match ISO 594-2 specifications for locking fittings, however, when tested according to ISO 594-2, no liquid or air leakage is observed.
- Section 13.2 Patency of lumen: No specifications given for a 25G ultra-thin wall needle, so comparison with a reference for this property was not possible for the 25G K-Pack Needle. |
| Sterility Assurance Level (SAL) | Sterility is assured by a validated sterilization method (Ethylene Oxide) in accordance with EN 550, achieving a SAL of 10^-6, as required by EN 556. Routine checks include physical parameter recordings and sterility control on biological indicators. |
| Biocompatibility | Tested in accordance with FDA General Program Memorandum # G95-1 (ISO 10993 Part 1) for External Communicating Devices, Blood Path Indirect, Limited Duration of Contact (
§ 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).