(28 days)
The 29G 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 29G Thin Wall 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 malc connector (nozzle) of a piston syringe.
The provided text describes a 510(k) submission for a medical device, the K-Pack II Needle - 29G Thin Wall. This submission aims to extend an existing product line and focuses on demonstrating substantial equivalence to predicate devices, rather than an in-depth study proving performance against specific acceptance criteria for a novel device.
Therefore, the requested information categories related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies are largely not applicable or cannot be extracted in the context of this 510(k) summary, as it is a type of regulatory submission focused on equivalency, not a detailed research study report.
However, I can extract information related to the device's characteristics and the basis for its safety and effectiveness claims.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the traditional sense of a clinical or performance study with defined numerical acceptance criteria and a detailed report of device performance against those criteria. The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implicitly met by confirming that the new device does not raise new questions of safety or effectiveness compared to the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of Claims) |
|---|---|
| Intended Use Equivalence | "The 29G Thin Wall K-Pack II 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." (Same as predicate devices) |
| Design Equivalence | Substantially equivalent to predicates. |
| Technology/Principle of Operation Equivalence | Substantially equivalent to predicates. |
| Materials Equivalence | Substantially equivalent to predicates. |
| Performance Equivalence | Substantially equivalent to predicates. (No new issues of safety or effectiveness raised by differences). |
| Sterility Assurance Level (SAL) | Achieved SAL of 10-6, validated according to EN 550, ISO 11135, and EN 556-1. |
| Ethylene Oxide Residual Levels | In compliance with EN ISO 10993-7. |
| Biocompatibility | Blood contacting materials tested in accordance with FDA G95-1 and ISO-10993-1. |
| Shelf Life/Expiration Dating | Established at 5 years (same as cleared K-Pack II Needles). |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. This document is a regulatory submission for substantial equivalence. It does not describe a "test set" in the context of a performance study with a specific sample size. The claims are based on engineering, manufacturing, and regulatory compliance standards applied to the device design and materials, and comparisons to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not Applicable. As no specific "test set" requiring expert ground truth establishment is described for a performance study, this information is not relevant to this document. The "ground truth" for regulatory approval here is whether the device meets the safety and effectiveness standards through substantial equivalence to legally marketed devices, which is assessed by the FDA.
4. Adjudication Method for the Test Set
Not Applicable. No "test set" with adjudication is mentioned in this submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This document concerns a hypodermic needle and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This document concerns a hypodermic needle and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is established through regulatory standards and established methods for medical device manufacturing and testing. This includes:
- Compliance with international standards: e.g., EN 550, ISO 11135, EN 556-1, EN ISO 10993-7, ISO-10993-1.
- Demonstration of substantial equivalence to previously cleared predicate devices (K984576 and K062608) in terms of intended use, design, technology/principle of operation, materials, and performance.
- Internal testing and validation (e.g., sterilization validation, biocompatibility testing, shelf-life studies) against accepted industry benchmarks and regulatory requirements.
8. The Sample Size for the Training Set
Not Applicable. This document does not concern a machine learning or AI algorithm, so there is no training set mentioned.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this is not applicable.
§ 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).