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The K-Pack Enhance Needle a sterile, hypodermic needle, 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 Enhance Needle is for general application - for injection of fluids or withdrawal of fluids.

The K-Pack Enhance Needle is a sterile hypodermic needle for single use consisting of a stainless steel cannula with nominal outside diameter of 0.33 mm or 0.40 mm and a length of 12 mm. The cannula is sharpened at one end and has 45° cut at the other end, which is joined to a female luer connector (hub) made of polycarbonate (PC) designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Enhance Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label. The case serves as needle protector. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide.

This document is a 510(k) clearance letter for the K-Pack Enhance Needle, which is a hypodermic single lumen needle. This device is a physical product and not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and how training set ground truth was established, are not applicable.

Here's the breakdown of the acceptance criteria and performance information that is relevant to this type of medical device:

Acceptance Criteria and Device Performance for K-Pack Enhance Needle

The K-Pack Enhance Needle is a physical medical device (hypodermic needle). Its acceptance criteria are based on various international and national standards for such devices, ensuring its safety, effectiveness, and substantial equivalence to a predicate device. The performance of the device against these standards is demonstrated through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device is a physical medical product, not an AI/ML powered device. Therefore, the concept of a "test set" in the context of data for an algorithm does not apply. Performance was evaluated through non-clinical testing (laboratory and bench testing) of the physical device as manufactured. The specific sample sizes for each non-clinical test (e.g., how many needles were tested for tensile strength, flow rate, or EO residuals) are not detailed in this summary document, but such testing would be performed on representative samples per relevant standards. Data provenance, in this case, would refer to the materials and manufacturing location (Terumo Europe N.V., Belgium) and the testing being conducted in accredited laboratories following international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical medical device. "Ground truth" expertise would involve engineers and quality control specialists performing direct measurements and assessments against specified technical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a physical medical device. Performance is determined by objective physical and chemical testing against defined standards.

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 is a physical medical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. For a physical device, "ground truth" equates to adherence to established engineering specifications, material properties, and performance benchmarks defined by national and international standards (e.g., ISO, USP, ASTM).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML powered device.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device.

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