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510(k) Data Aggregation
(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 < 0.1 mg/l | Met criterion (implied by submission for clearance). |
| 4. Size designation | Outside diameter and nominal length are expressed in mm (and G x ") | Met criterion (implied by submission for clearance). |
| 5. Colour coding | Hub and label are colour coded following ISO 6009 | Met criterion (implied by submission for clearance). |
| 6. Conical fitting | 6% luer taper, compliant with requirements of ISO 594-1 and ISO 594-2 | Met criterion (implied by submission for clearance). |
| 7. Effective needle length | The effective length = nominal length + 1 mm ± 2 mm | Met criterion (implied by submission for clearance). |
| 8. Lubricant | Needles are uniformly lubricated and the silicone is not visible as droplets on the outside surface of the needle, the quantity will not exceed 0.25 mg/cm2 | Met criterion (implied by submission for clearance). |
| 9. Needle point | The needle point of the 27G & 30G Thin Wall K-Pack II Needles is in the center of the bevel, is sharp and is free from extraneous matter, burr, edges and hooks. | Met criterion (implied by submission for clearance). |
| 10. Bonding strength between hub and cannula | The bonding strength between hub and cannula is ≥ 22N. | Met criterion (implied by submission for clearance). |
| 11. Patency of lumen | 27G: A stylet with a diameter of 0.19 mm is passing through the needle. 30G: A stylet with a diameter of 0.13 mm is passing through the needle. | Met criterion (implied by submission for clearance). |
| 12. Flow rate | 27G: ≥ 2.72 and ≤ 4.25 ml/min 30G: ≥ 0.73 and ≤ 1.14 ml/min | Met criterion (implied by submission for clearance). |
2. Sample size used for the test set and the data provenance
The document 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)." However, it does not specify the sample size used for each test or the data provenance (e.g., country of origin, retrospective/prospective). The tests listed are primarily physical and chemical property tests, typically performed in a laboratory setting by the manufacturer (Terumo Europe N.V. in Belgium).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving human interpretation of data or images to establish ground truth. The tests are for physical and performance characteristics of a medical device. The "ground truth" is established by adherence to international standards (EN ISO 7864) and direct measurement/observation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is not a study requiring adjudication of expert opinions.
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 submission is for a hypodermic needle, not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance of the K-Pack II Needle - 27G & 30G Thin Wall is based on established international standards and specifications as defined in EN ISO 7864 (1995). These standards prescribe methods for testing and acceptable ranges for various physical and functional properties (e.g., cleanliness, dimensions, flow rate, bonding strength). Additional biological evaluation standards (EN ISO 10993-7 for ethylene oxide residuals and FDA General Program Memorandum #G95-1 for biological evaluation) were also followed.
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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