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510(k) Data Aggregation
(71 days)
The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall being Hypodermic Single Lumen Needles 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.
The subject K-Pack II Needles are hypodermic single lumen needles, for single use consisting of stainless steel 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 hypodermic syringe. The needle is packed in a hard pack (cap-case) made of polypropylene. The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall will be an extension of the existing K-Pack II Needles product family.
The K-Pack II Needles are subject to a Special 510(k) submission due to the introduction of new product codes with increased cannula's inner diameter, resulting in different cannula wall types (ultra and extra thin wall versus thin wall). The device's performance was evaluated against several recognized consensus standards for hypodermic needles.
Here is a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is reported as meeting the acceptance criteria outlined by the specified standards.
| Requirement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Cleanliness | Visual inspection: free from particles and extraneous matter (normal/corrected-to-normal vision, 300-700 lx); 2.5x magnification: hub socket free from particles and extraneous matter. | Meets criteria (implied by safety and effectiveness claim) |
| 2. Limits for acidity or alkalinity | △ pH for extract solution within 1 unit of control fluid (EN ISO 7864). | Meets criteria (implied by safety and effectiveness claim) |
| 3. Limits for extractable metals | Extract solution content (corrected for control fluid) of Σ Pb, Sn, Zn, Fe ≤ 5 mg/l and Cd < 0.1 mg/l (EN ISO 7864). | Meets criteria (implied by safety and effectiveness claim) |
| 4. Conical fitting | Female luer (slip and lock) connector with 6% taper compliant to EN ISO 80369-7. Taper meets gauging requirements of ISO 594-1. | Meets criteria (implied by safety and effectiveness claim) |
| 5. Fluid leakage | No leakage forming a falling drop of water over 30-35s at 300-330 kPa (EN ISO 80369-7). | Meets criteria (implied by safety and effectiveness claim) |
| 6. Air leakage | Leakage not more than 0.005 Pa.m³/s over 15-20s at 80.0-88.0 kPa sub-atmospheric pressure (EN ISO 80369-7). | Meets criteria (implied by safety and effectiveness claim) |
| 7. Stress cracking | Meets fluid leakage requirements after being subjected to stresses (EN ISO 80369-7). | Meets criteria (implied by safety and effectiveness claim) |
| 8. Resistance to separation from axial load | Does not separate from reference connector over 10-15s with disconnection force between 23-25N (luer slip) or 32-35N (luer lock) (EN ISO 80369-7). | Meets criteria (implied by safety and effectiveness claim) |
| 9. Resistance to separation from unscrewing | Luer lock connectors do not separate from reference connector over 10-15s with unscrewing torque of 0.0198-0.0200 N.m (EN ISO 80369-7). | Meets criteria (implied by safety and effectiveness claim) |
| 10. Resistance to overriding | Luer lock connectors do not override threads/lugs of reference connector with applied torque of 0.15-0.17 N.m over 5-10s (EN ISO 80369-7). | Meets criteria (implied by safety and effectiveness claim) |
| 11. Stiffness test cannula | Deflection not greater than values specified in EN ISO 9626 when tested in accordance with EN ISO 9626. | Meets criteria (implied by safety and effectiveness claim) |
| 12. Resistance to breakage | Cannula does not break when tested in accordance with EN ISO 9626. | Meets criteria (implied by safety and effectiveness claim) |
| 13. Resistance to corrosion | Cannula shows no corrosion when tested in accordance with EN ISO 9626. | Meets criteria (implied by safety and effectiveness claim) |
| 14. Effective needle length | Nominal length + 1 mm/-2 mm in accordance with EN ISO 7864. | Meets criteria (implied by safety and effectiveness claim) |
| 15. Silicon amount on cannula | Uniformly lubricated, no visible droplets, quantity ≤ 0.25 mg/cm² (EN ISO 7864). | Meets criteria (implied by safety and effectiveness claim) |
| 16. Needle Penetration Resistance | Point value ≤ 0.10 N and Drag Value ≤ 0.04 N (internal method). | Meets criteria (implied by safety and effectiveness claim) |
| 17. Bonding strength between hub and cannula (axial) | ≥ 22N (EN ISO 7864). | Meets criteria (implied by safety and effectiveness claim) |
| 18. Patency of Lumen | Appropriate diameter stainless steel stylet passes through needle (EN ISO 7864); OR flow rate of water ≥ 80% of unprocessed needle tube of equivalent OD and length with minimum ID in accordance with ISO 9626 (internal method). | Meets criteria (implied by safety and effectiveness claim) |
| 19. Fitting strength hub/case | Force to axially pull needle hub from case is 0.5 N to 25 N (internal method). | Meets criteria (implied by safety and effectiveness claim) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each non-clinical test. However, it indicates that "The design of the K-Pack II Needles has been validated by Terumo Europe N.V. in accordance with the Design Control Requirements and recognized consensus standards". This implies testing was conducted by Terumo Europe N.V. in Belgium, likely as prospective testing as part of their design validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a hypodermic needle and the performance evaluation relies on standardized physical and chemical testing, not expert interpretation of results to establish ground truth in the way medical imaging or diagnostic devices would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the type of non-clinical testing performed on a hypodermic needle. The evaluation is based on objective measurements against specified criteria in international 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
This question is not applicable. The device is a hypodermic needle, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical device (hypodermic needle), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth or evaluation benchmarks are defined by the various international consensus standards (EN ISO 7864, EN ISO 9626, EN ISO 80369-7, EN ISO 6009, EN ISO 10993, EN ISO 11135, EN 556-1) and internal Terumo specifications (for 27G extra and ultra thin walls, and for some specific tests like needle penetration resistance and bonding strength). These standards specify objective physical, chemical, and functional criteria.
8. The sample size for the training set
This question is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
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