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510(k) Data Aggregation
(30 days)
The 29G x 5/16" Thin Wall K-Pack II Needles 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.
Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.
Acceptance Criteria and Device Performance Study for K-Pack II Needle - 29G x 5/16" Thin Wall
This document describes the acceptance criteria and a summary of verification activities conducted for the K-Pack II Needle - 29G x 5/16" Thin Wall, as presented in the provided 510(k) summary. The study aims to demonstrate substantial equivalence to predicate devices (K-Pack II Needles (K984576) and 29G x 1/2" Thin Wall K-Pack II Needles (K082820)).
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | ACCEPTANCE CRITERIA | REPORTED DEVICE PERFORMANCE |
|---|---|---|
| 1. Visual appearance | Silicon amount on cannula not visible as droplets. | Complies |
| 2. Limits for acidity or alkalinity | $\Delta$ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. | Complies |
| 3. Limits for extractable metals | The extract solution of the 29G K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: $\Sigma Pb, Sn, Zn, Fe \le 5 mg/l$, $Cd < 0.1 mg/l$ | Complies |
| 4. Needle Penetration Resistance | The penetration resistance of cannula point and drag complies with the limits specified as follow: Point value $\le 0.10 N$ and Drag Value $\le 0.04 N$ | Complies |
| 5. Conical fitting | The taper of the hub meets the gauging requirements of ISO 594-1. | Complies |
| 6. Fitting strength hub/case | The force to pull axially the needle hub from the case is minimum 0.5 N and maximum 25 N. | Complies |
| 7. Effective needle length | The effective length = nominal length + 1 mm/-2 mm. | Complies |
| 8. Silicon amount on cannula | 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. | Complies |
| 9. Resistance to breakage | The cannula does not break when tested in accordance with EN ISO 9626. | Complies |
| 10. Stiffness test cannula | The cannula shall show a deflection not greater than 0.37 mm in accordance with EN ISO 9626. | Complies |
| 11. Corrosion Resistance (cannula) | The cannula shall show no signs of corrosion caused by the immersion in a sodium chloride solution 0.5 M. | Complies |
| 12. Bonding strength between hub and cannula | The bonding strength between hub and cannula is $\ge$ 22N. | Complies |
| 13. Liquid leakage | There is no leak of liquid at the luer (lock) fitting when the needle hub is fixed to reference control fitting in accordance with to ISO 594-1 and ISO 594-2. | Complies |
| 14. Air leakage | There is no air leakage at luer (lock) fitting when the needle hub is fixed to a reference control fitting in accordance with to ISO 594-1 and ISO 594-2. | Complies |
| 15. Flow rate | Tolerance on flow rate: between 80% and 125% of nominal value. | Complies |
| 16. Torque Force Cap-Case | The torque force required to break the label and to remove the cap from the case is not more than 25 N.cm. | Complies |
| 17. Endotoxin reaction | The device is free from endotoxin reaction in accordance with European Pharm. 2.6.14. | Complies |
| 18. Abnormal toxicity | The device is free from abnormal toxicity in accordance with European Pharm. 2.6.9. | Complies |
| 19. Sterility | The device is sterile in accordance with European Pharm. 2.6.1. | Complies |
Study Information:
Based on the provided text, the following information can be extracted regarding the study:
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for each individual test or the overall test set. The data provenance is implied to be from internal testing conducted by Terumo Europe N.V. (Belgium), as indicated by "Design verification activities were conducted for the 29G x 5/16" Thin Wall K-Pack II Needles..." and the company's location. The study type is a verification activity to demonstrate substantial equivalence, which is typically conducted in a prospective manner on newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. For tests like visual appearance, penetration resistance, etc., the "ground truth" is likely established through adherence to specified engineering standards and internal quality control protocols, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set:
This information is not provided. The nature of these engineering and sterility tests suggests that adjudication methods like "2+1" or "3+1" (common in clinical image review) are not applicable. Compliance is measured against pre-defined quantitative or qualitative criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. The K-Pack II Needle is a physical medical device, and the verification activities focus on its physical and biological properties.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The K-Pack II Needle is a physical medical device, not an algorithm. The "standalone performance" here refers to the device's ability to meet its specifications independently. The verification activities described are essentially a standalone performance assessment of the device against its design requirements and relevant standards.
7. The Type of Ground Truth Used:
The ground truth used for these verification activities is based on:
- Established engineering standards: e.g., ISO 594-1, ISO 594-2, EN ISO 9626, EN ISO 11135-1, EN 556-1, EN ISO 10993-7.
- Regulatory guidelines: e.g., European Pharm. 2.6.14, European Pharm. 2.6.9, FDA General Program Memorandum #G95-1 (for biological evaluation).
- Internal specifications: for properties like visual appearance, silicon amount, and effective needle length, which are likely derived from design requirements and predicate device characteristics.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical needle, and therefore, there is no "training set" in the context of machine learning or AI models. The device undergoes design, manufacturing, and verification processes based on established engineering principles and standards.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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