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510(k) Data Aggregation
(102 days)
The K-Pack Surshield™ Needle is a sterile hypodermic needle for single use with a passive sharps protection feature that covers the cannula immediately and permanently after use; and is intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection as well as for injection in infusion lines.
The 25G K-Pack Surshield™ Needle is a 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 male connector (nozzle) of a piston syringe. Furthermore the needle has a passive sharps protection feature that covers the cannula immediately and permanently after use. The K-Pack Surshield™ Needle is packed in a hard pack (cap - case) which is sealed with a perforated self-adhesive paper label.
The provided document describes the K-Pack Surshield™ Needle, a hypodermic needle with a passive sharps protection feature. It includes a summary of verification activities and acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines acceptance criteria but does not explicitly state the reported device performance for each criterion in numerical or qualitative terms in the provided text. It only states that "All necessary verification and validation tests have been performed by testing the K-Pack Surhield™ Needle 25G x 5/8" - 0.5 x 16 mm in accordance with EN ISO 7864 (1995) and ISO/FDIS 23908 (2010)." This implies that the device met all acceptance criteria, but the specific results are not detailed.
| 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 acceptance criteria (tests performed). |
| 2. Limits for acidity or alkalinity | A pH for K-Pack Needles extract solution is within 1 unit of the control fluid. | Met acceptance criteria (tests performed). |
| 3. Limits for extractable metals | The extract solution of the K-Pack Surshield 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 acceptance criteria (tests performed). |
| 4. Size designation | Outside diameter and nominal length are expressed in mm (and G x "). | Met acceptance criteria (tests performed). |
| 5. Colour coding | Hub and label are colour coded following ISO 6009. | Met acceptance criteria (tests performed). |
| 6. Conical fitting | 6% luer taper, compliant with requirements of ISO 594-1 and ISO 594-2. | Met acceptance criteria (tests performed). |
| 7. Effective needle length | The effective length = nominal length + 1 mm/-2 mm. | Met acceptance criteria (tests performed). |
| 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 acceptance criteria (tests performed). |
| 9. Needle point | The needle point of the K-Pack Surshield Needles is in the center of the bevel, is sharp and is free from extraneous matter, burr, edges and hooks. | Met acceptance criteria (tests performed). |
| 10. Bonding strength between hub and cannula | The bonding strength between hub and cannula for this K-Pack Surshield Needle is ≥ 22N. | Met acceptance criteria (tests performed). |
| 11. Patency of lumen | A stylet with a diameter of 0.23 mm is passing through the needle. | Met acceptance criteria (tests performed). |
| 12. Flow rate | The flow rate for this needle is 3.0 ml/min. | Met acceptance criteria (tests performed). |
| 13. Visual marking indicating status of safety feature | Visual indication: Light blue = Ready for use No colour = Shield already locked | Met acceptance criteria (tests performed). |
| 14. Forces for activating the sharps injury protection feature | The force to activate the safety feature of the device is maximum 2.16 N. The force during use of the device is maximum 3.20 N. | Met acceptance criteria (tests performed). |
| 15. Forces for challenging the safety feature | Once in the safe mode, the safety feature shall withstand 10 cycles of a minimum overriding force of 80 N. | Met acceptance criteria (tests performed). |
| 16. Challenging the safety feature once in safe mode | Once in safe mode, the cannula tip cannot be accessed when the device is stressed during a 10 cycle procedure of minimum 80 N compressive load. | Met acceptance criteria (tests performed). |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that the verification and validation tests were performed "by testing the K-Pack Surhield™ Needle 25G x 5/8" - 0.5 x 16 mm." However, it does not specify the sample size used for these tests. The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned beyond the manufacturer being in Belgium and the device being for the general market (implied by 510(k) submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable or not provided in the context of this device. The tests described are primarily physical, chemical, and mechanical performance tests based on established international standards (EN ISO 7864, ISO/FDIS 23908, ISO 594-1, ISO 594-2, ISO 6009, EN ISO 11135-1, EN ISO 10993-7, FDA G95-1). These types of tests do not typically involve human experts establishing "ground truth" in the way image analysis or diagnostic AI studies would. For example, "cleanliness" is inspected by "normal or corrected-to-normal vision without magnification," which implies human observation but not necessarily an "expert" panel in the sense requested.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided. Since the tests are largely objective and defined by international standards, an adjudication method for consensus among experts is not typically required.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance with and without AI assistance, which is irrelevant for a physical medical device like a hypodermic needle with a safety feature.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable. The device is a physical medical device, not an algorithm or AI system. The "standalone" performance refers to the device's inherent physical and functional characteristics tested against specified criteria. The document indicates that tests were performed on the device itself against these criteria.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed on the K-Pack Surshield™ Needle is based on pre-defined technical specifications and international standards. These standards set the objective and measurable criteria for acceptable performance (e.g., specific force values, pH ranges, physical dimensions, visual clarity, bonding strength). For example, for "Bonding strength between hub and cannula," the ground truth is a force of "≥ 22N." For "Cleanliness," the ground truth is the absence of particles and extraneous matter as observed under specified conditions.
8. The Sample Size for the Training Set:
This information is not applicable. The K-Pack Surshield™ Needle is a physical medical device, not a machine learning or AI algorithm, and therefore does not have a "training set" in the context of data used for algorithm development. Its design and manufacturing processes are likely informed by engineering principles, material science, and regulatory standards, not by iterative learning from a data training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no "training set" for this physical medical device.
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