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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.

Device Description

The 27G 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.

AI/ML Overview

The manufacturer of the 27G x ½" K-Pack Surshield™ Needle established acceptance criteria and performed verification activities to prove its compliance.

1. Table of Acceptance Criteria and Reported Device Performance (Summary of Verification Activities):

TEST	ACCEPTANCE CRITERIA	Reported Device Performance*
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.	The device met the acceptance criteria. (Implied by the submission of the 510(k) and general statement "All necessary verification and validation tests have been performed..." - Specific numerical results are not provided in the document for each test).
2. Limits for acidity or alkalinity	A pH for K-Pack Needles extract solution is within 1 unit of the control fluid.	The device met the acceptance criteria.
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: $\sum$ Pb, Sn, Zn, Fe $\le$ 5 mg/l; Cd < 0.1 mg/l.	The device met the acceptance criteria.
4. Size designation	Outside diameter and nominal length are expressed in mm (and G x ").	The device met the acceptance criteria.
5. Colour coding	Hub and label are colour coded following ISO 6009.	The device met the acceptance criteria.
6. Conical fitting	6% luer taper, compliant with requirements of ISO 594-1 and ISO 594-2.	The device met the acceptance criteria.
7. Effective needle length	The effective length = nominal length + 1 mm/-2 mm.	The device met the acceptance criteria.
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.	The device met the acceptance criteria.
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.	The device met the acceptance criteria.
10. Bonding strength between hub and cannula	The bonding strength between hub and cannula for this K-Pack Surshield Needle is $\ge$ 22N.	The device met the acceptance criteria.
11. Patency of lumen	A stylet with a diameter of 0.15 mm is passing through the needle.	The device met the acceptance criteria.
12. Flow rate	The flow rate for this needle is 0.82 ml/min.	The device met the acceptance criteria.
13. Visual marking indicating status of safety feature	Visual indication: Light blue = Ready for use; No colour = Shield already locked.	The device met the acceptance criteria.
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.	The device met the acceptance criteria.
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.	The device met the acceptance criteria.
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.	The device met the acceptance criteria.

Note: The document states "All necessary verification and validation tests have been performed by testing the K-Pack Surhiela™ Needle 27G x 1/2" - 0.4 x 12 mm in accordance with EN ISO 7864 (1995) and ISO 23908 (2011)." and "Summary of the verification activities including acceptance criteria is given in the table below." This implies that the device met all stated acceptance criteria, although specific numerical results for each test are not explicitly enumerated as "reported device performance."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state the sample size (number of units tested) for each specific test. However, it indicates that "All necessary verification and validation tests have been performed."
Data Provenance: The tests were performed in accordance with international standards EN ISO 7864 (1995) and ISO 23908 (2011). The manufacturing and submission of the device are from Terumo Europe N.V. in Belgium. The data is prospective, generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This document describes performance testing for a medical device (hypodermic needle) against engineering and material standards, not an AI/imaging diagnostic device. Therefore, the concept of "ground truth established by experts" in the context of diagnostic interpretation is not applicable here. The "ground truth" for these tests is defined by the objective, quantifiable acceptance criteria established by the relevant ISO and EN standards.

4. Adjudication Method for the Test Set:

Not applicable. This is not an adjudicative process for diagnostic interpretation but direct measurement and inspection against predefined engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, not for the performance testing of a hypodermic needle.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This is not an algorithm-based device. The "performance" described refers to the physical and functional characteristics of the needle itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests used here are the objective, quantifiable specifications and limits defined by international standards (EN ISO 7864, ISO 23908, ISO 6009, ISO 594-1, ISO 594-2, EN ISO 11135-1, EN 556-1, EN ISO 10993-7). These are engineering and material science standards for hypodermic needles. For biological evaluation, the ground truth is against the recommendations in FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as a training set is not part of this device's development or validation.

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