(77 days)
The Clickfine AutoProtect Pen Needle for use with pen injector devices for the injection of fluids, including insulin and exenatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
The pen needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of fluids. Each needle is individually packaged in a sealed protective container with a peel tab.
The pen needle is used by peeling back the peel tab and snapping or screwing the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the skin, the safety shield glides into the housing enabling the needle to penetrate the skin barrier and the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism is activated. The pen-injector delivers the medicinal product through the needle.
After the injection, in order to remove the needle from the skin, the user withdraws the pen injector from the skin. As the pen and needle is withdrawn from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (providing passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect Pen Needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used.
This document describes a 510(k) premarket notification for the "Clickfine AutoProtect Pen Needle" (K152514). The purpose of this submission is to expand the range of needle lengths to include a 5 mm needle. The document references various ISO standards and internal protocols for performance testing to demonstrate substantial equivalence to the predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Test | Requirement (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Needle Assembly | ||
| Needle assembly attachment shall fit and function with needle-based injection systems specified in ISO 11608-1 | Clause 4.2.1 of ISO 11608-2: The pen needles were tested for compatibility with needle-based injection system as specified in ISO 11608-1. | Pass |
| Tubing dimensions | Clause 4.2.2, Table 1 of ISO 11608-2: Length of patient end: +/- 1.25 mm; Length of cartridge end: 5.7 – 7.0 mm. | Pass |
| Flow rate | Clause 4.3 of ISO 11608-2: Measurement of flow rate in accordance with Annex A. | Pass |
| Bond between hub and needle tube | Clause 9 of ISO 11608-2 and clause 13.1 of ISO 7864: The union of the hub and needle tube shall not break for at least 5 sec. while a force of at least 22 N is applied. | Pass |
| Needle points | Clause 4.5 of ISO 11608-2: Visually sharp at a 2.5x magnification; designed to minimize coring and fragmentation. | Pass |
| Lubrication | Clause 4.7 of ISO 11608-2: No visible droplets on the outside surface of the needle tube. | Pass |
| Dislocation of measuring point at the patient-end | Clause 8 of ISO 11608-2: maximum allowable dislocation acc. Clause 4.8, Table 2 for 5mm: 0.65mm and for 8mm: 0.9mm. | Pass |
| Functional compatibility with needle-based injection systems | Clause 11 of ISO 11608-2: Needle assembly torque: 0.07 +/- 0.01 Nm; Needle hub removal: less than 0.100 Nm; Dose accuracy: for doses ≤ 20 ml the calculated values were within ± 0.01 ml of the targeted dose; for doses > 20 ml the calculated values were within ± 5 % of the targeted dose. | Pass |
| Tubing Characteristics (ISO 9626/A1) | ||
| Tubing characteristics | Table 1 of ISO 9626/A1: The tubing is made of austenitic stainless steel acc. one of the designated types given in Table 1 of ISO 9626/A1. | Pass |
| Tubing diameters | Table 2 of ISO 9626/A1: Tubing dimensions meet outer and inner diameter requirements as defined in table 2 of ISO 9626/A1. | Pass |
| Stiffness | Clause 9 of ISO 9626: When tested in accordance with annex C of ISO 9626 the tubing shall show a deflection not greater than the relevant value given in table 3 of ISO 9626/A1. | Pass |
| Resistance to breakage | Clause 10 of ISO 9626: When tested in accordance with annex D of ISO 9626 and Table 4 of ISO 9626/A1 the tubing shall not break. | Pass |
| Limits for acidity and alkalinity | Clause 6 of ISO 9626: Tested in accordance with annex A and extract preparation of the tubing in accordance with Annex B: correction for the volume of titrant required for the control fluid shall not be more than 0.04 ml NaOH or 0.12 ml HCl to reach the end-point titration. | Pass |
| Resistance to corrosion | Clause 11 of ISO 9626: When tested in accordance with annex E, the immersed half of the tubing shall show no evidence of corrosion resulting from the test. | Pass |
| Device Integrity (ISO 7864) | ||
| Freedom of defects | Clause 11.3 in ISO 7864: When examined by normal or corrected-to-normal vision, the needle shall appear straight and of regular cross-section and wall thickness. (This requirement is listed twice in the document, here and below for ISO 7864) | Pass |
| Limits for extractable metals | Clause 6 of ISO 7864: When tested with a recognized method the content of lead, tin, zinc and iron shall be less than 5mg/l. The cadmium content shall be lower than 0.1 mg/l. | Pass |
| Freedom of defects (re-listed) | Clause 11.3 of ISO 7864: When examined by normal or corrected vision, the needle lube shall appear straight and of regular cross-section and wall thickness. | Pass |
| Sharps Injury Protection (ISO 23908) | ||
| Activation of the sharps injury protection | In accordance with ISO 23908 clause 5.2 the sharps injury protection feature shall be able to be activated by an appropriate force that eases actuation and avoids unintended actuation. An appropriate force was determined using a risk-based approach in accordance with ISO 14971. | Pass |
| Verification of safety feature activation | In accordance with ISO 23908, clause 5.3, needles were tested to provide evidence that once the safety feature was activated, they resist axial and lateral forces so as to prevent unintended exposure to the sharps. | Pass |
| Device design verification for needle tip protection after activation | In accordance to clause 5.4 of ISO 23908 it was demonstrated that a sphere of 6mm radius did not come into contact with the tip of the cannula, either before or immediately after triggering the safety mechanism. | Pass |
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 sample sizes for each specific test or the country of origin of the data. However, it indicates that the testing was conducted as part of "Design Control Activities" by Ypsomed AG, which is a Swiss company. The testing is prospective in nature, as it is conducted to verify the performance of the modified device before it is marketed. The data provenance can be inferred as originating from Ypsomed AG's internal testing facilities, likely in Switzerland, to demonstrate compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a medical device, not an AI/imaging device requiring expert adjudication for ground truth of imaging data. The "ground truth" for these tests is established by objective measurements against predefined acceptance criteria from international standards (ISO). Therefore, no human experts were used to establish a "ground truth" in the way it would be for, for example, classifying medical images. The expertise lies in the engineers and technicians performing the tests and interpreting the results against the standard requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable in the context of this device. The testing involves objective measurements and functional assessments against standards, not subjective interpretations requiring adjudication.
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 is a physical medical device (pen needle), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device. The "performance" described is the device's mechanical and functional compliance with established safety and quality standards, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is based on established international ISO standards (e.g., ISO 11608-2, ISO 9626, ISO 7864, ISO 23908) which define specific, measurable requirements for physical and functional characteristics of hypodermic needles and sharps injury protection devices. These standards represent scientific and engineering consensus on acceptable device performance and safety.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not an AI model.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).