(29 days)
The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.
The Ypsomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the peninjector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
The provided document describes the "Clickfine Pen Needle" and its substantial equivalence to a predicate device (K102108). The information focuses on regulatory compliance based on established international and internal standards rather than a typical clinical study with acceptance criteria often seen for AI/ML devices or diagnostic tools.
However, based on the provided text, I can extract the relevant information regarding performance and safety criteria, which serve as acceptance criteria for this device, and the "study" (referencing the assessments performed).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 11608-2:2012 (Needle based injection systems for medical use - Requirements and test methods - Part 2: Needles) | The device has met the requirements of the relevant sections of this standard. |
| Compliance with ISO 9626:1991/Amd.1:2001 (Stainless steel needle tubing for the manufacture of medical devices) | The device has met the requirements of the relevant sections of this standard. |
| Compliance with ISO 7864:1993 (Sterile hypodermic needles for single use) | The device has met the requirements of the relevant sections of this standard. |
| Overall safety and effectiveness for intended use (hypodermic injection of fluids) | The verifications have shown evidence that the Clickfine Pen Needles meet the acceptance criteria of these standards. Based on the results, it can be concluded that the device performance and safety are acceptable for the product. |
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 specify a "test set" sample size in the context of a clinical trial or algorithm evaluation. The performance and safety data are derived from "relevant assessments specified in the following international and internal standards and protocols." These standards (ISO 11608-2, ISO 9626, ISO 7864) typically involve laboratory testing of device components and finished products according to defined sampling plans, but the specific sample sizes used in Ypsomed's internal testing are not disclosed in this summary.
Data provenance: Given that Ypsomed AG is located in Switzerland, it can be inferred that the internal testing and data generation likely originated from Switzerland. The studies are prospective in the sense that they are validations and verifications performed on manufactured devices to ensure they meet specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not relevant or provided in the context of this device and its regulatory submission. The "ground truth" for a pen needle is its compliance with engineering and material standards, which is assessed through defined laboratory tests, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies or diagnostic evaluations, where human interpretation is involved. For a physical medical device like a pen needle, performance is assessed through objective, standardized physical and material tests.
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 not an AI-assisted diagnostic or interpretation device that would involve human readers.
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. Its performance is inherent in its physical and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Clickfine Pen Needle's performance and safety is its adherence to the technical specifications defined in the international standards:
- ISO 11608-2:2012: Focuses on the performance and safety of the needle unit in injection systems.
- ISO 9626:1991/Amd.1:2001: Specifies requirements for stainless steel tubing used in medical devices, including dimensional accuracy and material properties.
- ISO 7864:1993: Covers requirements for sterile hypodermic needles for single use, including sterility, sharpness, and cannula integrity.
Compliance with these standards, verified through objective testing methodologies, serves as the "ground truth."
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, no ground truth needed to be established for it.
§ 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).