(73 days)
The Clickfine pen needle is intended for the hypodermic injection of insulin into the body when attached to a peninjector.
The Ypsomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for insulin administration. Each needle is individually packaged in a sealed protective container with peel tab. The pen needles are used by peeling back the peel tab and snapping the while per table threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin 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 insulin through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
The provided text describes the 510(k) summary for the Ypsomed Clickfine Pen Needle. This document focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving new acceptance criteria for a novel AI-powered medical device.
Therefore, many of the requested points regarding AI, ground truth, experts, and specific clinical study designs are not applicable or cannot be extracted from this text. The information below is based only on the provided document.
Here's the information that can be extracted from the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ISO 11608-2:2000 Pen-injectors for medical use Part 2: Needles Requirements and test methods | Met the requirements of relevant sections |
| ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of medical devices | Met the requirements of relevant sections |
| ISO 7864:1993 Sterile hypodermic needles for single use | Met the requirements of relevant sections |
| ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing | Met the requirements of relevant sections |
| Puncture resistance of outer cap | Equivalent to Unmodified Device |
| Seal Integrity of Sterile barrier | Equivalent to Unmodified Device |
2. Sample size used for the test set and the data provenance:
- The document states "Ypsomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices."
- However, specific sample sizes for these tests are not provided in the document.
- The data provenance (e.g., country of origin, retrospective/prospective) is not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes testing against international standards for a physical medical device, not an AI or imaging device requiring expert ground truth in the traditional sense. The "ground truth" here is the pass/fail criteria of the specified standards.
4. Adjudication method for the test set:
- This is not applicable for the type of testing described (compliance with international standards for a physical device). The tests would likely have objective pass/fail criteria based on measurements.
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:
- This is not applicable. The device is a pen needle, not an AI-powered diagnostic tool. No AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a pen needle, not an algorithm.
7. The type of ground truth used:
- For the physical tests described, the "ground truth" is defined by the acceptance criteria and test methods specified in the cited international standards (e.g., ISO 11608-2, ISO 9626, ISO 7864, ISO 10993-1), as well as internal standards and protocols. Implicitly, functional equivalence to the predicate device (Disetronic Penfine Insulin Injection Pen Needles, K013782) also serves as a comparative benchmark.
8. The sample size for the training set:
- This is not applicable as the device is a physical pen needle, not an AI or machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- This is not applicable for the reasons stated in point 8.
§ 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).