(380 days)
Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids.
The proposed device, Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. It consists of needle tube, needle hub, spring, needle hub sheath, safety protective sheath, positioning ring, outer protective cap and sealing paper. The needle hub is clear, and the positioning ring and sealing paper contains colorants for the different gauge sizes. The Safety insulin needle for single use is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
The provided text does not describe a device that uses AI or machine learning, nor does it detail acceptance criteria related to such a device's performance based on a test set. Instead, it is a 510(k) premarket notification for a medical device (Safety Insulin Pen Needles), primarily focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing against established ISO and ASTM standards.
Therefore, I cannot extract the information required to populate the table and answer the questions about AI/ML device performance, ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies. The document explicitly states: "No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Safety Insulin Pen Needle, as clinical studies are not required for this medical device."
However, I can provide the acceptance criteria and performance data as presented in the document, which are related to non-clinical tests for a physical medical device, not an AI/ML diagnostic or predictive tool.
Here's a summary of the non-clinical performance data and criteria as per the document:
A. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|
| ISO 7864:2016 (Sterile hypodermic needles for single use.) | Complies with the standard requirements. |
| ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices.) | Complies with the standard requirements. |
| ISO 11608-2:2012 (Needle-based injection systems for medical use - Part 2: Needles) | Complies with the standard requirements. |
| ISO 10993-5:2009(R) (Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.) | Complies with the standard requirements. |
| ISO 10993-10:2010 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization) | Complies with the standard requirements. |
| ISO 10993-7:2008 (Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.) | Complies with the standard requirements. |
| ASTM F88/F88M-15 (Standard Test Method for Seal Strength of Flexible Barrier Materials.) | Complies with the standard requirements. |
| ASTM F1140/F1140M-13 (Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages) | Complies with the standard requirements. |
| **USP ** (Bacterial Endotoxins Test) | Complies with the standard requirements. |
| ISO 10993-11:2017 (Biological evaluation of medical devices Part 11: Tests for systemic toxicity) | Complies with the standard requirements. |
| **USP ** (Particulate Matter Test) | Complies with the standard requirements. |
| Sterility Assurance Level (SAL) | Achieves a SAL of 10-6. |
| Needle Performance Testing (across all proposed gauge and length sizes) | Test results comply with ISO 7864 and ISO 9626 standards requirements. |
| Biocompatibility Testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, subchronic toxicity, Particulate Matter) | Test results demonstrate biocompatibility and compliance with relevant ISO 10993 series standards and USP monographs as listed above. |
B. Information Not Applicable to this Submission (AI/ML Specifics)
The following information is not present in the provided document, as it pertains to AI/ML device studies, which this submission does not involve:
- Sample size used for the test set and data provenance: Not applicable. The tests are physical/chemical evaluations of the device, not performance on a data set.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there is no "ground truth" established by experts in the context of an AI/ML model for this device. The ground truth refers to the physical and chemical properties conforming to established engineering and biological standards.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable. This is for AI-assisted human reading performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: For this device, the "ground truth" is defined by compliance with the referenced ISO, ASTM, and USP standards for manufacturing quality, performance characteristics (e.g., fluid flow, needle strength), sterility, and biocompatibility.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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).