(250 days)
The Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
The proposed device, Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tubing, needle tip shield, needle base, needle base shield, sealing dialysis paper, glue and silicone oil. The needle base can be connected screwed onto the insulin pen.
The Pen Needle is offered in various gauge size and length.
The proposed device is available in radiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
This document describes the non-clinical testing performed to demonstrate the substantial equivalence of the "Easy Drip Disposable Insulin Needle" to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material | The needle shall be made of tubing materials specified in ISO 9626. | Complied |
| Dimensions | The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2. | Complied |
| Flow rate through the needle | The needles were tested in accordance with Annex A to ISO 11608-2. | Complied |
| Binding force between needle base and needle tubing | The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. | Complied |
| Needle tip appearance, needle tubing flawlessness, size of inside and outside diameter and puncturing force | The needle tip appearance shall fulfil the 4.5 of ISO 11608-2. The needle tubing flawlessness shall fulfil the requirements of ISO 7864:1993, 11.3. | Complied |
| Dislocation of measuring point patient end | Dislocation of the cannula point at the patient end shall be in accordance with Table 2 (ISO 11688-2) when tested in accordance with Clause 8 of ISO 11608-2. | Complied |
| Functional compatibility with needle-based injected systems | Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11 of ISO 11608-2. | Complied |
| Ease of assembly and disassembly | Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11 of ISO 11608-2. | Complied |
| Biocompatibility - Cytotoxicity | ISO 10093-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Under the conditions of the study, the subject device showed no evidence of cytotoxicity. |
| Biocompatibility - Sensitization | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device showed no evidence of sensitization. |
| Biocompatibility - Irritation | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device showed no evidence of skin irritation. |
| Biocompatibility - Hemocompatibility | ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ASTM F765 Standard Practice for Assessment of Hemolytic Properties of Materials | Under the conditions of the study, the subject device showed no evidence of hemolysis. |
| Biocompatibility - Systemic toxicity (acute) | ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. | Under the conditions of the study, the subject device showed no evidence of systemic toxicity. |
| Biocompatibility - Pyrogen | USP 34 NF 29 Pyrogen Test & USP . | non-pyrogenic |
| Sterility Assurance Level (SAL) | Achieve a SAL of 10^-6 | The validation report demonstrates that the sterilization of the proposed device can achieve a Sterility Assurance Level (SAL) of 10^-6. The radiation dose audit test reports showed that the minimum gamma radiation dose to achieve a 10^-6 SAL was acceptable according to ISO 11737-2:2012. (Note: The document states 10^8 in one place but implies 10^-6 is met). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test. However, it indicates that "nonclinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data is not explicitly stated in terms of country of origin, nor is it classified as retrospective or prospective; these are laboratory bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These were non-clinical bench tests performed against established international standards (ISO, ASTM, USP). Expert consensus is not typically used to establish ground truth for these types of tests; rather, the ground truth is defined by the objective pass/fail criteria of the specified standards.
4. Adjudication method for the test set
Not applicable. As noted above, these were objective non-clinical bench tests against standardized criteria.
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 document pertains to a medical device (insulin needle) and its non-clinical performance and biocompatibility, 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, not an algorithm.
7. The type of ground truth used
The ground truth for the non-clinical tests was established by adherence to and compliance with relevant international and national standards, including:
- ISO 7864 (Sterile hypodermic needles for single use)
- ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)
- ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods)
- ISO 10993 series (Biological evaluation of medical devices, including parts 4, 5, 10, 11)
- ASTM F765 (Standard Practice for Assessment of Hemolytic Properties of Materials)
- USP Pyrogen Test
- USP Bacterial Endotoxins Test
8. The sample size for the training set
Not applicable. This is a physical medical device submission, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
§ 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).