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510(k) Data Aggregation
(351 days)
The Injection Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
The Injection Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It consists of a seal, needle hub, needle tube, needle sheath and primary container. The Injection Pen Needle is offered in the following sizes: Model(s): 0.30x6mm/30G, 0.30x8mm/30G, 0.25x6mm/31G, 0.25x8mm/31G, 0.23x4mm/32G. It is a single-use disposable device that is provided sterile and has a shelf life of 3 years. The needle hub is connects to the pen injector and the needle tube punctures the sealed medicine container. The medicine solution is pushed out through the needle tube by the injection mechanism of the pen injector. The needle tube is a stainless steel needle tube with lubricant coating on the surface and a beveled tip. The seal (medical glue-coated dialysis paper) and the primary container (medical polypropylene) constitute the sterile barrier system of the product.
This document describes the non-clinical testing performed to demonstrate that the Injection Pen Needle (K192464) is substantially equivalent to the predicate device (Droplet Pen Needles, K171982).
Here's the breakdown of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|---|
| Performance | - ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test methods. | Met all acceptance criteria for all gauges and lengths of needles, supporting a 3-year shelf life. |
| - ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods. | ||
| - ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods - Part 2: Needles. | ||
| Compatibility | - Demonstrated with FDA cleared/approved injectors via ISO 11608-2:2012 clauses 4.4 and 4.9: PEN INJECTOR - HumaPen Luxura (K142518); PEN INJECTOR - NovoPen Echo (K182387); PEN INJECTOR - NOVOLOG MIX 70/30 (BLA 021172); PEN INJECTOR - LANTUS SOLOSTAR (BLA 021081). | Demonstrated compatibility. |
| Biocompatibility | - Evaluated per FDA Guidance: "Use of International Standard ISO 10993-1. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, June 2016" for limited contact (≤ 24 hrs) external communicating, circulating blood contacting device. | Met all acceptance criteria for endpoints. |
| - Endpoints evaluated: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017), Hemocompatibility (ISO 10993-4:2017, ASTM F756), Pyrogenicity (USP41 Bacterial Endotoxins Test). | ||
| Sterility & Shelf Life | - Sterilized by Ethylene Oxide to achieve a SAL of 10-6. | Met all acceptance criteria for sterility and ensured sterility maintained during a 3-year shelf life. |
| - Validated and tested in accordance with: ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices; ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the conducted tests (performance, biocompatibility, and sterility). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests, as they are likely laboratory-based non-clinical tests rather than clinical studies with human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The listed tests are non-clinical (laboratory/bench testing) of a medical device (Injection Pen Needle). They do not involve human experts establishing ground truth in the way a diagnostic study would. The acceptance criteria are based on recognized international and national standards and FDA guidance documents.
4. Adjudication method for the test set
This question is not applicable to non-clinical laboratory testing.
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 question is not applicable, as the device is an Injection Pen Needle, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as the device is an Injection Pen Needle, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the acceptance criteria specified in the referenced international and national standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 10993 series, ASTM F756, USP41 , ISO 11135, ASTM F1980). The device's performance is measured against these established quantitative or qualitative requirements.
8. The sample size for the training set
This question is not applicable, as the device is a physical medical device and not an AI model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable, as the device is a physical medical device and not an AI model.
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