(151 days)
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
The proposed device, Insulin 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 tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen. The Insulin Pen Needle is offered in various gauge sized and length. They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
The provided text describes a 510(k) summary for an Insulin Pen Needle, focusing on its substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, primarily through non-clinical testing and comparison to existing standards.
Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable or detailed in this document.
Here's an breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in the typical sense of a clinical or performance study. Instead, it states that the device 'complies with' various ISO and ASTM standards, which inherently define performance requirements. The performance specification for the proposed device is listed as "Comply with ISO 7864, ISO 9626, and ISO 11608-2."
Implicit Acceptance Criteria and Reported Performance (derived from compliance with standards and comparison table):
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7864 (Sterile hypodermic needles) | Complies with standard |
| ISO 9626 (Stainless steel needle tubing) | Complies with standard |
| ISO 11608-2 (Needle-based injection systems) | Complies with standard |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Complies with standard |
| ASTM F88/F88M-09 (Seal Strength) | Complies with standard |
| ISO 11737-2 (Sterilization microbiological methods) | Complies with standard |
| USP 35-NF30:2012 (Bacterial Endotoxins Test) | Complies with standard |
| Sterility Assurance Level (SAL): 10-6 | SAL: 10-6 |
| Shelf Life: 5 years | 5 years |
| Material (Tube: 304 Stainless Steel) | 304 Stainless Steel |
| Material (Hub: Polypropylene) | Polypropylene |
2. Sample size used for the test set and the data provenance
The document indicates "Non clinical tests were conducted to verify that the proposed device met all design specifications," but it does not specify the sample sizes used for these tests. The data provenance is not explicitly stated in terms of country of origin for specific test results, but the sponsor is located in China. The tests are non-clinical (laboratory-based) rather than retrospective or prospective human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes non-clinical performance testing against established engineering standards (ISO, ASTM, USP). There is no "ground truth" in the clinical sense established by human experts for a test set. The standards themselves define the "ground truth" for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As the tests are non-clinical, there is no need for expert adjudication.
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 a medical device (Insulin Pen Needle), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" is defined by the specifications and requirements set forth in the referenced international standards (ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-7, ASTM F88/F88M-09, ISO 11737-2, USP 35-NF30:2012). The device's performance is compared against these engineering and manufacturing benchmarks.
8. The sample size for the training set
Not applicable. This pertains to non-clinical device testing and manufacturing compliance, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the context of this device submission.
§ 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).