(127 days)
The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
The proposed device, Disposable Insulin Pen Needle, is a single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of needle tube, inner sheath, cup, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The proposed device is available in following specifications: Gauge 33G, 32G, 31G, 30G, 29G, 28G and Length (mm) 4mm, 6mm, 8mm, 12mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Insulin Pen Needle:
This document is a 510(k) summary for a medical device seeking market clearance, specifically a Disposable Insulin Pen Needle. For such a device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally based on compliance with recognized consensus standards and non-clinical performance testing rather than clinical trials or AI/software performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines a comprehensive set of non-clinical tests and biocompatibility tests. The acceptance criteria are implicit in verifying that the proposed device "met all design specifications" and that "the test result comply with the related standard requirements."
| Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|
| Cleanliness (ISO 7864:2016 Clause 4.3) | The test result comply with the related standard requirements. |
| Limits for acidity or alkalinity (ISO 7864:2016 Clause 4.4) | The test result comply with the related standard requirements. |
| Limits for extractable metals (ISO 7864:2016 Clause 4.5) | The test result comply with the related standard requirements. |
| Size designation (ISO 7864:2016 Clause 4.6) | The test result comply with the related standard requirements. |
| Colour coding (ISO 7864:2016 Clause 4.7) | The test result comply with the related standard requirements. |
| Needle hub (ISO 7864:2016 Clause 4.8) | The test result comply with the related standard requirements. |
| Needle Cap (ISO 7864:2016 Clause 4.9) | The test result comply with the related standard requirements. |
| Needle tube (ISO 7864:2016 Clause 4.10) | The test result comply with the related standard requirements. |
| Needle point (ISO 7864:2016 Clause 4.11) | The test result comply with the related standard requirements. |
| Bond between hub and needle tube (ISO 7864:2016 Clause 4.12) | The test result comply with the related standard requirements. |
| Patency of lumen (ISO 7864:2016 Clause 4.13) | The test result comply with the related standard requirements. |
| Surface finish (ISO 9626:2016 Clause 5.2) | The test result comply with the related standard requirements. |
| Cleanliness (ISO 9626:2016 Clause 5.3) | The test result comply with the related standard requirements. |
| Limits for acidity and alkalinity (ISO 9626:2016 Clause 5.4) | The test result comply with the related standard requirements. |
| Size designation (ISO 9626:2016 Clause 5.5) | The test result comply with the related standard requirements. |
| Dimensions (ISO 9626:2016 Clause 5.6) | The test result comply with the related standard requirements. |
| Stiffness (ISO 9626:2016 Clause 5.8) | The test result comply with the related standard requirements. |
| Resistance to breakage (ISO 9626:2016 Clause 5.9) | The test result comply with the related standard requirements. |
| Resistance to corrosion (ISO 9626:2016 Clause 5.10) | The test result comply with the related standard requirements. |
| Material (ISO 11608-2:2012 Clause 4.1) | The test result comply with the related standard requirements. |
| Dimensions (ISO 11608-2:2012 Clause 4.2) | The test result comply with the related standard requirements. |
| Determination of flow rate through the needle (ISO 11608-2:2012 Clause 4.3) | The test result comply with the related standard requirements. |
| Bond between hub and needle tube (ISO 11608-2:2012 Clause 4.4) | The test result comply with the related standard requirements. |
| Needle points (ISO 11608-2:2012 Clause 4.5) | The test result comply with the related standard requirements. |
| Freedom from defects (ISO 11608-2:2012 Clause 4.6) | The test result comply with the related standard requirements. |
| Lubrication (ISO 11608-2:2012 Clause 4.7) | The test result comply with the related standard requirements. |
| Dislocation of measuring point at patient end (ISO 11608-2:2012 Clause 4.8) | The test result comply with the related standard requirements. |
| Ease of assembly and disassembly (ISO 11608-2:2012 Clause 4.9) | The test result comply with the related standard requirements. |
| Determination of functional compatibility with needle-based injection systems (ISO 11608-2:2012 Clause 4.10) | The test result comply with the related standard requirements. |
| Seal strength (ASTM F88/F88-15) | The test result comply with the related standard requirements. |
| Dye penetration (ASTM F1929-15) | The test result comply with the related standard requirements. |
| EO residue (ISO 10993-7:2008) | The test result comply with the related standard requirements. |
| ECH residue (ISO 10993-7:2008) | The test result comply with the related standard requirements. |
| Bacteria Endotoxin Limit (USP , 20 EU per device) | The test result comply with the related standard requirements. |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device. The test result comply with the related standard requirements. |
| Sterilization validation (ANSI/AAMI/ISO 11135-1:2007, SAL: 10-6) | The test result comply with the related standard requirements. |
| Cytotoxicity (ISO 10993 standards) | No Cytotoxicity |
| Intracutaneous Reactivity (ISO 10993 standards) | No Irritation to Skin |
| Skin Sensitization (ISO 10993 standards) | No skin sensitization |
| Acute Systemic Toxicity (ISO 10993 standards) | No Systemic Toxicity |
| Pyrogen (ISO 10993 standards) | No pyrogen |
| Hemolysis Test (ISO 10993 standards) | No hemolysis |
2. Sample size used for the test set and the data provenance:
The document states, "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It also mentions "aging samples" for shelf life evaluation and testing of "all proposed models" for needle gauge differences.
- Sample Size: The exact sample sizes for each specific test are not provided in this summary. However, for medical device testing against standards, specified sample sizes are typically defined within the standards themselves or agreed upon with regulatory bodies.
- Data Provenance: The tests were conducted by Zhejiang Kindley Medical Devices Co.,Ltd in China (PRC), as they are the submitter. The data is retrospective in the sense that the tests were performed on the device prototypes and models before submission for clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information is not applicable to this document. The "ground truth" for a medical device like an insulin pen needle is established by its physical and functional properties meeting recognized international standards (e.g., ISO, ASTM). It does not involve expert clinical assessment of images or data in the way AI performance studies would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where there's a need for expert consensus on patient outcomes or diagnoses, particularly when dealing with subjective interpretations or complex clinical endpoints. For a mechanical device tested against engineering standards, the results are typically objective 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. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document describes a physical medical device (insulin pen needle) and its non-clinical performance against engineering standards. There is no AI component or human reader interpretation involved in its evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is derived from compliance with established international consensus standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 10993, ANSI/AAMI/ISO 11135-1, ASTM F88/F88-15, ASTM F1929-15, USP ). These standards define the acceptable physical, mechanical, chemical, and biological properties for hypodermic needles and pen needles.
8. The sample size for the training set:
There is no training set in the context of this device's evaluation. "Training set" refers to data used to train machine learning models. This is about physical device testing.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device evaluation.
§ 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).