(270 days)
This device is intended for use to inject fluids into or withdraw fluids from parts of the surface of the skin
The device consists of a metal tube that is beveled at one end and at the other end join to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by blister paper and sterilized by E.O. gas.
The provided document describes the acceptance criteria and the study that proves the EZ-Inject Single Use Needle device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement – Test (Standard) | Acceptance Criteria (Implicitly "Pass" based on Results) | Reported Device Performance |
|---|---|---|
| Visual check | Pass | Pass |
| Dimension | Pass | Pass |
| Elasticity | Pass | Pass |
| Flexural strength | Pass | Pass |
| Pullout | Pass | Pass |
| Cleanliness (ISO 7864) | Pass | Pass |
| Limits for acidity or alkalinity (ISO 7864) | Pass | Pass |
| Limits for extractable metals | Pass | Pass |
| Needle hub (Conical fitting, Colour of hub) | Pass | Pass |
| Needle tube (Tolerances on length, Lubricant) | Pass | Pass |
| Needle point | Pass | Pass |
| Bond between hub and needle tube | Pass | Pass |
| Patency of lumen | Pass | Pass |
| Tolerances on length (ISO 7864) | Pass | Pass |
| Stiffness (ISO 9626) | Pass | Pass |
| Resistance to breakage (ISO 9626) | Pass | Pass |
| Resistance to corrosion (ISO 9626) | Pass | Pass |
| Cleanliness (ISO 9626) | Pass | Pass |
| Limits for acidity or alkalinity (ISO 9626) | Pass | Pass |
| LAL test (Bacterial Endotoxin) (USP 41, ) | Pass | Pass |
| Luer connector performance (ISO 80369) | Pass | Pass |
| Dimension (ISO 80369) | Pass | Pass |
| Biocompatibility Tests: | ||
| Cytotoxicity | Pass | Pass |
| Skin Sensitization Test | Pass | Pass |
| Intracutaneous Reactivity Test | Pass | Pass |
| Acute Systemic Toxicity Test | Pass | Pass |
| Pyrogen Test | Pass | Pass |
| Hemolysis Test | Pass | Pass |
| Particulate matter in injections | Pass | Pass |
| Sterility & LAL Tests: | ||
| LAL test | Pass | Pass |
| E.O sterilization validation | Pass | Pass |
| Sterility test | Pass | Pass |
| E.O Residual test | Pass | Pass |
| Hub/needle bond strength | N/A (Compared to predicate, met ISO 7864) | 18 G-40 mm : 137.7 N, 19 G-40 mm: 177.8 N, etc. (All listed values resulted in "Pass") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test or the provenance (country of origin, retrospective/prospective) of the data, as these are typically bench tests performed on manufactured devices. The studies are described as "Bench test" and "The performance tests," suggesting these were conducted in a laboratory setting by the manufacturer (POONGLIM Pharmatech Inc., Korea).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document describes bench testing, biocompatibility testing, and sterility testing according to international standards (ISO, USP). For these types of tests, ground truth is established by objective measurements and adherence to specified standard limits rather than expert human interpretation in the way, for example, a radiologist would interpret an image. Therefore, there is no mention of "experts" in the context of establishing ground truth for individual test cases as it would apply to a clinical study. The tests are conducted by qualified laboratory personnel following established protocols.
4. Adjudication Method for the Test Set
Given that the performance evaluation relies on bench tests against objective, quantitative standards (e.g., ISO and USP standards), an adjudication method like "2+1" or "3+1" (common in clinical trials with subjective endpoints) is not applicable. The results are binary (Pass/Fail) based on whether the device meets the specified criteria in the relevant standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a single-use hypodermic needle, and its performance evaluation focuses on physical, chemical, and biological safety and efficacy aspects through bench testing, not on comparative effectiveness with human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The EZ-Inject Single Use Needle is a physical medical device, not a software algorithm or an AI system. Therefore, the concept of a "standalone algorithm" performance study is irrelevant to this submission.
7. Type of Ground Truth Used
The ground truth for evaluating the device's performance is based on International Standards and Pharmacopeial Monographs. Specifically, the document references:
- ISO 7864: Sterile hypodermic needles for single use.
- ISO 9626: Stainless steel needle tubing for the manufacture of medical devices.
- ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications.
- ISO 6009: Hypodermic needles for single use - Colour coding for identification.
- USP 41, : United States Pharmacopeia for Bacterial Endotoxin Test.
- ISO 10993-5, -10, -11, -4, -7: Biological evaluation of medical devices (for Cytotoxicity, Irritation/Sensitization, Systemic Toxicity, Interaction with blood, Ethylene oxide residuals).
- ISO 11135:2014: Sterilization of health-care products - Ethylene oxide.
- ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
These standards define the acceptable physical properties, material safety, sterility, and functional performance limits, which serve as the "ground truth" for each test.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device. It does not involve a training set as would be used for machine learning or AI models. There is no algorithm being "trained."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set involved for this physical medical device, the concept of establishing ground truth for a training set is not relevant.
§ 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).