(309 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 text describes the acceptance criteria and performance data for the Kopac Sterile Needle as part of its 510(k) submission (K172483) to the FDA.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement – Test (ISO 7864) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Inner and Outer Surface | No bumps and flaws on the outer surface. Smooth, electrolytically polished or equivalent. No hazardous oxides, dusts, and powders on the inner surface. Sharply polished blade without visible bending, uniform cross-section and thickness. | Pass |
| When injecting glycerin into the needle tube or needle hub, coloring of glycerin should not take place. | Glycerin should not cause coloring. | Pass |
| When a lubricant is applied on the needle tube, the lubricant must be non-toxic and satisfy ISO 7864. When observed by unaided eyes, no lubricant drops should be found on the inner and outer surfaces of the needle tube. | Lubricant must be non-toxic, satisfy ISO 7864, and no lubricant drops visible on inner/outer surfaces. | Pass |
| Dimensions (Measured using digital vernier calipers and digital thickness gauge) | Outer diameter of the needle tube must be satisfied. Length of the needle tube must be satisfied. | Pass |
| The needle hub and hub hole | When the test gauge indicated on the figure below is inserted into the hub hole at low pressure, the taper must fit with the taper gauge of the hub hole. Also, the nozzle of the needle hub must be within the gauge limit. | Pass |
| Elasticity | Return to original position when bent to 12° using a protractor. | Pass |
| Flexural strength | No snapping when bent to 90° using a protractor. | Pass |
| Pullout | Measurement of maximum value using a tension and compression tester (specific criteria not detailed, but implied to meet an acceptable threshold). | Pass |
| Stiffness (ISO 9626 Annex B) | When tested in accordance with the method given in ISO 9626 Annex B, apply a downward force given in table at a speed 1 mm/min. Measure the deflection of the tubing at the point of application of the force (specific deflection limits not detailed, but implied to meet an acceptable threshold within the standard). | Pass |
| Resistance to breakage (ISO 9626 Annex C) | The cannula edge shall be sharply ground to a regular cross-section and thickness, with no visible bending. No visible breakage when examined by normal or corrected vision. | Pass |
| Resistance to corrosion (ISO 9626 Annex D) | The tubing is partially immersed in sodium chloride solution ($\text{c(NaCl)} = 0.5mol/L$) at ($\text{23±2}$)°C, for 7h±5min. The immersed half of the tubing shall show no evidence of corrosion resulting from the test compared visually with the unimmersed portion. | Pass |
| Biocompatibility (ISO 10993 Series) | Cytotoxicity: Pass (ISO 10993-5 criteria). Skin Sensitization: Pass (ISO 10993-10 criteria). Intracutaneous Reactivity: Pass (ISO 10993-10, maximization test for delayed hypersensitivity criteria). Acute Systemic Toxicity: Pass (ISO 10993-11 criteria). Pyrogen Test: Pass (ISO 10993-11, Annex F criteria). Hemolysis Test: Pass (ISO 10993-4 criteria). | Pass |
| Sterility and LAL test | LAL test: Pass (USP39 , Bacterial Endotoxins Test, Unit: EU/Device - specific limit not provided but implied to be below the threshold). E.O sterilization validation: Pass (ISO 11135:2014, EO 30%, CO2 70%, Temp: 55°C, Exposure time: 5 hours - implying successful sterilization). Sterility test: Pass (ISO 11737-2 criteria - implying no microbial growth). E.O Residual test: Pass (ISO 10993-7:2008 criteria). | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each of the bench tests. It broadly states “Bench test were performed.” and lists various types of tests. Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but these are standard bench tests typically performed 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 the qualifications of those experts
This information is not applicable to this submission. The "ground truth" for a device like a hypodermic needle is established through objective physical, chemical, and biological measurements against international standards (ISO, USP) and predefined specifications, not through expert consensus on interpretation.
4. Adjudication method for the test set
Not applicable. The tests are quantitative or qualitative assessments against defined standards, not subjective interpretations requiring 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 submission for a medical device (hypodermic needle), not an AI/software as a medical device (SaMD) that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests relies on:
- International Standards: Primarily ISO 7864 (Hypodermic needles for single use), ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods), ISO 10993 series (Biological evaluation of medical devices), ISO 11135 (Sterilization of health-care products — Ethylene oxide), ISO 11737-2 (Sterilization of medical devices — Microbiological methods), and USP39 (Bacterial Endotoxins Test).
- Defined Specifications: Manufacturer's internal specifications for dimensions, material properties, and visual characteristics.
- Objective Measurements: Using instruments like digital vernier calipers, digital thickness gauges, protractors, tension and compression testers, and laboratory analyses for chemical and biological properties.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI model was used.
§ 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).