(87 days)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a luer lock or luer slip syringe and injection devices for general purpose fluid injection. The Sterile Hypodermic Needles for Single Use is for single use only. After opening the inner packaging and taking out the product, tighten the needle to the syringe and remove the protective cover, extract the drug liquid, exhaust the air and then inject. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
This document outlines the acceptance criteria and supporting study details for a Sterile Hypodermic Needle for Single Use (K231720) according to its 510(k) summary. This is not an AI/ML-based device, so many of the requested fields (especially those related to AI algorithm performance, human reader studies, and ground truth establishment for AI training/test sets) are not applicable.
The "device" in question is a physical medical device (hypodermic needles), not a software or AI-driven system. Therefore, the acceptance criteria and study descriptions are focused on physical and biological performance, rather than algorithm performance.
Acceptance Criteria and Device Performance for Sterile Hypodermic Needles for Single Use (K231720)
The substantial equivalence determination for this device is based on its compliance with established international and national standards for medical devices, rather than a comparative effectiveness study involving human readers or AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|---|
| I. Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 | All evaluation acceptance criteria were met. |
| Skin Sensitization | ISO 10993-10:2010 | All evaluation acceptance criteria were met. |
| Hemolysis | ISO 10993-4:2017 | All evaluation acceptance criteria were met. |
| Intracutaneous Reactivity | ISO 10993-10:2010 | All evaluation acceptance criteria were met. |
| Acute Systemic Toxicity | ISO 10993-11:2017 | All evaluation acceptance criteria were met. |
| Pyrogenicity | ISO 10993-11:2017 (for testing); Device non-pyrogenic (for general claim) | All evaluation acceptance criteria were met; Non-pyrogenic. |
| Particulate Matter | USP Particulate Matter in Injections | Met USP acceptance criteria. |
| II. Sterilization & Shelf Life | ||
| Sterilization Validation | ISO 11135:2014 (EO Sterilization) | Sterilization method validated to ISO11135. |
| EO Residue | ISO 10993-7:2008 | Compliant with ISO 10993-7:2008. |
| ECH Residue | ISO 10993-7:2008 | Compliant with ISO 10993-7:2008. |
| Bacterial Endotoxin | USP42-NF37 | Compliant with USP42-NF37. |
| Shelf Life (Stability) | Ageing test (method not specified but implies meeting performance over time) | Five (5) years. |
| Sterile Barrier Packaging | ASTM F88/F88M-15 (Seal Strength) | Compliant. |
| ASTM F1929-15 (Dye Penetration) | Compliant. | |
| ASTMF1140/F1140M-13 (Creep/Burst Testing) | Compliant. | |
| ASTM F2096-11 (Gross Leakage) | Compliant. | |
| III. Performance Testing | ||
| Cleanliness | ISO 7864:2016 Clause 4.3; ISO 9626:2016 Clause 5.3 | Complied (implied by "all evaluation acceptance criteria were met" for biocompatibility tests which can be affected by cleanliness, and by general statement of compliance with these standards). |
| Limits for acidity or alkalinity | ISO 7864:2016 Clause 4.4; ISO 9626:2016 Clause 5.4 | Complied. |
| Limits for extractable metals | ISO 7864:2016 Clause 4.5 | Complied. |
| Tubular needle designation | ISO 7864:2016 Clause 4.6 | Complied. |
| Color coding | ISO 7864:2016 Clause 4.7; ISO 6009 | Complied (Color-coded per ISO 6009). |
| Needle hub | ISO 7864:2016 Clause 4.8; ISO 80369-7 | Complied. |
| Needle cap | ISO 7864:2016 Clause 4.9 | Complied. |
| Needle tube (Tolerance on length, Freedom from defects, Lubricant) | ISO 7864:2016 Clause 4.10 | Complied. |
| Needle Point | ISO 7864:2016 Clause 4.11 | Complied. |
| Bond between Tube and Hub | ISO 7864:2016 Clause 4.12 | Complied. |
| Patency of Lumen | ISO 7864:2016 Clause 4.13 | Complied. |
| Surface finish & visual appearance | ISO 9626:2016 Clause 5.2 | Complied. |
| Size designation | ISO 9626:2016 Clause 5.5 | Complied. |
| Dimensions | ISO 9626:2016 Clause 5.6 | Complied. |
| Stiffness | ISO 9626:2016 Clause 5.8 | Complied. |
| Resistance to breakage | ISO 9626:2016 Clause 5.9 | Complied. |
| Resistance to corrosion | ISO 9626:2016 Clause 5.10 | Complied. |
| Dimensional requirements for luer connectors | ISO 80369-7:2021 Clause 5 | Complied. |
| Fluid leakage (Positive pressure liquid leakage) | ISO 80369-7:2021 Clause 6.1.3 | Complied. |
| Sub-atmospheric pressure air leakage | ISO 80369-7:2021 Clause 6.2 | Complied. |
| Stress cracking | ISO 80369-7:2021 Clause 6.3 | Complied. |
| Resistance to separation from axial load | ISO 80369-7:2021 Clause 6.4 | Complied. |
| Resistance to separation from unscrewing | ISO 80369-7:2021 Clause 6.5 | Complied. |
| Resistance to overriding | ISO 80369-7:2021 Clause 6.6 | Complied. |
| IV. Labeling | 21 CFR Part 801 | Met the requirements of 21 CFR Part 801. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. Testing of physical medical devices typically involves testing a statistically significant sample size from a production lot to demonstrate compliance with standards. The data provenance is implied to be from laboratory testing performed on the manufacturer's device, likely in China (where the manufacturer is located). The testing is prospective for the purpose of demonstrating compliance for this specific device model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical medical device (hypodermic needle), not an AI/ML diagnostic or image analysis system. Ground truth is established through validated laboratory test methods and established international/national standards, not through expert consensus in the medical imaging context.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is established through objective laboratory testing against defined standards (e.g., ISO, ASTM, USP), not through the adjudication of medical opinion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic aids that assist human readers in interpreting medical images. This device is a sterile hypodermic needle, a physical disposable medical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation in the context of an AI algorithm was not done. This is not an algorithmic device.
7. The Type of Ground Truth Used
The "ground truth" for this physical device is defined by the acceptance criteria specified in the referenced international standards (e.g., ISO 10993, ISO 7864, ISO 9626, ISO 80369, ASTM, USP). These standards define the physical, chemical, and biological properties a device must meet to be considered safe and effective for its intended use. Testing protocols outlined within these standards serve as the objective 'ground truth' against which the device's performance is measured. Compliance is determined by the device meeting all the specified numerical and qualitative requirements of these standards.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of a physical medical device. The manufacturing process is controlled by Good Manufacturing Practices (GMP) and validated testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" involved in the development or evaluation of this physical medical device.
§ 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).