(175 days)
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Safety Hypodermic Needles for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose which consists of 1) Needle, 2) Safety shield, 3) Protective Cap, 4) Needle Hub. The proposed device is available in a variety needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:
This device, Sterile Safety Hypodermic Needles for Single Use (K221080), is a medical device and therefore its acceptance criteria and validation studies are primarily focused on demonstrating its safety and effectiveness, often by showing substantial equivalence to a legally marketed predicate device.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely based on compliance with recognized international standards and demonstration of comparable performance to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard / Test) | Reported Device Performance / Compliance |
|---|---|---|
| Material/Design Performance | Needle performance (e.g., strength, sharpness, corrosion resistance) | Complied with ISO 7864:2016 (Sterile Hypodermic Needles for Single Use) and ISO 9626:2016 (Stainless Steel Needle Tubing for the Manufacture of Medical Devices). |
| Luer Connector Compatibility | Small-bore connectors for liquids and gases in healthcare applications | Complied with ISO 80369-7: 2016 (Connectors for intravascular or hypodermic applications) and ISO 80369-20:2015 (Common test methods). |
| Safety Mechanism Functionality | Ability to cover the needle immediately after use to minimize accidental needlesticks | A simulated clinical study performed according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature (August 9, 2005) and ISO 23908:2011 demonstrated that the proposed device met pre-established criteria. Safety feature tests on the proposed device and predicate device demonstrated that both meet the acceptance criteria. |
| Biocompatibility | Absence of adverse biological reactions (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogenicity, material-mediated toxicity) | Complied with ISO 10993-1, including testing for Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, and Material Mediated Toxicity. The test results did not show any adverse effect. |
| Particulate Matter | Limits for particulate matter in injections | Complied with USP Particulate Matter in Injections and met the USP acceptance criteria. |
| Sterility | Assurance of sterility for medical devices | Sterilization process (Ethylene Oxide) validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10-6. EO and Ethylene Chlorohydrin (ECH) residuals were below limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below 20 EU/device in accordance with USP . |
| Packaging Integrity | Maintenance of sterile barrier after manufacturing and during transportation | Simulated transportation testing in accordance with ASTM D4169-16 on final, packaged, and sterile devices. Sterile Barrier Packaging tests performed: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), Dye Penetration (ASTM F1929-15). |
| Shelf-life | Demonstrated functional and sterile performance over the specified shelf-life | A 5-year shelf-life is validated using FDA recognized standard ASTM F1980-16. Both baseline and accelerated shelf-life testing were conducted, demonstrating the device will perform as intended to support the proposed 5-year shelf-life. |
2. Sample size used for the test set and the data provenance
The document specifies "test sets" for various non-clinical tests. However, it does not provide specific numerical sample sizes for each test. For example, it states:
- Simulated Clinical Study: "A simulated clinical study was performed on proposed device according to FDA Guidance... and ISO 23908:2011 to evaluate the safety mechanism of the proposed device."
- Safety Feature Test: "The safety feature test was performed on both proposed device and predicate device..."
- Biocompatibility Testing: "The following testing was conducted: Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Material Mediated Toxicity."
The data provenance is retrospective in the sense that these are non-clinical (laboratory/bench) tests conducted by the manufacturer as part of the premarket submission. The country of origin of the data is not explicitly stated for each test, but the manufacturing company (Sichuan Prius Biotechnology Co., Ltd.) is based in China. The adherence to international ISO and ASTM standards implies a global applicability of the testing methodologies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of device (hypodermic needle) does not involve subjective interpretation or a "ground truth" derived from human experts in the same way an AI diagnostic device would. The "ground truth" for these tests are the objective acceptance criteria defined by the recognized standards (e.g., a specific force required for needle penetration, a certain level of extractable chemicals, or a maximum particle count). Therefore, no human experts were used to establish ground truth in the context of diagnostic interpretation. The experts involved would be those performing and interpreting the bench and lab tests according to the standards, but not interpreting "cases" for a diagnostic task.
4. Adjudication method for the test set
Not applicable. This is not a diagnostic device requiring adjudication of expert interpretations for a test set. The tests are objective measurements against established international standards.
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 device is a sterile safety hypodermic needle, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
The ground truth used for this device's evaluation is primarily objective metrics derived from recognized international standards (e.g., ISO, ASTM, USP) and the FDA's guidance documents. These standards define measurable acceptance criteria for device performance, safety features, biocompatibility, sterility, and shelf-life.
8. The sample size for the training set
Not applicable. This device is a physical medical instrument evaluated through non-clinical testing against standards, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical 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).