(78 days)
Sterile Hypodermic Needle for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
The proposed device, Sterile Hypodermic Needles For Single Use consists of needle tube, needle hub and hard pack(Butt-end lower protective cap and Upper needle protective cap) or protective cap for needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the colour complies with ISO 6009. Sterile Hypodermic Needles for Single Use have two kinds of sterile barrier type, paper-film package type and hard-pack package. Besides the sterile barrier, the materials of middle package and outer package are same. Middle package is made of 350g ivory board and the outer package is made from double-corrugated paper. The conical fitting of Sterile Hypodermic Needles for Single Use is luer can be used with syringes or other medical device which have 6% conical fitting. It is provided as sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials.
This is a 510(k) premarket notification for a medical device (Sterile Hypodermic Needles for Single Use), which focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against predefined acceptance criteria for a new AI or diagnostic device. As such, most of the requested information regarding acceptance criteria and study details for an AI/diagnostic device is not applicable or cannot be extracted from this document.
However, I can provide information based on the reported performance specifications (which serve as acceptance criteria for basic device characteristics) and the non-clinical performance testing conducted to demonstrate compliance with relevant standards.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
For a medical device like a hypodermic needle, acceptance criteria are typically defined by compliance with recognized international standards for manufacturing, materials, and specific performance attributes. The document states that the proposed device complies with these standards, thus the reported performance meets the acceptance criteria.
| Acceptance Criterion (Standard/Test) | Reference Standard / Performance | Reported Device Performance |
|---|---|---|
| Material/Design Specifications | ||
| Needle tube material | Stainless Steel (SUS 304) | Stainless Steel (SUS 304) |
| Needle hub material | Polypropylene (PP) | Polypropylene (PP) |
| Protective cap material | Polypropylene (PP) | Polypropylene (PP) |
| Conical fitting | Luer | Luer |
| Color coding | Per ISO 6009 | Color-coded per ISO 6009 |
| Single use | Yes | Yes |
| Sterilization | ||
| Sterilization method | EO | EO |
| Sterilization Assurance Level (SAL) | $10^{-6}$ | $10^{-6}$ |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Biocompatibility | Per ISO 10993-1, -4, -5, -7, -10, -11 | Evaluation conducted per ISO 10993-1, -4, -5, -7, -10, -11. Tests included Cytotoxicity, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity. Evaluation meets requirements. |
| Per USP | Conforms to USP : Particulate Matter for injection | |
| Physical Performance/Dimensions | Per ISO 7864:2016 (Requirements and test methods) | Complies with ISO 7864:2016 |
| Per ISO 9626:2016 (Stainless steel needle tubing) | Complies with ISO 9626:2016 | |
| Per ISO 80369-7:2021 (Small-bore connectors) | Complies with ISO 80369-7:2021 | |
| Per ISO 80369-20:2015 (Common test methods) | Complies with ISO 80369-20:2015 | |
| Packaging/Sealing | Per ASTM F88/F88M-15 (Seal Strength) | Complies with ASTM F88/F88M-15 |
| Per ASTM F1929-15 (Seal Leaks) | Complies with ASTM F1929-15 | |
| Needle Gauge & Length (Specific Measurements) | All test results meet acceptance criteria per standards (ISO 7864, ISO 9626) | All test results meet acceptance criteria per standards. Specific dimensions are provided in Table 19-1. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test conducted to demonstrate compliance with the standards (e.g., number of needles tested for bend strength, fluid leakage, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and "all test results meet the acceptance criteria per the standards." The provenance of the testing data (e.g., country of origin, retrospective/prospective) is not detailed, though the manufacturer is based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a mechanical medical device (hypodermic needle), not an AI or diagnostic device that relies on expert interpretation for ground truth. Compliance is determined by physical and chemical testing against established international standards.
4. Adjudication method for the test set
Not applicable. Testing is against objective criteria defined by international standards rather than subjective human assessment 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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used
The ground truth is established by international standards and their specified test methods, such as ISO 7864 (Sterile hypodermic needles), ISO 9626 (Stainless steel needle tubing), ISO 80369 series (Small-bore connectors), ISO 10993 series (Biocompatibility), ASTM standards for packaging, and USP for particulate matter. These standards define the acceptable performance limits and methodologies for testing.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
Not applicable.
§ 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).