(175 days)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for general purpose fluid injection/ aspiration.
The Sterile 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 needle and a needle hub. The proposed device is available in variety of needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe.
This information is pertaining to a 510(k) premarket notification for a medical device called "Sterile Hypodermic Needles for Single Use." This is a regulatory submission for a device, not a study of an AI algorithm. Therefore, many of the requested categories are not applicable.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the device was tested against recognized international standards for hypodermic needles. The "reported device performance" is essentially that the device "complied with" these standards.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| ISO 80369-7: 2016 | Complied |
| ISO 80369-20:2015 | Complied |
| ISO 7864: 2016 | Complied |
| ISO 9626: 2016 | Complied |
| ISO 10993-1 | Complied (Biocompatibility) |
| USP | Met acceptance criteria |
| ISO 11135:2014 | Complied (Sterility) |
| ISO 10993-7:2008 | Complied (EO/ECH residuals) |
| USP | Complied (Bacterial Endotoxins) |
| ASTM F1886 / F1886M-16 | Performed |
| ASTM F88/F88-15 | Performed |
| ASTM F1929-15 | Performed |
| ASTM D4169-16 | Performed |
| ASTM F1980-16 | Performed |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each non-clinical test. It states that tests were "conducted" and "met" or "complied" with standards.
- Data Provenance: The document does not explicitly state the country of origin for the data (beyond the manufacturer being in China), nor whether it was retrospective or prospective. Given it's a 510(k) submission, the testing would generally be prospective to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is not a study involving ground truth established by human experts for interpretive tasks. The evaluation is based on objective measurements against engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for non-clinical engineering and biological tests.
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 device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's evaluation consists of the acceptance limits and methodologies defined by recognized international and national standards (e.g., ISO, USP, ASTM). The device's performance is measured against these objective criteria.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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).