(183 days)
The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
The TK Sterile Hypodermic Needle is a hypodermic single lumen needle, designed for use with syringe and injection devices for general purpose fluid injection / aspiration. The TK Sterile Hypodermic Needle are offered in various gauge sizes and needle lengths. The TK Sterile Hypodermic Needle is sterilized by EtO gas. The TK Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use. Hypodermic needle for single use can be used Hypodermic injection. It suits users of different age and is the basic methods of infusion. And the device does not have the safety mechanism.
The provided document is a 510(k) summary for a medical device called the "TK Sterile Hypodermic Needle." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the performance of an AI/ML algorithm. Therefore, many of the requested items related to AI/ML studies are not applicable to this document.
However, I can extract information regarding the safety and performance testing conducted to support the substantial equivalence claim.
1. Table of acceptance criteria and the reported device performance:
The document primarily states that the device's performance "conforms to" or "meets the requirements" of various ISO and ASTM standards. The specific quantitative acceptance criteria (e.g., maximum force, minimum flow rate) are not listed in this summary, nor are the precise numerical results of the tests. The summary indicates compliance rather than detailed performance metrics.
| Test Category | Standard(s) | Reported Device Performance |
|---|---|---|
| Chemical Properties | ISO7864 | Results conform to ISO7864 (Limits for acidity/alkalinity, extractable metals) |
| Sterility | USP | No microbial growth was observed, in line with USP requirements |
| Biocompatibility | ISO 10993-1, -4, -5, -10, -11, -12; FDA Blue Book #G95-1 | Evaluation meets the requirements for Cytotoxicity, endotoxin, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity |
| Needle Dimensions | ISO9626 | (Implied compliance, not explicitly stated as "conforms" but part of the comparison) |
| General Requirements | ISO7864 | (Implied compliance, part of comparison) |
| Small-Bore Connectors | ISO80369-7 | (Implied compliance, part of comparison) |
| Color Coding | ISO 6009 | (Implied compliance, part of comparison) |
| Packaging | ISO11607-1, ISO11607-2, ASTM F1980, ASTM F1929, ASTM F88 | (Implied compliance, part of comparison) |
| Sterilization Process | ISO11135 | (Implied compliance, part of comparison) |
| Labeling | 21 CFR Part 801 | Meets the requirements of 21 CFR Part 801 |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for the non-clinical tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective, though they are inherently prospective tests designed to prove compliance with standards for the device being submitted.
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 as the document describes non-clinical laboratory testing against established international standards, not studies involving expert evaluation for ground truth like in AI/ML performance testing.
4. Adjudication method for the test set:
This is not applicable. Laboratory tests against standards do not typically involve adjudication in the way AI/ML studies do (e.g., 2+1 reader consensus). The tests yielded objective physical, chemical, or biological results.
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:
This is not applicable. There is no AI/ML component described for the TK Sterile Hypodermic Needle, and thus no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established within the referenced international standards (e.g., ISO, ASTM, USP). For example, for sterility, the ground truth is the absence of microbial growth as detected by USP. For biocompatibility, it's the satisfactory outcome of specific biological tests as per ISO 10993.
8. The sample size for the training set:
This is not applicable. There is no AI/ML component, and therefore no training set.
9. How the ground truth for the training set was established:
This is not applicable. There is no AI/ML component, and therefore no training set or ground truth for it.
Summary of Study:
The studies described are non-clinical bench and lab tests performed to demonstrate that the TK Sterile Hypodermic Needle meets the safety and performance requirements of established international and national standards relevant to hypodermic needles. These tests include:
- Chemical properties inspection according to ISO7864.
- Sterility inspection according to USP.
- Biocompatibility evaluation according to ISO 10993 series and FDA Blue Book Memorandum #G95-1, covering tests like Cytotoxicity, endotoxin, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, and Pyrogenicity.
- Conformity to other design and performance standards such as ISO7864 (general requirements), ISO80369-7 (small-bore connectors), ISO 6009 (color coding), ISO9626 (stainless steel needle tubing), and packaging standards (ISO11607-1, ISO11607-2, ASTM F1980, ASTM F1929, ASTM F88).
- Compliance with sterilization process standards (ISO11135) and labeling regulations (21 CFR Part 801).
The conclusion of the submission is that the TK Sterile Hypodermic Needle is substantially equivalent to the predicate device (U&U Sterile Hypodermic Needle K132552) based on the comparison of technological characteristics and the non-clinical testing demonstrating compliance with relevant standards.
§ 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).