(45 days)
The Sterile Hypodermic Needles 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 a needle tube, needle hub and protective cap. The needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the color complies with ISO 6009.The protective cap is made of PP and does not contact the patient. The conical fitting of Sterile Hypodermic Needles For Single Use is a luer that can be used with other medical devices which have 6% conical fitting. It is provided sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials. And the Hypodermic Needles For Single Use are individually packaged in a sterile Sterile barrier.
This document is a 510(k) summary for a medical device (Sterile Hypodermic Needles for Single Use). It details the substantial equivalence of the proposed device to a predicate device, focusing on non-clinical performance and biocompatibility.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on compliance with a set of international and national standards, which dictate the performance and safety requirements for sterile hypodermic needles. The "reported device performance" is essentially the statement that the device complies with these standards.
Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Performance (Physical) | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | "The test results demonstrated that the proposed device complies with... ISO 7864:2016" |
| ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (Note: The document lists "Hypodermic needles for single use Colour coding for identification A" under 9626, but the predicate comparison correctly lists 9626:2016 as "Stainless steel needle tubing...") | "The test results demonstrated that the proposed device complies with... ISO 9626:2016" | |
| ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications | "The test results demonstrated that the proposed device complies with... ISO 80369-7:2021" | |
| ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods | "The test results demonstrated that the proposed device complies with... ISO 80369-20:2015" | |
| Sterilization | Sterilization Assurance Level (SAL) | 10^-6 (Same as predicate) |
| Ethylene Oxide (EO) Sterilization method | EO (Same as predicate) | |
| ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals | "The test results demonstrated that the proposed device complies with... ISO 10993-7:2008" | |
| Biocompatibility | ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (including Cytotoxicity, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity) | "The biocompatibility evaluation for the subject device was conducted in accordance with... ISO 10993-1," and "The evaluation of the above testing items meets the requirements." Test results demonstrated compliance with ISO 10993-4, -5, -10, -11. |
| Pyrogenicity (Non-pyrogenic) | Non-pyrogenic (Same as predicate) | |
| Particular Matter | USP : Particulate Matter for injection | "Conforms to USP : Particulate Matter for injection" and "Particulate testing per USP is required to ensure the safe clinical application." |
| Packaging/Sterile Barrier | ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials. (Sterility) | "The test results demonstrated that the proposed device complies with... ASTM F88/F88M-15" |
| ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration | "The test results demonstrated that the proposed device complies with... ASTM F1929-15" | |
| Labeling | 21 CFR Part 801 (General Labeling Requirements) - | "Meets the requirements of 21 CFR Part 801." (Same as predicate) |
Study Proving Device Meets Acceptance Criteria
The study conducted to prove the device meets the acceptance criteria is a non-clinical performance testing study. This type of study demonstrates equivalence by showing that the proposed device performs comparably to a legally marketed predicate device against established performance and safety standards.
1. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual test (e.g., how many needles were tested for seal strength, how many samples for biocompatibility). It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, for each listed standard (ISO, ASTM, USP), there are usually defined sample size requirements for the tests prescribed within that standard.
- Data Provenance: The document implies that the testing was performed by or for Zhejiang Kindly Medical Device Co., Ltd., based in Zhejiang Province, China. The testing appears to be retrospective, as it was completed before the 510(k) submission. No specific country of origin is mentioned for the data itself beyond the company's location.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: For this type of medical device (sterile hypodermic needles) and the nature of the non-clinical performance testing, "ground truth" is not established by human experts in the way it would be for AI/imaging diagnostics. Instead, the ground truth is defined by the objective, quantified pass/fail criteria outlined in the referenced international standards (e.g., flow rate requirements, needle stiffness, biocompatibility limits). The "experts" involved are presumed to be the qualified laboratory personnel conducting the tests and interpreting the results against the standard's specifications. Their qualifications are not explicitly stated.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None (Not Applicable): Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially for evaluating diagnostic performance (e.g., radiology reads where multiple experts might disagree). This non-clinical study relies on objective, measurable parameters against established standard criteria, so human adjudication in this sense is not relevant.
4. 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:
- No (Not Applicable): An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers interpret medical images or data. This submission is for a physical medical device (hypodermic needles), not an AI diagnostic tool. Therefore, no MRMC study was performed.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No (Not Applicable): This question also pertains to AI algorithm performance. A hypodermic needle does not involve an algorithm, nor does it have "human-in-the-loop performance" in the sense of a software-assisted task.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Standard-defined Objective Criteria: The ground truth for this device is based on the objective, measurable pass/fail criteria specified within the referenced international standards (ISO, ASTM, USP). For example, a needle must meet specific force requirements for penetration, sterility levels, or biocompatibility limits as defined by these standards. This is fundamentally different from a diagnostic ground truth (e.g., confirmed pathology diagnosis for an image).
7. The sample size for the training set:
- Not Applicable: This device is a physical product, not a machine learning model. Therefore, there is no "training set." The performance is validated through direct physical and chemical testing.
8. How the ground truth for the training set was established:
- Not Applicable: As there is no training set, this question is not relevant.
§ 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).