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510(k) Data Aggregation
(152 days)
Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe is intended for use in the 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 needle sticks.
Hypodermic Safety Needle: The Hypodermic Safety Needle is intended to be used with a 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 device is used for subcutaneous injection, intramuscular injection, intravenous injection of blood, and preparation of liquid medicine. The needle tube will be pushed into the safety cap after use. It is designed to aid in the prevention of needlestick injuries.
The device is a disposable anti-needle stick syringe made of the following components: Needle cap, Needle tube, Safety shield, Needle hub, Barrel, Plunger, Plunger stopper.
This document describes the premarket notification (510(k)) for the Hypodermic Safety Needle and Hypodermic Safety Needle with Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the way an AI/ML device would.
However, I can extract the information you've requested based on the regulatory submission's approach to performance and safety, interpreting the "acceptance criteria" as compliance with relevant international standards and the "study" as the non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | Meets all performance standards |
| ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods | Meets all performance standards |
| ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods | Meets all performance standards |
| ISO 594-1: Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 1: General requirements | Meets all performance standards |
| ISO 594-2: Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 2: Lock fittings | Meets all performance standards |
| ISO 23908: Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling | Meets all performance standards |
| ISO 6009: Hypodermic needles for single use - Color coding for identification | Meets all performance standards |
| ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Biocompatibility) | Conforms to ISO 10993-1 (No new testing performed as components unchanged) |
| ISO 11135:2014: Sterilization of health care products - Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices | Conforms to ISO 11135:2014 (No new testing performed as sterilization process unchanged) |
| AAMI TIR28:2016: Product adoption and process equivalence for ethylene oxide sterilization | Conforms to AAMI TIR28:2016 (No new testing performed as sterilization process unchanged) |
| Sterility Assurance Level (SAL) | 10^-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the performance testing. The "data provenance" for non-clinical performance testing would typically be from in-house or contracted laboratory testing conducted by the manufacturer (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in China). These are prospective tests designed to show compliance with the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device submission. The "ground truth" for these tests are the objective technical requirements and measurement methods defined by the international ISO standards. Compliance is determined by whether the device's measured performance falls within the specified limits of these standards, not by expert consensus on clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of device performance testing does not involve human adjudication in the way clinical diagnostic studies do. Compliance against standards is an objective measurement.
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 a conventional medical device (safety needle/syringe), not an AI/ML diagnostic or assistive device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a conventional physical medical device, not an algorithm or software. No standalone performance testing in this context was performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the objective technical requirements and test methods defined by recognized international standards (ISO standards). Device performance is measured against these established, quantitative benchmarks.
8. The sample size for the training set
Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a conventional medical device, not an AI/ML device.
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