(543 days)
Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Single use Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions.
The device has three model with the following:
(1) Single use Needle (108 model codes including Sofjec-16-13)
Single use Needle consist of Cap, Needle and Hub and Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization.
(2) Single use Syringe with Needle (1734 model codes including HJ-1-16G-13)
Single use Syringe with Needle consist of Syringe, Cap, Needle and Hub and Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization and the syringes are two type of Luer Slip and Luer Lock. These device are injecting the medicine with syringes. This device is finished biocompatibility test and performance test for safety.
(3) Membrane Filter Syringe (16 model codes including HJM-18-1)
This devices are consists of membrane filter needle and syringe. Membrane filter needle is attached 0.5nm filtration membrane (Acrylic copolymer material). Syringe is two type. (Luer slip type and Luer lock type) This device is Filtering with syringes and injection device is finished biocompatibility test and performance test for safety.
This document is a 510(k) premarket notification for medical devices (syringes and needles), which primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain the kind of acceptance criteria and performance study details typically found for novel AI/ML medical devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement in ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not present in this document.
This document details the following aspects relevant to the device clearance:
1. Acceptance Criteria and Device Performance:
- The document does not specify quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML device.
- Instead, the "acceptance criteria" are compliance with established international standards for medical devices of this type. The "reported device performance" is the statement that the device "Complied with" these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7886-1:2017: Sterile Hypodermic Syringes | Complied with |
| ISO 7864:2016: Sterile Hypodermic Needles | Complied with |
| ISO 9626:2016: Stainless steel needle tubing | Complied with |
| ISO 80369-7:2016: Small-bore connectors | Complied with |
| ISO 10993-1: Biocompatibility | Complied with |
| USP : Particulate Matter | Met USP acceptance criteria |
| ASTM F1980: Accelerated Aging (for shelf-life) | Complied with (3-year shelf life) |
| EN ISO 11135: Ethylene Oxide Sterilization | Complied with |
| ISO 10993-7: Ethylene Oxide sterilization residuals | Complied with |
| USP , : Pyrogen Test (Endotoxin) | Complied with (Endotoxin) |
| ISTA 2017 2A: Simulated transportation test | Complied with (Integrity Test) |
2. Sample Size and Data Provenance:
- This document does not refer to "test sets" or "training sets" in the context of AI/ML models. The performance assessment is based on physical and chemical testing of the devices themselves, performed according to the listed ISO and USP standards.
- The data provenance is from the manufacturer's internal testing as part of their regulatory submission for a physical medical device (needles and syringes), not AI/ML data. The manufacturer is Hwajin Medical Co., Ltd. from South Korea. The studies are non-clinical (laboratory/bench testing) and not specifically "retrospective" or "prospective" in the same sense as clinical trials or AI/ML data collection.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. Ground truth, in this context, refers to the established standards and test methods for physical properties and biocompatibility of medical devices. There are no "experts establishing ground truth" in the sense of image annotation or clinical diagnosis for an AI/ML model. The "experts" would be the scientists and engineers who developed and performed the standard tests to verify compliance.
4. Adjudication Method:
- Not applicable. There is no human interpretation or adjudication process described as it would be for an AI/ML diagnostic output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done, as this is a submission for a physical medical device (syringe/needle), not an AI/ML diagnostic aid. Therefore, there is no effect size of human readers improving with AI assistance.
6. Standalone Performance:
- Not applicable. This is a physical device, so the concept of "algorithm only without human-in-the-loop performance" does not apply. The device's "standalone" performance is its ability to meet the defined ISO and USP standards.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is compliance with internationally recognized medical device performance standards (ISO, USP, ASTM, EN), and biocompatibility testing results. It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device, so there is no "training set." The product development and manufacturing processes conform to quality system regulations.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reason as above.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).