(258 days)
Jung Rim single use hypodermic syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The Single use hypodermic Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The product consists of a Barrel, Piston, Gasket, Needle Needle cap. The Single use hypodermic Syringe with Needle are offered various sizes (Luer slip (1.3.5,10,20,30,50 (ml)), and Needle size (16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G) Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users. These are sterile (Eo gas sterilization). The devices are disposable, single use devices.
The Jung Rim Medical "Jung Rim single use hypodermic Syringe with Needle" is a medical device intended for injecting or withdrawing fluids from the body. The acceptance criteria and the study verifying these criteria are detailed below:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material/Design Conformance: | |
| ISO 7886-1 (Syringes for single use - Part 1: Syringes for manual use) | Successfully met |
| ISO 7864 (Sterile hypodermic needles for single use) | Successfully met |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Successfully met |
| ISO 6009 (Hypodermic needles - Colour coding for identification) | Successfully met |
| ISO 594-1 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements) | Successfully met |
| Biocompatibility: | |
| ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) for devices categorized as External communicating devices, Limited exposure. | Successfully passed |
| Sterilization: | |
| ISO 11135 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) - using half-cycle method. | Validated using half-cycle method. |
| ISO 10993-7 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals) - maximum levels of residues of ethylene oxide and ethylene chlorohydrins. | Will not exceed limits presented. |
| Shelf-life: | |
| Testing to support shelf-life of 5 years after sterilization. | Supports a shelf-life of 5-years after sterilization. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test outlined (ISO7886-1, ISO7864, etc.). It generally states that the device was "successfully tested" to meet the applicable requirements.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective, beyond the fact that no prospective clinical trials were conducted.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This section is not applicable. The study involves performance testing against international standards for medical devices (syringes and needles), not a diagnostic or AI device where expert ground truth would be established for image or data interpretation. The ground truth for this device is the adherence to established engineering and material standards.
4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish a ground truth, such as in medical image analysis. For device performance testing against ISO standards, the results are typically quantitative and objectively measured against predefined thresholds, not subject to expert adjudication in this manner.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools where human readers interpret data with and without AI assistance. The Jung Rim Medical device is a physical medical instrument (syringe and needle), and thus an MRMC study is not applicable.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. The device is a physical medical instrument, not an algorithm or AI system. Therefore, performance testing for an algorithm is not relevant.
7. Type of Ground Truth Used:
The ground truth used for this device's evaluation is international standards and regulations (e.g., ISO7886-1, ISO7864, ISO9626, ISO6009, ISO594-1, ISO10993-1, ISO11135, ISO10993-7). The device's performance was measured against the specific requirements and specifications detailed within these standards to ensure safety and effectiveness.
8. Sample Size for the Training Set:
This section is not applicable. The device is a physical medical apparatus, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the reasons stated in point 8.
§ 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).