(204 days)
The device is indicated for local administration, and regional administration, specifically, wound infiltrations, peripheral nerve block, and epidural block. The device is not indicated for subarachnoid/spinal blocks.
The proposed device is a disposable neuraxial syringe consist of three components: piston, plunger and barrel; and provided in a variety of volumes: 1ml, 3ml, 6ml, 10ml, 30ml, 35ml, 50ml, 30ml and 60 ml. The barrel of the syringe is printed with graduated markings indicating the volume of liquid inside the barrel.
The proposed device is used to inject anesthesia medicine with the cooperation of the spinal anesthesia needles and epidural anesthesia needles which has an NRFit connectors in compliance with ISO 80369-6. The NRFit tip could help to reduce the residual risk of misconnections.
The proposed device is provided in two statuses: sterile. The non-sterile NRFit syringe is intended to be sterilized prior to use to repackagers/medical device manufacturers, and the sterile NRFit syringe is supplied to the end user. The sterilized product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
The acceptance criteria and device performance for the NRFit Syringe are detailed in Section 8 of the provided 510(k) summary (pages 5 and 6 of the document). The study demonstrating the device meets these criteria is referred to as "Non-Clinical Test Conclusion."
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is reported as conformity to the specified standards and their respective clauses/annexes.
| Individual Test Defined in ISO 80369-6 (for connectors) | Acceptance Criteria (Requirement Defined in ISO 80369-6) | Reported Device Performance |
|---|---|---|
| Fluid Leakage | Clause 6.1 | Conforms |
| Stress Cracking | Clause 6.3 | Conforms |
| Resistance to separation from axial load | Clause 6.4 | Conforms |
| Resistance to separation from unscrewing | Clause 6.5 | Conforms |
| Resistance to overriding | Clause 6.6 | Conforms |
| Individual Test Defined in ISO 7886-1:1993 (for syringes) | Acceptance Criteria (Requirement Defined in ISO 7886-1:1993) | Reported Device Performance |
|---|---|---|
| Cleanliness | Clause 5 | Conforms |
| Limits for acidity or alkalinity | Clause 6 | Conforms |
| Limits for extractable metals | Clause 7 | Conforms |
| Lubricant | Clause 8 | Conforms |
| Tolerance on graduated capacity | Clause 9 | Conforms |
| Graduated scale | Clause 10 | Conforms |
| Barrel | Clause 11 | Conforms |
| Piston/plunger assembly | Clause 12 | Conforms |
| Dead space | Clause 14.1 | Conforms |
| Freedom from air and liquid leakage past piston | Clause 14.2 | Conforms |
Additionally, the device was tested against and found to comply with the following standards:
- ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
- USP 39-NF34 Bacterial Endotoxins Test
- ISO 80369-20:2015 Small bore connectors for liquids and gases in healthcare applications- Part 20: Common test methods
- USP Particulate Matter in Injections (Method 1)
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each individual test. It indicates that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data (country of origin, retrospective or prospective) is not specified, but the submission is from Jiangsu Caina Medical Co., Ltd in China, suggesting the tests were likely conducted by or for them.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these non-clinical tests is established by the specifications of the referenced ISO and ASTM standards, not by expert consensus from medical professionals.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against established standard requirements, not subjective assessments requiring adjudication.
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 medical device (syringe) and not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (syringe) and not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests is based on engineering and performance specifications defined within internationally recognized standards (ISO, ASTM, USP). This includes measurable physical properties and biological safety limits.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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).