(30 days)
The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
The Vesco Medical NRFit Tip Syringes are sterile, single use devices consisting of rigid polypropylene barrels and plungers with a synthetic rubber gasket. The tips of the syringe barrels are NRFit ISO 80369-6 compliant. The NRFit tip allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrel is printed with graduated markings indicating, in milliliters, the volume of liquid inside the syringe barrel.
The document provides information on the non-clinical testing conducted for the Vesco Medical NRFit™ Tip Syringes to demonstrate substantial equivalence to predicate devices. Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Basic Syringe Functions | BS EN ISO 7886-1:1997 | In compliance. |
| Determination of Dead Space | BS EN ISO 7886-1:1997 | In compliance. |
| Liquid Leakage at Syringe Piston Under Compression | BS EN ISO 7886-1:1997 | In compliance. |
| Air Leakage Past Syringe Piston During Aspiration and for Separation of Piston and Plunger | BS EN ISO 7886-1:1997 | In compliance. |
| Fluid Leakage (Connector) | ISO 80369-20:2015 and ISO 80369-6 (for positive pressure fluid leakage) | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Stress Cracking (Connector) | ISO 80369-20:2015 and ISO 80369-6 | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to separation from axial load (Connector) | ISO 80369-20:2015 and ISO 80369-6 | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to separation from unscrewing (Connector) | ISO 80369-20:2015 and ISO 80369-6 | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to overriding (Connector) | ISO 80369-20:2015 and ISO 80369-6 | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Disconnection by unscrewing (Connector) | ISO 80369-20:2015 | (Implied met standards, as it is listed as performed during compliance testing for NRFit™ Tip Syringes) - no specific pass/fail noted, but overall conclusion points to compliance. |
| NRFit Dimensional Verification | ISO 80369-20:2015 and ISO 80369-6 for NRFit dimensional verification | Met the standards. The NRFit connector helps reduce the residual risk of misconnections. |
| Biocompatibility | ISO 10993-1:2009, with FDA modified matrix presented in General Program Memorandum # G95-1 | Same materials, manufacturer, manufacturing materials as primary predicate. (Claimed "Substantially equivalent" based on this). |
2. Sample Size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It only states that "Verification and validation Testing was performed with the Vesco Medical NRFit Tip Syringes."
The data provenance is from non-clinical tests performed by Jiangyin Caina Technology Co., Ltd and Vesco Medical. No country of origin is explicitly stated for the testing facilities within this document, though Jiangyin Caina Technology Co., Ltd is likely a Chinese company based on its name. These tests are non-clinical verification and validation studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is a series of non-clinical, laboratory-based performance tests against international standards (ISO). There are no "experts" establishing ground truth in the context of clinical or diagnostic performance; instead, the ground truth is defined by the technical specifications and criteria set forth in the ISO standards themselves.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically employed in studies where human interpretation or subjective assessment of data is involved (e.g., medical image interpretation). For objective physical and mechanical tests against ISO standards, the results are directly measured and compared to predefined pass/fail criteria.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aid devices, particularly those involving AI in image interpretation. The device in question, Vesco Medical NRFit™ Tip Syringes, is a physical medical device (syringe) and does not involve AI or human "readers" in its function or evaluation in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/software as a medical device. The Vesco Medical NRFit™ Tip Syringes is a physical device subject to physical and mechanical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these non-clinical tests is based on international standards and specifications (e.g., ISO 80369-6:2016, ISO 80369-20:2016, BS EN ISO 7886-1:1997). The device's performance is measured against the specific requirements and pass/fail criteria outlined in these standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of non-clinical performance testing for a physical medical device like a syringe. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device and study.
§ 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).