(186 days)
For use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes.
The 200mL Syringe for Stellant Injectors are syringes / kits intended for use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes. Each configuration is listed below in the "Models"section and provided sterile. To further define the device, the kits may include (depending on package configuration) extension lines, fill tubes, prime tubes, and spikes. The extension lines are used to connect the svringe to a patient's IV. The prime tube is used for catching fluid while purging air from the extension line. The fill tubes and spikes are used to connect the syringe to contrast media or saline containers for filling. The Fascia (installed on the surface of the injector case and through which the ram/ram tip moves) and the RamTip (connected to the injector ram and to which the syringe is connected), used in adapting the Medrad* Stellant* Injector for use with the Coeur 200mL Syringe for Stellant Injectors are not sterile, and after installation onto the injector, remain installed as long as the Coeur 200mL Syringe for Stellant Injectors is used with the injector. (Cleaning instructions for the Fascia and Ram Tip are provided in the IFU.)
Principle of operation- The syringe plunger is engaged by the equipment ram and moved forward and back for filling and injection purposes.
The provided text is a 510(k) summary for the Coeur 200mL Syringe for Stellant Injectors. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about an AI/ML powered device, a multi-reader multi-case (MRMC) comparative effectiveness study, or details about ground truth establishment as would be relevant for such a device.
Here's an analysis based on the information provided, focusing on what can be extracted and noting what cannot, given the nature of the device (a syringe, not an AI system):
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present acceptance criteria and device performance in a formal table format as requested, nor does it define acceptance criteria in numerical targets. Instead, it lists the types of nonclinical tests performed and states that the product conforms to various standards or functions as intended. Since this is a mechanical device, performance is typically assessed against engineering specifications and international standards rather than AI-specific metrics like AUC, sensitivity, or specificity.
| Test Type | Standard/Requirement | Reported Performance |
|---|---|---|
| Visual Verification | Conformance to visual requirements | Inspection of the product for conformance to visual requirements |
| Dimensional Evaluation | Conformance to Coeur drawing specifications | Inspection of the product to verify dimensional acceptance |
| ISO 594-2:1998 | Liquid leakage, air leakage, separation force, ease of assembly, resistance to overriding, and stress cracking | Evaluation to applicable requirements of the ISO 594 standard |
| ISO 7886-2 | Cleanliness, limits for acidity and alkalinity, limits for extractable metals, lubricant, tolerance on graduated capacity, graduated scale, piston plunger assembly, and nozzle | Evaluation to applicable requirements of the ISO 7886-2 standard |
| Injector Fit Evaluation | Fit with Medrad® Stellant® Injector | Evaluation of syringe, fascia and ram tip for fit with the Medrad® Stellant® Injector |
| Volume Evaluation | Accuracy of volume | Evaluation of volume accuracy |
| Functional Testing (Syringe/Fascia/Ram Tip) | Function with Medrad® Stellant® Injector | Functional testing was conducted to evaluate function with the Medrad® Stellant® Injector |
| Pressure Testing (Syringe) | 400 psi for 10 seconds | Syringe held at 400psi for 10 seconds |
| Pressure Testing (Extension Line) | 400 psi for 2.5 minutes | Extension Line held at 400psi for 2.5 minutes |
| Pull Testing (Extension Lines) | Correct assembly and bonding process | Conducted to verify correct assembly and bonding process |
| Functional Testing (Spike) | Ability to connect, allow fluid flow | Evaluated ability to connect to syringe, bottle port, bag, and allow fluid flow |
| Age Verification | Maintain performance for 1 year | Leveraged 1-year expiration from similar marketed devices and included aging study |
| Biocompatibility | Suitability for intended purposes | All test results indicate suitability of materials per ISO 10993-1 guidance |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each nonclinical test (e.g., how many syringes were pressure tested). It refers to "inspection of the product," "evaluation of product," and "functional testing" without providing the number of units tested. This is standard for a 510(k) for a mechanical device, where testing often involves a statistically determined sample or a representative sample.
Data provenance is not applicable here as the "performance data" refers to in-house laboratory testing of the physical syringe components, not clinical data from patients. There's no country of origin for "data" in the sense of patient records, nor is it retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical syringe, not an AI/ML device relying on expert-annotated ground truth. "Ground truth" in this context would likely refer to engineering specifications and measurements performed by qualified technicians.
4. Adjudication method for the test set
Not applicable. There is no adjudicated "ground truth" for this type of mechanical device testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those using AI, to compare human performance with and without AI assistance. This document is for a medical syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
Not applicable in the AI/ML context. For a syringe, "ground truth" corresponds to established engineering specifications, international standards (ISO 594-2, ISO 7886-2), and the physical properties of the materials. Performance is verified against these objective, predetermined values.
8. The sample size for the training set
Not applicable. There is no training set for a mechanical syringe.
9. How the ground truth for the training set was established
Not applicable. There is no training set or associated ground truth for a mechanical syringe.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.