(59 days)
The Vistron CT Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for diagnostic studies in computed tomography.
The Medrad Vistron CT Injection System is a programmable, syringe-based fluid delivery system for delivery of contrast media during computed tomography procedures. The Vistron CT Injector is a modified version of the Medrad EnVision CT Injector. It has the same indications for use and the same intended use as the predicate device. No changes to the fundamental scientific technology were made nor are any new risks introduced by this modification.
The Vistron CT Injector is comprised of three main components - Injector Head, System Power Unit (SPU), and Remote Monitor (a.k.a. Intelligent Hand Unit). The Medrad Vistron CT Injector System, like the EnVision CT Injector System, uses a 125ml and 200ml Front Load Sterile Disposable Syringe.
The MEDRAD VISTRON CT INJECTION SYSTEM is a syringe-based fluid delivery system for contrast media during computed tomography procedures. The relevant sections of the 510(k) summary do not explicitly define specific numerical acceptance criteria for performance metrics (such as accuracy of volume or flow rate delivery) with corresponding measured device performance in a tabular format. Instead, the document discusses that the device is a modified version of a predicate device (Medrad EnVision CT Injection System) and that the design controls and validation testing support its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with explicit numerical acceptance criteria and corresponding reported device performance values. It generally states that "Testing also demonstrated that the Vistron CT Injection System met the applicable requirements of the following standards: IEC 601-1, IEC 601-1-2, IEC 1000-4-6, IEC 1000-4-8, IEC 1000-4-11, IEC 1000-3-2, IEC 1000-3-3, IEC 529, UL 2601, and CSA C22.2 No. 601.1-M90." Compliance with these standards is the overarching acceptance criterion, but the specific performance parameters and their achieved values are not detailed.
However, the document lists several functional features and technological characteristics of the new device and compares them to the predicate device. While not "acceptance criteria" in the traditional sense of a specific performance threshold, these define the expected operational ranges and capabilities.
| Feature | Acceptance/Expected Range (Based on Design) | Reported Device Performance (Implied by equivalence and standards compliance) |
|---|---|---|
| Programmed Volume | 10 to 125 ml or 10 to 200 ml depending on syringe size | Meets programmed volume within acceptable limits (implied by standards) |
| Programmed Flow Rate | 0.1 ml/sec to 9.9 ml/sec (settable in 0.1 ml/sec increments) | Meets programmed flow rate within acceptable limits (implied by standards) |
| Pressure Limiting | 50 psi to 300 psi (increments of 50 psi) | Operates within pressure limits and provides alerts/terminates injection (implied by standards) |
| Injection Profile Phases | 1 - 4 Phases Per Injection | Functions as programmed with 1-4 phases |
| Hold Capability | 0 - 600 seconds (temporarily interrupt injection) | Functions as programmed with hold capability |
| Scan Delay | 0-99 seconds | Functions as programmed with scan delay countdown |
| Autofill Fill Rate | Fixed at 2 ml/sec | Fills at fixed 2 ml/sec rate |
| Syringe Sensing | Determines 125ml or 200ml syringe size; senses proper installation | Accurately senses syringe size and installation |
| Syringe Heater Temperature | Maintains 87.8° to 105.8°F | Maintains temperature within specified range |
| Safety Stop Mechanism | Electrical Stop with a Software Backup System (over-volume, over flow rate, pressure/stall) | Functions to stop injection upon detection of unsafe conditions |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "As part of the design control a risk analysis was performed, and design verification and validation testing was conducted to support the conclusion drawn by the risk analysis." However, it does not provide details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). Given the device type (injection system), the testing would likely involve bench testing and simulated use, rather than human patient data in the context of this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the 510(k) summary. For a device like an injection system, "ground truth" often refers to engineering specifications and performance benchmarks established by the manufacturer and validated through rigorous testing. Technical experts involved in design validation would be engineers and quality assurance personnel, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
This information is not provided as it's not typically relevant for the type of device and testing described in this 510(k) where the focus is on meeting engineering specifications and safety standards. Adjudication methods (like 2+1, 3+1 expert consensus) are more common in studies involving subjective assessments of medical images or diagnoses, which is not the case here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance to measure improvements in diagnostic accuracy. The Medrad Vistron CT Injection System is an active medical device for contrast media delivery, not an imaging interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of "standalone performance" typically applies to AI algorithms. The Medrad Vistron CT Injection System is an electromechanical device with embedded software. Its performance is inherently "standalone" in mechanical and electrical functions (e.g., delivering a specific volume at a specific flow rate) without continuous human intervention during the injection phase, but it absolutely requires human operators for setup and monitoring. The entire system's performance, including its automated features, was tested.
7. The Type of Ground Truth Used:
For this device, the "ground truth" would be established by engineering specifications and validated measurement techniques. This means:
- Physical Measurements: Using calibrated instruments to verify delivered volume, flow rate, pressure, temperature maintenance, etc., against predefined engineering targets.
- Functional Testing: Verifying that all programmed features (e.g., scan delay, hold, autofill, safety stops) operate as intended and within specified tolerances.
- Compliance with Standards: Adherence to the listed international and national safety and performance standards (IEC, UL, CSA).
8. The Sample Size for the Training Set:
This information is not applicable in the context of this device and associated documentation. The Medrad Vistron CT Injection System is an electromechanical device, and while it contains software for control and user interface, it is not an AI/ML-based device that would undergo a "training" phase with a dataset in the way a machine learning model does.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not an AI/ML system requiring a training set with ground truth in the typical sense. The "ground truth" for its development would be the engineering requirements and validated performance standards used during its design and verification process.
§ 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.