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510(k) Data Aggregation
(78 days)
MEDRAD VISTRON CT INJECTOR SYSTEM
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 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 predicate Vistron CT Injector System, uses a 125ml and 200ml Front Load Sterile Disposable Svringe. The only difference is that the modified Injector accommodates the use of an alternate 200ml contrast pre-filled syringe, and it now has an Imaging System Interface.
The Medrad Vistron CT Injection System is a programmable, syringe-based fluid delivery system for the delivery of contrast media during computed tomography procedures. The modified device accommodates an alternate 200ml contrast pre-filled syringe and now has an Imaging System Interface.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the functional features of the Medrad Vistron CT Injection System and compares it to a predicate device (Medrad Vistron CT Injection System, K982814). The acceptance criteria are implied by the functional specifications that state the system performs as described or matches the predicate device.
| Feature | Acceptance Criteria (Modified Device) | Reported Device Performance |
|---|---|---|
| Programmed Volume | 10 ml to 125 ml or 10 ml to 200 ml depending on syringe size. | The volume of contrast medium delivered is settable for each phase of the injection profile. Range is 10 ml to 125 ml or 10 ml to 200 ml depending on the size of syringe used. |
| Programmed Flow Rate | 0.1 ml/sec to 9.9 ml/sec, settable in 0.1 ml/sec increments for each phase. | The flow rate is the ratio of fluid volume delivered to the injection duration (ml/sec) and is settable, in 0.1 ml/sec increments, for each phase of the injection profile. Range is 0.1 ml/sec to 9.9 ml/sec. |
| Pressure Limiting | Settable from 50 psi to 300 psi in 50 psi increments. Injection proceeds at reduced flow or terminates on stall. | System has a settable pressure limit, range 50 psi to 300 psi with increments of 50 psi. If reached, injection proceeds at reduced flow or terminates on stall. User alerted via audible beeps and indicator light. |
| Program Parameters | User can program fluid volume, flow rate, injection duration, pressure limit, phase/level, and scan delay. | The user can program the injector with fluid volume, flow rate, injection duration, pressure limit value, program phase/level, and scan delay parameters. |
| Injection Profile | Sequence of one or more phases, up to a maximum of 4. | The user can program a sequence of one or more program phases, up to a maximum of 4, in which each phase delivers fluid according to the program parameters defined for that phase. |
| Hold Capability | Remains armed, injection stops when enabled, resumes when cancelled. Max 10 minutes, then disarms. | "Hold" allows the user to temporarily interrupt an injection. System remains armed, injection stops until cancellation, then resumes. Remains in "Hold" for max 10 minutes, after which unit disarms, audible beep, message displayed. |
| Scan Delay | 0-99 seconds. Audible beep and countdown clock at 0. | "Scan Delay" is a function user can program (0-99 seconds). Interval begins simultaneously with first phase. Visible countdown clock (1 second increments). Audible beep when countdown reaches 0. |
| Autofill | Load specified amount (25, 50, 75, 100, 125, 150, 175, or 200ml) at 2ml/sec. Non-functional with alternate 200ml syringe. | "Autofill" allows the user to load a specified amount of fluid into a syringe (25, 50, 75, 100, 125, 150, 175, or 200ml depending on syringe size). Fill rate fixed at 2ml/sec. Non-functional when an alternate 200ml syringe is installed. |
| Single/Multi Arm | Single Arm: executes once, then disarms. Multi Arm: repeats without re-arming until insufficient contrast. | User can select "Single Arm" (single injection, then disarms) or "Multiple Arm" (repeats programmed injection without re-arming until insufficient contrast). Alerts user if insufficient volume for full injection. |
| Syringe Sensing | Determines syringe size (125ml, 200ml, alternate 200ml) and proper installation. Adjusts parameters, error message if not installed. | "Syringe Sensing" determines which compatible Medrad syringe size (125ml, 200ml cr an alternate 200ml contrast prefilled syringe) is installed and senses proper installation. Adjusts pressure, volume, flow. Issues error message if improperly installed. |
| Syringe Heater | Maintains preheated contrast medium temperature within 87.8° to 105.8°F. | Maintains the temperature of preheated contrast medium within the syringe from 87.8° to 105.8°F. |
| Safety Stop | Continuously monitors critical functions, secondary microprocessor checks for over-volume, over-flow, pressure/stall, hardware comparator for over-pressure. Opens relay to cut power, enters maintenance state. | All critical system functions continuously monitored. Secondary microprocessor monitors for over-volume, over flow rate, and pressure/stall; hardware comparator for over-pressure. Opens relay to cut power, maintenance state. |
| Retract Control | Returns piston to fully retracted. Operates only when syringe is detached. | Control provided to return the piston to its fully retracted station. Only operational when the syringe is detached. Syringe Sensing detects syringe presence. |
| Imaging System Interface (ISI) | Interconnects Injector Head and Remote Monitor, provides isolated interface with CT Scanner. Receives inputs from CT to initiate/stop, controls outputs to activate scan. Verifies functionality. | Resides in SPU, acts as interconnect for Injector Head and Remote Monitor. Provides isolated interface with CT Scanner. One input (two signal lines), one output (three signal lines). Controlled by Remote Controller. Receives CT inputs to initiate/stop injection, controls outputs to activate scan. Verifies input/output signals. |
| Syringe System Accommodation | 200ml, 125ml, Alternate 200ml | The only difference is that the modified Injector accommodates the use of an alternate 200ml contrast pre-filled syringe. (Also 125ml and 200ml Front Load Sterile Disposable Syringe) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "design verification and validation testing was conducted" and "Test results concluded that the design specifications for the Vistron CT Injection System were met." However, it does not provide details on the sample size used, the specific tests performed, or the provenance of any data (e.g., country of origin, retrospective or prospective). It only states that these tests were conducted as part of design controls in compliance with FDA's Quality System Requirements.
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 document. The testing described appears to be engineering verification and validation against technical specifications rather than clinical performance evaluation requiring expert ground truth in the traditional sense of medical image analysis.
4. Adjudication Method for the Test Set
This information is not provided in the document. As noted above, the testing appears to be technical validation, not a multi-expert clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes technical verification and validation of a medical device, focusing on its functional specifications and safety, not on human reader performance with or without AI assistance. The device itself is an injector system, not an AI or imaging diagnostic tool that would typically be evaluated with MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a contrast injection system with no "algorithm only" component that would perform diagnostic or analytical tasks independently. Its "intelligence" is in its programmable features and safety mechanisms, which assist human operators. The testing performed would be considered standalone in the sense that the device's technical functions were verified, but not in the context of an AI algorithm's performance.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is the engineering design specifications and recognized industry standards. The device's performance was compared against these predefined criteria (e.g., flow rate, pressure limits, temperature range, correct syringe sensing, safety stop functionality). This is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is an electro-mechanical system with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software operates based on predefined logic and parameters, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as #8. There is no training set for this type of device. The software "logic" is established through design and programming based on functional requirements and safety considerations.
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(59 days)
MEDRAD VISTRON CT INJECTOR SYSTEM
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.
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