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.

Device Description

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.

AI/ML Overview

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.

Summary

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MEDRAD VISTRON CT INJECTION SYSTEM 510(K) SUMMAR

August 7, 1998

K982814

Official Contact:	Jan Dobscha, Senior Regulatory Affairs CoordinatorMedrad, Inc.One Medrad DriveIndianola, PA 15051(412) 767-2400 ext. 3280
Classification:	Injector with Syringe, Angiographic
Common/Usual Name:	Powered Injector with Syringe
Proprietary Name:	Medrad Vistron CT Injection System
Predicate Device:	Medrad EnVision CT Injection System (K934086)

Device Description:

Technical Description: Medrad, Inc.

· Medrad Drive

15051-0780

:12) 767-2400

SYSTEM POWER UNIT (SPU) The System Power Unit houses the injector's main power . supply. It receives 110/220 VAC input and distributes power to the Injector Head via the Injector Head cable and to the Remote Monitor.
INJECTOR HEAD The Injector Head is the main user interface. It is the main point of user data entry and display feedback data. It contains the mechanical subsystem (motor and plunger piston) that delivers fluid through an attached syringe. It also consists of the syringe interface, position encoder, syringe position/size sensors, user display/control interface, electronic controls, and safety circuits. The syringe heat maintainer and the hand held startswitch connect externally to the head.

The Injector Head processes keyboard inputs from the hard keys on the control panel, It displays injection parameters and operating Remote Monitor, or hand held startswitch. information on the control panel's LEDs, and processes handswitch input. It also provides a standby switch which places the system in a standby mode; that is, it disables power to functional system components but keeps power supplied to all system microprocessors.

REMOTE MONITOR (a.k.a. Intelligent Hand Unit) The purpose of the Remote Monitor is to allow the operator to interact with the Injector Head without being near the Head. It permits the operator to view two phases of the injector's programmed parameters and to control the injector's Start/Hold and Disarm functions. The Remote Monitor provides LED readouts to display Scan Delay, Injected Volume, Injection, Phase, Flow Rate, and Volume information. It connects to the System Power Unit by means of an integral cord set. It can be placed up to 100 feet from the System Power Unit.

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Image /page/1/Picture/0 description: The image shows the word "MEDRAD" in a stylized, bold, sans-serif font. The letters are all capitalized and appear to be slightly slanted to the right. A small circled "R" symbol, indicating a registered trademark, is present to the upper right of the letter "D".

MANUAL STARTSWITCH A hand-held push button handswitch, connected to the Injector . Head via a cable, allows the operator to initiate, suspend, or resume a programmed injection.

Functional Features:

The volume of contrast medium delivered is settable for each phase Programmed Volume of the iniection profile. The range is 10 ml to 125 ml or 10 ml to 200 ml depending on the size of syringe used.

The flow rate is the ratio of fluid volume delivered to the injection Programmed Flow Rate duration (ml/sec) and is settable, in 0.1 ml/sec increments, for each phase of the injection profile. The range is 0.1 ml/sec to 9.9 ml/sec.

The system has a settable pressure limit. The range is 50 psi to 300 Pressure Limiting psi with increments of 50 psi. In the event of a pressure limit being reached, the injection will proceed at a reduced flow rate until the programmed volume has been delivered, unless a stall condition occurs: A stall condition will automatically terminate the injection. The user is alerted via audible beeps and an indicator light on the Injector Head control panel.

The user can program the injector with fluid volume, flow rate, Program Parameters injection duration, pressure limit value, program phase/level, and scan delay parameters.

Injection Profile 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" allows the user to temporarily interrupt an injection. When the user Hold enables the "Hold" function, the system remains armed, but the injection stops until the user cancels the hold function, whereupon the injection resumes from the point at which it was interrupted. The injector will remain in the "Hold" condition for a maximum of ten minutes, after which the unit disarms, an audible beep is emitted and a message is displayed on the Iniector Head and Remote Monitor.
Scan Delay "Scan Delay" is a function that the user can program into the injection profile to indicate to the user that thev should begin the scan. The "Scan Delay" interval begins simultaneously with the first phase of the injection profile. The interval duration can be set from 0 seconds to 99 seconds. A visible "Scan Delay" countdown clock, which shows the time remaining in 1 second increments, is located on the Injector Head control panel and Remote Monitor. When the countdown clock reaches 0 an audible beep emitted from the Injector Head and Remote Monitor alerts the user.
"Autofill" allows the user to load a specified amount of fluid into a syringe by Autofill actuating a control on the Iniector Head. Once the "Autofill" control is activated the head will load the specified amount of fluid into the syringe without further operator interaction. The user may select volumes of 25, 50, 75, 100, 125, 150, 175, or 200ml depending on the syringe size used. The fill rate is fixed at 2ml/sec.
Single/Multi Arm The user can select one of two arming modes. "Single Arm" allows the execution of a single injection profile after pressing the start switch. After the programmed injection has been completed, the unit disarms. "Multiple Arm" allows the programmed injection to be repeated without re-arming the injector. After completing its programmed injection, the injector remains in the armed state. The user can press the Start switch again to repeat the same programmed injection. Repeated activation of the Start switch will

Image /page/1/Picture/12 description: The image shows a logo with the letter 'Q' at the top. Below the 'Q', the word 'Quality' is written in a smaller font size. The logo appears to be for a company or organization that emphasizes quality.

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deliver the programmed injection until there is insufficient contrast media in the syringe to complete a full injection. At this point, the injector will inform the user, by flashing the Volume Remaining display, that there is insufficient volume for another injection. The operator is permitted to complete the injection with less than the programmed volume available in the syringe.

"Syringe Sensing" is a system on the injector head that determines which of Syringe Sensing the two compatible Medrad syringe sizes (125ml or 200ml) is installed on the injector head, and also senses whether or not the syringe has been installed properly. After determining the size of the syringe that has been installed, the iniector adjusts its pressure, volume and flow characteristics accordingly. If the syringe has not been properly installed, the injector issues an error message on the Injector Head control panel alerting the user that the syringe is not correctly installed.
Svringe Heater The Syringe heater maintains the temperature of preheated contrast medium within the syringe while the syringe is attached to the Injector. The heater operating temperature range is 87.8° to 105.8°F.
Safety Stop All critical system functions are continuously monitored during an injection to insure that the actual injection values do not deviate from the programmed values beyond a specified limit. A secondary microprocessor in the Injector Head constantly monitors the electrical signals of the injector system. It monitors for over-volume, over flow rate, and pressure/stall; a hardware comparitor circuit monitors for over-pressure. When the backup monitoring system detects one of these conditions, it will open a relay to cut power to the piston motor and the injector system is placed in a maintenance state.
Retract Control A control provided to return the piston to its fully retracted station. A single touch of a button is required to activate and complete this operation. This function is only operational when the syringe is detached from the injector system. The Syringe Sensing system detects whether or not a syringe is in place.

Intended Use:

The Vistron CT Injection System is a svringe-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.

Image /page/2/Picture/8 description: The image shows a logo with a stylized letter 'Q' that forms a circular arrow, suggesting a cycle or continuous process. Below the 'Q', the words 'Quality' and 'of Life' are stacked vertically. The logo appears to represent a concept related to improving or maintaining the quality of life through a cyclical or ongoing effort.

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Technological Characteristics:

Feature	Medrad Vistron CT Injector(New Device)	Medrad EnVision CT Injector(K934086)
Information Display	Large Colored LED's	Monochrome LCD
Programming Keys	Dedicated Function Keys	Non-Dedicated Keys - SoftwareDetermined
Multi-Phase	1 - 4 Phases Per Injection	1 - 10 Phases Per Injection
Arming Modes	Single/Multi Arm	Single/Multi Arm
Protocol StorageCapability	Stores last protocol used	50 Protocols
Hold Capability	0 - 600 seconds	0 - 600 seconds
Scan Delay	0-99 seconds	0 - 99 seconds
Safety Stop Mechanism	Electrical Stop with a SoftwareBackup System	Electrical Stop with a Software BackupSystem
Syringe System	200ml, 125ml	200ml, 125ml
Programmed Volume	10 to 125 ml or 10 to 200 mlDepending on Syringe Size	1 to 125 ml or 1 to 200 mlDepending on Syringe Size
Volume RemainingReadout	LED	LED
Fill Rate	2 ml/sec	2 ml/sec to 9.9 ml/sec
Flow Rate	Settable .1 ml/sec to 9.9 ml/sec(Settable for each injection duringprogramming only)	Variable .1 ml/sec to 9.9 ml/sec(Settable for each injection duringprogramming and during injection.)
Pressure Limit	Settable from 50 to 300 PSI	Settable from 25 to 300 PSI
Pause	No	Programmable - 1 sec to 10 min
KVO	No	Continuous or Intermittent - Avgminimum flow rate of .6 ml/sec
Autofill	Fill rate fixed at 2 ml/sec	Fill rate 2 ml/sec to 9 ml/sec in 1 ml/secincrements
Retract Control	Yes	Yes
Remote Start Switch	Yes	Yes

Supporting Data:

Medrad has established, as part of its Quality System, design controls in compliance with FDA's Quality System Requirements. These design controls are applied to all Medrad product development processes and product design changes. These design controls were applied to the development of the Vistron CT Injector and meet the requirements of the FDA's QSRs.

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.

Conclusion:

The results of the risk analysis concluded that the modifications to the EnVision CT Injector did not introduce any new or additional risks relative to the use of this device. 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. Therefore, it has been determined that the Vistron CT Injection System is safe and effective for its intended use when used as prescribed in the User Operation Manual.

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OCT - 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jan E. Dobscha Regulatory Affairs Coordinator Medrad, Inc. One Madrad Drive Indianola, PA 15051

Re: K982814 Trade Name: Medrad Vistron CT Injection System Requlatory Class: II Product Code: DXT Dated: September 11, 1998 Received: September 14, 1998

Dear Ms. Dobscha:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act

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Paqe 2 - Ms. Jan E. Dobscha

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation wo (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory -Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

K982814 510(k) Number:

Device Name: Medrad Vistron CT Injection System

Indications for Use/Intended Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Ringer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-CounterUse_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.