MEDRAD VISTRON CT INJECTOR SYSTEM

K982814 · Medrad, Inc. · DXT · Oct 9, 1998 · Cardiovascular

Device Facts

• Record ID: K982814
• Device Name: MEDRAD VISTRON CT INJECTOR SYSTEM
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Oct 9, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

Programmable, syringe-based fluid delivery system for CT contrast media. Components: Injector Head, System Power Unit, Remote Monitor. Inputs: user-programmed injection parameters (volume, flow rate, pressure limit, scan delay) via keyboard/control panel. Operation: mechanical motor/plunger piston delivers fluid from 125ml or 200ml sterile disposable syringes. Features: syringe sensing, heater, autofill, multi-phase programming, remote start/hold. Used in clinical CT settings by healthcare professionals. Output: controlled contrast injection into patient vascular system. Safety: secondary microprocessor monitors electrical signals for over-volume, over-flow, and pressure/stall; hardware comparator for over-pressure; automatic stall termination. Benefits: precise, automated contrast delivery for diagnostic imaging.

Clinical Evidence

Bench testing only. No clinical data presented. Verification and validation testing performed to confirm compliance with design controls and safety standards including 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.

Technological Characteristics

Syringe-based fluid delivery system. Components: Injector Head, System Power Unit, Remote Monitor. Power: 110/220 VAC. Sensing: position encoder, syringe size/presence sensors. Heating: syringe heater (87.8°F to 105.8°F). Safety: secondary microprocessor monitoring, hardware pressure comparator, electrical stop. Connectivity: wired remote monitor (up to 100ft). Standards: IEC 601-1, IEC 601-1-2, IEC 1000 series, IEC 529, UL 2601, CSA C22.2 No. 601.1-M90.

Indications for Use

Indicated for delivery of intravenous contrast media into the human vascular system for diagnostic computed tomography (CT) studies. Prescription use only.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• Medrad EnVision CT Injection System (K934086)

Submission Summary (Full Text)

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MEDRAD VISTRON CT INJECTION SYSTEM 510(K) SUMMAR

August 7, 1998

K982814

| Official Contact: | Jan Dobscha, Senior Regulatory Affairs Coordinator<br>Medrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] 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

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.

- 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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- 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

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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<br>(New Device) | Medrad EnVision CT Injector<br>(K934086) |
|--------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Information Display | Large Colored LED's | Monochrome LCD |
| Programming Keys | Dedicated Function Keys | Non-Dedicated Keys - Software<br>Determined |
| Multi-Phase | 1 - 4 Phases Per Injection | 1 - 10 Phases Per Injection |
| Arming Modes | Single/Multi Arm | Single/Multi Arm |
| Protocol Storage<br>Capability | 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 Software<br>Backup System | Electrical Stop with a Software Backup<br>System |
| Syringe System | 200ml, 125ml | 200ml, 125ml |
| Programmed Volume | 10 to 125 ml or 10 to 200 ml<br>Depending on Syringe Size | 1 to 125 ml or 1 to 200 ml<br>Depending on Syringe Size |
| Volume Remaining<br>Readout | 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<br>(Settable for each injection during<br>programming only) | Variable .1 ml/sec to 9.9 ml/sec<br>(Settable for each injection during<br>programming 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 - Avg<br>minimum 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/sec<br>increments |
| 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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) ✓

OR

Over-The-CounterUse_

(Optional Format 1-2-96)