(78 days)
Not Found
No
The document describes a programmable fluid delivery system for contrast media injection during CT scans. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis that would indicate the use of AI/ML technology. The modifications mentioned are related to syringe compatibility and an imaging system interface, not advanced algorithms.
No
The device is used to deliver contrast media for diagnostic studies (computed tomography), not for treating a disease or condition.
No
The device is an injection system for delivering contrast media, which aids in diagnostic studies, but it does not perform the diagnostic imaging or analysis itself.
No
The device description explicitly states it is comprised of three main hardware components: Injector Head, System Power Unit (SPU), and Remote Monitor. It also mentions the use of syringes. This indicates it is a hardware-based medical device with software control, not a software-only device.
Based on the provided information, the Vistron CT Injection System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of contrast media during computed tomography applications" and for "injecting intravenous contrast medium into the human vascular system for diagnostic studies in computed tomography." This describes a device used in vivo (within the living body) to facilitate imaging, not a device used in vitro (outside the living body) to examine specimens like blood, urine, or tissue.
- Device Description: The description focuses on the mechanical and electronic components for fluid delivery, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples, detect specific substances in samples, or provide diagnostic information based on the analysis of samples.
Therefore, the Vistron CT Injection System is a medical device used in conjunction with a diagnostic imaging modality (CT) to enhance the visualization of anatomical structures, but it does not perform in vitro diagnostic testing itself.
N/A
Intended Use / 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.
Product codes
DXT
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 Vistron 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 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.
- 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. The SPU has essentially been unchaged from the predicate device. The only change is that it now also contains circuitry for the imaging system interface. (See description below)
- 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/controlinterface, electronic controls, and safety circuits. The syringe heat maintainer and the hand held startswitch connect externally to the head.
The Iniector Head processes keyboard inputs from the hard keys on the control panel. Remote Monitor, or hand held startswitch. It displays injection parameters and operating 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. The only change is that it now contains software for the imaging system interface. (See description below)
- 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 iniector'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. The Remote Monitor has essentially been unchanged from the predicate device. The only change is that it now contains software for the imaging system interface. (See description below)
- 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.
- lmaging System Interface (ISI) (Also known as Autolink) A small printed circuit board (pcb) . that resides in the System Power Unit. The pcb acts as an interconnect card for the Injector Head and Remote Monitor, and provides an isolated interface connection between the Injector and CT Scanner. There is one input and one output to the operator. The input is composed of two signal lines and the output has three signal lines. All signal lines are fully isolated in order to provide protection to the Injector and CT Scanner. Physical connection to the CT Scanner is via a DB25 connector. The ISI pcb is controlled by the Rernote Controller. An Injector System Interface software module was added to the Remote Controller software to effect this function. The Injector System Interface module receives inputs from CT Scanner which are used to initiate or stop an injection. It also controls outputs to the CT Scanner which are used to activate Throughout its processing the Imaging System Interface software verifies the a scan. functionality of all input and output signals.
Functional Features: Except for the change to the Syringe Sensing and the addition of the Imaging System Interface, the functional specifications have not changed. The following is a summary of the Injector's specifications.
Programmed Volume - The volume of contrast medium delivered is settable for each phase of the injection profile. The range is 10 mi to 125 ml or 10 ml to 200 ml depending on the size of syringe used.
Programmed Flow Rate - The flow rate is the ratio of fluid volume delivered to the injection duration (milsec) 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.
Pressure Limiting - The system has a settable pressure limit. The range is 50 psi to 300 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 voiume 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.
Program Parameters - 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 - 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 - "Hold" allows the user to temporarily interrupt an injection. When the user 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 Injector 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 they should begin the scan. The "Scan Delay" interval begins simultaneously with the first phase of the injection profile. The interval duration can be set fiorn seconds to 99 seconds. A visible "Scan Delay" countdown clock, which shows the time remaining in 1 second increments, is located on the Iniector 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 - "Autofill" allows the user io load a specified amount of fluid into a syringe by actuating a control on the Injector Head. Once the "Autofili" 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. "The Autofili feature is non-functionalwhen an alternate 200ml syringe is installed.
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. "Multipie Arm" allows the programmed injection to be repeated without re-arning 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 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 complete the injection with iess than the programmed volume available in the syringe.
Syringe Sensing - "Syringe Sensing" is a svstem on the injector head that determines which of the two compatible Medrad syringe sizes ( 125ml, 200ml cr an alternate 200ml contrast prefilled syringe) is installed on the injector nead, and also senses whetner or not the syringe has been installed properly. After determining the size of the syringe that has been installed, the injector 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 svringe is not correctly installed.
Syringe Heater - The Syringe heater maintains the temperature of preheated contrast medium within the syringe while the syringe is attached to the Injector. The heater operature 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 microprocessorin 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.
Imaging System Interface - An interface between the Injector and CT Scanner. Permits the operator to initiate a scan sequence from the Injector, or to trigger an injection from the CT Scanner. This is a new feature, described in detail above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results concluded that the design specifications for the Vistron CT Iniection System were met. The Vistron CT Injection System meets 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 substantially equivalent to the predicate device for its intended use when used as prescribed in the User Operation Manual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUL 2 1 1999
MEDRAD VISTRON CT INJECTION SY
Mav 3, 1999
| Official Contact: | Jan Dobscha, Senior Regulatory Affairs Coordinator
Medrad, Inc.
One Medrad Drive
Indianola, 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 Vistron CT Injection System (K982814) |
Medrad, Inc.
Technical Description
One Medrad Drive
Indianola, PA 15051-0780
(412) 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 Vistron 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 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.
- 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. The SPU has essentially been unchaged from the predicate device. The only change is that it now also contains circuitry for the imaging system interface. (See description below)
- 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/controlinterface, electronic controls, and safety circuits. The syringe heat maintainer and the hand held startswitch connect externally to the head.
The Iniector Head processes keyboard inputs from the hard keys on the control panel. Remote Monitor, or hand held startswitch. It displays injection parameters and operating 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. The only change is that it now contains software for the imaging system interface. (See description below)
Image /page/0/Picture/13 description: The image shows a black and white graphic of the letter Q. The letter is in a bold, sans-serif font and appears to be slightly distorted or textured. Below the letter, there is some indistinct text that is difficult to read due to the image quality. The overall impression is that the image is a close-up of a logo or a design element featuring the letter Q.
1
Image /page/1/Picture/0 description: The image shows the word "medrad" in a stylized, bold, black font. The letters are slightly slanted to the right, giving the word a dynamic appearance. A registered trademark symbol is present to the upper right of the last letter, indicating that the brand name is protected. The overall design is clean and modern, making the logo easily recognizable.
- 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 iniector'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. The Remote Monitor has essentially been unchanged from the predicate device. The only change is that it now contains software for the imaging system interface. (See description below)
- 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.
- lmaging System Interface (ISI) (Also known as Autolink) A small printed circuit board (pcb) . that resides in the System Power Unit. The pcb acts as an interconnect card for the Injector Head and Remote Monitor, and provides an isolated interface connection between the Injector and CT Scanner. There is one input and one output to the operator. The input is composed of two signal lines and the output has three signal lines. All signal lines are fully isolated in order to provide protection to the Injector and CT Scanner. Physical connection to the CT Scanner is via a DB25 connector. The ISI pcb is controlled by the Rernote Controller. An Injector System Interface software module was added to the Remote Controller software to effect this function. The Injector System Interface module receives inputs from CT Scanner which are used to initiate or stop an injection. It also controls outputs to the CT Scanner which are used to activate Throughout its processing the Imaging System Interface software verifies the a scan. functionality of all input and output signals.
Functional Features: Except for the change to the Syringe Sensing and the addition of the Imaging System Interface, the functional specifications have not changed. The following is a summary of the Injector's specifications.
Programmed Volume - The volume of contrast medium delivered is settable for each phase of the injection profile. The range is 10 mi to 125 ml or 10 ml to 200 ml depending on the size of syringe used.
Programmed Flow Rate - The flow rate is the ratio of fluid volume delivered to the injection duration (milsec) 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.
Pressure Limiting - The system has a settable pressure limit. The range is 50 psi to 300 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 voiume 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.
Program Parameters - 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 - 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.
Image /page/1/Picture/10 description: The image shows a logo with a stylized letter 'Q' in a square. Below the square, the words 'Quality for Life' are printed in a simple, sans-serif font. The 'Q' is large and bold, dominating the logo's design.
2
Image /page/2/Picture/0 description: The image shows the word "medrad" in a stylized, bold, black font. The letters are slightly slanted to the right, giving the word a dynamic appearance. A small registered trademark symbol is located to the upper right of the letter "d".
Hold - "Hold" allows the user to temporarily interrupt an injection. When the user 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 Injector 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 they should begin the scan. The "Scan Delay" interval begins simultaneously with the first phase of the injection profile. The interval duration can be set fiorn seconds to 99 seconds. A visible "Scan Delay" countdown clock, which shows the time remaining in 1 second increments, is located on the Iniector 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 - "Autofill" allows the user io load a specified amount of fluid into a syringe by actuating a control on the Injector Head. Once the "Autofili" 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. "The Autofili feature is non-functionalwhen an alternate 200ml syringe is installed.
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. "Multipie Arm" allows the programmed injection to be repeated without re-arning 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 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 complete the injection with iess than the programmed volume available in the syringe.
Syringe Sensing - "Syringe Sensing" is a svstem on the injector head that determines which of the two compatible Medrad syringe sizes ( 125ml, 200ml cr an alternate 200ml contrast prefilled syringe) is installed on the injector nead, and also senses whetner or not the syringe has been installed properly. After determining the size of the syringe that has been installed, the injector 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 svringe is not correctly installed.
Syringe Heater - The Syringe heater maintains the temperature of preheated contrast medium within the syringe while the syringe is attached to the Injector. The heater operature 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 microprocessorin 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.
Image /page/2/Picture/8 description: The image shows a logo with a large, stylized letter 'Q' in black, positioned above the words 'Quality for Life' in a smaller font size. The 'Q' is bold and slightly tilted, giving it a dynamic appearance. The text below is aligned to the left, suggesting a brand or organization focused on quality of life.
3
Image /page/3/Picture/0 description: The image shows the word "medrad" in a stylized, bold, black font. The letters are slightly slanted to the right, giving the word a dynamic appearance. A small registered trademark symbol is located to the upper right of the letter "d".
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.
Imaging System Interface - An interface between the Injector and CT Scanner. Permits the operator to initiate a scan sequence from the Injector, or to trigger an injection from the CT Scanner. This is a new feature, described in detail above.
The Vistron CT Injection System is a syringe-based fluid delivery system Intended Use: indicated for delivery of cor:trast 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.
| Feature | Medrad Vistron CT Injector
with ISI & PPCM
(Modified Device) | Medrad Vistron CT Injector
(K982814)
Predicate |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Information Display | Large Colored LEDs | Large Colored LEDs |
| Programming Keys | Non-Dedicated Keys - Software
Determined | Dedicated Function Keys |
| Multi-Phase | 1 - 4 Phases per Injection | 1 - 4 Phases per Injection |
| Arming Modes | Single/Multi Arm | Single/Multi Arm |
| Protocol Storage Capability | Stores last protocol used | Stores last protocol used |
| Hold Capability | 0 - 600 seconds | 0 - 600 seconds |
| Scan Delay | 0-99 seconds | 0 - 99 seconds |
| Safety Stop Mechanism | Electrical Stop with a Software
Backup System | Electrical Stop with a Software
Backup System |
| Syringe System | 200ml, 125ml, Alternate 200ml | 200ml, 125ml |
| Programmed Volume | 1 to 125ml or 1 to 200 ml
Depending on Syringe Size | 1 to 125 ml or 1 to 200 ml
Depending on Syringe Size |
| Volume Remaining
Readout | LED | LED |
| Fill Rate | 2 ml/sec to 9.9 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 during
programming and during injection.) | Settable .1 ml/sec to 9.9 ml/sec
(Settable for each injection during
programming and during injection.) |
| Pressure Limit | Settable from 50 to 300 PSI | Settable from 50 to 300 PSI |
| Autofill | Fill rate fixed at 2 ml/sec. (Non-
functional when PPCM is used.) | Fill rate fixed at 2 ml/sec |
| Retract Control | Yes | Yes |
| Imaging System Interface
(AutoLink) | Yes | No |
| Remote Start Switch | Yes | Yes |
Technological Characteristics
Image /page/3/Picture/6 description: The image shows a logo with a large letter Q in a black square. Below the Q, the words "Quality for life" are written in a smaller font. The logo appears to be a symbol or emblem representing quality of life.
4
Image /page/4/Picture/0 description: The image shows the word "medrad" in a stylized, bold, sans-serif font. The letters are black, and there is a registered trademark symbol to the right of the letter "d". The font appears to be slightly italicized or slanted to the right.
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 tesling was conducted to support the conclusion drawn by the risk analysis.
Conclusion:
Test results concluded that the design specifications for the Vistron CT Iniection System were met. The Vistron CT Injection System meets 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 substantially equivalent to the predicate device for its intended use when used as prescribed in the User Operation Manual.
Image /page/4/Picture/6 description: The image shows a logo with a stylized letter 'Q' at the top, rendered in a bold, blocky font. Below the 'Q', the words 'Quality' and 'for life' are stacked vertically, written in a smaller, simpler font. The overall design is clean and suggests a focus on quality.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 1999
Ms. Jan Dobscha Sr. Regulatory Affairs Coordinator Medrad, Inc. One Medrad Drive Indianola, PA 15051
Re: K991557 Medrad Vistron CT Injection System Trade Name: Requlatory Class: II Product Code: DXT Dated: June 18, 1999 Received: June 21, 1999
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 legally 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, good 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 Reqister. 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 for devices
6
Page 2 - Ms. Jan E. Dobscha
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requlation 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/0 description: The image shows the word "MEDRAD" in a stylized, blocky font. The letters are all capitalized and appear to be bold. A circled "R" symbol, indicating a registered trademark, is located to the upper right of the word.
:
14 17:11
. . . . . . .
INDICATION FOR USE
510(k) Number: _ _____________________________________________________________________________________________________________________________________________________________
| Device Name: Medrad Vistron CT Injection System | ||
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Indications for Use/Intended Use:
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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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Ohrstyn M. Soe Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number 199155
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-CounterUse __________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)