(22 days)
No
The document explicitly states "No advanced scientific principles beyond those normally associated with electro-mechanical devices are employed" and there are no mentions of AI, DNN, or ML.
No
The device is used for delivering contrast media for diagnostic studies (CT scans), not for treating a disease or condition.
No
This device is an injector system used to deliver contrast media for diagnostic studies; it is not performing any diagnostic function itself.
No
The device description explicitly states it is a "programmable syringe-based fluid delivery system" comprised of "three main components - Master Control Unit (MCU), Display Control Unit (DCU), Injector Head (HCU)," indicating it is a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of contrast media into the human vascular system for diagnostic studies in computed tomography. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically involving testing of samples like blood or tissue).
- Device Description: The device is a fluid delivery system for injecting contrast media. It does not perform any diagnostic testing on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the EnVision CT Injection System is a medical device used in conjunction with a diagnostic imaging modality (CT), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The EnVision 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 EnVision CT Injection System is a modified version of the EnVision CT Injector (K934086). 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 EnVision CT Injection System is a programmable syringe-based fluid delivery system for delivery of contrast media during computed tomography procedures. Programming is achieved via a touch screen LCD display. No advanced scientific principles beyond those normally associated with electro-mechanical devices are employed.
The EnVision CT Injector is comprised of the three main components - Master Control Unit (MCU), Display Control Unit (DCU), Injector Head (HCU). The Medrad EnVision CT Injector System, like the predicate EnVision CT Injector System, uses a 125ml and 200ml Front Load Sterile Disposable Syringe. 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
-
Master Control Unit (MCU) is the "center" of the EnVision CT Injector System. Contained . within the MCU is the microprocessor, system power supply, and ancillary ports for service access. Power comes into the MCU and is distributed to the remaining units. The DCU and Injector Head are connected to the MCU through various cabling. The MCU gathers information from the DCU and HCU, interprets the information, executes the injection, controls the head's plunger piston motor, and monitors injection feedback from the HCU. The microprocessor processes key and display information to and from the DCU, and stores and retrieves injection program and panel information from the user. It processes commands and formats data for the service port, monitors vital system status information and communications, and interacts with external imaging interfaces. It also controls the operation of an optional Remote DCU.
-
Display Control Unit (DCU) (primary) The is the main user interface and is controlled by a microprocessor. It is the main point of user data entry and display feedback data display.
components but keeps power supplied to all system microprocessors. The only change is that it now contains software for the imaging system interface. -
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 Duration, 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 chanqe is that it now contains software for the imaging system interface.
-
. 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.
-
. Imaging 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 Iniector 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 Remote 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 a scan. Throughout its processing, the Imaging System Interface software verifies the 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. functionality has not changed. The following is a summary of the Injector's specifications.
- Program The user can program the injector with the following injection parameters: fluid volume, flow rate, injection duration, pause or pause/KVO, and scan delay.
- The user can program a sequence of one or more program phases, up to a Injection Profile maximum of 10, in which each phase delivers fluid according to the program parameters defined for that phase.
- Pause A command which can be programmed into the injection profile which causes the injector to stop for a programmed interval between phases. The pause duration can be set from 1 second to 10 minutes in one second increments.
- Pause/KVO Keep Vein Open (KVO) is an option that the user can specify for any PAUSE programmed into the injection profile. KVO causes the injection of fluid at a low average flow rate to keep the vein at the catheter site from clotting during a programmed "Pause". The KVO flow can be continuous or intermittent with an average flow rate of .01 ml/sec.
- 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.
Scan Delav "Scan Delay" is a function that the user can program into the injection profile to initiate a scan by a CT machine that has been properly connected to the Envision CT's relay closure. The "Scan Delay" interval beains 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 DCU. When the countdown clock reaches 0 an audible beep alerts the user.
"Autofill" allows the user to load a specified amount of fluid into a svringe by Autofill "actuating a control or the Injector Head. "Once the "Autoffil" control is activated the head will load the specified amount of fluid into the svringe without further operator interaction The user may select volumes of 25, 50, 75, 100. 125, 150, 175, or 200 depending on the syringe size used. The range for the user selectable fill rate is 2ml/sec to 9.9ml/sec. The Autofill feature is non-functional when an alternate 200ml contrast prefilled svringe 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. "Multiple Arm" allows the programmed iniection 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 deliver the programmed injection until there is insufficient contrast media in the syringe to complete a full injection. At this point, the iniector will inform the user that there is insufficient yolume for another injection.
"Syringe Sensing" is a system on the injector head that determines which of the Syringe Sensing three compatible syringe sizes (125ml, 200ml or an alternate 200ml contrast prefilled syringe) is installed on the injector head, and also senses whether or not the syringe has been installed properly. The injector head "reads" coded slots molded into the flange of the syringe which tell the injector what size syringe has been installed. 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 DCU alerting the user that the syringe is not correctiv 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 operating temperature 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 microprocessor in the MCU and HCU constantly monitors the electrical functions of the injector system. The HCU monitors for over volume and over flow rate, and the MCU monitors for over volume and over flow rate, as well as pressure/stall and over-pressure. When the backup monitoring system detects one of these conditions, it will open a relay in the HCU to cut power to the piston motor and the injector system is placed in a maintenance state.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography
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 EnVision CT Injection System were met. The EnVision CT Injection System meets the applicable requirements of the following standards:
IEC 529 (IPX1) = Classificationsof Degrees of Protection Provided by Enclosures
- IEC 601-1, Amendments 1 and 2 = Medical Electric Equipment Part 1: General
- requirements for safety, 1. Collateral standard: Safety requirements for medical electrical systems
- IEC 601-1-2 = Medical Electrical Equipment Part 1.2 Collateral standard: Electromagnetic Compatibility - Immunity Requirements and Tests
- IEC 801-2 = ESD Immunity
- IEC 801-3 = Radiated Immunity
- IEC 801-4 = EFT/Burst Immunity
- IEC 801-5 = Surge Immunity
- UL 2601-1:1994 = Standard for Medical Equipment
- CSA C22.2 No. 601.1-M90 = Medical Electrical Equipment Part 1: General Requirements for Safety
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
Image /page/0/Picture/1 description: The image shows the word "MERAD" in a bold, sans-serif font. Above the word "MERAD" is the text "K993728" in a cursive font. To the right of the word "MERAD" is a circled R symbol, indicating a registered trademark. The text and logo are in black and white.
MEDRAD EnVision CT INJECTION SYSTEM 510(K) SUMMARY
October 29, 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: | EnVision CT Injection System |
| Predicate Device: | EnVision CT Injection System (K934086) |
Medrad, Inc.
One Medrad Drive Indianola, PA 15051-0780 (412) 767-2400
. Technical Description:
Device Description:
The Medrad EnVision CT Injection System is a modified version of the EnVision CT Injector (K934086). 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 EnVision CT Injection System is a programmable syringe-based fluid delivery system for delivery of contrast media during computed tomography procedures. Programming is achieved via a touch screen LCD display. No advanced scientific principles beyond those normally associated with electro-mechanical devices are employed.
The EnVision CT Injector is comprised of the three main components - Master Control Unit (MCU), Display Control Unit (DCU), Injector Head (HCU). The Medrad EnVision CT Injector System, like the predicate EnVision CT Injector System, uses a 125ml and 200ml Front Load Sterile Disposable Syringe. 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
- Master Control Unit (MCU) is the "center" of the EnVision CT Injector System. Contained . within the MCU is the microprocessor, system power supply, and ancillary ports for service access. Power comes into the MCU and is distributed to the remaining units. The DCU and Injector Head are connected to the MCU through various cabling. The MCU gathers information from the DCU and HCU, interprets the information, executes the injection, controls the head's plunger piston motor, and monitors injection feedback from the HCU. The microprocessor processes key and display information to and from the DCU, and stores and retrieves injection program and panel information from the user. It processes commands and formats data for the service port, monitors vital system status information and communications, and interacts with external imaging interfaces. It also controls the operation of an optional Remote DCU.
- Display Control Unit (DCU) (primary) The is the main user interface and is controlled by a microprocessor. It is the main point of user data entry and display feedback data display.
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 large, stylized letter Q in black against a white background. The letter is bold and slightly tilted, giving it a dynamic appearance. Below the Q, there are some blurred lines of text, which are illegible due to the image quality. The overall composition is simple, focusing on the prominent letter and its design.
1
Image /page/1/Picture/0 description: The image shows the word "medrad" in a bold, sans-serif font. The letters are all in lowercase, except for the "d", which is in uppercase. There is a registered trademark symbol to the right of the "d". The word is black and the background is white.
- 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 Duration, 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 chanqe 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.
- . Imaging 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 Iniector 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 Remote 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 a scan. Throughout its processing, the Imaging System Interface software verifies the 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. functionality has not changed. The following is a summary of the Injector's specifications.
- Program The user can program the injector with the following injection parameters: fluid volume, flow rate, injection duration, pause or pause/KVO, and scan delay.
- The user can program a sequence of one or more program phases, up to a Injection Profile maximum of 10, in which each phase delivers fluid according to the program parameters defined for that phase.
- Pause A command which can be programmed into the injection profile which causes the injector to stop for a programmed interval between phases. The pause duration can be set from 1 second to 10 minutes in one second increments.
- Pause/KVO Keep Vein Open (KVO) is an option that the user can specify for any PAUSE programmed into the injection profile. KVO causes the injection of fluid at a low average flow rate to keep the vein at the catheter site from clotting during a programmed "Pause". The KVO flow can be continuous or intermittent with an average flow rate of .01 ml/sec.
- 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.
Image /page/1/Picture/11 description: The image shows a logo with a stylized letter 'Q' in bold, black font. Below the 'Q', the words 'Quality' and 'Life' are stacked vertically in a smaller, less bold font. The overall design is simple and conveys a sense of quality and well-being.
2
Image /page/2/Picture/0 description: The image shows the word "MEDRAD" in a stylized, bold, black font. The letters are slanted to the right, giving the word a dynamic appearance. A small registered trademark symbol is visible to the right of the word.
Scan Delav "Scan Delay" is a function that the user can program into the injection profile to initiate a scan by a CT machine that has been properly connected to the Envision CT's relay closure. The "Scan Delay" interval beains 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 DCU. When the countdown clock reaches 0 an audible beep alerts the user.
"Autofill" allows the user to load a specified amount of fluid into a svringe by Autofill "actuating a control or the Injector Head. "Once the "Autoffil" control is activated the head will load the specified amount of fluid into the svringe without further operator interaction The user may select volumes of 25, 50, 75, 100. 125, 150, 175, or 200 depending on the syringe size used. The range for the user selectable fill rate is 2ml/sec to 9.9ml/sec. The Autofill feature is non-functional when an alternate 200ml contrast prefilled svringe 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. "Multiple Arm" allows the programmed iniection 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 deliver the programmed injection until there is insufficient contrast media in the syringe to complete a full injection. At this point, the iniector will inform the user that there is insufficient yolume for another injection.
"Syringe Sensing" is a system on the injector head that determines which of the Syringe Sensing three compatible syringe sizes (125ml, 200ml or an alternate 200ml contrast prefilled syringe) is installed on the injector head, and also senses whether or not the syringe has been installed properly. The injector head "reads" coded slots molded into the flange of the syringe which tell the injector what size syringe has been installed. 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 DCU alerting the user that the syringe is not correctiv 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 operating temperature 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 microprocessor in the MCU and HCU constantly monitors the electrical functions of the injector system. The HCU monitors for over volume and over flow rate, and the MCU monitors for over volume and over flow rate, as well as pressure/stall and over-pressure. When the backup monitoring system detects one of these conditions, it will open a relay in the HCU to cut power to the piston motor and the injector system is placed in a maintenance state.
Image /page/2/Picture/7 description: The image shows a logo with a stylized letter 'Q' in a black square. Below the square, the word "Quality" is written in a simple font. Underneath "Quality", the phrase "'or' life" is written in a smaller font size.
3
Image /page/3/Picture/0 description: The image shows the word "MEDRAD" in all caps and in a bold, sans-serif font. The letters are black, and the background is white. There is a small circle with an R inside of it to the right of the letter D, indicating that the word is a registered trademark.
| 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 initate a scan sequence from the Injector, or to trigger an injection from the CT Scanner. This is a new feature, described in detail |
above.
Technological Characteristics
| Feature | Medrad EnVision CT Injector
with ISI & PPCM
(Modified Device) | Medrad EnVision CT Injector
(K934086)
Predicate |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Information Display | Monochrome LCD | Monochrome LCD |
| Programming Keys | Non-Dedicated Keys - Software
Determined | Non-Dedicated Keys - Software Determined |
| Arming Modes | Single/MultiArm | Single/MultiArm |
| Multi-Phase | 1 - 10 Phases per Injection | 1 - 10 Phases per Injection |
| Protocol Storage
Capability | 50 | 50 |
| 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 |
| Automatic Piston Retract | 25 sec | 25 sec |
| Volume Remaining
Readout | LED | LED |
| 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 |
| Autofill | Selectable - increments of 25ml for
125ml syringe; increments of 50 for
200ml syringe; inactive for alternate
200ml syringe | Selectable - increments of 25ml for 125ml syringe;
increments of 50ml for 200ml syringe |
| Fill Rate | 2 ml/sec to 9.9 ml/sec | 2 ml/sec to 9.9 ml/sec |
| Flow Rate | Variable .1 ml/sec to 9.9 ml/sec | Variable .1 ml/sec to 9.9 ml/sec |
| Pause | Programmable 1 sec to 10 min | Programmable 1 sec to 10 min |
| KVO | Continuous or intermittent-
AVG minimum flow rate of .01
ml/min | Continuous or intermittent -
AVG minimum flow rate of .01 ml/min |
| Pressure Limit | Settable from 50 to 300 PSI | Settable from 50 to 300 PSI |
| Remote Start Switch | Yes | Yes |
| Imaging System
Interface (aka
Communicator) | Yes | No |
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 EnVision 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.
Image /page/3/Picture/7 description: The image shows a logo with a stylized letter 'Q' in a bold, black font. Below the 'Q', the words 'Quality for Life' are printed in a smaller, sans-serif font. The logo appears to be designed to convey a sense of quality and purpose related to life.
4
Image /page/4/Picture/0 description: The image shows the word "medrad" in a bold, sans-serif font. The letters are all capitalized, and the word is slightly slanted to the right. There is a registered trademark symbol to the right of the word. The word appears to be a logo or brand name.
Conclusion:
Test results concluded that the design specifications for the EnVision CT Injection System were met. The EnVision CT Injection System meets the applicable requirements of the following standards:
IEC 529 (IPX1) = Classificationsof Degrees of Protection Provided by Enclosures
- IEC 601-1, Amendments 1 and 2 = Medical Electric Equipment Part 1: General
- requirements for safety, 1. Collateral standard: Safety requirements for medical electrical systems
- IEC 601-1-2 = Medical Electrical Equipment Part 1.2 Collateral standard: Electromagnetic Compatibility - Immunity Requirements and Tests
- IEC 801-2 = ESD Immunity
- IEC 801-3 = Radiated Immunity
- IEC 801-4 = EFT/Burst Immunity
- IEC 801-5 = Surge Immunity
- UL 2601-1:1994 = Standard for Medical Equipment
- CSA C22.2 No. 601.1-M90 = Medical Electrical Equipment Part 1: General Requirements for Safety
Therefore, it has been determined that the EnVision 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/14 description: The image shows a logo with a stylized letter "Q" in a square. Below the "Q", the words "Quality" and "for Life" are stacked on top of each other. The logo appears to be a symbol or emblem associated with a brand or organization that emphasizes quality of life.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1999
Ms. Jan Dobscha Sr. Requlatory Affairs Coordinator Medrad, Inc. One Medrad Drive Indianola, PA 15051
Re: K993728 Medrad Envision CT Injection System Trade Name: Requlatory Class: II Product Code: DXT Dated: October 29, 1999 November 4, 1999 Received:
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 Requlation (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 obliqation 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 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 leqally 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 (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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Chitoplyth-Ar
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Image /page/7/Picture/0 description: The image shows the word "medrad" in a stylized, blocky font. The letters are all capitalized and in black. A registered trademark symbol is present to the right of the word.
INDICATION FOR USE
510(k) Number:___
Device Name: Medrad Envision CT Injection System
Indications for Use/Intended Use:
The EnVision 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)
Ohrsto Mle for Witten
(Division Sign: Off) Division of Cardiovascular, Respiratory, Division of Cardiovascular, Respices
and Neurological Devices
510(k) Number __________________________________________________________________________________________________
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)