(74 days)
Not Found
No
The description mentions microprocessor control and a "centralized control system for all system functions," but there is no mention of AI, ML, or any learning or adaptive capabilities. The "OptiBolus" feature is described as a user-selectable, pre-programmed exponential decaying flow rate, not an algorithm that learns or adapts.
No
The device is used to enhance diagnostic images for CT scans, which aids in diagnosis rather than directly treating a condition.
No
Explanation: This device is designed to inject contrast media to enhance diagnostic images, not to perform diagnosis itself.
No
The device description clearly outlines multiple hardware components including a Power Head, Power Pack, Console, and Syringes, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to inject a substance (radiopaque contrast media) into a patient's vascular system to enhance diagnostic images. This is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a system for delivering contrast media, including a power head, power pack, console, and syringes. These components are all related to the physical act of injection and control of the injection process.
- Lack of IVD Characteristics: An IVD device typically involves testing biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information. This device does not perform any such testing.
The device is clearly intended for use in a clinical setting to facilitate diagnostic imaging procedures, but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.
Product codes
DXT
Device Description
The CT9000ADV / OptiBolus Injection System delivers radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiBolus feature is used to enable an exponential decaying flow rate injection that will optimize the contrast usage and provide an extended period of uniform enhancement. The OptiBolus feature can be turned on or off by the user for any given injection protocol.
The major components of the system are:
- Power Head- The CT 9000ADV / OptiBolus Powerhead is contained in a sturdy metal case. The Powerhead contains the operator interfaces for viewing injection information, controlling the fill and expel operation, starting and stopping an injections for enabled and injecting states and the interface for connection of the various syringes. The Powerhead communicates its gathered information to the Power Pack.
- Power Pack- Contains the power supply and main microprocessor. The power supply converts the line voltage to the working voltage for the powerhead and console (approximately 24-vdc). The main processor provides a centralized control system for all system functions. The Powerhead and Console each contain a remote microprocessor that is used to control their localized functions.
- Console- Communicates with the Power Pack to program and initiate injection protocols, displays the injection status, and displays an iniection timer. The Console provides the means for the operator to enable, disable and view an OptiBolus injection. The Console display provides a simulated display that represents the OptiBolus injection as it progresses.
- Syringes- The CT9000ADV / OptiBolus Injection System accommodates the Mallinckrodt 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 200-ml syringe. These syringes are commonplace on the market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
patient's vascular system, venous system
Indicated Patient Age Range
Humans
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)
Not Found
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
1031339
JUL 1 1 2003
Special 510(k) Summary
1. Company Identification
Mallinckrodt Inc., Liebel-Flarsheim Business 2111 East Galbraith Road Cincinnati, OH 45237
Establishment Registration: 1518293
2. Contact Person
Ellis Rogers Quality Manager Phone: (513) 948-4041 Fax: (513) 948-5708
3. 510(k) Preparation Date
4/15/2003
4. Device Name
Trade Name: CT9000ADV / OptiBolus Common Name: Power Injector
5. Device Classification
Class II
6. Indications for Use
The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.
7. Description of Device
The CT9000ADV / OptiBolus Injection System delivers radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiBolus feature is used to enable an exponential decaying flow rate injection that will optimize the contrast usage and provide an extended period of uniform enhancement. The OptiBolus feature can be turned on or off by the user for any given injection protocol.
The major components of the system are:
1
- Power Head- The CT 9000ADV / OptiBolus Powerhead is contained in a sturdy metal case. 1. The Powerhead contains the operator interfaces for viewing injection information, controlling the fill and expel operation, starting and stopping an injections for enabled and injecting states and the interface for connection of the various syringes. The Powerhead communicates its gathered information to the Power Pack.
- Power Pack- Contains the power supply and main microprocessor. The power supply 2. converts the line voltage to the working voltage for the powerhead and console (approximately 24-vdc). The main processor provides a centralized control system for all system functions. The Powerhead and Console each contain a remote microprocessor that is used to control their localized functions.
-
- Console- Communicates with the Power Pack to program and initiate injection protocols, displays the injection status, and displays an iniection timer. The Console provides the means for the operator to enable, disable and view an OptiBolus injection. The Console display provides a simulated display that represents the OptiBolus injection as it progresses.
- Syringes- The CT9000ADV / OptiBolus Injection System accommodates the Mallinckrodt 4. 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 200-ml syringe. These syringes are commonplace on the market.
8. Substantial Equivalence
The Predicate injector to the CT9000ADV / OptiBolus Injection System is the CT 8000 Digital Injection System, 510(k) number K912944 currently marketed under the name CT 9000ADV.
The predicate device (CT 8000 Digital Injection System) is designed to meet both the ordinary needs of the market as well as advanced needs. Both devices share the same fundamental technology. The CT9000ADV / OptiBolus version of the system however is designed to provide a bolus shaping injection. A bolus shaping injection is an injection that ramps to a set flow rate and then once achieved, begins to deay using an exponential algorithm to a preset minimum flow rate. This injection process injection patented by Drs. Heiken. Bae and Brinks.
Below is a table comparing a predicate device to the proposed CT9000ADV / OptiBolus Injection System.
| Feature | CT9000ADV / OptiBolus
Injector System
(New Device) | CT 8000
Digital Injection System
Predicate Device
(K912944) |
|-------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Multi-phasic Injections | 4 phases per protocol or a
single OptiBolus injection
protocol | 4 phases per protocol |
| Protocol Storage | 12 protocols | 12 protocols |
| X-ray Scan Delay Timer | 99 seconds | 99 seconds |
| Syringe Sizes | All pre-filled volumes of
Mallinckrodt 125-ml;
Liebel-Flarsheim 200-ml | All pre-filled volumes of
Mallinckrodt 125-ml;
Liebel-Flarsheim 200-ml |
| Syringe Drive System | Electromechanical | Electromechanical |
| Syringe Heater | Yes | Yes |
| Syringe Fill Rate | 2 to 15-ml/sec | 2 to 15-ml/sec. |
| Flow Rate | 0.1 to 8-ml/sec | 0.1 to 8-ml/sec |
| Max Pressure Limit | 300 psi | 300 psi |
2
| Pressure Limit Control | User settable | User settable |
|---|---|---|
| Flushing System | Manual | Manual |
| Remote Start | Yes | Yes |
| Display Technology | LCD | LCD |
| Program Memory | Yes | Yes |
| Number of Control Panel Buttons | 8 soft-keys on touchscreen interface - same functions as predicate device. | 8 |
| Post Injection Readout | Yes | Yes |
| Printer Option | Yes | Yes |
| Interface | Relays & Optical Couplings | Relays & Optical Couplings |
| Safety Stop Mechanism | Electrical Stop when injection parameters are out of spec. | Electrical Stop when injection parameters are out of spec. |
| User Interface | ||
| Remote Control | Yes | Yes |
| Fill/ Expel Control | Push buttons on Power Head and Manual Knob | Push buttons on Power Head and Manual Knob |
| Programming Injections | Buttons on Console | Buttons on Console |
| Volume Remaining Display | Display on Powerhead and Console | Display on Powerhead and Console |
| Materials | Plastic and metal | Plastic and metal |
| Anatomical Injection Site | Injection into venous system | Injection into venous system |
| Function and Purpose | The injection of X-ray contrast agents for the purpose of enhancing diagnostic CT imaging of humans. | The injection of X-ray contrast agents for the purpose of enhancing diagnostic CT imaging of humans. |
| Target Population | Humans | Humans |
| Sterility (Syringe) | Injectors are not sterile products, Syringes and Disposables are provided sterile | Injectors are not sterile products, Syringes and Disposables are provided sterile |
ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle is blank. Inside the circle is a symbol that looks like three curved lines.
JUL 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mallinckrodt, Inc. c/o Mr. Ellis Rogers Liebel-Flarsheim 2111 E. Galbraith Road Cincinnati, OH 45237
Re: K031339
CT9000ADV/OptiBolus Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: June 11, 2003 Received: June 17, 2003
Dear Mr. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Ellis Rogers
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours,
XQaletu
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. Statement of Indications
The intended use of the CT9000ADV / OptiBolus Injection System is the same as the predicate CT 8000 Digital Injection System.
Indications for Use: The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.
NOCeTM
510(k) Number LOSS
Prescription Use Only