OPTIBOLUS

K031339 · Mallinckrodt Inc., Liebel-Flarsheim Business · DXT · Jul 11, 2003 · Cardiovascular

Device Facts

• Record ID: K031339
• Device Name: OPTIBOLUS
• Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
• Product Code: DXT · Cardiovascular
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended 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.

Device Story

Electromechanical power injector for radiopaque contrast media; used in CT imaging. System comprises power head, power pack, and console. Operator programs injection protocols via console; system delivers contrast at controlled flow rates, volumes, and timing using motor-driven syringe mechanism. Features 'OptiBolus' mode: exponential decaying flow rate injection to optimize contrast usage and provide uniform enhancement. Power head contains operator interfaces for fill/expel control and injection monitoring. Microprocessor-based control system manages flow parameters; includes safety stop mechanism for out-of-spec parameters. Benefits include improved diagnostic image quality through optimized contrast delivery. Used in clinical settings by healthcare professionals.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological comparison and bench testing of the injection system parameters.

Technological Characteristics

Electromechanical syringe drive system; plastic and metal construction. Microprocessor-controlled flow rate (0.1-8 ml/sec), volume, and timing. Features include syringe heater, LCD interface, and remote control. Connectivity via relays and optical couplings. Power supply converts line voltage to 24-vdc. OptiBolus feature uses exponential decay algorithm for flow rate control.

Indications for Use

Indicated for humans requiring radiopaque contrast media injection into the vascular system to enhance diagnostic CT imaging. 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

• CT 8000 Digital Injection System (K912944)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

## 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:

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- 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.
- 3. 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<br>Injector System<br>(New Device) | CT 8000<br>Digital Injection System<br>Predicate Device<br>(K912944) |
|-------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Multi-phasic Injections | 4 phases per protocol or a<br>single OptiBolus injection<br>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<br>Mallinckrodt 125-ml;<br>Liebel-Flarsheim 200-ml | All pre-filled volumes of<br>Mallinckrodt 125-ml;<br>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 |

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| 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 |

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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 [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 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 [phone] or [phone] 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