OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION

K063503 · Mallinckrodt Inc., Liebel-Flarsheim Business · IZQ · Apr 27, 2007 · Cardiovascular

Device Facts

• Record ID: K063503
• Device Name: OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
• Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
• Product Code: IZQ · Cardiovascular
• Decision Date: Apr 27, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The OptiVantage DH Injector System with Enhanced Communication is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

Device Story

OptiVantage DH Injector System with Enhanced Communication is a motor-driven, electromechanical contrast delivery system; used in clinical settings (CT suites) by healthcare professionals. System components: power head, console, power supply, and syringes. Power head contains dual electromechanical syringe drive systems (motor/gearbox/ball screw) to fill/expel contrast media or saline. Console allows programming/initiating injection protocols (up to 6 phases) and monitoring status. Device features OptiBolus multiphasic injection method. Enhanced communication provides additional safety enforcement features compared to predicate. Output: controlled flow/volume of contrast media into patient vascular system. Healthcare providers use output to achieve enhanced diagnostic images for CT scans. Benefits: precise, automated contrast delivery for improved diagnostic image quality.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Electromechanical motor-driven syringe system; 24-vdc power supply; touch screen color LCD controls on console and power head; CAN bus interface; syringe heater; supports 125-ml pre-filled and 200-ml empty syringes. Materials: plastic and metal. Software-controlled injection protocols. Not sterile (syringes/disposables are sterile).

Indications for Use

Indicated for use in humans requiring contrast-enhanced diagnostic imaging via computed tomography (CT) to inject radiopaque contrast media into the vascular system.

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

• OptiVantage DH Power Injection System (K042744)

Submission Summary (Full Text)

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K063503

APR 2 7 2007

# 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

Dale Moore Quality Manager Phone: [phone] Fax: [phone] Email: [e-mail]

### 3. 510(k) Preparation Date

11/15/2006

#### 4. Device Name

Trade Name: OptiVantage DH Injector System with Enhanced Communication Common Name: Power Injector

### 5. Device Classification

Class II

#### 6. Indications for Use

The OptiVantage DH Injector System with Enhanced Communication is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

## 7. Description of Device

The OptiVantage DH Injector System with Enhanced Communication delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage DH Injector System with Enhanced Communication consists of 4 main components, just like the predicate device:

- し、 Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe.
- Power Supply- The power supply converts the line voltage to the working voltage for the power head 2. and console (approximately 24-vdc).

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- Console Communicates with the Power Head to program and initiate injection protocols, displays the 3. injection status, and displays a timer.
- Syringes The OptiVantage DH Injector System with Enhanced Communication accommodates the 4. Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.

## 8. Substantial Equivalence

The predicate injector to the OptiVantage DH Injector System with Enhanced Communication is the OptiVantage DH Power Injection System, 510(k) number K042744.

The OptiVantage DH Injector System with Enhanced Communication maintains the same intended use as the optivate device. It is intended to be used for the specific purpose of injecting radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injector System with Enhanced Communication consists of four main components in the same manner as the predicate device: a Power Head, a Console, a Power Supply, and Syringes. Both the OptiVantage DH Injector System with Enhanced Communication and the predicate device consist of the same fundamental technology. They are motor driven, electromechanical devices which are software controlled. The OptiBolus function on the OptiVantage DH Injector System with Enhanced Communication and the predicate device implements a multiphasic injection method for injecting contrast media and/or saline.

The OptiVantage DH Injector System with Enhanced Communication differs from the predicate device in that it contains a product enhancement that adds a layer of enforcement for safety features found on the currently marketed predicate device.

Below is a table that compares the predicate device to the proposed OptiVantage DH Injector System with Enhanced Communication.

| Feature | OptiVantage DH Injector System with<br>Enhanced Communication (New Device) | OptiVantage DH Power Injection<br>System Predicate Device (K042744) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended to be used for the specific<br>purpose of injecting radiopaque contrast<br>media into a patient's vascular system to<br>obtain diagnostic images when used with<br>computed tomography (i.e. "CT")<br>equipment | Intended to be used for the specific<br>purpose of injecting radiopaque contrast<br>media into a patient's vascular system to<br>obtain diagnostic images when used with<br>computed tomography (i.e. "CT")<br>equipment |
| Multi-phasic<br>Injections | 6 phases per protocol | 6 phases per protocol |
| OptiBolus | Yes | Yes |
| Protocol Storage | 40 protocols | 40 protocols |
| Syringe Sizes | All pre-filled volumes of Mallinckrodt<br>125-ml syringes & Liebel-Flarsheim 200<br>ml empty syringe | All pre-filled volumes of Mallinckrodt<br>125-ml syringes & Liebel-Flarsheim 200<br>ml empty syringe |
| Single or Dual Syringe<br>Modality | Single syringe and Dual syringe capability | Single syringe and Dual syringe capability |
| Syringe Drive System | Electromechanical | Electromechanical |
| Syringe Heater | Yes (Built-in, Powerhead controlled) | Yes (Built-in, Powerhead controlled) |
| Syringe Fill Rate | 2 to 15 ml/sec | 2 to 15 ml/sec |
| Flow Rate | 0.1 to 10 ml/sec | 0.1 to 10 ml/sec |
| Max Pressure Limit | 325 psi | 325 psi |
| Pressure Limit<br>Control | User-settable or automatic<br>25 psi increments | User-settable or automatic<br>25 psi increments |
| Flushing System | Manual or via injector | Manual or via injector |

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| Feature | OptiVantage DH Injector System with<br>Enhanced Communication (New Device) | OptiVantage DH Power Injection<br>System Predicate Device (K042744) |
|-----------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Remote Start | Yes | Yes |
| Scan Delay | 0-600 seconds | 0 - 600 seconds |
| Phase Delays | 0 - 600 seconds plus Pause | 0 - 600 seconds plus Pause |
| Console Controls | Touch screen Color LCD | Touch screen Color LCD |
| Power head Controls | Touch screen Color LCD | Touch screen Color LCD |
| Post Injection Readout | Yes | Yes |
| OEM Interface | Relays & Optical Couplings/Serial (CAN) | Relays & Optical Couplings/Serial (CAN) |
| Safety Stop<br>Mechanism | Electrical Stop when injection parameters<br>are out of specifications | Electrical Stop when injection parameters<br>are out of specifications |
| Remote Check for Air | Yes | Yes |
| Volume Remaining<br>Display | Displayed on Power Head and Console | Displayed on Power Head and Console |
| Used Syringe<br>Detection | Yes (with Enhanced Communication) | Yes |
| Materials | Plastic and metal | Plastic and metal |
| Target Population | Humans | Humans |
| Sterility (Syringe) | Injectors are not sterile products. Syringes<br>and Disposables are provided sterile. | Injectors are not sterile products. Syringes<br>and Disposables are provided sterile. |

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2007

Mallinckrodt, Inc., Liebel-Flarsheim Business c/o Mr. Dale Moore Quality Manager 2111 East Galbraith Road Cincinnati, OH 45237

Re: K063503

> OptiVantage DH Injector System with Enhanced Communication Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II (two) Product Code: IZQ Dated: March 30, 2007 Received: April 2, 2007

Dear Mr. Moore:

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. Ilisting 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. Dale Moore

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]. 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 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/industry/support/index.html.

Sincerely yours,

Duna R. Varner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## MALLINCKRODT ealthcare Divis

## Attachment #14 Indications for Use

510(k) Number (if known): K063503

Device Name: OptiVantage DH Injector System with Enhanced Communication

Indications For Use:

The OptiVantage DH Injector System with Enhanced Communication is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Dana R. Valunes

(Division Sign-Off) (Division Sign-Off)

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- 510(k) Number K063503