OPTIV ANTAGE DH POWER INJECTION SYSTEM

K042744 · Mallinckrodt Inc., Liebel-Flarsheim Business · DXT · Nov 30, 2004 · Cardiovascular

Device Facts

• Record ID: K042744
• Device Name: OPTIV ANTAGE DH POWER INJECTION SYSTEM
• Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
• Product Code: DXT · Cardiovascular
• Decision Date: Nov 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The OptiVantage DH Injection System 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 Injection System is a power injector for CT imaging; delivers radiopaque contrast media and saline into patient vascular system. System comprises power head, console, power supply, and syringes. Power head features dual electromechanical drive systems (motor/gearbox/ball screw) to control flow rate and volume; console allows programming/initiating injection protocols. Used in clinical settings by healthcare professionals. Device provides multi-phasic injection capability (up to 6 phases); allows automated flushing with saline. Output is controlled delivery of contrast/saline to enhance diagnostic images. Safety features include user-settable pressure limits, remote start, and electrical stop mechanism for out-of-spec parameters. Benefits include precise, automated contrast delivery for improved image quality.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence established through comparative performance testing of electromechanical specifications, pressure limits, and functional features against the predicate device.

Technological Characteristics

Electromechanical power injector; motor-driven ball screw drive system. Components: power head, console, power supply. Materials: plastic and metal. Connectivity: optional OEM interface (relays, optical couplings, serial). Software-controlled injection protocols. Syringe heater included. Max pressure 325 psi. Flow rate 0.1-10 ml/sec.

Indications for Use

Indicated for human patients requiring contrast media injection into the vascular system for diagnostic imaging during computed tomography (CT) procedures.

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

• CT9000ADV / OptiBolus Injection System (K031339)

Reference Devices

• Unnamed injector (K022116)

Submission Summary (Full Text)

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NOV 3 0 2004

# 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] Email: [e-mail]

## 3. 510(k) Preparation Date

10/2/04

#### 4. Device Name

Trade Name: OptiVantage DH Injection System Common Name: Power Injector

#### 5. Device Classification

Class II

#### 6. Indications for Use

The OptiVantage DH Injection System 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 Injection System 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 is made up of the following major components:

- . 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 knpbs. The OptiVantage uses a drive system that is similar to existing Mallinetcrodt injectors. 11he marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drines 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 and console (approximately 24-vdc).

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- Console Communicates with the Power Head to program and initiate injection protocols, . displays the injection status, and displays a timer.
- Syringes The OptiVantage Injection System accommodates the Mallinckrodt 125-ml pre-filled . syringe styles and pre-filled saline syringes as well as a 200 ml front loading empty syringe. These syringes are commonplace on the market.

# 8. Substantial Equivalence

The predicate injector to the OptiVantage DH Injection System is the CT9000ADV / OptiBolus Injection System, 510(k) number K031339.

The OptiVantage DH Injector System maintains the same intended use as the predicate device. It is intended to be your a goten mastiants the same micheculas as a the predicate device. In vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injector System 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 and the predicate device consist of the same fundamental technology. They are motor driven, electromechanical devices which are software controlled.

The OptiVantage DH Injector System differs primarily from the predicate device in that it contains a second identical drive system as a feature to conveniently inject a flushing solution (i.e. aline) in conjunction with the main contrast injection. The flushing injection can currently be accomplished with the predicate device by interfacing to another injector (K022116). The OptiVantage DH Injector System simply offers a more convenient method for accomplishing this.

| Feature | OptiVantage<br>Injector System<br>(New Device) | CT9000ADV / OptiBolus<br>Injection System<br>Predicate Device<br>(K031339) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | 4 phases per protocol |
| OptiBolus | Yes | Yes |
| Protocol Storage | 40 protocols | 12 protocols |
| Syringe Sizes | All pre-filled volumes of Mallinckrodt<br>125-ml contrast syringes &<br>Liebel-Flarsheim 200 ml empty syringe | All pre-filled volumes of Mallinckrodt<br>125-ml contrast syringes &<br>Liebel-Flarsheim 200 ml empty syringe |
| Single or Dual Syringe<br>Modality | Single syringe and Dual syringe capability | Single syringe and Dual syringe (when<br>interfaced) |
| 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 10 ml/sec | 0.1 to 9.9 ml/sec |
| Max Pressure Limit | 325 psi | 325 psi |
| Pressure Limit | User-settable or automatic | User-settable |

Below is a table that compares the predicate device to the proposed OptiVantage Injection System.

and and the many of the comments of the Management of the many of the more of the many of the many of the many

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| Feature | OptiVantage<br>Injector System<br>(New Device) | CT9000ADV / OptiBolus<br>Injection System<br>Predicate Device<br>(K031339) |
|-----------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Control | 25 psi increments | 25 psi increments |
| Flushing System | Manual or via injector | Manual or via injector (with interface) |
| Remote Start | Yes | Yes |
| Scan Delay | 0 - 600 seconds | 0 - 500 seconds |
| Phase Delays | 0 - 600 seconds plus Pause | 0 - 254 seconds plus Pause |
| Console Controls | Touch screen Color LCD | Touch screen Color LCD |
| Power head Controls | Touch screen Color LCD | Keypad |
| Post Injection Readout | Yes | Yes |
| OEM Interface<br>(Optional) | Relays & Optical Couplings or Serial | Relays & Optical Couplings |
| 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 | 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2004

Mallinckrodt, Inc. c/o Mr. Ellis Rogers Quality Manager 2111E East Galbraith Road Cincinnati. OH 45237

K042744 Re:

OptiVantage DH Power Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: November 1, 2004 Received: November 2, 2004

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, 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 (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]. 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/dsma/dsmamain.html

Sincerely yours,

Duna R. Holmes

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

Enclosure ..

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### Attachment 5

## Indications for Use

510(k) Number (if known): K042744

Device Name: OptiVantage DH Power Injection System

Indications For Use:

The OptiVantage DH Injection System 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma P. Varlines

(Division, St ... all) Cardiovascular Devices

... Number KOA 2

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