OPTISTAR MR INJECTOR SYSTEM

K984088 · Mallinckrodt Inc., Liebel-Flarsheim Business · DXT · Dec 6, 1999 · Cardiovascular

Device Facts

• Record ID: K984088
• Device Name: OPTISTAR MR INJECTOR SYSTEM
• Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Indications for Use

The Optistar MR Injector System is intended for injecting MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans.

Device Story

Optistar MR Injector System is a contrast delivery system for MRI procedures. System components include a console (control room), power pack, and powerhead (scanning room). Operator programs injection parameters (volume, flow rate) via console touch screen. Powerhead drives lead screw rams to push plungers of 25 ml or 60 ml syringes, expelling contrast or saline through a Y-tubing set to the patient. System supports single or dual-phase injections and a 'drip mode' to maintain venous access. Remote hand switch allows operator to start/stop injections. Device provides visual status via lights on powerhead. Benefits include precise, automated delivery of contrast media to enhance diagnostic imaging. Used by clinicians in MR suites.

Clinical Evidence

Bench testing only. Performance verified through accuracy testing of delivered flow rate, volume, pressure, drip mode, and manual ram speeds. Testing confirmed system operates within specified parameters for both 25 ml and 60 ml syringe sizes across single and dual-phase protocols.

Technological Characteristics

Electromechanical injector system; lead screw ram drive mechanism. Materials: plastics and nonferrous metals. Power: 110V AC console, 24 VDC power pack (battery-powered). Connectivity: wired communication between console, power pack, and powerhead. Syringe sizes: 25 ml and 60 ml. User interface: touch screen console. Safety: electrical stop mechanism for out-of-spec parameters; pressure monitoring/limiting. Sterilization: disposables provided sterile.

Indications for Use

Indicated for injection of MR contrast agents and flushing solutions to enhance diagnostic imaging in humans. Contraindicated for use in magnetic fields greater than 1.5 Tesla; specific contraindications determined by prescribing physician based on contrast media package inserts.

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

• Medrad Spectris MR Injection System (K935668)

Submission Summary (Full Text)

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DEC - 6 1999

Image /page/0/Picture/2 description: The image shows the logo for Liebel-Flarsheim, which is identified as "A MALLINCKRODT COMPANY" in smaller letters below the main text. The logo consists of the letters "LF" in a stylized, bold font on the left. To the right of the letters is the name "Liebel-Flarsheim" in a serif typeface.

# Optistar MR Injector System 510(k) Summary

November 4, 1998

| Contact Name: | Bridget Drake<br>Compliance Administrator<br>Liebel-Flarsheim<br>2111 E. Galbraith Rd.<br>Cincinnati, OH 45215<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Optistar MR Injector System |
| Common Name: | Injector System |
| Classification Name: | Injector and Syringe, Angiographic |
| Predicate Device: | Medrad Spectris MR Injection System (K935668) |

### Intended Use:

The Optistar MR Injector System is intended for injecting MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans.

### Description:

The Optistar MR is a contrast delivery system that is designed to inject image enhancing contrast media into the vascular system of a human during an MRI (Magnetic Resonance Imaging) procedure.

The main components of the Optistar MR system are the console, power pack, and powerhead. The console resides in the control room of the MR suite, while the power pack and powerhead remain in the scanning room with the patient. The parameters of the injection, such as volume and flow rate are programmed by the operator using a touch screen on the console. The console is powered by AC line voltage at 110 Volts at 60 Hz. The console communicates with the 24 VDC powerpack which in turn supplies power and the injection parameters to the powerhead. The powerhead performs the injections by driving one or two lead screw rams. The rams push the plunger of a syringe

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syringe, which expels fluid from the barrel of the syringe. The console, power pack and powerhead are discussed in greater detail below.

Powerhead: The powerhead provides a means for accepting and identifying a given syringe and then applying a force to the plunger of the syringe via a ram, which ejects contrast from the syringe. The powerhead communicates with the power pack in order to determine the flow rates and volumes designated by the user. This information is then relayed to the injector. The powerhead resides in the imaging room with the scanner.

Console: The console is the main user interface for the iniector system. It allows the user to input the injection parameters via a touch screen as well as view the results of an injection. The console incorporates a remote hand switch for starting or stopping an injection. The console resides in the control room of the MR imaging suite.

Power Pack: The power pack is the interface between the console and the powerhead. The power pack processes the information input by the user from the console and relays this information to the powerhead. The power pack also supplies the powerhead with DC voltage. Two batteries supply the power pack. The power pack resides in the imaging room with the scanner.

The system is designed to deliver two injections per procedure. It can deliver a single or dual phase contrast injection from a user filled syringe and then follow up with an injection of a flushing solution, such as saline. To accomplish this task the powerhead holds two syringes with the ability to inject both syringes. Two syringe sizes can be used with the Optistar MR system, a 60 ml size and a 25 ml size. In addition, a Y tubing set is used to transfer the contrast flushing solution to the patient. One short leg of the Y connects to the contrast filled syringe using a luer lock connector. The other short leg of the Y connects to the syringe with the flushing solution using a luer lock connector. The long single leg of the Y goes to the patient.

The system also includes a battery charger, which is used to recharge the 24 V batteries.

#### Substantial Equivalence:

A comparison chart is shown on the next page that compares the technological characteristics of the Optistar MR Injection System to the predicate device, the Spectris MR Injection System. The performance and effectiveness of the Optistar MR is substantially equivalent to the predicate device. The new injector safely and successfully injects MR contrast media at user specified flow rates and volumes in an MR environment. The primary differences from the predicate device lie in the area of user preference features. The differences do not adversely affect the safety or efficacy of the device. A summary of the testing that verified the technological characteristics of the Optistar MR follow shall follow the comparison chart.

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| Characteristic/<br>Feature | Spectris<br>(predicate device)<br>(K935668) | Optistar MR<br>(new device) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Multiphasic Contrast<br>Injections | 2 phases per protocol | 2 phases per protocol |
| Protocol Storage | 20 protocols | 20 protocols |
| Injection History | Stores last 5 injection results | Stores last 20 injection results |
| Scan Delay | 00:00 - 00:59 minutes | 00:00 - 00:59 minutes |
| Syringe System - A side | 65 ml | 60 ml or 25 ml |
| Syringe System - B side | 65 ml | 60 ml or 25 ml |
| Volume | 1-63 in 1 ml increments | 1-61 in 1 ml increments (60 ml syringe)<br>1-27 in 1 ml increments (25 ml syringe) |
| Flow Rate - Contrast | 0.1 to 10 ml/sec<br>in 0.1 ml/sec increments | 25 ml syringe - 0.1 to 8.0 ml/sec in 0.1<br>ml/sec increments<br>60 ml syringe - 0.1 to 10 ml/sec in 0.1<br>ml/sec increments |
| Flow Rate - Flushing fluid | 0.1 to 10 ml/sec in 0.1 ml/sec<br>increments | 25 and 60 ml syringe - 0.1 to 7.0 ml/sec<br>in 0.1 ml/sec increments |
| Max Pressure Limit | 300 psi | For 25 ml syringe - 200 psi(adjustable)<br>For 60 ml syringe - 150 psi(adjustable) |
| Remote Start Switch | Yes | Yes |
| Mode for keeping a vein<br>open | Yes | Yes - Drip Mode |
| Safety Stop Mechanism | Electrical stop when injection<br>parameters are out of spec | Electrical stop when injection<br>parameters are out of spec |
| Fill/expel control | push buttons on head | push buttons on head |
| Air detection | operator visual inspection | operator visual inspection |
| Programming injections | Touch screen display | Touch screen display |
| Injection status display | lights on top of power head | lights on top of power head |
| Materials | Plastics and nonferrous metals | Plastics and nonferrous metals |
| Anatomical sites | Contrast injection into venous system. | Contrast injection into venous system. |
| Intended use | The injection of MR contrast agents<br>and flushing solutions for the purpose<br>of enhancing diagnostic imaging of<br>humans. | The injection of MR contrast agents<br>and flushing solutions for the purpose<br>of enhancing diagnostic imaging of<br>humans. |
| Target population | Humans | Humans |
| Sterility | Disposables are provided sterile | Disposables are provided sterile |

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# Performance Testing:

Performance testing was completed in order to verify that the Optistar MR Injector System was capable of achieving the specification parameters for the system as outlined in the substantial equivalence chart. Verification of the system's ability to accurately achieve these values validates the substantial equivalence claims. Injection performance was tested for accuracy of delivered flow rate, volume, pressure, drip mode and manual speeds.

### Volume

Fluid delivery of an injector is characterized by the volume delivered and the flow rate. The volume delivered is the most critical parameter in that it has the greatest effect on image quality. During the testing, the volume delivered was accurately measured and compared to the volume programmed. Over the range of volumes programmed, the Optistar MR Injector system successfully delivered the programmed volume within the allowable specification accuracy. This held true regardless of syringe size (25 ml or 60 ml), injection side (A or B) or phase type (single or dual).

# Flow Rate

The second most important variable in delivering fluid to a patient is flow rate. During the test injections, the time duration for an injection was recorded along with the volume delivered. The flow rate delivered was then calculated. Any injection accurately measured, that was not pressure limited, fell within the specified range. At higher flow rates, through a restricted orifice, the injector limits the pressure in the syringe by reducing the flow rate. In this case, the flow rate will not be achieved; however, the programmed volume will still be delivered.

# Pressure

During an injection, the injector monitors pressure in order to determine if the injection should be pressure limited. An upper limit is set for each syringe type used in the injector, in order to avoid failure of the syringe. During a number of injections pressure was measured and compared to the pressure displayed by the injector. In all cases the injector was within the accuracy range

# Drip Mode

Drip mode is used to keep a catheter or a vein open. The injector achieves this by administrating small increments of fluid over short time intervals. The injector allows the programming of the volume increment, a time interval and a flow rate. The performance of drip mode was evaluated by measuring the total volume delivered over a predetermined time period. Given a volume increment, a time interval, a flow rate and a measuring time period an expected volume was calculated and then compared to an actual measured volume to determine the accuracy for those parameters. Over the range of various drip mode parameters, the system fell within the specified accuracy range for all cases.

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# Manual Retract and Extend Speeds

The Optistar MR Injector has two speeds for manually moving the rams. By depressing either the forward or reverse key, the ram should move 1 ml/s. By pressing the accelerator key in combination with the forward or reverse key, the ram should move 5 ml/s. The tested speeds were within a specified accuracy range for both slow and fast speeds, for both A and B side, and for both 25 ml and 60 ml syringes.

#### Conclusion

The Optistar MR Injector System proved its ability to perform within its specified parameters. As a result, its performance is deemed acceptable and substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 1999

Ms. Bridget Drake Compliance Administrator Mallinckrodt Inc. Liebel-Flarsheim Business 2111 E. Galbraith Rd. P.O. Box 156305 Cincinnati, OH 45215-6305

Re: K984088 Optistar MR Injector System Trade Name: Requlatory Class: II Product Code: DXT September 3, 1999 Dated: September 7, 1999 Received:

Dear Ms. Drake:

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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 obligation you might have under sections 531 through 542 of the Act

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Page 2 - Ms. Bridget Drake

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 and additionally 809.10 for in vitro diagnostic devices), 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 Also, please note the regulation entitled, [phone]. "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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ohitopmth fr

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Page 1 of 1

510(k) NUMBER (IF KNOWN): K984088

Optistar MR Injector System DEVICE NAME:

INDICATIONS FOR USE:

The Optistar MR is designed to inject MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans. Contraindications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media Not to be used in a magnetic field greater than 1.5 package inserts. Tesla.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

Christopher for Witten

Division of Cardiovascular Respira and Neurological D 510(k) Number