MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE

K033881 · Medrad, Inc. · DXT · Mar 2, 2004 · Cardiovascular

Device Facts

• Record ID: K033881
• Device Name: MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The ISI module option is intended for the specific purpose of allowing an injector to interface with a CT scanner.

Device Story

Syringe-based fluid delivery system for CT contrast media; consists of injector head, display control unit (DCU), and sterile disposables. Imaging System Interface (ISI) module added as accessory to enable communication between injector and CT scanner. Operated by clinical staff in CT suites. System features multi-phase injection (up to 6 phases), programmable flow rates (0.1-10.0 ml/s), and pressure limits. Provides real-time pressure graphing and volume monitoring. Benefits include automated, precise contrast delivery synchronized with CT imaging protocols, reducing manual coordination requirements.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by comparative performance testing of the injector system and the ISI module interface against the predicate device.

Technological Characteristics

Syringe-based injector; PET barrel (Voridian 7352), polycarbonate plunger (GE Lexan 141), polyisoprene cover (Helvoet Pharma R2522-58). Luer fittings compliant with ISO 594-1/2. EtO sterilization. Connectivity via ISI module to CT scanner. Software-based safety stops with backup monitoring. Programmable multi-phase injection control.

Indications for Use

Indicated for human patients undergoing diagnostic computed tomography (CT) studies requiring intravenous contrast media injection.

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 Stellant CT Injector System (K023183)

Submission Summary (Full Text)

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MAR - 2 2004

## 510(k) Summary

| OFFICIAL CONTACT: | Troy A. Jack<br>Regulatory Affairs Analyst<br>Medrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] ext. 3305 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Injector with Syringe, Angiographic |
| COMMON NAME(S): | Powered Injector with Syringe |
| PROPRIETARY NAME: | Medrad Stellant CT Injector System with Imaging<br>System Interface Module |
| PREDICATE DEVICE: | Medrad Stellant CT Injector System (K023183) |
| INTENDED USE: | The Medrad Stellant CT Injector System is intended<br>for the specific purpose of injecting intravenous<br>contrast media into humans for diagnostic studies in<br>computed tomography (CT) applications. The ISI<br>module option is intended for the specific purpose of<br>allowing an injector to interface with a CT scanner. |

DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:

The Medrad Stellant CT Injector System with the ISI feature maintains the same intended use, similar operational parameters, similar labeling and is used in a manner intoniate ass, and in the Stellant CT Injector System with ISI Module is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for computed the organy studies. The addition of the ISI Module option to the Stellant CT Injector System simply establishes an interface between the injector and the CT scanner.

The Stellant CT Injector System with ISI Module is comprised of the same main components as the predicate device: an Injector Head, a Display Control Unit (DCU) and sterile disposables. The Imaging System Interface Module is added to the system as an Differences between the predicate device and the Stellant CT Injector accessory. System with ISI functionality are detailed in the following Comparison Matrix:

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## TABLE 1 - COMPARISON OF STELLANT INJECTOR SYSTEM with ISI MODULE AND STELLANT CT INJECTOR SYSTEM

| Feature | Predicate Device:<br>Stellant CT Injector System (K023183) | Proposed Device:<br>Stellant CT Injector System with ISI<br>Module |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | Intended to be used for the specific purpose of<br>injecting intravenous contrast media into<br>humans for diagnostic studies in computed<br>tomography (CT) applications. The ISI module<br>option is intended for the specific purpose of<br>allowing an injector to interface with a CT<br>scanner. | Same |
| Single or Dual Syringe System | Single and dual syringe models | Same |
| Information Display | Color LCD | Same |
| Programming Keys | Non-dedicated keys -- software determined | Same |
| Touch screen | Yes | Yes |
| Multi-Phase | 1 - 6 phases per injection | Same |
| Arming Modes | Single | Same |
| Protocol Storage Capability | 32 protocols | Same |
| Hold Capability | 20 minutes max. | Same |
| Scan Delay | 1 - 300 seconds | Same |
| Safety Stop Mechanism | Multi-layered software stops with backup<br>monitoring | Same |
| Syringe System | Single syringe model: 200 ml syringe<br>Dual syringe model: two 200 ml syringes | Same |
| Programmed Volume | 1 to 200 ml | Same |
| Volume Remaining Readout | LED on injector head; graphical and numeric<br>on LCD | Same |
| Fill Rate | Variable up to 10 ml/sec | Same |
| Flow Rate | 0.1ml/s to 10.0 ml/s | Same |
| Programmable Pressure Limit | 325 PSI default, user settable 50 to 300 PSI | Same |
| Pause | Programmable - 1 sec to 900 sec in 1 sec<br>increments | Same |
| Autofill | Fill rate 4 ml/sec | Same |
| Retract Control | Yes (Automatic) | Yes |
| Remote Start Switch | Yes | Yes |
| Pressure Graph | Yes | Yes |
| Syringe Sensing | Yes | Yes |
| Autoload | Yes | Yes |
| Auto Dock/Retract/Advance | Yes; user-selectable autodock and advance;<br>user-selectable auto-retract | Yes. Same functionality. |
| Protocol Lock / Remote Arming | Yes | Yes |
| Remote Check for Air (from<br>Head) | Yes | Yes |
| Scan Delay | 1sec to 300 sec in 1sec increments | Same |
| Store/Recall | 32 protocols | Same |
| Test Inject | Yes | Yes |
| Syringe Heat Maintainer | Yes | Yes |
| Packaging | Tyvek lid covering polystyrene tray | Same |
| Sterilization | EtO sterilization | Same |
| Method of determining Pyrogen- Freeness | Limulus Amebocyte Lysate test to USP requirements | Same |
| Luer Fittings | ISO 594-1 & ISO 594-2 compliant design | Same |
| Syringe: | | |
| Barrel Material Composition | Voridian (Eastman) 7352 PET | Same |
| Barrel Length | 7.504" | Same |
| Barrel OD | 2.002" | Same |
| Barrel ID | 1.844" | Same |
| Plunger Material Composition | GE Lexan 141 Polycarbonate | Same |
| Plunger Cover | Helvoet Pharma Polyisoprene R2522-58 | Same |
| Plunger Silicone Coating | Dow Corning 360 | Same |
| Barrel Flange | Easy-engage design for non-rotational orientation (no alignment necessary) | Same |
| Syringe sensing feature | Grooves at bottom of barrel to be optically identified | Same |
| Connector Tubing Components: | | |
| Maximum Pressure | 400 | Same |
| Tube Material | Unichem PVC | Same |
| Tube Length | 60" | Same |
| Bonding Agent | Cyclohexanone | Same |
| T-connector | Medical grade polycarbonate | Same |
| Burron DP 1000 Spike | ABS | Same |
| Priming Tube | Low density polyethylene | Same |

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## TABLE 2 COMPARISON OF STERILE DISPOSABLES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2004

Medrad, Inc. c/o Mr. Troy A. Jack Regulatory Affairs Analyst One Medrad Drive Indianola, Pa 15051

Re: K033881

K033881
Medrad Stellant CT Injector System with Imaging System Interface Module Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II (two) Product Code: DXT Dated: December 12, 2003 Received: December 15, 2003

Dear Mr. Jack:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is reley pe device is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regars) and enactment date of the Medical Device Amendments, or to conninered pror to Milly 20, 1977) in accordance with the provisions of the Federal Food, Drug, de vices mat have been results in asse approval of a premarket approval application (PMA). and Costictle Act () tee) and to novice, subject to the general controls provisions of the Act. The I va may, merciolo, mainer of the Act include requirements for annual registration, listing of general controls providions 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. 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

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Page 2 - Mr. Troy A. Jack

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,

R R R

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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## Indications for Use

510(k) Number (if known): K033881

Device Name: Medrad Stellant CT Injector System with Imaging System Interface Module

Indications For Use:

The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The ISI module option is intended for the specific purpose of allowing an injector to interface with a CT scanner.

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 Device Evaluation (ODE)

| Division Sign-off | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number: | K033881 |

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