MEDRAD STELLANT CT INJECTOR SYSTEM

K023183 · Medrad, Inc. · DXT · Jan 10, 2003 · Cardiovascular

Device Facts

• Record ID: K023183
• Device Name: MEDRAD STELLANT CT INJECTOR SYSTEM
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Jan 10, 2003
• 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.

Device Story

The Medrad Stellant CT Injector System is a syringe-based fluid delivery system used in clinical settings to inject contrast media into the human vascular system for CT imaging. The system consists of an injector head, a display control unit, and sterile disposables. It supports single or dual syringe configurations. Operators program injection parameters—including flow rate, volume, and pressure limits—via a touch-screen interface. The device features automated functions such as syringe loading, docking, retraction, and advancement. During operation, the system monitors pressure and flow, providing real-time feedback via a pressure graph and numeric/graphical volume readouts on a color LCD. A multi-layered software safety system with backup monitoring ensures controlled delivery. The device benefits patients by enabling precise, automated contrast administration, which is essential for high-quality diagnostic CT scans. It is intended for use by trained healthcare professionals.

Clinical Evidence

Bench testing only. No clinical data was required or provided. Design verification and validation testing were conducted to confirm that the device meets design specifications and applicable international standards.

Technological Characteristics

Syringe-based fluid delivery system. Materials: PET (syringe barrel), Polycarbonate (plunger, T-connector), Polyisoprene with silicone coating (plunger cover), PVC (tubing), ABS (spike), Polyethylene (priming tube). Luer fittings compliant with ISO 594-1 & ISO 594-2. Features color LCD touch screen, multi-phase injection (1-6 phases), and automated syringe handling. Sterilization: EtO. Connectivity: Standalone system with remote start/check capabilities. Software-based safety monitoring with multi-layered stops.

Indications for Use

Indicated for the injection of intravenous contrast media into the human vascular system for diagnostic computed tomography (CT) studies. For 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

• Medrad EnVision CT Injector System (K934086 and K993728)

Submission Summary (Full Text)

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JAN 1 9 2003

Image /page/0/Picture/1 description: The image shows the word "medrad" in a bold, sans-serif font. The letters are all in lowercase, except for the "R" which is capitalized. There is a registered trademark symbol to the upper right of the letter "d". The word is black and the background is white.

## Special 510(k) SUMMARY OF SAFETY AND EFFECTIVEN

| Submitter's Name: | Medrad Inc. |
|----------------------|--------------------------------------------------------|
| Submitter's Address: | One Medrad Drive, Indianola, PA 15051 USA |
| Telephone Number: | [phone], ext. 3536 |
| Fax Number: | [phone] |
| Contact Person: | Frank Pelc |
| Date: | September 23, 2002 |
| Proprietary Name: | Medrad Stellant CT Injector System |
| Common Name: | Powered Injector with Syringe |
| Classification: | DXT |
| Classification Name: | Injector and Syringe, Angiographic |
| Predicate Device: | Medrad EnVision CT Injector System K934086 and K993728 |

Substantial Equivalence: The information provided in this premarket notification demo
that the proposed device is substantially equivalent to a legally marketed device. The prmonstrates he proposed Medrad, Inc. Is substantially equivalent to a lega Stellant CT Injector System is substantially equivalent to the EnVision CT Injector System ledrad Drive (K934086 and K993728).

15051-0780

The Medrad Stellant CT Injector System maintains the same intended use, similar operational 2) 767-2400 parameters, similar labeling and is used in a manner similar to the predicate device.

> Like the EnVision, the Stellant 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 tomography studies.

The Stellant CT Injector System is comprised of the same main components as the predicate device: an Injector Head, a Display Control Unit, and sterile disposables.

Medrad has established, as part of its Quality System, design controls in compliance with FDA's Quality System Regulations (QSRs). These design controls are applied to all Medrad product development processes and product design changes. These design controls were applied to the development of the Stellant CT Injector and meet the requirements of the FDA's QSRs.

As part of the design control a risk analysis was performed, and design verification and validation testing was conducted to support the conclusion drawn by the risk analysis.

Test results demonstrate that the design specifications for the Stellant CT Injector System were met and that the Stellant CT Injector System meets the applicable requirements of the international standards cited. Therefore, it has been determined that the Stellant CT Injection is substantially equivalent to the predicate device, its predecessor, for its intended use when used as prescribed in the User Operation Manual.

A comparison of features and principles of operation between the proposed device and predicate device is provided in the table below.

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Image /page/1/Picture/0 description: The image shows the word "medrad" in a stylized, bold, black font, with a registered trademark symbol to the right of the word. Below the word "medrad", the number "K023183" is written in a handwritten style. The number is also in black ink. The background of the image is white.

## COMPARISON DATA

| Feature | Proposed Device:<br>Stellant CT Injector System | Predicate Device:<br>EnVision CT Injector System<br>(K934086 and K993728) |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended Use | Intended to be used for the specific<br>purpose of injecting intravenous contrast<br>media into humans for diagnostic studies<br>in computed tomography (CT) applications. | Same |
| Single or Dual Syringe<br>System | Single and dual syringe models | Single syringe system |
| Information Display | Color LCD | Monochrome LCD |
| Programming Keys | Non-dedicated keys - software determined | Non-dedicated Keys - Software<br>Determined |
| Touch screen | Yes | Yes |
| Multi-Phase | 1 - 6 phases per injection | 1-10 Phases Per Injection |
| Arming Modes | Single | Single/Multi-Arm |
| Protocol Storage<br>Capability | 32 protocols | 50 Protocols |
| Hold Capability | 20 minutes max. | 0 - 600 seconds |
| Scan Delay | 1 - 300 seconds | 0 - 99 seconds |
| Safety Stop Mechanism | Multi-layered software stops with backup<br>monitoring | Electrical stop with a software<br>backup system |
| Syringe System | Single syringe model: 200 ml syringe<br>Dual syringe model: two 200 ml syringes | One 200 ml or 125 ml syringe |
| Programmed Volume | 1 to 200 ml | 1 to 200 ml or 1 to 125 ml<br>depending on syringe size |
| Volume Remaining<br>Readout | LED on injector head; graphical and<br>numeric on LCD | LED |
| Fill Rate | Variable up to 10 ml/sec | 2 ml/sec to 9.9 ml/sec |
| Flow Rate | 0.1ml/s to 10.0 ml/s | 0.1 ml/sec to 9.9 ml/sec |
| Programmable Pressure<br>Limit | 325 PSI default, user settable 50 to 300<br>PSI | Settable from 25 to 300 PSI |
| Pause | Programmable - 1 sec to 900 sec in 1 sec<br>increments | Programmable - 1 sec to 10 min |
| Autofill | Fill rate 4 ml/sec | Fill rate 2 ml/sec to 9 ml/sec in 1<br>ml/sec increments |
| Retract Control | Yes (Automatic) | Yes |
| Remote Start Switch | Yes | Yes |
| Pressure Graph | Yes | No |
| Syringe Sensing | Yes | Yes |
| Autoload | Yes | Yes |
| Auto<br>Dock/Retract/Advance | Yes; user-selectable autodock and advance;<br>user-selectable auto-retract | No |
| Protocol Lock / Remote<br>Arming | Yes | No |
| Remote Check for Air<br>(from Head) | Yes | No |
| Scan Delay | 1sec to 300 sec in 1sec increments | 0 - 99 sec in 1 sec increments |
| Store/Recall | 32 protocols | 50 protocols |
| Test Inject | Yes | Yes |
| Syringe Heat Maintainer | Yes | Yes |
| Sterile Disposables | | |
| Feature | Proposed Device:<br>Stellant CT Injector System | Predicate Device:<br>EnVision CT Injector System<br>(K934086 and K993728) |
| Packaging | Tyvek lid covering polystyrene tray | Same |
| Sterilization | EtO sterilization | Same |
| Luer Fittings | ISO 594-1 & ISO 594-2 compliant design | Same |
| Syringe: | | |
| Barrel Material<br>Composition | PET | Same |
| Barrel Length | 7.504" | 7.273" |
| Barrel OD | 2.002" | Same |
| Barrel ID | 1.844" | Same |
| Plunger Material<br>Composition | Polycarbonate | Same |
| Plunger Cover | Polyisoprene with silicone coating | Same |
| Connector Tubing<br>Components: | | |
| Maximum Pressure | 400 | 355 |
| Tube Material | PVC | Same |
| Tube Length | 60" | Same |
| Bonding Agent | Cyclohexanone | Same |
| T-connector | Polycarbonate | Same |
| Spike | ABS | None |
| Priming Tube | Polyethylene | None |

Image /page/1/Picture/3 description: The image shows a logo with a stylized letter "Q" in a bold, sans-serif font. The "Q" is partially obscured by a square shape, giving it a modern and abstract appearance. Below the "Q", the word "Quality" is written in a smaller, lighter font, suggesting that the logo represents a brand or organization focused on quality.

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Image /page/2/Picture/0 description: The image shows the word "medran" in a stylized, bold, sans-serif font, with a circled R trademark symbol next to it. Below the word, there is a handwritten alphanumeric code that reads "K023183". The text is black and the background is white.

Image /page/2/Picture/2 description: The image shows a logo with a stylized letter 'Q' in a bold, sans-serif font. Below the 'Q', there are two lines of text that appear to say 'Quality' and 'of Life'. The text is in a smaller font size than the 'Q' and is slightly blurred, making it difficult to read clearly. The logo has a simple, clean design.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual one.

JAN 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medrad, Inc. Mr. Frank W. Pelc III Regulatory Affairs Coordinator One Medrad Drive Indianola, PA 15051-0780

Re: K023183

> Trade/Device Name: Medrad Stellant CT Injector System Regulation Number: CFR 870.1650 Regulation Name: Angiographic injector and syringe. Regulatory Class: Class II Product Code: DXT Dated: December 10, 2002 Received: December 11, 2002

Dear Mr. Pelc:

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.

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

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Page 2 - Mr. Frank W. Pelc III

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 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 yours.

Kaila Tuh

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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Intended Use

## Indications for Use Statement

510(k) Number:

K023183

Device Name: Medrad Stellant CT Injector System

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

DaGTM

diovascu

510(k) Number K023183

Prescription Use √

Over-The-Counter Use_____(Per 21 CFR 801.109)