MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

K241849 · Imaxeon Pty, Ltd. · IZQ · Nov 5, 2024 · Cardiovascular

Device Facts

• Record ID: K241849
• Device Name: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
• Applicant: Imaxeon Pty, Ltd.
• Product Code: IZQ · Cardiovascular
• Decision Date: Nov 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, on the venous side, of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), OPTIRAY® (loversol), or OMNIPAQUE™ (Iohexol) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation and 0.9% Sodium Chloride Injection USP (saline) to human subjects undergoing examinations in computed tomography (CT). The system is to be used by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent. The Day Set is used for a maximum time of twenty-four (24) hours, or for a maximum of 25 bottles of contrast media, whichever comes first. The Patient Line must be discarded after each patient procedure. The Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast media containers are to be discarded after their respective use times have expired or the Day Set use life has expired, whichever occurs first. Saline should only be used to deliver multiple single doses to multiple patients when used with the MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is punctured, it should not be removed from the work area during the entire period of use. Saline containers are to be discarded with the Day Set. The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.

Device Story

Automated contrast injection system for CT; uses piston-based electromechanical drive to deliver contrast media and saline from multi-patient Day Set to patient via single-use Patient Line. Comprises Scan Room Unit (injection delivery) and Control Room Unit (remote monitoring/control via wired/wireless connection). Features include air detection (optical/ultrasonic/software), occlusion detection (motor current monitoring), and heat maintenance. Optional software-based features include scanner connectivity (ISI2 module/Connect.CT), personalized patient protocols (P3T), and automated documentation. Operated by trained radiological technologists in CT suites. System synchronizes injection with scanner timing; provides individualized protocols based on patient weight, iodine concentration, and tube voltage. Benefits include consistent fluid delivery, workflow efficiency, and reduced manual handling of contrast media.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (volume/flow accuracy, pressure, air/occlusion detection, heat maintenance, battery, reliability), software verification/validation (IEC 62304), cybersecurity, biocompatibility (ISO 10993-1), chemical compatibility, sterilization validation (ISO 11137), and human factors/usability testing (IEC 62366-1).

Technological Characteristics

Piston-based electromechanical injector; PVC tubing; radiation-sterilized disposables. Features optical/ultrasonic air detection and software-based occlusion monitoring. Connectivity via wired/wireless interfaces (ISI2 module, Connect.CT). Complies with IEC 60601-1 and 60601-1-2. Software-based protocol management and documentation.

Indications for Use

Indicated for controlled, automatic venous administration of specific iodinated contrast media (Ultravist, Isovue, Optiray, Omnipaque) and saline in human subjects (adults and pediatrics) undergoing CT examinations. Used by trained healthcare professionals in licensed radiological facilities.

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

• CT Exprès™ 3D Contrast Media Delivery System (K151048)

Reference Devices

• MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (K192370)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

November 5, 2024

Imaxeon Pty Ltd % Dr. Gopal Abbineni Director, Regulatory Affairs, Radiology Medical Devices Bayer Medical Care, Inc. 1 Baver Drive Indianola, Pennsylvania 15051

Re: K241849

Trade/Device Name: MEDRAD Centargo CT Injection System: MEDRAD Centargo Day Set: MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: IZO Dated: October 2, 2024 Received: October 3, 2024

Dear Dr. Gopal Abbineni:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

{2}------------------------------------------------

Sincerely,

Shruti N. Mistry -S

Shruti Mistry Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241849

Device Name

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

Indications for Use (Describe)

MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, on the venous side, of ULTRAVIST® (lopromide), ISOVUE® (lopamidol), OPTIRAY® (loversol) or OMNIPAQUE™ (lohexol) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation and 0.9% Sodium Chloride Injection USP (saline) to human subjects undergoing examinations in computed tomography (CT). The system is to be used by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

The Day Set is used for a maximum time of twenty four (24) hours, or for a maximum of 25 bottles of contrast media, whichever comes first. The Patient Line must be discarded after each patient procedure. The Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast media containers are to be discarded after their respective use times have expired or the Day Set use life has expired, whichever occurs first.

Saline should only be used to deliver multiple single doses to multiple patients when used with the MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is punctured, it should not be removed from the work area during the entire period of use. Saline containers are to be discarded with the Day Set.

The ISI2 module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically, with the letters in a bold, sans-serif font. The word is enclosed in a circular shape that is divided into two halves. The top half of the circle is green, and the bottom half is blue.

510(k) Summary Imaxeon Pty Ltd. MEDRAD® Centargo CT Injection System The Summary is prepared in conformance with 21CFR 807.92

#### l. SUBMITTER

Imaxeon Pty Ltd. Unit 1 38-46 South Street Rydalmere NSW 2116 Australia Contact: Mr. Anhua Hu Email: [e-mail] Phone: [phone]

US Correspondent Contact: Dr. Gopal Abbineni Bayer Medical Care Inc. 1 Bayer Drive Indianola PA 15051 United States Email: [e-mail] Phone: [phone]

US Alternative Contact: Ms. Hortense Allison Bayer Medical Care Inc. 1 Bayer Drive Indianola PA 15051 United States Email: [e-mail] Phone: [phone]

Date Prepared: October 4, 2024

#### II. DEVICE

| Trade Name: | MEDRAD® Centargo CT Injection System |
|----------------------------|---------------------------------------|
| | MEDRAD® Centargo Day Set |
| | MEDRAD® Centargo Patient Line |
| | MEDRAD® Centargo Replacement Spike |
| | MEDRAD® ISI2 Module |
| Common Name: | Automatic injector for contrast media |
| Classification Name: | Injector, Contrast Medium, Automatic |
| Classification Regulation: | 21 CFR 870.1650 |
| Regulatory Class: | Class II |
| Product Code: | IZQ |

#### PREDICATE DEVICE III.

Trade Name:

CT Exprès™ 3D Contrast Media Delivery System

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image features the Bayer company logo, which consists of the word "BAYER" arranged vertically within a circle. The circle is divided into two halves, with the top half being green and the bottom half being blue. A thin white line separates the two halves of the circle. The letters of the word "BAYER" are in a bold, sans-serif font and are colored in a dark gray or black.

| 510(k) Number: | K151048 |
|-----------------------------------------------------------------|---------------------------------------|
| Common Name: | Automatic injector for contrast media |
| Classification Name: | Injector, Contrast Medium, Automatic |
| Classification Regulation: | 21 CFR 870.1650 |
| Regulatory Class: | Class II |
| Product Code: | IZQ |
| This predicate has not been subject to a design-related recall. | |

### IV. REFERENCE DEVICE

| Trade Name: | MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation |
|----------------------------|----------------------------------------------------------------------|
| Number: | K192370 |
| Common Name: | Injector and Syringe, Angiographic |
| Classification Name: | Injector and Syringe, Angiographic |
| Classification Regulation: | 21 CFR 870.1650 |
| Regulatory Class: | Class II |
| Product Code: | DXT |

### V. DEVICE DESCRIPTION

The MEDRAD® Centargo CT Injection System (Centargo) is an automated contrast injection system intended to be used to inject intravenous contrast media and saline into humans for diagnostic studies in CT applications. Centargo is intended for use with the following approved contrast media in an Imaging Bulk Package (IBP):

- . ULTRAVIST® (Iopromide) NDA 021425/S-034
- . ISOVUE® (lopamidol) NDA 020327/S-023
- . OPTIRAY® (loversol) IBP NDA 020923/S-026
- . OMNIPAQUE™ (lohexol) NDA 020608/S-045

Centargo is based on well-established technologies for injection, using a piston-based electromechanical device. The system is designed to protect the patient against air injection by incorporating multiple sensors to detect air within the fluid pathway. The system is comprised of two main modules:

- Scan Room Unit – responsible for handling the contrast/saline and delivering injections
- . Control Room Unit - controls, monitors, and communicates with the Scan Room Unit through wired or wireless connection

The Scan Room Unit is located within the scan room whereas the Control Room Unit is not. When communicating via wired or wireless connection, the Control Room Unit can remotely control the Scan Room Unit and initiate and execute injections. However, the Scan Room Unit can operate independently without the use of the Control Room Unit via the Scan Room Unit's graphical user interface (GUI).

The Scan Room Unit is available in two different configurations:

- . Pedestal with battery and AC power

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the Bayer company logo. The logo is a circle with the word "BAYER" written vertically in the center. The circle is divided into two halves, with the top half being a light green color and the bottom half being a light blue color. The letters in the word "BAYER" are all capitalized and in a bold, sans-serif font. The logo is simple and recognizable, and it is often used to represent the Bayer company.

- Overhead mount with AC power only ●
The fluids are delivered from a multi-patient disposable set (Day Set) through a single use patient line (Patient Line). The Day Set is labeled for 24 hours or for a maximum of 25 bottles of contrast media, whichever comes first. Fluid source spikes (Replacement Spike) are for single container use.

The system is intended to be used in a CT suite. It is intended to be operated by personnel with training and experience in CT procedures and use of CT injection systems. Operators will consist of radiological technologists trained in the use of the equipment. This system is intended for use on the general patient population, including adults and pediatrics.

## Options and Accessories

All optional set-ups and accessories for Centargo are related to software-based features. They are either software license enabled or require a hardware accessory to be connected (the ISI2 Module). The following types of options are available for Centargo:

- . Scanner connectivity related options - enables injectors and scanners to communicate
- . Smart Protocols related options -- computes individualized contrast injection protocols
- . Automated documentation related options – transfers data with external systems

## Scanner connectivity related options

These options enable injectors and scanners to communicate, enhancing clinical capability by synchronizing scan timing and simplifying operator workflow. There are three different options for connecting a Centargo to a scanner:

- ISI-700 (accessory ISI2 Module required) – Proprietary interface
- . ISI-900 (accessory ISI2 Module required) – CiA-425 standard based, Class IV
- Connect.CT (software only) – Proprietary interface

## Smart Protocols related options

Injection protocols may be either fixed standard protocols with fixed volumes and rates for all patients (i.e., one size fits all), or they can be personalized for each patient (e.g., be weight based). Protocols can also be adapted for the iodine concentration in use as well as the scanner tube voltage. Finally, protocols can also be adapted for the particulars of some study types and the specific CT scanner capabilities being used. The three kinds of Smart Protocols available on Centargo are:

- . Personalized Patient Protocol Technology (P3T)
- . Iodine Load/Dose Based Protocols, lodine Delivery Rate Based Protocols
- . Tube Voltage Based Protocols

## Automated documentation related options

Centargo by default is a standalone injection system that operates in accordance with its intended use without any network connections being required. If a customer prefers to have injection information transmitted to their hospital system (e.g., Radiology Information System (RIS)), they may purchase one or

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image contains the logo for Bayer. The logo is a circle with the word "BAYER" stacked vertically in the center. The circle has a green and blue gradient. The word "BAYER" is in a sans-serif font.

more automated documentation options. These options are for customer convenience and are not themselves considered medical devices as their sole function is to transfer data.

### VI. INDICATIONS FOR USE

MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, on the venous side, of ULTRAVIST® (lopromide), ISOVUE® (lopamidol), OPTIRAY® (loversol), or OMNIPAQUE™ (lohexol) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation and 0.9% Sodium Chloride Injection USP (saline) to human subjects undergoing examinations in computed tomography (CT). The system is to be used by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

The Day Set is used for a maximum time of twenty-four (24) hours, or for a maximum of 25 bottles of contrast media, whichever comes first. The Patient Line must be discarded after each patient procedure. The Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast media containers are to be discarded after their respective use times have expired or the Day Set use life has expired, whichever occurs first.

Saline should only be used to deliver multiple single doses to multiple patients when used with the MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is punctured, it should not be removed from the work area during the entire period of use. Saline containers are to be discarded with the Day Set.

The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VII.

A table comparing key features of the subject device (Centargo) and predicate device (CT Exprès) is provided below.

{8}------------------------------------------------

| Item | Predicate Device (K151048): | Subject Device (K241849): | Comparison |
|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| | CT Exprès™ 3D Contrast Media Delivery<br>System | MEDRAD® Centargo CT Injection System | |
| Class | II | II | Same |
| FDA Regulation<br>Number | 21 CFR 870.1650 | 21 CFR 870.1650 | Same |
| Classification<br>Product Code | IZQ | IZQ | Same |
| Intended Use/<br>Indications for Use | The CT Exprès™ 3D Contrast Media Delivery<br>System is indicated for controlled automatic<br>administration, on the venous side, of contrast<br>media and saline, to human subjects while<br>undergoing examination by means of a<br>computed tomography (CT) scanner.<br><br>The CT Exprès™ 3D Contrast Media Delivery<br>System is specifically indicated for use in CT<br>procedures for the delivery of Isovue<br>(Iopamidol Injection) contrast media as<br>supplied in Imaging Bulk Package (IBP), for a<br>maximum of 20 bottles of contrast media or a<br>maximum of ten (10) hours, whichever comes<br>first, per Day Set III HP disposable. The Bottle<br>Spike disposable is for single-bottle use only<br>and must be discarded with the contrast<br>media bottle. The Patient Set disposable must<br>be discarded after each patient procedure.<br><br>The CT Exprès™ 3D is to be used only by and<br>under quasi-continuous supervision of trained<br>health care professionals in an appropriate<br>licensed health care facility, in a room<br>designated for radiological procedures that | MEDRAD® Centargo CT Injection System is an<br>automated contrast injection system that is<br>indicated for the controlled, automatic<br>administration, on the venous side, of<br>ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol),<br>OPTIRAY® (loversol), or OMNIPAQUE™ (lohexol)<br>contrast media as supplied in an approved<br>Imaging Bulk Package (IBP) presentation and<br>0.9% Sodium Chloride Injection USP (saline) to<br>human subjects undergoing examinations in<br>computed tomography (CT). The system is to be<br>used by and under quasi-continuous supervision<br>of trained healthcare professionals in an<br>appropriate licensed healthcare facility, in a<br>room designated for radiological procedures that<br>involve intravascular administration of contrast<br>agent.<br><br>The Day Set is used for a maximum time of<br>twenty-four (24) hours, or for a maximum of 25<br>bottles of contrast media, whichever comes first.<br>The Patient Line must be discarded after each<br>patient procedure. The Replacement Spike is for<br>single-container use only and must be discarded<br>with the fluid container. Contrast media | Same Intended Use |
| Item | Predicate Device (K151048):<br>CT Exprès™ 3D Contrast Media Delivery<br>System | Subject Device (K241849):<br>MEDRAD® Centargo CT Injection System | Comparison |
| | involve intravascular administration of a<br>contrast agent. | containers are to be discarded after their<br>respective use times have expired or the Day Set<br>use life has expired, whichever occurs first.<br>Saline should only be used to deliver multiple<br>single doses to multiple patients when used with<br>the MEDRAD® Centargo CT Injection System and<br>the provided Saline Tag. Once the port of the<br>saline container is punctured, it should not be<br>removed from the work area during the entire<br>period of use. Saline containers are to be<br>discarded with the Day Set.<br>The ISI2 Module is indicated for the specific<br>purpose of allowing an injector to interface with<br>an imaging scanner. | |
| System Components | | | |
| System | CT Exprès Injector Unit<br>CT Exprès Control Panel | Centargo Scan Room Unit<br>Centargo Control Room Unit | Same |
| Accessories | CT Exprès Hand Switch<br>CT Exprès Stand | ISI2 Module | Different and<br>Substantially Equivalent |
| Heat Maintainer | CT Exprès Bottle Insulator | Heat maintainer is integral to the device | Different and<br>Substantially Equivalent |
| Disposables | CT Exprès Day Set III HP<br>CT Exprès Patient Set<br>CT Exprès Bottle Spike Type B (25mm) | Centargo Day Set<br>Centargo Patient Line<br>Centargo Replacement Spike | Same |
| Item | Predicate Device (K151048):<br>CT Exprès™ 3D Contrast Media Delivery<br>System | Subject Device (K241849):<br>MEDRAD® Centargo CT Injection System | Comparison |
| Weight | Injector: Approx. 10 kg<br>Console: Approx. 2.1 kg | Injector (Scan Room Unit): Approx. 75 kg<br>Control Room Unit: Approx. 7 kg | Different and<br>Substantially Equivalent |
| Dimensions | Injector: 44 x 32 x 16 cm<br>Console: 30 x 20 x 22 cm | Injector (Scan Room Unit): 168 x 76 x 69 cm<br>Control Room Unit (W3CZ): 27 x 38 x 20 cm<br>Control Room Unit (Workflow Hub): 27 x 36<br>x 19 cm | Different and<br>Substantially Equivalent |
| Power Requirement | | | Different and |
| Rated Voltage: | 110 to 240 V AC | 100 to 240 V AC | Substantially Equivalent |
| Rated Current: | 1.6 A | 336-377 VA | |
| Rated Frequency: | 50/60Hz | 50/60Hz | |
| Display Type | Color LCD with touch screen | Color LCD with touch screen | Same |
| Characteristics | | | |
| Remote Operation | Yes | Yes | Same |
| Single Patient Use<br>Disposable | Patient Set | Patient Line…