(131 days)
No
The document describes a standard automated contrast injection system based on established electromechanical technology and sensors. There is no mention of AI, ML, or any features that would suggest the use of such technologies for tasks like image analysis, predictive modeling, or adaptive control based on patient data.
No.
The device is used for administering contrast media for diagnostic purposes (imaging in CT scans) and does not provide therapeutic benefit.
No
Explanation: The device is an automated contrast injection system used to administer contrast media for diagnostic studies in CT applications. It facilitates the imaging process but does not perform the diagnosis itself.
No
The device description clearly states it is a "piston-based electromechanical device" and is comprised of a "Scan Room Unit" and "Control Room Unit," which are physical hardware components. The summary also details performance studies related to hardware aspects like injection volume, flow rate, pressure, air detection, heat maintenance, battery performance, occlusion detection, and electrical safety.
Based on the provided information, the MEDRAD® Centargo CT Injection System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MEDRAD® Centargo CT Injection System is used to administer contrast media and saline directly into the patient's body during a CT scan. It is an injection system, not a system that analyzes samples taken from the body.
- Intended Use: The intended use clearly states the system is for the "controlled, automatic administration... of contrast media... and 0.9% Sodium Chloride Injection USP (saline) to human subjects undergoing examinations in computed tomography (CT)." This describes a therapeutic or procedural function, not an in vitro diagnostic function.
Therefore, the MEDRAD® Centargo CT Injection System is a medical device used in conjunction with a diagnostic imaging modality (CT), but it is not an IVD itself.
N/A
Intended Use / 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® (Iopromide), ISOVUE® (Iopamidol), 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.
Product codes (comma separated list FDA assigned to the subject device)
IZQ
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® (Iopamidol) 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
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
general patient population, including adults and pediatrics.
Intended User / Care Setting
trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
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.
CT suite
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Device performance testing included verification of the system injection volume and flow rate accuracy, pressure accuracy, air detection, heat maintenance, battery performance, occlusion detection, and protocol management. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
- Software verification and validation was performed. All test results were acceptable.
- Cybersecurity testing was conducted. Testing provides a reasonable assurance that the device and related systems are cybersecure.
- Biocompatibility testing was performed. The Centargo sterile disposables met all acceptance criteria and have been determined to be compatible for their intended use.
- Chemical Integrity testing was performed to support the material compatibility.
- Cleaning/disinfection validation was performed, and testing results demonstrated the efficacy of the cleaning and disinfection procedures.
- Sterility, Packaging, and Shelf-Life Testing were performed. All testing passed and the product performance met all prior established acceptance criteria.
- Contamination Control Testing was performed. It has been concluded that MEDRAD® Centargo CT Injection has the ability to maintain sterile fluid path and resist the ingress of microorganisms when used as intended.
- Human Factors/Usability testing were performed in a simulated use environment. The results demonstrated that the overall residual risk is low, and users can operate the system as safely and effectively as the predicate device.
- Reliability testing was performed. All testing passed and the demonstrated performance met all prior established acceptance criteria.
- Electromagnetic Compatibility (EMC) and Electrical Safety Testing were performed. All testing passed and the demonstrated performance met all prior established acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
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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: Anhua.hu@bayer.com Phone: +61 439078849
US Correspondent Contact: Dr. Gopal Abbineni Bayer Medical Care Inc. 1 Bayer Drive Indianola PA 15051 United States Email: gopal.abbineni@bayer.com Phone: +1 202-657 8090
US Alternative Contact: Ms. Hortense Allison Bayer Medical Care Inc. 1 Bayer Drive Indianola PA 15051 United States Email: hortense.allison@bayer.com Phone: +1 412-935 7777
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
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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
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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
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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 | |||
| System | MEDRAD® Centargo CT Injection System | ||
| Class | II | II | Same |
| FDA Regulation | |||
| Number | 21 CFR 870.1650 | 21 CFR 870.1650 | Same |
| Classification | |||
| Product Code | IZQ | IZQ | Same |
| Intended Use/ | |||
| Indications for Use | The CT Exprès™ 3D Contrast Media Delivery | ||
| System is indicated for controlled automatic | |||
| administration, on the venous side, of contrast | |||
| media and saline, to human subjects while | |||
| undergoing examination by means of a | |||
| computed tomography (CT) scanner. |
The CT Exprès™ 3D Contrast Media Delivery
System is specifically indicated for use in CT
procedures for the delivery of Isovue
(Iopamidol Injection) contrast media as
supplied in Imaging Bulk Package (IBP), for a
maximum of 20 bottles of contrast media or a
maximum of ten (10) hours, whichever comes
first, per Day Set III HP disposable. The Bottle
Spike disposable is for single-bottle use only
and must be discarded with the contrast
media bottle. The Patient Set disposable must
be discarded after each patient procedure.
The CT Exprès™ 3D is to be used only by and
under quasi-continuous supervision of trained
health care professionals in an appropriate
licensed health care facility, in a room
designated for radiological procedures that | 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™ (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 | Same Intended Use |
| Item | Predicate Device (K151048):
CT Exprès™ 3D Contrast Media Delivery
System | Subject Device (K241849):
MEDRAD® Centargo CT Injection System | Comparison |
| | involve intravascular administration of a
contrast agent. | 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. | |
| System Components | | | |
| System | CT Exprès Injector Unit
CT Exprès Control Panel | Centargo Scan Room Unit
Centargo Control Room Unit | Same |
| Accessories | CT Exprès Hand Switch
CT Exprès Stand | ISI2 Module | Different and
Substantially Equivalent |
| Heat Maintainer | CT Exprès Bottle Insulator | Heat maintainer is integral to the device | Different and
Substantially Equivalent |
| Disposables | CT Exprès Day Set III HP
CT Exprès Patient Set
CT Exprès Bottle Spike Type B (25mm) | Centargo Day Set
Centargo Patient Line
Centargo Replacement Spike | Same |
| Item | Predicate Device (K151048):
CT Exprès™ 3D Contrast Media Delivery
System | Subject Device (K241849):
MEDRAD® Centargo CT Injection System | Comparison |
| Weight | Injector: Approx. 10 kg
Console: Approx. 2.1 kg | Injector (Scan Room Unit): Approx. 75 kg
Control Room Unit: Approx. 7 kg | Different and
Substantially Equivalent |
| Dimensions | Injector: 44 x 32 x 16 cm
Console: 30 x 20 x 22 cm | Injector (Scan Room Unit): 168 x 76 x 69 cm
Control Room Unit (W3CZ): 27 x 38 x 20 cm
Control Room Unit (Workflow Hub): 27 x 36
x 19 cm | Different and
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
Disposable | Patient Set | Patient Line | Same |
| Operating Principle | Rotary peristaltic pump | Servo driven piston | Different and
Substantially Equivalent |
| Used to administer
contrast media and
saline | Yes | Yes | Same |
| Operational Characteristics | | | |
| Programmable
Pressure Limit | Yes, 8 bar (ca. 120 psi) | Yes, 20.68 bar (300 psi). User programmable | Different and
Substantially Equivalent |
| Injection | Up to 24 phases per patient | Up to 60 phases per patient (6 phases per | Different and |
| Capabilities | (8 phases per injection; up to 3 injections
per patient) | injection: up to 10 injections per patient) | Substantially Equivalent |
| Injection Rates for
Contrast Media | 0.5-9.0 mL/s | 0.1 to 10 mL/s | Different and
Substantially Equivalent |
| Item | Predicate Device (K151048):
CT Exprès™ 3D Contrast Media Delivery
System | Subject Device (K241849):
MEDRAD® Centargo CT Injection System | Comparison |
| Injection Rates for
Saline | 0.1-9.0 mL/s | 0.1 to 10 mL/s | Different and
Substantially Equivalent |
| Injection Volume
per Injection | 10-200 mL per injection | 1-400 mL per injection
1 mL to 200 mL for contrast and flush
phases, 1 mL to 400 mL for Dual Flow
phases, in 1 mL increments.
A total of 400 mL of contrast can be
delivered in the same injection if both
contrast reservoirs contain the same type
and concentration. | Different and
Substantially Equivalent - |
| Flow Rate Accuracy | $\pm$ 10% for a programmed injection volume
between 10 mL and 59 mL
$\pm$ 6% for a programmed injection volume
between 60 mL and 200 mL | $\pm$ (5% + 0.1) mL/s when averaged over 2
seconds for flow rates >5 mL/s or averaged
over 10 mL for flow rates ≤5 mL/s | Different and
Substantially Equivalent - |
| Volume Accuracy | $\pm$ 10% for a programmed injection volume
between 10 mL and 59 mL
$\pm$ 6% for a programmed injection volume
between 60 mL and 200 mL | Contrast or saline phase:
• $\pm$ (2% + 1) mL
Simultaneous (DualFlow) phase:
For ratio Particulate Matter in Injections. The Centargo sterile disposables met all acceptance criteria and have been determined to be compatible for their intended use.
D. Chemical Compatibility Testing
Chemical Integrity testing was performed to support the material compatibility of the MEDRAD® Centargo CT Injection System Disposable sets with the following contrast media:
- . ULTRAVIST® (Iopromide) Image Bulk Presentation
- ISOVUE® (Iopamidol) Image Bulk Presentation .
- OPTIRAY® (loversol) Image Bulk Presentation ●
- OMNIPAQUE™ (Iohexol) Image Bulk Presentation
E. Cleaning and Disinfection Validation Testing
Cleaning/disinfection validation was performed, and testing results demonstrated the efficacy of the cleaning and disinfection procedures.
F. Sterility, Packaging, and Shelf-Life Testing
The MEDRAD® Centargo CT Injection System disposable sets are Radiation sterilized and are validated to a SAL of 10 °. The testing was performed as per the following standards.
- . ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products-Microbiological methods-Part 1: Determination of microorganisms on products.
- . ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods -Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization process.
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- ISO 11137-1 First edition 2006-04-15- Sterilization of health care products-Radiation-Part1: requirements for development validation and routine control of a sterilization process for medical devices.
- ISO 11137-2 Third edition 2013-06-01 [Including AMD1:2022]: Sterilization of health care products- Radiation Part 2: Establishing the sterilization dose.
- . IS0 11607-1 Second edition 2019-02: Packaging for terminally sterilized medical devices-part 1: Requirements for materials sterile barrier systems and packaging systems.
- . The sterilization testing passed, and the product performance met all prior established acceptance criteria.
- . Disposables functional testing was performed on accelerated aged samples and results confirmed the performance for the labeled shelf-life.
- Package stability testing was demonstrated via verification of aged product that had been preconditioned. Testing was acceptable to satisfy the package testing requirements. Additionally, product testing was successfully completed after exposure to shipping and handling conditions.
G. Contamination Control Testing
Bayer performed the following contamination control studies:
- Microbial ingress study and
- Cross contamination study
Based on the results obtained, it has been concluded that MEDRAD® Centargo CT Injection has the ability to maintain sterile fluid path and resist the ingress of microorganisms when used as intended.
H. Human Factors/ Usability Testing
Human Factors/Usability testing were performed in a simulated use environment to optimize the device design and support the safe use of the MEDRAD® Centargo CT injection System. The summative evaluation is conducted as per the following standard and FDA Guidance.
- . IEC 62366-1 Edition 1.1 2020-06 Consolidated version. Medical devices-Part 1: Application of Usability engineering to medical devices.
- . Applying Human Factors and Usability Engineering to Medical Devices (Guidance for Industry and FDA Staff) February 3, 2016.
The results demonstrated that the overall residual risk is low, and users can operate the system as safely and effectively as the predicate device.
l. Reliability Testing
Reliability testing was performed using statistical methods to demonstrate the capability to meet system performance requirements sequentially and repeatedly. All testing passed and the demonstrated performance met all prior established acceptance criteria.
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Image /page/20/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically inside of a circle. The circle has a green border on the left side and a blue border on the right side. The word "BAYER" is written in a bold, sans-serif font.
J. Electromagnetic Compatibility (EMC) and Electrical Safety Testing
Electromagnetic compatibility and electrical safety testing were performed in accordance with the following standards:
- ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . ANSI AAMI IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Testing included verification of both configurations, including in conjunction with the ISI2 Module accessory. All testing passed and the demonstrated performance met all prior established acceptance criteria.
K. Animal Studies: Not Applicable
- L. Clinical Testing: Not Applicable
Summary
In summary, the conclusions drawn from the nonclinical and other tests (discussed above) demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device (K151048).
XI. CONCLUSION
Bayer considers the MEDRAD® Centargo CT Injection System (Centargo) to be substantially equivalent to the predicate device, CT Exprès™ 3D Contrast Media Delivery System (K151048). This conclusion is based upon the devices having the same intended use and comparable technological characteristics. While there are differences in design and technology, these differences do not raise new questions of safety or effectiveness when compared to the predicate device. Centargo has demonstrated its ability to perform within its specified parameters and operate as intended by the users of the device. As a result, its performance is deemed acceptable and substantially equivalent to the predicate device.