(131 days)
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.
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.
The provided text describes a 510(k) premarket notification for the MEDRAD® Centargo CT Injection System. This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific clinical acceptance criteria for an AI/ML model for diagnostic purposes.
Therefore, the information required to populate a table of acceptance criteria for an AI model (like sensitivity, specificity, AUC) and details about study design for AI model performance (expert ground truth, MRMC studies, training set details) are not present in the provided document. The document describes a medical device, an angiographic injector, and the testing outlined is typical for hardware and software validation of such a device, including:
- Performance testing: Verification of injection volume, flow rate accuracy, pressure accuracy, air detection, heat maintenance, battery performance, occlusion detection, and protocol management.
- Software Verification and Validation Testing: Adherence to IEC 62304 and FDA guidance for device software.
- Biocompatibility Testing: According to ISO 10993-1.
- Chemical Compatibility Testing: With various contrast media.
- Cleaning and Disinfection Validation Testing:
- Sterility, Packaging, and Shelf-Life Testing: Adherence to ISO standards.
- Contamination Control Testing: Microbial ingress and cross-contamination studies.
- Human Factors/Usability Testing: According to IEC 62366-1 and FDA guidance.
- Reliability Testing:
- Electromagnetic Compatibility (EMC) and Electrical Safety Testing: Adherence to ANSI/AAMI IEC standards.
The document explicitly states "Animal Studies: Not Applicable" and "Clinical Testing: Not Applicable." This reinforces that the submission is about a device (injector) and its accessory components, not a diagnostic AI/ML algorithm that would undergo the rigorous clinical validation described in your prompt.
Based on the information available in the provided text, it is not possible to complete the requested table and answer the specific questions about AI/ML model acceptance criteria and study details. The document provides information relevant to the safety and effectiveness of an injection system, not an AI diagnostic tool.
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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"
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(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).
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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
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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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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.
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| Item | Predicate Device (K151048): | Subject Device (K241849): | Comparison |
|---|---|---|---|
| CT Exprès™ 3D Contrast Media DeliverySystem | MEDRAD® Centargo CT Injection System | ||
| Class | II | II | Same |
| FDA RegulationNumber | 21 CFR 870.1650 | 21 CFR 870.1650 | Same |
| ClassificationProduct Code | IZQ | IZQ | Same |
| Intended Use/Indications for Use | The CT Exprès™ 3D Contrast Media DeliverySystem is indicated for controlled automaticadministration, on the venous side, of contrastmedia and saline, to human subjects whileundergoing examination by means of acomputed tomography (CT) scanner.The CT Exprès™ 3D Contrast Media DeliverySystem is specifically indicated for use in CTprocedures for the delivery of Isovue(Iopamidol Injection) contrast media assupplied in Imaging Bulk Package (IBP), for amaximum of 20 bottles of contrast media or amaximum of ten (10) hours, whichever comesfirst, per Day Set III HP disposable. The BottleSpike disposable is for single-bottle use onlyand must be discarded with the contrastmedia bottle. The Patient Set disposable mustbe discarded after each patient procedure.The CT Exprès™ 3D is to be used only by andunder quasi-continuous supervision of trainedhealth care professionals in an appropriatelicensed health care facility, in a roomdesignated for radiological procedures that | MEDRAD® Centargo CT Injection System is anautomated contrast injection system that isindicated for the controlled, automaticadministration, on the venous side, ofULTRAVIST® (Iopromide), ISOVUE® (Iopamidol),OPTIRAY® (loversol), or OMNIPAQUE™ (lohexol)contrast media as supplied in an approvedImaging Bulk Package (IBP) presentation and0.9% Sodium Chloride Injection USP (saline) tohuman subjects undergoing examinations incomputed tomography (CT). The system is to beused by and under quasi-continuous supervisionof trained healthcare professionals in anappropriate licensed healthcare facility, in aroom designated for radiological procedures thatinvolve intravascular administration of contrastagent.The Day Set is used for a maximum time oftwenty-four (24) hours, or for a maximum of 25bottles of contrast media, whichever comes first.The Patient Line must be discarded after eachpatient procedure. The Replacement Spike is forsingle-container use only and must be discardedwith the fluid container. Contrast media | Same Intended Use |
| Item | Predicate Device (K151048):CT Exprès™ 3D Contrast Media DeliverySystem | Subject Device (K241849):MEDRAD® Centargo CT Injection System | Comparison |
| involve intravascular administration of acontrast agent. | containers are to be discarded after theirrespective use times have expired or the Day Setuse life has expired, whichever occurs first.Saline should only be used to deliver multiplesingle doses to multiple patients when used withthe MEDRAD® Centargo CT Injection System andthe provided Saline Tag. Once the port of thesaline container is punctured, it should not beremoved from the work area during the entireperiod of use. Saline containers are to bediscarded with the Day Set.The ISI2 Module is indicated for the specificpurpose of allowing an injector to interface withan imaging scanner. | ||
| System Components | |||
| System | CT Exprès Injector UnitCT Exprès Control Panel | Centargo Scan Room UnitCentargo Control Room Unit | Same |
| Accessories | CT Exprès Hand SwitchCT Exprès Stand | ISI2 Module | Different andSubstantially Equivalent |
| Heat Maintainer | CT Exprès Bottle Insulator | Heat maintainer is integral to the device | Different andSubstantially Equivalent |
| Disposables | CT Exprès Day Set III HPCT Exprès Patient SetCT Exprès Bottle Spike Type B (25mm) | Centargo Day SetCentargo Patient LineCentargo Replacement Spike | Same |
| Item | Predicate Device (K151048):CT Exprès™ 3D Contrast Media DeliverySystem | Subject Device (K241849):MEDRAD® Centargo CT Injection System | Comparison |
| Weight | Injector: Approx. 10 kgConsole: Approx. 2.1 kg | Injector (Scan Room Unit): Approx. 75 kgControl Room Unit: Approx. 7 kg | Different andSubstantially Equivalent |
| Dimensions | Injector: 44 x 32 x 16 cmConsole: 30 x 20 x 22 cm | Injector (Scan Room Unit): 168 x 76 x 69 cmControl Room Unit (W3CZ): 27 x 38 x 20 cmControl Room Unit (Workflow Hub): 27 x 36x 19 cm | Different andSubstantially 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 UseDisposable | Patient Set | Patient Line | Same |
| Operating Principle | Rotary peristaltic pump | Servo driven piston | Different andSubstantially Equivalent |
| Used to administercontrast media andsaline | Yes | Yes | Same |
| Operational Characteristics | |||
| ProgrammablePressure Limit | Yes, 8 bar (ca. 120 psi) | Yes, 20.68 bar (300 psi). User programmable | Different andSubstantially 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 injectionsper patient) | injection: up to 10 injections per patient) | Substantially Equivalent |
| Injection Rates forContrast Media | 0.5-9.0 mL/s | 0.1 to 10 mL/s | Different andSubstantially Equivalent |
| Item | Predicate Device (K151048):CT Exprès™ 3D Contrast Media DeliverySystem | Subject Device (K241849):MEDRAD® Centargo CT Injection System | Comparison |
| Injection Rates forSaline | 0.1-9.0 mL/s | 0.1 to 10 mL/s | Different andSubstantially Equivalent |
| Injection Volumeper Injection | 10-200 mL per injection | 1-400 mL per injection1 mL to 200 mL for contrast and flushphases, 1 mL to 400 mL for Dual Flowphases, in 1 mL increments.A total of 400 mL of contrast can bedelivered in the same injection if bothcontrast reservoirs contain the same typeand concentration. | Different andSubstantially Equivalent - |
| Flow Rate Accuracy | $\pm$ 10% for a programmed injection volumebetween 10 mL and 59 mL$\pm$ 6% for a programmed injection volumebetween 60 mL and 200 mL | $\pm$ (5% + 0.1) mL/s when averaged over 2seconds for flow rates >5 mL/s or averagedover 10 mL for flow rates ≤5 mL/s | Different andSubstantially Equivalent - |
| Volume Accuracy | $\pm$ 10% for a programmed injection volumebetween 10 mL and 59 mL$\pm$ 6% for a programmed injection volumebetween 60 mL and 200 mL | Contrast or saline phase:• $\pm$ (2% + 1) mLSimultaneous (DualFlow) phase:For ratio <80%, or that occurs following acontrast phase of ≥20 mL:• Combined fluid volume: $\pm$ (4% +2) mL• Contrast: $\pm$ (4% +2) mL• Saline: $\pm$ (4% +2) mLFor ratio ≥80% without preceding contrastphase of 20 mL or greater: | Different andSubstantially Equivalent - |
| Item | Predicate Device (K151048):CT Exprès™ 3D Contrast Media DeliverySystem | Subject Device (K241849):MEDRAD® Centargo CT Injection System | Comparison |
| Combined fluid volume: +(4% + 7) mL /-(4% +2) mL Contrast: ±(4% +2) mL Saline: +(4% + 7) mL /- (4% +2) mL | |||
| Contrast MediaContainer Volume | 200 & 500 mL (IBPs) | 200 & 500 mL (IBPs) | Same |
| Saline Flush | Yes | Yes | Same |
| Needle Size | 16-24 G | 18-24 G | Different andSubstantially Equivalent |
| Injection Pause | 0-400 seconds | 0-900 seconds | Different andSubstantially Equivalent |
| Injection ProtocolStorage | Yes | Yes | Same |
| Priming/Filling Rate | 1.5 mL/s (manual)6.0 mL/s (automatic) | 2.0 mL/s (manual)6.0 mL/s (automatic) | Different andSubstantially Equivalent |
| Air DetectionPrinciple | Outlet: Ultrasound | Inlet: OpticalOutlet: UltrasonicIn reservoir: Software | Different andSubstantially Equivalent |
| Technical DetectionLimit of air in tubing | 0.04 mL | 0.001 mL | Different andSubstantially Equivalent |
| Item | Predicate Device (K151048):CT Exprès™ 3D Contrast Media Delivery System | Subject Device (K241849):MEDRAD® Centargo CT Injection System | Comparison |
| Air Detector AlertLimit | For programmed injection volume $\le$ 35 mL CM, 1.25 mLFor programmed injection volume $\ge$ 35 mL CM, 1.25 mL if fragment air bubble, otherwise an additional air volume of 0.75 mL is tolerated.Note: The volume of the Patient Set (after the air detector) is 8 mL | In reservoir: 1 mLOutlet: 1 mL or greaterNote: The volume of the Patient Line after the air detector is approximately 11 mL | Different andSubstantially Equivalent |
| Occlusion DetectionPrinciple | Fail safe piezo-resistive pressure sensor | Software control via motor current monitoring | Different andSubstantially Equivalent |
| Occlusion DetectionAlert Limit | $132 \text{ PSI } \pm 17.4 \text{ PSI } (9.1 \text{ bar } \pm 1.2 \text{ bar})$ | Settable to 300 psi. Maximum over pressure is programmed value +50 psi | Different andSubstantially Equivalent |
| Injector Software Features (Optional features) | |||
| Smart Protocols:PersonalizedPatient ProtocolTechnology (P3T)Cardiac | No | Yes. P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta. | Different andSubstantially Equivalent |
| Smart Protocols:PersonalizedPatient ProtocolTechnology (P3T)PA | No | Yes. P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta. | Different andSubstantially Equivalent |
| Smart Protocols:PersonalizedPatient Protocol | No | Yes. P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys). | Different andSubstantially Equivalent |
| Item | Predicate Device (K151048):CT Exprès™ 3D Contrast Media DeliverySystem | Subject Device (K241849):MEDRAD® Centargo CT Injection System | Comparison |
| Technology (P3T)Abdomen | |||
| Smart Protocols:Iodine Load/DoseBased, lodineDelivery RateBased, and TubeVoltage BasedProtocols | No | Yes. Iodine Load/Dose Based, lodineDelivery Rate Based, and Tube VoltageBased Protocols | Different andSubstantially Equivalent |
| Informatics | No | Yes - This feature offers the user the abilityto associate patient/exam information withinjection details and send the output to oneor more hospital systems (e.g. RadiologyInformation System) | Different andSubstantially Equivalent |
| Connectivity Accessory | |||
| Imaging SystemInterface (ISI2)Accessory | No | Yes. The ISI2 Module is indicated for thespecific purpose of allowing an injector tointerface with a scanner. | Different andSubstantially Equivalent |
| Connect.CT | No | Yes. The Connect.CT application is indicatedfor the specific purpose of allowing theinjector to interface with a CT scanner. | Different andSubstantially Equivalent |
| Disposables | |||
| Patient Tubing | |||
| Components | Patient Set CassettePatient Set TubingPinch ClampPatient Connector with Safety Cap | Patient Line Tube2X check valvesPatient Line Connector | Different andSubstantially Equivalent |
| Safety FeatureAgainst Re-use | Break away pin designed to break oninsertion | Via software controls | Different andSubstantially Equivalent |
| Item | Predicate Device (K151048):CT Exprès™ 3D Contrast Media DeliverySystem | Subject Device (K241849):MEDRAD® Centargo CT Injection System | Comparison |
| Day Set | |||
| Components | T-connectorContrast media line x2Spike for saline lineSaline lineFilter x2Reservoir x2Tubing guide x2 | Reservoir x3ManifoldPlunger x3Inlet tubing x3Air detector tubingSpike adapter x3Replaceable spike with dust cap x3Stopcock x3 | Different andSubstantially Equivalent |
| Contrast Media LineTubing Material | PVC tubing | PVC Tubing | Same |
| Saline Line TubingMaterial | PVC tubing | PVC Tubing | Same |
| Spike | |||
| Spike Size | 25 mm | 28 mm | Different andSubstantially Equivalent |
| Safety FeatureAgainst Re-Use | Spike tip designed to break off into bottleon removal | Spike is removable with the bottle, labelinginstructions on workflow | Different andSubstantially Equivalent |
| Biocompatibility | |||
| BiocompatibilityTesting | Yes | Yes | Same |
Table 1 – Key Feature Comparison
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Image /page/14/Picture/0 description: The image features the Bayer company logo, which consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The logo is encircled by a ring that transitions in color from green at the top to blue at the bottom. The word "BAYER" is rendered in a neutral gray color, providing a clear contrast against the white background.
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INTENDED USE/INDICATIONS FOR USE COMPARISON VIII.
Intended Use/Indications for Use comparison discussion:
The Intended Use of Centargo is the same as the CT Exprès 3D Contrast Media Delivery System as both devices are intended for the controlled, automatic administration of contrast media and saline on the venous side to human subjects while undergoing examination by means of a computed tomography (CT) scanner. The differences in allowing the use of different contrast agents do not change the intended use of the device. All of the contrast agents are iodinated agents, Centargo has been tested to demonstrate the compatibility with the listed contrast agents, and the differences in contrast agents do not raise different questions of safety and effectiveness when compared to the predicate device. The substantial equivalence of the MEDRAD® Centargo CT Injection System has been confirmed through chemical compatibility testing, biocompatibility and EMC testing. The ISI2 is included in the indications for use statement to specify the scanner connectivity via cables. While there are differences between the subject device and predicate in terms of scanner connectivity, our successful software testing confirmed there are no new or different questions of safety or effectiveness.
The additional of the saline tag in the indications for use statement adds clarity for users and based on our usability studies, mention of it does not raise new or different questions of safety and effectiveness when compared to the predicate device.
IX. TECHNOLOGICAL COMPARISON
Technological comparison discussion:
Both systems aim to deliver fluids consistently and reliably according to user programmed protocols. Although there are differences in the technology used to deliver fluids (Plunger/barrel-based vs peristaltic pump), the Centargo system fluid delivery performance has been demonstrated to be as safe and effective as the predicate device. Likewise, while there are differences in physical design and operational characteristics, Centargo has demonstrated device performance against established acceptance criteria and testing did not raise new questions of safety and effectiveness.
Software features and connectivity accessories are available on Centargo and were verified and validated using the same test methods as the reference device (MEDRAD® Stellant FLEX CT Injection System, (K192370). Testing with Centargo did not raise new questions of safety and effectiveness when compared to the predicate device.
Both the predicate (CT Exprès) and subject (Centargo) devices are used in conjunction with disposables that create a fluid pathway from the bottles of contrast media and the saline
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container to the patient. While there are differences in design, the disposables have demonstrated device performance against established acceptance criteria and testing did not raise new questions of safety and effectiveness when compared to the predicate device.
While there are differences in design and technology, these differences do not raise new questions of safety and effectiveness when compared to the predicate device. Centargo has demonstrated its ability to perform within its specified parameters and operate as intended by users of the device. As a result, the device is deemed as safe and effective as the predicate device.
PERFORMANCE DATA X.
A. Performance Testing
- . 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. Testing also verified that the device was not affected by environmental conditions such as atmospheric conditions and handling. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
- The Centargo device is a Class II device and is classified by the FDA per 21 CFR 870.1650 (Angiographic Injector and Syringe). There are no special controls for the injector itself. However, as the system also includes disposables, the device testing included verification and validation in accordance with the Guidance for Industry and FDA Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)]: July 11, 2008. Testing addressed the risks and recommended mitigation measures identified in the guidance.
- The MEDRAD® Centargo CT Injection System disposables were tested for performance and ● verified in accordance with the following standard:
- . ISO 8536-4:2010, Infusion equipment for medical use-Part 4: Infusion sets for single use. Only applicable requirements from ISO 8536-4 were tested. The results indicate the disposable conforms to its pre-determined specifications.
B. Software Verification and Validation Testing
Software verification and validation was performed in accordance with the following standards:
- . IEC 62304 Edition 1.1 2015-06 Consolidated Version: Medical device Software life cycle processes FDA Guidance for the Content of Premarket Submissions for Device Software Functions Contained in Medical Devices: Guidance for Industry and FDA Staff, June 14, 2023, and Guidance for Industry and Food and Drug Administration Staff - Off-The-Shelf Software Use in Medical Devices, August 11, 2023. Test results were evaluated against established acceptance criteria; all test results were acceptable.
- . Cybersecurity testing was conducted according to Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Final Guidance for Industry and Food and Drug Administration Staff, September 27, 2023. Testing provides a reasonable assurance that the device and related systems are cybersecure.
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C. Biocompatibility Testing
The MEDRAD® Centargo CT Injection System disposables have both direct and indirect patient contacting materials which were verified in accordance with the following standard:
-
ISO 10993-1 Fifth Edition:2018, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
The following endpoints were evaluated to characterize the biocompatibility profile based on the classification of the devices (externally communicating, indirect blood path, limited contact (<= 24 h)): -
Cytotoxicity
-
Hemocompatibility (Hemolysis only)
-
Sensitization
-
Irritation / Intracutaneous Reactivity
-
Acute Systemic Toxicity
-
Materials Mediated Pyrogenicity
Particulate testing was completed according to methodology described in USP <788> 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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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.
§ 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.