(105 days)
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, including Stellant FLEX CT Syinge Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous imaging saline, into humans for diagnostic studies in computed tomography (CT) and mammography. For complete prescribing information, refer both to the current drug labeling for information relating to "imaging agent".
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation is a softwarecontrolled power injection system used for the administration of intravenous imaging agents, including saline, into humans for diagnostic studies in computed tomography (CT) and mammography. The system is comprised of an injector head and mount, a base, and a workstation. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration.
The provided text describes a 510(k) premarket notification for the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, primarily focusing on an administrative update to expand its indications for use to include mammography. This document does not contain the typical structure of a clinical study or performance evaluation with specific acceptance criteria and detailed results as one might find for an AI/ML medical device.
The "study" referenced is a systematic review of clinical literature (Zanardo, et al., 2019), not a new performance study conducted by the device manufacturer. Therefore, a direct table of acceptance criteria and reported device performance from a primary study on this device for mammography is not available in the provided text. The document focuses on demonstrating substantial equivalence by showing that existing clinical practices for Contrast-Enhanced Spectral Mammography (CESM) align with the capabilities of the MEDRAD® Stellant FLEX system.
Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations:
1. Table of "Acceptance Criteria" and Reported Device Performance
As mentioned, there are no explicit "acceptance criteria" presented in the document in the format of a performance study for the device's expanded use in mammography. Instead, the document argues for substantial equivalence by demonstrating that the device's technical specifications align with standard practices reported in clinical literature for CESM.
The "reported device performance" refers to the device's technical specifications and capabilities, which are compared to the requirements for CESM as described in the Zanardo et al. review.
| Feature/Parameter (Implicit "Acceptance Criteria") | Reported Device Performance (as per comparison to predicate and literature) | Comments/Reference |
|---|---|---|
| Intravenous Imaging Agent Injection | Capable of injecting intravenous imaging agents, including saline. | Device description |
| Compatibility with CT/Mammography Diagnostic Studies | Indicated for diagnostic studies in CT and mammography. | Indications for Use |
| Single or Dual Syringe System | Dual syringe system. | Same as predicate |
| Volume Range (Syringe) | 1 to 200 ml or 1 to 150 ml (depending on syringe size). | Same as predicate |
| Fill Speed | 1.0 to 10.0 ml/s | Same as predicate |
| Flow Rate Range | 0.1 to 10 ml/s | Same as predicate. Matches/exceeds typical CESM flow rates (1.5-5 ml/s) |
| Pause Phase | 1 to 900 s | Same as predicate. Relevant for scan delays. |
| Programmable Pressure Limit | Choice of 50/345 to 325/2241 PSI/kPa | Same as predicate |
| Automated Power Injector Use | Automated injection system (software-controlled). | Device description. 85% of studies in Zanardo et al. used power injectors. |
| Saline Flush Capability | Dual syringe allows saline flush capability. | 62% of patients in Zanardo et al. received saline flush. |
| Contrast Agent Dosing/Concentration | Can deliver within approved dose ranges and routes. Matches example protocols in Zanardo et al. (1-2 ml/kg, 300 mg I/ml or higher). | Zanardo et al. review |
| Scan Delay Capability | Device configurable for scan delays. | Matches typical CESM scan delays (0.5 to 5 minutes, most commonly 2 minutes) in Zanardo et al. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for "Test Set": Not applicable in the context of this 510(k) submission as a new "test set" in the traditional sense was not generated for this device's performance in mammography. The reliance is on existing clinical literature.
- The Zanardo, et al. (2019) systematic review included 84 articles from 22 countries. These articles covered a total of 14,012 patients.
- Data Provenance: Retrospective, as it is a systematic review of previously published clinical studies. The data originates from various countries as indicated by the 22 countries of origin for the studies included in the review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This question is not directly applicable. The Zanardo et al. systematic review aggregated data from numerous published studies, each with its own methodology, potentially involving many clinicians (experts) in their respective institutions. The review itself was conducted by its authors (M. Zanardo, et al.). The "ground truth" was established within the individual studies evaluated in the systematic review based on their diagnostic procedures and outcomes.
4. Adjudication Method for the Test Set
- Not applicable. The Zanardo et al. paper is a systematic review, not a study that involved expert adjudication of a new test set for this specific device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done, and this device (an angiographic injector) is not an AI/ML-based diagnostic device. The question regarding human reader improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a hardware/software system for injecting contrast media, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in the context of the Zanardo et al. review would be the clinical diagnostic information and outcomes reported in the individual studies that were part of the systematic review. This would vary by study but would typically include various diagnostic findings from imaging (e.g., biopsy results, surgical pathology, clinical follow-up) that validated the contrast-enhanced mammography findings.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2019
Bayer Medical Care, Inc. Alison Maloney Head Regulatory Affairs Radiology 100 Bayer Blvd Whippany, New Jersey 07981
Re: K192370
Trade/Device Name: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: October 16, 2019 Received: October 17, 2019
Dear Alison Maloney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).
Sincerely,
For CAPT Alan M. Stevens 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
510(k) Number (if known) K192370
Device Name
MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
Indications for Use (Describe)
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, including Stellant FLEX CT Syinge Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous imaging saline, into humans for diagnostic studies in computed tomography (CT) and mammography. For complete prescribing information, refer both to the current drug labeling for information relating to "imaging agent".
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) |
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Bayer Medical Care, Inc.
K191060
510(k) SUMMARY
Bayer Medical Care, Inc. MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
| 1 Bayer DriveIndianola, PA 15051Phone: (862) 404-8106 | |
|---|---|
| Contact Person: | Alison MaloneyHead Regulatory Affairs RadiologyPhone: (862) 404-8106Email: alison.maloney@bayer.com |
| Date Prepared: | December 12, 2019 |
| Device Tradename: | MEDRAD® Stellant FLEX CT Injection System withCertegra® Workstation |
| Common orUsual Name: | Injector and Syringe, Angiographic |
| Product Code: | DXT |
| Classification: | Class II, 21 CFR Part 870.1650, Angiographic injector and syringe |
| Predicate Device: | MEDRAD® Stellant FLEX CT Injection System withCertegra® Workstation, K182273 |
Device Description:
Submitter:
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation is a softwarecontrolled power injection system used for the administration of intravenous imaging agents, including saline, into humans for diagnostic studies in computed tomography (CT) and mammography. The system is comprised of an injector head and mount, a base, and a workstation. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration.
Refer to the Comparison to Predicate Device section for additional information regarding device functions, specifications, etc.
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Intended Use / Indications for Use:
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous imaging agents, including saline, into humans for diagnostic studies in computed tomography (CT) and mammography. For complete prescribing information, refer both to the current drug labeling and to the device labeling for information relating to "imaging agent".
Substantial Equivalence / Comparison of Technological Characteristics:
The purpose of this submission is to modify the Indications for Use for the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation cleared per K182273. This is an administrative update to add mammography.
The only modifications that were made to the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation cleared per K182273 are to the labeling. The fundamental scientific technology, software graphical user interface, and principle of operation are the same as those of the predicate device.
A comparison between the modified device and the device cleared per K182273 is provided in Table 1 and Table 2. As illustrated in Table 1, the fluid delivery features and performance specifications are the same for the predicate and subject device Injection System and WorkStation. Table 2 illustrates that the features of the Injection System Syringe Kits also remain the same as those of the predicate device.
Table 1: Device Comparison Table of Subject and Predicate Device Fluid Delivery Features and Performance Specifications
| Feature | Subject DeviceMEDRAD® Stellant FLEXCT Injection System withCertegra® Workstation | Predicate DeviceMEDRAD® StellantFLEX CT InjectionSystem with Certegra®Workstation | Comments |
|---|---|---|---|
| Intended Use | The MEDRAD® Stellant FLEXCT Injection System withCertegra® Workstation isintended for injectingintravenous contrast media andsaline into the human vascularsystem for diagnostic studies. | The MEDRAD® StellantFLEX CT Injection Systemwith Certegra®Workstation is intended forinjecting intravenouscontrast media and salineinto the human vascularsystem for diagnosticstudies. | Same |
| Feature | Subject Device | Predicate Device | Comments |
| MEDRAD® StellantFLEX CT InjectionSystem with Certegra®Workstation | MEDRAD® StellantFLEX CT InjectionSystem withCertegra®Workstation | ||
| Indications for Use | The MEDRAD® StellantFLEX CT Injection Systemwith Certegra®Workstation, includingStellant FLEX CT SyringeKits and ConnectorTubing, is indicated for thespecific purpose ofinjecting intravenousimaging agents, includingsaline, into humans fordiagnostic studies incomputed tomography(CT) andmammography. Forcomplete prescribinginformation, refer both tothe current drug labelingand to the device labelingfor information relating to"imaging agent". | The MEDRAD®Stellant FLEX CTInjection System withCertegra®Workstation, includingStellant FLEX CTSyringe Kits andConnector Tubing, isindicated for thespecific purpose ofinjecting intravenouscontrast media orsaline into humans fordiagnostic studies incomputedtomography (CT). | Mammographyhas beenadded. Use ofsaline wordingslightly changed |
| Single or Dual SyringeSystem | Dual syringe | Dual syringe | Same |
| Volume Range | 1 to 200 ml or 1 to 150ml(depending on 200 ml or150 ml syringe size) | 1 to 200 ml or 1 to150 ml(depending on 200 mlor 150 ml syringesize) | Same |
| Fill Speed | 1.0 to 10.0 ml/s | 1.0 to 10.0 ml/s | Same |
| Flow Rate Range | 0.1 to 10 ml/s | 0.1 to 10 ml/s | Same |
| Pause Phase | 1 to 900 s | 1 to 900 s | Same |
| Hold Capability | 20 minutes max. | 20 minutes max. | Same |
| Autofill | Yes | Yes | Same |
| ProgrammablePressure Limit(PSI/kPa) | Choice of 50/345,100/689, 150/1034,200/1379, | Choice of 50/345,100/689, 150/1034,200/1379, | Same |
| Feature | Subject Device | Predicate Device | Comments |
| MEDRAD® StellantFLEX CT InjectionSystem with Certegra®Workstation | MEDRAD® StellantFLEX CT InjectionSystem withCertegra®Workstation | ||
| 225/1551, 250/1724, | 225/1551, 250/1724, | ||
| 300/2068, 325/2241 | 300/2068, 325/2241 | ||
| Protocol Memory | 250 protocols of up to 6phases each | 250 protocols of up to 6phases each | Same |
| Protocol ProgrammingParameters | Flow rate, volumeand/or duration | Flow rate, volumeand/or duration | Same |
| Parametric DataOutput/ InformaticsCompatibility | Yes | Yes | Same |
| Injection HistoryMemory | Unlimited | Unlimited | Same |
| Control Room Unit | Windows-basedWorkstation withintegrated hardwarecomponents | Windows-basedWorkstation withintegrated hardwarecomponents | Same |
| Information Display(Control Room) | Color LCD | Color LCD | Same |
| Programming Keys(Workstation) | Software-generated viaan LCD touch screen | Software-generated viaan LCD touchscreen | Same |
| Programming Keys(Head Module) | Dedicated keys oninjector Head | Dedicated keys oninjectorHead | Same |
| Retract Control | Manual and Automatic | Manual andAutomatic | Same |
| Check for AirConfirmation | Operator visualinspection;user confirmed | Operator visualinspection;user confirmed | Same |
| Start/Stop Switch(HandSwitch) | Start, Stop and Pausefunctionality | Start, Stop and PauseFunctionality | Same |
| Feature | Subject Device | Predicate Device | Comments |
| MEDRAD® StellantFLEX CT InjectionSystem with Certegra®Workstation | MEDRAD® StellantFLEX CT InjectionSystem withCertegra®Workstation | ||
| Pressure Graph | Yes | Yes | Same |
| Syringe Sensing | Optical (Barcode) | Optical (Barcode) | Same |
| Autoload | Yes | Yes | Same |
| Auto Dock/Retract/Advance | Yes; user-selectable auto- dock and advance; user-selectable auto-retract | Yes; user-selectable auto- dock and advance; user-selectable auto-retract | Same |
| Protocol Lock / Remote Arming | Yes | Yes | Same |
| Simultaneous Injection | Yes (DualFlow) | Yes (DualFlow) | Same |
| Test Inject | Yes | Yes | Same |
| Reminders | 1 to 300 s in 1 s increments | 1 to 300 s in 1 s increments | Same |
| Syringe Heat Maintainer | Yes | Yes | Same |
| Syringe Heat Maintainer Range | 95 degrees F +/- 9 degrees(35 degrees C +/- 5 degrees) | 95 degrees F +/- 9 degrees(35 degrees C +/- 5 degrees) | Same |
| P3T Functionality | Includes P3T Cardiac, P3T PA, and P3T Abdomen functionality | Includes P3T Cardiac, P3T PA, and P3T Abdomen Functionality | Same |
| P3T Cardiac Indications | P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature thoracic | P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart pulmonary | Same |
| Feature | Subject Device | Predicate Device | Comments |
| MEDRAD® StellantFLEX CT InjectionSystem with Certegra®Workstationandabdominal aorta. | MEDRAD® StellantFLEX CT InjectionSystem withCertegra®Workstationvasculature,thoracic, andabdominal aorta. | ||
| P3T PA Indications | P3T PA is indicatedfor use with CTAngiography of thecardiac structures,coronary arteries,chambers of the heart,pulmonaryvasculature, thoracic,andabdominal aorta. | P3T PA is indicatedfor use with CTAngiography of thecardiac structures,coronary arteries,chambers of theheart, pulmonaryvasculature,thoracic, andabdominal aorta. | Same |
| P3T AbdomenIndications | P3T Abdomen isindicated for use withCT imaging ofabdominal organs(i.e., liver, pancreas,kidneys). | P3T Abdomen isindicated for usewith CT imaging ofabdominal organs(i.e., liver, pancreas,kidneys). | Same |
| P3T User Interface | When licensed, theuser can opt to use theP3T softwareaccessories for anygiven injection. Theuser is required toconfirm or change thesuggested protocolbefore beginning aninjection. | When licensed, theuser can opt to usethe P3T softwareaccessories for anygiven injection. Theuser is required toconfirm or change thesuggested protocolbefore beginning aninjection. | Same |
| Imaging SystemInterface(ISI) - Functionality | Yes. The ISI moduleoption is indicated forthe specific purpose ofallowing an injector tointerface with a CTscanner. | Yes. The ISI moduleoption is indicated forthe specific purposeof allowing an injectorto interface with a CTscanner. | Same |
| Connect.CT | Yes. TheConnect CT | Yes. The Connect.CTapplication is | Same |
| Feature | Subject DeviceMEDRAD® StellantFLEX CT InjectionSystem with Certegra®Workstation | Predicate DeviceMEDRAD® StellantFLEX CT InjectionSystem with Certegra®Workstation | Comments |
| Functionality | application isindicated for thespecific purpose ofallowing the injectorto interface with a CTscanner | indicated for thespecific purpose ofallowing the injectorto interface with a CTscanner |
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| Feature | Subject Device | Predicate Device | Comments | |
|---|---|---|---|---|
| Construction | Injector compatibility | MEDRAD® Stellant FLEXSyringe KitsMEDRAD® Stellant FLEXCT Injection System withCertegra® Workstation | MEDRAD® Stellant FLEXCT Injection System withCertegra® Workstation | Same |
| Syringe Volume(contrast) | Choice of 150 ml or 200 ml | Choice of 150 ml or 200 ml | Same | |
| Syringe Volume(saline) | Choice of 150 ml or 200 ml | Choice of 150 ml or 200 ml | Same | |
| Materials | Syringe Barrel | PET | PET | Same |
| Syringe BarrelLubrication | Silicone | Silicone | Same | |
| Plunger SupportRing | Polycarbonate | Polycarbonate | Same | |
| Plunger Cover | Polypropylene and TPV withcolorant | Polypropylene and TPVwith colorant | Same | |
| Dust Caps | Polypropylene | Polypropylene | Same | |
| Spikes | ABS | ABS | Same | |
| Packaging Type,Material | Tyvek lid coveringpolystyrene tray | Tyvek lid coveringpolystyrene tray | Same | |
| Sterilization | E-Beam | E-Beam | Same | |
| Biological | Sterility AssuranceLevel (SAL) | 10-6 | 10-6 | Same |
| Pyrogenicity | Non-Pyrogenic Fluid Path | Non-Pyrogenic Fluid Path | Same | |
| Latex Content | Not made with natural rubberlatex | Not made with naturalrubberlatex | Same | |
| DEHP | No | No | Same | |
| Performance | Pressure Rating | 400 psi (2410 kPa) | 400 psi (2410 kPa) | Same |
| Syringe Sensingand IdentificationFluid Detection | Clear Syringe, FluiDots andBeacon indicators | Clear Syringe, FluiDotsand Beacon indicators | Same |
Table 2: Device Comparison Table of Subject and Predicate Device Injection System Syringe Kits
Discussion of similarities/differences:
The fundamental scientific technology, software graphical user interface, and principle of operation are the same as those of the predicate device.
The only modifications that were made to the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation cleared per K182273 are to the labeling change consists of updating the disposable instruction for use to include the new indications for use. The operation manual was also updated to include a warning of safe distance between the patient and non
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patient devices, general training requirements, references to studies on use of contrast imaging agent in mammoqraphy and updating of IFU.
The difference in IFU was supported by clinical literature references. The labeling was modified to add a diagram of the mammography suite and a caution about not installing the Workstation in the patient area. The required training section was also updated. However, this labeling is the same approach used in the existing contrast enhanced mammography machines to mitigate the same risk.
The addition of mammography to the indication for use does not raise different questions of safety and effectiveness as confirmed by the literature references.
Non-Clinical Performance Data:
Based on the risk analysis, it was determined that there are no new hazards as a result of the modification to the IFU. Therefore, verification testing was not necessary to demonstrate that the modified indication for use remains safe and effective.
Performance testing performed with the subject device which was provided in previous 510(k)s remains applicable.
Clinical Performance Data:
Zanardo, et. al1 reviewed technical parameters, acquisition protocols and adverse reactions (ARs) for contrast-enhanced spectral mammography (CESM). A systematic search in databases, including MEDLINE/EMBASE, was performed to extract publication year, country of origin, study design: patients; mammography unit/vendor, radiation dose, low-/high energy tube voltage; contrast molecule, concentration and dose; injection modality, ARs and acquisition delay; order of views; examination time. Of 120 retrieved articles, 84 were included from 22 countries (September 2003-January 2019), totaling 14,012 patients. The aim of this work was to review CESM studies focusing on adopted technique, contrast agent issues and acquisition workflow.
Example protocols described in Zanardo, et. al1 have utilized different available non-ionic LOCM concentrations in dose ranges between 1-2 ml/kg. Injector flow rates between 1.5 -5 ml/s and iodine concentrations of 300 mg I/ml or higher were used. Of the studies that included a specification of the contrast injection modality, automated power injectors were used in 85% of the studies (90% of the patients). Of the total patient population from the study, 62% of the patients received a saline flush. The scan delay between completed injection and start of the imaging sequence ranged from 0.5 to 5 minutes, most commonly 2 minutes.
Zanardo, et. al notes that the common use of a power contrast injector (87% of all studies, with the remaining 13% coming from a single research group) is assumed from CT and MRI protocols in which it has been demonstrated to be effective in obtaining a stable contrast inflow and bolus shape. Moreover, the use of a power injector allows for the administration of a bolus chaser reported only in 42% of all articles, a technical refinement that has shown good results in CT.
The Zanardo, et. al1 data confirm that the flow rates, dosage and volume of contrast media as well as the scan delays used in CEM are consistent with those of CT imaging and use of Stellant FLEX. Therefore, the Zanardo, et, al1 article supports a substantial equivalence finding for use of Stellant FLEX in CEM.
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation may be used to deliver an iodinated X-ray contrast agent within its approved dose range and route of administration. In addition to the example protocols from Zanardo 20191 and other literature or quidelines, the injector can deliver protocols prescribed by the licensed healthcare professional if those are within the injector specifications.
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, is intended only for use with approved contrast agents. For complete prescribing information, refer to current drug labeling.
1Zanardo, M, et al. (2019) Technique, protocols and adverse reactions for contrast-enhanced spectral mammography (CESM): a systematic review. Insights into Imaging 10:76.
Substantial Equivalence:
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation is substantially equivalent in design, performance, and technological characteristics to the predicate devices for its intended purpose. The minor differences in indication for use between the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation and its predicate device raise no new issues of safety or effectiveness. Thus, the MEDRAD® Stellant FLEX CT Iniection System with Certegra® Workstation is substantially equivalent.
§ 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.