MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

K192370 · Bayer Medical Care, Inc. · DXT · Dec 13, 2019 · Cardiovascular

Device Facts

• Record ID: K192370
• Device Name: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
• Applicant: Bayer Medical Care, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended 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".

Device Story

Software-controlled power injection system; delivers intravenous imaging agents and saline for CT and mammography. System comprises injector head, mount, base, and Certegra workstation. User programs volume, flow rate, and duration via LCD touchscreen. Features include dual-syringe capability, optical syringe sensing, programmable pressure limits, and P3T automated protocol software. Used in clinical imaging suites; operated by healthcare professionals. Output includes controlled fluid delivery and injection history data. Benefits include stable contrast inflow, bolus shaping, and automated administration consistent with established imaging protocols.

Clinical Evidence

No new clinical testing performed. Substantial equivalence supported by a systematic literature review (Zanardo et al., 2019) of 84 studies involving 14,012 patients. Review confirmed that power injectors are used in 85% of contrast-enhanced spectral mammography studies, with flow rates and volumes consistent with CT imaging protocols supported by the Stellant FLEX system.

Technological Characteristics

Dual-syringe power injector; PET syringe barrels; silicone lubrication; polycarbonate plunger support; E-Beam sterilization (SAL 10^-6). Connectivity via Certegra workstation. Software-controlled with optical barcode syringe sensing. Pressure rating 400 psi (2410 kPa). Flow rate range 0.1-10 ml/s. Non-pyrogenic fluid path; latex-free; DEHP-free.

Indications for Use

Indicated for humans undergoing diagnostic studies in computed tomography (CT) and mammography requiring intravenous injection of imaging agents and saline.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (K182273)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). 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

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

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 ([e-mail]) or phone [phone] 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

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

# 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) | |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

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

Bayer Medical Care, Inc.

### K191060

#### 510(k) SUMMARY

#### Bayer Medical Care, Inc. MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation

| | 1 Bayer Drive<br>Indianola, PA 15051<br>Phone: [phone] |
|--------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alison Maloney<br>Head Regulatory Affairs Radiology<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 12, 2019 |
| Device Tradename: | MEDRAD® Stellant FLEX CT Injection System with<br>Certegra® Workstation |
| Common or<br>Usual 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 with<br>Certegra® 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.

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

#### 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 Device<br>MEDRAD® Stellant FLEX<br>CT Injection System with<br>Certegra® Workstation | Predicate Device<br>MEDRAD® Stellant<br>FLEX CT Injection<br>System with Certegra®<br>Workstation | Comments |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | The MEDRAD® Stellant FLEX<br>CT Injection System with<br>Certegra® Workstation is<br>intended for injecting<br>intravenous contrast media and<br>saline into the human vascular<br>system for diagnostic studies. | The MEDRAD® Stellant<br>FLEX CT Injection System<br>with Certegra®<br>Workstation is intended for<br>injecting intravenous<br>contrast media and saline<br>into the human vascular<br>system for diagnostic<br>studies. | Same |
| Feature | Subject Device | Predicate Device | Comments |
| | MEDRAD® Stellant<br>FLEX CT Injection<br>System with Certegra®<br>Workstation | MEDRAD® Stellant<br>FLEX CT Injection<br>System with<br>Certegra®<br>Workstation | |
| Indications for Use | The MEDRAD® Stellant<br>FLEX CT Injection System<br>with Certegra®<br>Workstation, including<br>Stellant FLEX CT Syringe<br>Kits and Connector<br>Tubing, is indicated for the<br>specific purpose of<br>injecting intravenous<br>imaging agents, including<br>saline, into humans for<br>diagnostic studies in<br>computed tomography<br>(CT) and<br>mammography. For<br>complete prescribing<br>information, refer both to<br>the current drug labeling<br>and to the device labeling<br>for information relating to<br>"imaging agent". | The MEDRAD®<br>Stellant FLEX CT<br>Injection System with<br>Certegra®<br>Workstation, including<br>Stellant FLEX CT<br>Syringe Kits and<br>Connector Tubing, is<br>indicated for the<br>specific purpose of<br>injecting intravenous<br>contrast media or<br>saline into humans for<br>diagnostic studies in<br>computed<br>tomography (CT). | Mammography<br>has been<br>added. Use of<br>saline wording<br>slightly changed |
| Single or Dual Syringe<br>System | Dual syringe | Dual syringe | Same |
| Volume Range | 1 to 200 ml or 1 to 150<br>ml<br>(depending on 200 ml or<br>150 ml syringe size) | 1 to 200 ml or 1 to<br>150 ml<br>(depending on 200 ml<br>or 150 ml syringe<br>size) | 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 |
| Programmable<br>Pressure Limit<br>(PSI/kPa) | Choice of 50/345,<br>100/689, 150/1034,<br>200/1379, | Choice of 50/345,<br>100/689, 150/1034,<br>200/1379, | Same |
| Feature | Subject Device | Predicate Device | Comments |
| | MEDRAD® Stellant<br>FLEX CT Injection<br>System with Certegra®<br>Workstation | MEDRAD® Stellant<br>FLEX CT Injection<br>System with<br>Certegra®<br>Workstation | |
| | 225/1551, 250/1724, | 225/1551, 250/1724, | |
| | 300/2068, 325/2241 | 300/2068, 325/2241 | |
| Protocol Memory | 250 protocols of up to 6<br>phases each | 250 protocols of up to 6<br>phases each | Same |
| Protocol Programming<br>Parameters | Flow rate, volume<br>and/or duration | Flow rate, volume<br>and/or duration | Same |
| Parametric Data<br>Output<br>/ Informatics<br>Compatibility | Yes | Yes | Same |
| Injection History<br>Memory | Unlimited | Unlimited | Same |
| Control Room Unit | Windows-based<br>Workstation with<br>integrated hardware<br>components | Windows-based<br>Workstation with<br>integrated hardware<br>components | Same |
| Information Display<br>(Control Room) | Color LCD | Color LCD | Same |
| Programming Keys<br>(Workstation) | Software-generated via<br>an LCD touch screen | Software-generated via<br>an LCD touch<br>screen | Same |
| Programming Keys<br>(Head Module) | Dedicated keys on<br>injector Head | Dedicated keys on<br>injector<br>Head | Same |
| Retract Control | Manual and Automatic | Manual and<br>Automatic | Same |
| Check for Air<br>Confirmation | Operator visual<br>inspection;<br>user confirmed | Operator visual<br>inspection;<br>user confirmed | Same |
| Start/Stop Switch<br>(Hand<br>Switch) | Start, Stop and Pause<br>functionality | Start, Stop and Pause<br>Functionality | Same |
| Feature | Subject Device | Predicate Device | Comments |
| | MEDRAD® Stellant<br>FLEX CT Injection<br>System with Certegra®<br>Workstation | MEDRAD® Stellant<br>FLEX CT Injection<br>System with<br>Certegra®<br>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<br>(35 degrees C +/- 5 degrees) | 95 degrees F +/- 9 degrees<br>(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® Stellant<br>FLEX CT Injection<br>System with Certegra®<br>Workstation<br>and<br>abdominal aorta. | MEDRAD® Stellant<br>FLEX CT Injection<br>System with<br>Certegra®<br>Workstation<br>vasculature,<br>thoracic, and<br>abdominal aorta. | |
| P3T PA Indications | P3T PA is indicated<br>for use with CT<br>Angiography of the<br>cardiac structures,<br>coronary arteries,<br>chambers of the heart,<br>pulmonary<br>vasculature, thoracic,<br>and<br>abdominal aorta. | P3T PA is indicated<br>for use with CT<br>Angiography of the<br>cardiac structures,<br>coronary arteries,<br>chambers of the<br>heart, pulmonary<br>vasculature,<br>thoracic, and<br>abdominal aorta. | Same |
| P3T Abdomen<br>Indications | P3T Abdomen is<br>indicated for use with<br>CT imaging of<br>abdominal organs<br>(i.e., liver, pancreas,<br>kidneys). | P3T Abdomen is<br>indicated for use<br>with CT imaging of<br>abdominal organs<br>(i.e., liver, pancreas,<br>kidneys). | Same |
| P3T User Interface | When licensed, the<br>user can opt to use the<br>P3T software<br>accessories for any<br>given injection. The<br>user is required to<br>confirm or change the<br>suggested protocol<br>before beginning an<br>injection. | When licensed, the<br>user can opt to use<br>the P3T software<br>accessories for any<br>given injection. The<br>user is required to<br>confirm or change the<br>suggested protocol<br>before beginning an<br>injection. | Same |
| Imaging System<br>Interface<br>(ISI) - Functionality | Yes. The ISI module<br>option is indicated for<br>the specific purpose of<br>allowing an injector to<br>interface with a CT<br>scanner. | Yes. The ISI module<br>option is indicated for<br>the specific purpose<br>of allowing an injector<br>to interface with a CT<br>scanner. | Same |
| Connect.CT | Yes. The<br>Connect CT | Yes. The Connect.CT<br>application is | Same |
| Feature | Subject Device<br>MEDRAD® Stellant<br>FLEX CT Injection<br>System with Certegra®<br>Workstation | Predicate Device<br>MEDRAD® Stellant<br>FLEX CT Injection<br>System with Certegra®<br>Workstation | Comments |
| Functionality | application is<br>indicated for the<br>specific purpose of<br>allowing the injector<br>to interface with a CT<br>scanner | indicated for the<br>specific purpose of<br>allowing the injector<br>to interface with a CT<br>scanner | |

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

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

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

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

{9}------------------------------------------------

{10}------------------------------------------------

| | Feature | Subject Device | Predicate Device | Comments |
|--------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------|
| Construction | Injector compatibility | MEDRAD® Stellant FLEX<br>Syringe Kits<br>MEDRAD® Stellant FLEX<br>CT Injection System with<br>Certegra® Workstation | MEDRAD® Stellant FLEX<br>CT Injection System with<br>Certegra® Workstation | Same |
| | Syringe Volume<br>(contrast) | Choice of 150 ml or 200 ml | Choice of 150 ml or 200 ml | Same |
| | Syringe Volume<br>(saline) | Choice of 150 ml or 200 ml | Choice of 150 ml or 200 ml | Same |
| Materials | Syringe Barrel | PET | PET | Same |
| | Syringe Barrel<br>Lubrication | Silicone | Silicone | Same |
| | Plunger Support<br>Ring | Polycarbonate | Polycarbonate | Same |
| | Plunger Cover | Polypropylene and TPV with<br>colorant | Polypropylene and TPV<br>with colorant | Same |
| | Dust Caps | Polypropylene | Polypropylene | Same |
| | Spikes | ABS | ABS | Same |
| | Packaging Type,<br>Material | Tyvek lid covering<br>polystyrene tray | Tyvek lid covering<br>polystyrene tray | Same |
| | Sterilization | E-Beam | E-Beam | Same |
| Biological | Sterility Assurance<br>Level (SAL) | 10-6 | 10-6 | Same |
| | Pyrogenicity | Non-Pyrogenic Fluid Path | Non-Pyrogenic Fluid Path | Same |
| | Latex Content | Not made with natural rubber<br>latex | Not made with natural<br>rubber<br>latex | Same |
| | DEHP | No | No | Same |
| Performance | Pressure Rating | 400 psi (2410 kPa) | 400 psi (2410 kPa) | Same |
| | Syringe Sensing<br>and Identification<br>Fluid Detection | Clear Syringe, FluiDots and<br>Beacon indicators | Clear Syringe, FluiDots<br>and 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

{11}------------------------------------------------

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.

{12}------------------------------------------------

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.