MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

K182273 · Bayer Medical Care, Inc. · DXT · Nov 1, 2018 · Cardiovascular

Device Facts

• Record ID: K182273
• Device Name: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
• Applicant: Bayer Medical Care, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Nov 1, 2018
• Decision: SESE
• Submission Type: Special
• 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 contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors. 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. 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. P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys). The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner. The Connect.CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

Device Story

Automated injection system for CT contrast media/saline; utilizes disposable syringes and connector tubing. System comprises injector head and Certegra Workstation; P3T software accessories compute individualized injection protocols based on patient/scanner parameters. Used in clinical CT settings by healthcare professionals. Operator programs volume, flow rate, and duration via capacitive touch screen; system provides real-time pressure monitoring and injection history. P3T software assists in protocol standardization; ISI/Connect.CT modules enable communication with CT scanners. Benefits include consistent contrast delivery, optimized scan timing, and automated documentation of injection parameters.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by bench testing (fluid delivery, flow rates, pressure, electrical safety per IEC 60601-1, EMC), reliability testing, and human factors/usability engineering validation.

Technological Characteristics

Software-controlled angiographic injector. Materials: PET (syringe barrel), silicone (lubricant), polycarbonate (plunger support), polypropylene/TPV (plunger cover/caps), ABS (spikes), PVC (tubing). Energy: Electrical. Connectivity: Networked/Interface with CT scanners. Sterilization: E-Beam (syringes/tubing) or Ethylene Oxide (tubing). User interface: Capacitive touch screen.

Indications for Use

Indicated for humans undergoing diagnostic CT studies requiring intravenous contrast media or saline injection. P3T modules indicated for CT angiography of cardiac structures, coronary arteries, heart chambers, pulmonary vasculature, thoracic/abdominal aorta, and abdominal organs (liver, pancreas, kidneys).

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 (K173773)
• MEDRAD Stellant CT Injector System with Certegra Workstation (K173773)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 1, 2018

Bayer Medical Care Inc. Lisa Ewing Deputy Director, Global Regulatory Strategy 1 Bayer Drive Indianola, Pennsylvania 15051

### Re: K182273

Trade/Device Name: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 28, 2018 Received: October 1, 2018

Dear Lisa Ewing:

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael John -S 2018.11.01 14:53:32 -04'00'

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K182273

#### Device Name

MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD® Stellant FLEX Syringe Kits, MEDRAD® Stellant CT Injection System with Certegra Workstation, MEDRAD® Stellant Syringe Kits, MEDRAD® Stellant Connector Tubing

#### Indications for Use (Describe)

MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation

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 contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

#### MEDRAD® Stellant FLEX Syringe Kits

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 contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

#### MEDRAD® Stellant CT Injection System with Certegra Workstation

The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

#### MEDRAD® Stellant Syringe Kits

The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.

#### MEDRAD® Stellant Connector Tubing

The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.

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

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | 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.*

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:

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

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### Indications for Use

#### 510(k) Number (if known) K182273

#### Device Name

P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

#### Indications for Use (Describe)

#### P3T Cardiac

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.

#### P3T PA

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.

#### P3T Abdomen

P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).

ISI

The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.

#### Connect.CT

The Connect. CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

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

| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------|
|--------------------------------------------------------------------------------------------------------|---------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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Image /page/4/Picture/1 description: The image shows the logo for Bayer. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are in a dark blue color. The wordmark is surrounded by a circular design with two colors. The top half of the circle is green, and the bottom half is blue.

## 510(k) Summary

| Submitter: | Bayer Medical Care Inc. |
|---------------------------|-------------------------------------------------------------------|
| | 1 Bayer Drive |
| | Indianola, PA 15051 |
| Contact Person: | Lisa A. Ewing |
| | Deputy Director, Global Regulatory Strategy, Device New Product |
| | Development |
| | Phone: [phone] |
| | Email: [e-mail] |
| Date Prepared: | October 30, 2018 |
| Device Trade Name: | MEDRAD® Stellant FLEX CT Injection System with Certegra |
| | Workstation |
| | MEDRAD® Stellant FLEX Syringe Kits |
| | MEDRAD® Stellant CT Injection System with Certegra Workstation |
| | MEDRAD® Stellant Syringe Kits |
| | MEDRAD® Stellant Connector Tubing |
| | P3T Cardiac |
| | P3T PA |
| | P3T Abdomen |
| | ISI |
| | Connect.CT |
| Common Name: | Angiographic Injector and Syringe |
| Classification Name: | Injector and Syringe, Angiographic [21 CFR 870.1650] |
| Product Code: | DXT |
| Classification: | Class II |
| Primary Predicate Device: | The subject devices are substantially equivalent to the following |
| | devices: |
| | MEDRAD Stellant FLEX CT Injection System with Certegra |
| | Workstation, K173773 |
| | MEDRAD Stellant CT Injector System with Certegra Workstation, |
| | K173773 |

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#### Device Description: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. 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.

#### MEDRAD Stellant CT Injection System with Certegra Workstation

The MEDRAD Stellant CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. 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.

#### Personalized Patient Protocol Technology (P3T)

The Stellant P3T software accessories compute individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration for individualized dosing, and for increasing the consistency of individualized injection protocols among clinicians.

#### Imaging System Interface (ISI)

The ISI module options allow an injector to interface with a CT scanner.

### Connect.CT

The Connect.CT application allows an injector to interface with a CT scanner.

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#### Indications for Use:

### MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation

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 contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

#### MEDRAD® Stellant FLEX Syringe Kits

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 contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

#### MEDRAD® Stellant CT Injection System with Certegra Workstation

The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

#### MEDRAD® Stellant Syringe Kits

The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD Stellant Injectors.

#### MEDRAD® Stellant Connector Tubing

The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.

#### P3T Cardiac

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.

#### P3T PA

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.

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

### P3T Abdomen

P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).

ાટા

The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.

### Connect.CT

The Connect.CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

### Comparison to the Predicate Device:

The fundamental scientific technology, principle of operation and indications for use of the proposed devices are unchanged from the predicate devices, the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation cleared in K173773 and the MEDRAD Stellant CT Injection System with Certegra Workstation cleared in K173773. The differences between the proposed devices and the predicate devices do not introduce new issues of safety and effectiveness. Additionally, the proposed devices and the predicate device share similarities in functional design and performance specifications.

The updated Workstation assembly has been developed as an alternative to the existing Workstation used with the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and the MEDRAD Stellant CT Injection System with Certegra Workstation.

Table 1 provides a detailed comparison of the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation (proposed device) with the predicate device, the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation cleared per K173773. Table 2 provides a detailed comparison of the MEDRAD Stellant CT Injection System with Certegra Workstation (proposed device) with the predicate device, the MEDRAD Stellant CT Injection System with Certegra Workstation cleared per K173773.

The Workstation design change does not involve any changes to the MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, or Connect.CT.

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

Table 1. Comparison of Fluid Delivery Features and Performance Specifications in MEDRAD Stellant FLEX CT Injection System with Certegra Workstation as cleared in K173773 (Predicate) and MEDRAD Stellant FLEX CT Injection System with Certegra Workstation K182273 (Proposed)

| Feature | MEDRAD Stellant FLEX CT<br>Injection System with<br>Certegra Workstation as<br>cleared in K173773<br>(Predicate) | MEDRAD Stellant FLEX CT<br>Injection System with<br>Certegra Workstation<br>K182273 (Proposed) | Rationale for Change | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indications for Use | The MEDRAD Stellant FLEX<br>CT Injection System with<br>Certegra Workstation,<br>including Stellant FLEX CT<br>Syringe Kits and Connector<br>Tubing, is indicated for the<br>specific purpose of injecting<br>intravenous contrast media<br>or saline into humans for<br>diagnostic studies in<br>computed tomography (CT)<br>applications. | Same | N/A | |
| Single or Dual Syringe<br>System | Dual syringe | Same | N/A | |
| Volume Range | 1 to 200 ml or 1 to 150 ml<br>(depending on 200 ml or 150<br>ml syringe size) | Same | N/A | |
| Fill Speed | 1.0 to 10.0 ml/s | Same | N/A | |
| Flow Rate Range | 0.1 to 10 ml/s | Same | N/A | |
| Pause Phase | 1 to 900 s | Same | N/A | |
| Hold Capability | 20 minutes max. | Same | N/A | |
| Autofill | Yes | Same | N/A | |
| Programmable Pressure<br>Limit (PSI/kPa) | Choice of 50/345, 100/689,<br>150/1034, 200/1379,<br>225/1551, 250/1724,<br>300/2068, 325/2241 | Same | N/A | |
| Protocol Memory | 250 protocols of up to 6<br>phases each | Same | N/A | |
| Protocol Programming<br>Parameters | Flow rate, volume and/or<br>duration | Same | N/A | |
| Parametric Data Output<br>/ Informatics<br>Compatibility | Yes | Same | N/A | |
| Injection History Memory | Unlimited | Same | N/A | |
| Control Room Unit | Windows-based Workstation<br>with separate hardware<br>components | Windows-based<br>Workstation with integrated<br>hardware components | Integration of hardware<br>components for aesthetic<br>improvement, modular<br>design and serviceability.<br>No impact on safety and<br>effectiveness. | |
| Information Display<br>(Control Room) | Color LCD | Same | N/A | |
| Programming Keys<br>(Control Room) | Software-generated via an<br>LCD resistive touch screen | Software-generated via an<br>LCD capacitive touch screen | Touch screen calibration not<br>required for capacitive touch<br>screen. No impact on safety | |
| Feature | MEDRAD Stellant FLEX CT<br>Injection System with<br>Certegra Workstation as<br>cleared in K173773<br>(Predicate) | MEDRAD Stellant FLEX CT<br>Injection System with<br>Certegra Workstation<br>K182273 (Proposed) | Rationale for Change | |
| Programming Keys<br>(Scan Room) | Dedicated keys on injector<br>head | Same | N/A | |
| Retract Control | Manual and Automatic | Same | N/A | |
| Check for Air<br>Confirmation | Operator visual inspection;<br>user confirmed | Same | N/A | |
| Start/Stop Switch (Hand<br>Switch) | Start, Stop and Pause<br>functionality | Same | N/A | |
| Pressure Graph | Yes | Same | N/A | |
| Syringe Sensing | Optical (Barcode) | Same | N/A | |
| Autoload | Yes | Same | N/A | |
| Auto<br>Dock/Retract/Advance | Yes; user-selectable auto-<br>dock and advance; user-<br>selectable auto-retract | Same | N/A | |
| Protocol Lock / Remote<br>Arming | Yes | Same | N/A | |
| Simultaneous Injection | Yes (DualFlow) | Same | N/A | |
| Test Inject | Yes | Same | N/A | |
| Reminders | 1 to 300 s in 1 s increments | Same | N/A | |
| Syringe Heat Maintainer | Yes | Same | N/A | |
| Syringe Heat Maintainer<br>Range | 95 degrees F +/- 9 degrees<br>(35 degrees C +/- 5<br>degrees) | Same | N/A | |
| P3T Functionality | Includes P3T Cardiac, P3T<br>PA, and P3T Abdomen<br>functionality | Same | N/A | |
| P3T Cardiac Indications | P3T Cardiac is indicated for<br>use with CT Angiography of<br>the cardiac structures,<br>coronary arteries, chambers<br>of the heart, pulmonary<br>vasculature, thoracic, and<br>abdominal aorta. | Same | N/A | |
| P3T PA Indications | P3T PA is indicated for use<br>with CT Angiography of the<br>cardiac structures, coronary<br>arteries, chambers of the<br>heart, pulmonary<br>vasculature, thoracic, and<br>abdominal aorta. | Same | N/A | |
| P3T Abdomen<br>Indications | P3T Abdomen is indicated<br>for use with CT imaging of<br>abdominal organs (i.e., liver,<br>pancreas, kidneys). | Same | N/A | |
| Feature | MEDRAD Stellant FLEX CT<br>Injection System with<br>Certegra Workstation as<br>cleared in K173773<br>(Predicate) | MEDRAD Stellant FLEX CT<br>Injection System with<br>Certegra Workstation<br>K182273 (Proposed) | Rationale for Change | |
| P3T User Interface | When licensed, the user can<br>opt to use the P3T software<br>accessories for any given<br>injection. The user is<br>required to confirm or<br>change the suggested<br>protocol before beginning an<br>injection. | Same | N/A | |
| Imaging System<br>Interface (ISI) -<br>Functionality | Yes. The ISI module option<br>is indicated for the specific<br>purpose of allowing an<br>injector to interface with a<br>CT scanner. | Same | N/A | |
| Connect.CT<br>Functionality | Yes. The Connect.CT<br>application is indicated for<br>the specific purpose of<br>allowing the injector to<br>interface with a CT scanner | Same | N/A | |
| Feature | MEDRAD Stellant CT<br>Injection System with<br>Certegra Workstation as<br>cleared in K173773<br>(Predicate) | MEDRAD Stellant CT<br>Injection System with<br>Certegra Workstation<br>K182273 (Proposed) | Rationale for Change | |
| Indications for Use | The MEDRAD Stellant CT<br>Injection System with<br>Certegra Workstation is<br>indicated for the specific<br>purpose of injecting<br>intravenous contrast media<br>or saline into humans for<br>diagnostic studies in<br>computed tomography (CT)<br>applications. | Same | N/A | |
| Single or Dual Syringe<br>System | Dual syringe | Same | N/A | |
| Volume Range | 1 to 200 ml (for 200 ml<br>syringe size) | Same | N/A | |
| Fill Speed | 1.0 to 10.0 ml/s | Same | N/A | |
| Flow Rate Range | 0.1 to 10 ml/s | Same | N/A | |
| Pause Phase | 1 to 900 s | Same | N/A | |
| Hold Capability | 20 minutes max. | Same | N/A | |
| Autofill | Yes | Same | N/A | |
| Programmable Pressure<br>Limit (PSI/kPa) | Choice of 50/345, 100/689,<br>150/1034, 200/1379,<br>225/1551, 250/1724,<br>300/2068, 325/2241 | Same | N/A | |
| Protocol Memory | 250 protocols of up to 6<br>phases each | Same | N/A | |
| Protocol Programming<br>Parameters | Flow rate, volume and/or<br>duration | Same | N/A | |
| Parametric Data Output<br>/ Informatics<br>Compatibility | Yes | Same | N/A | |
| Injection History Memory | Unlimited | Same | N/A | |
| Control Room Unit | Windows-based Workstation<br>with separate hardware<br>components | Windows-based<br>Workstation with integrated<br>hardware components | Integration of hardware<br>components for aesthetic<br>improvement, modular<br>design and serviceability.<br>No impact on safety and<br>effectiveness. | |
| Information Display<br>(Control Room) | Color LCD | Same | N/A | |
| Programming Keys<br>(Control Room) | Software-generated via an<br>LCD resistive touch screen | Software-generated via an<br>LCD capacitive touch screen | Touch screen calibration not<br>required for capacitive touch<br>screen. No impact on safety<br>and effectiveness. | |
| Programming Keys<br>(Scan Room) | Dedicated keys on injector<br>head | Same | N/A | |
| Retract Control | Manual and Automatic | Same | N/A | |
| Feature | MEDRAD Stellant CT<br>Injection System with<br>Certegra Workstation as<br>cleared in K173773<br>(Predicate) | MEDRAD Stellant CT<br>Injection System with<br>Certegra Workstation<br>K182273 (Proposed) | Rationale for Change | |
| Check for Air<br>Confirmation | Operator visual inspection;<br>user confirmed | Same | N/A | |
| Start/Stop Switch (Hand<br>Switch) | Start, Stop and Pause<br>functionality | Same | N/A | |
| Pressure Graph | Yes | Same | N/A | |
| Syringe Sensing | Optical | Same | N/A | |
| Autoload | Yes | Same | N/A | |
| Auto<br>Dock/Retract/Advance | Yes; user-selectable auto-<br>dock and advance; user-<br>selectable auto-retract | Same | N/A | |
| Protocol Lock / Remote<br>Arming | Yes | Same | N/A | |
| Simultaneous Injection | Yes (DualFlow) | Same | N/A | |
| Test Inject | Yes | Same | N/A | |
| Reminders | 1 to 300 s in 1 s increments | Same | N/A | |
| Syringe Heat Maintainer | Yes | Same | N/A | |
| Syringe Heat Maintainer<br>Range | 95 degrees F +/- 9 degrees<br>(35 degrees C +/- 5<br>degrees) | Same | N/A | |
| P3T Functionality | Includes P3T Cardiac, P3T<br>PA and P3T Abdomen<br>functionality | Same | N/A | |
| P3T Cardiac Indications | P3T Cardiac is indicated for<br>use with CT Angiography of<br>the cardiac structures,<br>coronary arteries, chambers<br>of the heart, pulmonary<br>vasculature, thoracic, and<br>abdominal aorta. | Same | N/A | |
| P3T PA Indications | P3T PA is indicated for use<br>with CT Angiography of the<br>cardiac structures, coronary<br>arteries, chambers of the<br>heart, pulmonary<br>vasculature, thoracic, and<br>abdominal aorta. | Same | N/A | |
| P3T Abdomen<br>Indications | P3T Abdomen is indicated<br>for use with CT imaging of<br>abdominal organs (i.e., liver,<br>pancreas, kidneys). | Same | N/A | |
| P3T User Interface | When licensed, the user can<br>opt to use the P3T software<br>accessories for any given<br>injection. The user is<br>required to confirm or<br>change the suggested<br>protocol before beginning an<br>injection | Same | N/A | |
| Feature | MEDRAD Stellant CT<br>Injection System with<br>Certegra Workstation as<br>cleared in K173773<br>(Predicate) | MEDRAD Stellant CT<br>Injection System with<br>Certegra Workstation<br>K182273 (Proposed) | Rationale for Change | |
| Imaging System<br>Interface (ISI) -<br>Functionality | Yes. The ISI module option<br>is indicated for the specific<br>purpose of allowing an<br>injector to interface with a<br>CT scanner. | Same | N/A | |
| Connect.CT<br>Functionality | Yes. The Connect.CT<br>application is indicated for<br>the specific purpose of<br>allowing the injector to<br>interface with a CT scanner. | Same | N/A | |
| Feature | MEDRAD Stellant FLEX<br>Syringe Kits as cleared in<br>K173773 (Predicate) | MEDRAD Stellant FLEX<br>Syringe Kits K182273<br>(Proposed) | Rationale for Change | |
| Indications for Use | The MEDRAD Stellant FLEX<br>CT Injection System with<br>Certegra Workstation,<br>including Stellant FLEX CT<br>Syringe Kits and Connector<br>Tubing, is indicated for the<br>specific purpose of injecting<br>intravenous contrast media<br>or saline into humans for<br>diagnostic studies in<br>computed tomography (CT)<br>applications. | Same | N/A | |
| Injector<br>compatibility | MEDRAD Stellant FLEX CT<br>Injection System with<br>Certegra Workstation | Same | N/A | |
| Syringe Volume<br>(contrast) | Choice of 150 ml or 200 ml | Same | N/A | |
| Syringe Volume<br>(saline) | Choice of 150 ml or 200 ml | Same | N/A | |
| Syringe Barrel | PET | Same | N/A | |
| Syringe Barrel<br>Lubrication | Silicone | Same | N/A | |
| Plunger Support<br>Ring | Polycarbonate | Same | N/A | |
| Plunger Cover | Polypropylene and TPV with<br>new colorant | Same | N/A | |
| Dust Caps | Polypropylene | Same | N/A | |
| Spikes | ABS…