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

K173773 · Bayer Medical Care, Inc. · DXT · Aug 17, 2018 · Cardiovascular

Device Facts

• Record ID: K173773
• 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: Aug 17, 2018
• 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 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 administration. System comprises injector head, Certegra workstation, disposable syringe kits, and connector tubing. User programs volume, flow rate, and duration via workstation; system executes injection. P3T software computes individualized protocols based on patient/scanner parameters. ISI and Connect.CT modules enable interface with CT scanners for synchronized imaging. Used in clinical settings by healthcare professionals. Output includes controlled fluid delivery and injection history/informatics data. Benefits include consistent dosing, workflow efficiency, and individualized patient protocols.

Clinical Evidence

No clinical data. Bench testing only. Verification included system performance (flow, pressure, volume), disposable mechanical/pressure testing (ISO 594, ISO 11607-1), biocompatibility (ISO 10993-1), sterilization validation (ISO 11137), electrical safety/EMC (IEC 60601-1), shelf-life/shipping (ISTA 2A), and human factors engineering (EN 62366-1).

Technological Characteristics

Software-controlled electromechanical injector. Materials: PET (syringe barrel), Polycarbonate (T-connector), PVC (tubing), Polypropylene/TPV (plunger cover). Sensing: Optical/2D barcode. Connectivity: Networked workstation (Windows-based). Sterilization: E-Beam or Ethylene Oxide. Software: Rule-based protocol management and informatics.

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 CT Injector System with P3T Cardiac (K082905)
• MEDRAD Stellant CT Injection System with Extravasation Detection System Accessory (K063090)

Submission Summary (Full Text)

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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 & 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.

August 17, 2018

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

# Re: K173773

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, IZQ Dated: July 19, 2018 Received: July 20, 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 avare 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 2018.08.17 12:34:14 -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) K173773

#### 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) |

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# Indications for Use

### 510(k) Number (if known) K173773

#### 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 class="checkbox"></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span class="checkbox"></span> 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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# 510(k) Summary

| Submitter: | Bayer Medical Care Inc.<br>1 Bayer Drive<br>Indianola, PA 15051 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa A. Ewing<br>Deputy Director, Global Regulatory Strategy, Device New Product<br>Development<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | August 15, 2018 |
| Device Trade Name: | MEDRAD® Stellant FLEX CT Injection System with Certegra<br>Workstation<br>MEDRAD® Stellant FLEX Syringe Kits<br>MEDRAD® Stellant CT Injection System with Certegra Workstation<br>MEDRAD® Stellant Syringe Kits<br>MEDRAD® Stellant Connector Tubing<br>P3T Cardiac<br>P3T PA<br>P3T Abdomen<br>ISI<br>Connect.CT |
| Common Name: | Angiographic Injector and Syringe |
| Classification Name: | Injector and Syringe, Angiographic [21 CFR 870.1650] |
| Product Code: | DXT, IZQ |
| Classification: | Class II |
| Primary Predicate Device: | The subject device is substantially equivalent to the following<br>devices:<br>Injector System – MEDRAD Stellant CT Injector System with P3T<br>Cardiac K082905 |
| Secondary Predicate Device: | Syringe Kit – MEDRAD Stellant CT Injector System with Extravasation<br>Detection System Accessory, K063090 |

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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 svstem, it is designed to allow a user to fill disposable svringes 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.

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# 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 intended use/indications for use of the proposed devices are unchanged from the predicate devices, the MEDRAD Stellant CT Injection System cleared in K082905 and the MEDRAD Stellant Syringe Kits cleared in K063090. Additionally, the proposed injection systems (MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and MEDRAD Stellant CT Injection System with Certegra Workstation) and the predicate Stellant CT Injection System share similarities in functional design, performance specifications and materials.

The tables below provide a detailed comparison of the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation to the predicate MEDRAD Stellant CT Injection System, the MEDRAD Stellant CT Injection System with Certegra Workstation to the predicate MEDRAD Stellant CT Injection System, the MEDRAD Stellant FLEX Syringe Kits to the predicate MEDRAD Stellant Syringe Kits, the MEDRAD Stellant Syringe Kits to the predicate MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing to the predicate MEDRAD Stellant Connector Tubing.

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Table 1. Comparison of Fluid Delivery Features and Performance Specifications in MEDRAD Stellant CT Injection System as cleared in K082905 (Predicate) and MEDRAD Stellant FLEX CT Injection System with Certegra Workstation K173773 (Proposed).

| Feature | MEDRAD Stellant CT<br>Injection System as<br>cleared in K082905<br>(Predicate) | MEDRAD Stellant FLEX<br>CT Injection System<br>with Certegra<br>Workstation K173773<br>(Proposed) | Rationale for Change |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The MEDRAD Stellant CT<br>Injection System is<br>intended for the specific<br>purpose of injecting<br>intravenous contrast media<br>into humans for diagnostic<br>studies in computed<br>tomography (CT)<br>applications. | The MEDRAD Stellant<br>FLEX CT Injection<br>System with Certegra<br>Workstation, including<br>Stellant FLEX CT<br>Syringe Kits and<br>Connector Tubing, is<br>indicated for the specific<br>purpose of injecting<br>intravenous contrast<br>media or saline into<br>humans for diagnostic<br>studies in computed<br>tomography (CT)<br>applications. | Product name updated;<br>references to Stellant FLEX<br>syringe kits and connector tubing,<br>as well as saline, added for<br>clarity. |
| Single or Dual Syringe<br>System | Available in both single or<br>dual syringe injector head<br>model. | Dual syringe model only | Only dual syringe head model<br>available on Stellant FLEX. |
| Volume Range | 1 to 200 ml (for 200 ml<br>syringe size) | 1 to 200 ml or 1 to 150<br>ml (depending on 200 ml<br>or 150 ml syringe size) | Consistency with offered syringe<br>volumes. |
| 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>250/1724, 300/2068,<br>325/2241 | Choice of 50/345,<br>100/689, 150/1034,<br>200/1379, 225/1551,<br>250/1724, 300/2068,<br>325/2241 | Option of 225 PSI/1551 kPa<br>added to dropdown menu for<br>user convenience. |
| Protocol Memory | 32 protocols of up to 6<br>phases each | 250 protocols of up to 6<br>phases each | Customer convenience of ability<br>to store additional protocols. |
| Protocol Programming<br>Parameters | Flow rate and volume<br>(system calculates<br>duration) | Flow rate, volume and/or<br>duration | Added functionality for user to<br>program by any two of three<br>parameters. System calculates<br>the third. |
| Parametric Data Output<br>/ Informatics<br>Compatibility | None | Yes | Data output and informatics<br>compatibility added for customer<br>convenience. |
| Injection History Memory | None | Unlimited | Customer convenience of ability<br>to access injection history. |
| Control Room Unit | VxWorks-based display | Windows-based | Current technology; informatics |
| Feature | MEDRAD Stellant CT<br>Injection System as<br>cleared in K082905<br>(Predicate) | MEDRAD Stellant FLEX<br>CT Injection System<br>with Certegra<br>Workstation K173773<br>(Proposed) | Rationale for Change |
| Information Display<br>(Control Room) | Color LCD | Same | N/A |
| Programming Keys<br>(Control Room) | Software-generated via an<br>LCD touch<br>screen | 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 | Optical (Barcode) | Different technology required for<br>encoding additional syringe<br>information. |
| 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 |
| Scan Delay | 1 to 300 s in 1 s increments | None | Scan Delay with Reminders on<br>Stellant FLEX to allow for more<br>than one user-defined timed<br>notification. |
| Reminders | None | 1 to 300 s in 1 s<br>increments | Reminders are user-defined<br>timing notifications generated<br>during the injection sequence.<br>Expanded capability from single<br>purpose Scan Delay to allow for<br>more than one user-defined<br>timed notification from the start of<br>the injection. |
| 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<br>for use with CT<br>Angiography of the cardiac<br>structures, coronary<br>arteries, chambers of the<br>heart, pulmonary<br>vasculature, thoracic, and | Same | N/A |
| Feature | MEDRAD Stellant CT<br>Injection System as<br>cleared in K082905<br>(Predicate) | MEDRAD Stellant FLEX<br>CT Injection System<br>with Certegra<br>Workstation K173773<br>(Proposed) | Rationale for Change |
| P3T PA Indications | P3T PA is indicated for use<br>with CT Angiography of the<br>cardiac structures,<br>coronary arteries,<br>chambers of the heart,<br>pulmonary vasculature,<br>thoracic, and abdominal<br>aorta. | Same | N/A |
| P3T Abdomen<br>Indications | P3T Abdomen is indicated<br>for use with CT imaging of<br>abdominal organs (i.e.,<br>liver, pancreas, kidneys). | Same | N/A |
| P3T User Interface | When licensed, the user<br>can opt to use the P3T<br>software accessories for<br>any given injection. The<br>user is required to confirm<br>or change the suggested<br>protocol before beginning<br>an injection. | Same | N/A |
| Imaging System<br>Interface (ISI) -<br>Functionality | Yes. The ISI module<br>option is indicated for the<br>specific purpose of allowing<br>an injector to interface with<br>a 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 | MEDRAD Stellant CT Injection | Rationale for Change |
| | Injection System as<br>cleared in K082905<br>(Predicate) | System with Certegra<br>Workstation K173773<br>(Proposed) | |
| Indications for Use | The MEDRAD Stellant CT<br>Injection System is intended<br>for the specific purpose of<br>injecting intravenous<br>contrast media into humans<br>for diagnostic studies in<br>computed tomography (CT)<br>applications. | The MEDRAD Stellant CT<br>Injection System with Certegra<br>Workstation is indicated for the<br>specific purpose of injecting<br>intravenous contrast media or<br>saline into humans for<br>diagnostic studies in computed<br>tomography (CT) applications. | Product name updated;<br>reference to saline added<br>for clarity. |
| Single or Dual Syringe<br>System | Available in both single or<br>dual syringe injector head<br>model. | Dual syringe model only | Only dual syringe head<br>model available on<br>Stellant with Certegra<br>Workstation. |
| 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>250/1724, 300/2068,<br>325/2241 | Choice of 50/345, 100/689,<br>150/1034, 200/1379, 225/1551,<br>250/1724, 300/2068, 325/2241 | Option of 225 PSI/1551<br>kPa added to dropdown<br>menu for user<br>convenience. |
| Protocol Memory | 32 protocols of up to 6<br>phases each | 250 protocols of up to 6 phases<br>each | Customer convenience of<br>ability to store additional<br>protocols. |
| Protocol Programming<br>Parameters | Flow rate and volume<br>(system calculates duration) | Flow rate, volume and/or<br>duration | Added functionality for<br>user to program by any<br>two of three parameters.<br>System calculates the<br>third. |
| Parametric Data Output<br>/ Informatics<br>Compatibility | None | Yes | Data output and<br>informatics compatibility<br>added for customer<br>convenience. |
| Injection History Memory | None | Unlimited | Customer convenience of<br>ability to access injection<br>history. |
| Control Room Unit | VxWorks-based display<br>control unit | Windows-based Workstation | Current technology;<br>informatics accessory<br>compatibility. |
| Information Display<br>(Control Room) | Color LCD | Same | N/A |
| Programming Keys<br>(Control Room) | Software-generated via an<br>LCD touch<br>screen | Same | N/A |
| Retract Control | Manual and Automatic | Same | N/A |
| Feature | MEDRAD Stellant CT<br>Injection System as<br>cleared in K082905<br>(Predicate) | MEDRAD Stellant CT Injection<br>System with Certegra<br>Workstation K173773<br>(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…