Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a software-controlled injection system and a software accessory (P3T) that computes injection protocols based on user-defined parameters and patient characteristics. While this involves computation and potentially complex algorithms, there is no mention of the system learning from data or adapting its behavior based on experience, which are hallmarks of AI/ML. The description focuses on pre-programmed logic and user-defined inputs.

Therapeutic

No

The device is indicated for injecting contrast media or saline for diagnostic studies in computed tomography (CT) applications, rather than for treating a disease or condition.

Diagnostic

No

The device is an injection system used to administer contrast media or saline for diagnostic studies in CT applications. It is not itself a diagnostic device, but rather a tool that enables diagnostic studies.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system". It also describes hardware components like "disposable syringes" and the system being designed to "allow a user to fill disposable syringes to perform an injection". The performance studies also include extensive bench testing on hardware components like "device performance (filling, protocol management, fluid delivery, flow rates, volumes, pressures, environmental conditions)" and "disposables performance (mechanical functions, pressure capabilities, packaging)". While software is a key component, the device is clearly a system that includes hardware for fluid delivery.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications." This describes a device used in vivo (within the body) for administering substances to aid in imaging, not for testing samples in vitro (outside the body).
Device Description: The device description reinforces this by stating it's used for the "administration of intravenous CT contrast media and saline into the human vascular system."
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to facilitate the imaging process by delivering contrast agents.

Therefore, the device falls under the category of a medical device used for administering substances during a diagnostic imaging procedure, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DXT, IZQ

Device Description

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.

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.

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.

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

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography (CT)

Anatomical Site

Cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta, abdominal organs (i.e., liver, pancreas, kidneys).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant CT Injection System with Certegra Workstation, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing share common design elements with the predicate MEDRAD Stellant CT Injection System, the predicate MEDRAD Stellant Syringe Kits, and the predicate MEDRAD Stellant Connector Tubing. Complete bench testing was performed on all design changes unique to the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and MEDRAD Stellant FLEX Syringe Kits. Likewise, complete bench testing was performed on all design changes unique to the MEDRAD Stellant CT Injection System with Certegra Workstation and MEDRAD Stellant Syringe Kits. Where bench testing on shared elements of the design existed from the predicate MEDRAD Stellant CT Injection System, the MEDRAD Stellant Syringe Kits, and from similar devices, performance requirements and test data were analyzed and leveraged. The combined bench test results and analysis results confirm that the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant CT Injection System with Certegra Workstation, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing meet product specification and performance requirements.

The following testing was successfully completed:

Device performance testing included verification of the system disposable filling and preparation, protocol management, fluid delivery—both sequential and simultaneous, flow rates, volumes, and pressures. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
Disposables performance testing included verification of the syringe and connector tubing mechanical functions and pressure capabilities (ISO 594), and packaging (ISO 11607-1). All testing passed and the demonstrated product performance met all prior established acceptance criteria.
Biocompatibility testing was conducted on the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing to verify that these devices meet the requirements of ISO 10993-1:2009. The test program included: Cytotoxicity, Hemocompatibility (Hemolysis), Sensitization, Irritation / Intracutaneous Reactivity, Acute Systemic Toxicity (Acute Systemic Injection, Materials Mediated Pyrogen).
Sterilization conditions have been validated on the syringe and connector tubing kits in accordance with ISO 11137-1, ISO 11137-2 and ISO 11137-3 to provide a Sterility Assurance Level of 10-6. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
Safety and Compatibility testing included verification of configurations and specifications, circuitry, compliance with IEC 60601-1 and EMC requirements, electrical safety controls, ability to detect failures in communication and controls, programming keys, and sensors, and safe operation. All testing passed and the demonstrated product performance demonstrated met all prior established acceptance criteria.
Shelf-life and shipping testing included verification that the system performance was not affected by four-year aging and shelf-life (for disposable syringes and connector tubing) and packaged transit and storage (ISTA 2A, for the injector system). All testing passed and the demonstrated performance met all prior established acceptance criteria.
Reliability testing was performed using statistical methods to demonstrate the capability to sequentially and repeatedly meet system performance requirements. Testing verified there was no degradation to performance when the Stellant FLEX CT Injection System with Certegra Workstation and Informatics processes were run simultaneously. Similarly, testing verified there was no degradation to performance when the Stellant CT Injection System with Certegra Workstation and Informatics processes were run simultaneously. All testing passed and the demonstrated performance met all prior established acceptance criteria.
Simulated Use and Human Factors testing was performed by using the injector systems and disposables in a simulated clinical environment to validate the clinical user needs were met by the design per EN 62366-1: 2015 and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." Testing demonstrated that no new or different questions of safety or effectiveness were raised.
Cleaning and disinfection vas performed per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," and confirmed that the injection systems meets their cleaning and disinfection requirements.

No clinical testing was required or performed to support this Traditional 510(k) Premarket Notification.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082905, K063090

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

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 & 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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)

	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."

3

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)

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."

4

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: (412) 406-3780
Email: lisa.ewing@bayer.com |
| Date Prepared: | August 15, 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, IZQ |
| Classification: | Class II |
| Primary Predicate Device: | The subject device is substantially equivalent to the following
devices:
Injector System – MEDRAD Stellant CT Injector System with P3T
Cardiac K082905 |
| Secondary Predicate Device: | Syringe Kit – MEDRAD Stellant CT Injector System with Extravasation
Detection System Accessory, K063090 |

5

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.

6

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 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.

8

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
Injection System as
cleared in K082905
(Predicate) | MEDRAD Stellant FLEX
CT Injection System
with Certegra
Workstation K173773
(Proposed) | Rationale for Change |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The MEDRAD Stellant CT
Injection System is
intended for the specific
purpose of injecting
intravenous contrast media
into humans for diagnostic
studies in computed
tomography (CT)
applications. | 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. | Product name updated;
references to Stellant FLEX
syringe kits and connector tubing,
as well as saline, added for
clarity. |
| Single or Dual Syringe
System | Available in both single or
dual syringe injector head
model. | Dual syringe model only | Only dual syringe head model
available on Stellant FLEX. |
| Volume Range | 1 to 200 ml (for 200 ml
syringe size) | 1 to 200 ml or 1 to 150
ml (depending on 200 ml
or 150 ml syringe size) | Consistency with offered syringe
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
Limit (PSI/kPa) | Choice of 50/345, 100/689,
150/1034, 200/1379,
250/1724, 300/2068,
325/2241 | Choice of 50/345,
100/689, 150/1034,
200/1379, 225/1551,
250/1724, 300/2068,
325/2241 | Option of 225 PSI/1551 kPa
added to dropdown menu for
user convenience. |
| Protocol Memory | 32 protocols of up to 6
phases each | 250 protocols of up to 6
phases each | Customer convenience of ability
to store additional protocols. |
| Protocol Programming
Parameters | Flow rate and volume
(system calculates
duration) | Flow rate, volume and/or
duration | Added functionality for user to
program by any two of three
parameters. System calculates
the third. |
| Parametric Data Output
/ Informatics
Compatibility | None | Yes | Data output and informatics
compatibility added for customer
convenience. |
| Injection History Memory | None | Unlimited | Customer convenience of ability
to access injection history. |
| Control Room Unit | VxWorks-based display | Windows-based | Current technology; informatics |
| Feature | MEDRAD Stellant CT
Injection System as
cleared in K082905
(Predicate) | MEDRAD Stellant FLEX
CT Injection System
with Certegra
Workstation K173773
(Proposed) | Rationale for Change |
| Information Display
(Control Room) | Color LCD | Same | N/A |
| Programming Keys
(Control Room) | Software-generated via an
LCD touch
screen | Same | N/A |
| Retract Control | Manual and Automatic | Same | N/A |
| Check for Air
Confirmation | Operator visual inspection;
user confirmed | Same | N/A |
| Start/Stop Switch (Hand
Switch) | Start, Stop and Pause
functionality | Same | N/A |
| Pressure Graph | Yes | Same | N/A |
| Syringe Sensing | Optical | Optical (Barcode) | Different technology required for
encoding additional syringe
information. |
| Autoload | Yes | Same | N/A |
| Auto
Dock/Retract/Advance | Yes; user-selectable auto-
dock and advance; user-
selectable auto-retract | Same | N/A |
| Protocol Lock / Remote
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
Stellant FLEX to allow for more
than one user-defined timed
notification. |
| Reminders | None | 1 to 300 s in 1 s
increments | Reminders are user-defined
timing notifications generated
during the injection sequence.
Expanded capability from single
purpose Scan Delay to allow for
more than one user-defined
timed notification from the start of
the injection. |
| Syringe Heat Maintainer | Yes | Same | N/A |
| Syringe Heat Maintainer
Range | 95 degrees F +/- 9 degrees
(35 degrees C +/- 5
degrees) | Same | N/A |
| P3T Functionality | Includes P3T Cardiac, P3T
PA and P3T Abdomen
functionality | Same | N/A |
| 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, and | Same | N/A |
| Feature | MEDRAD Stellant CT
Injection System as
cleared in K082905
(Predicate) | MEDRAD Stellant FLEX
CT Injection System
with Certegra
Workstation K173773
(Proposed) | Rationale for Change |
| P3T PA Indications | 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. | Same | N/A |
| P3T Abdomen
Indications | P3T Abdomen is indicated
for use with CT imaging of
abdominal organs (i.e.,
liver, pancreas, kidneys). | Same | N/A |
| P3T User Interface | When licensed, the user
can opt to use the P3T
software accessories for
any given injection. The
user is required to confirm
or change the suggested
protocol before beginning
an injection. | Same | N/A |
| Imaging System
Interface (ISI) -
Functionality | Yes. The ISI module
option is indicated for the
specific purpose of allowing
an injector to interface with
a CT scanner. | Same | N/A |
| Connect.CT
Functionality | Yes. The Connect.CT
application is indicated for
the specific purpose of
allowing the injector to
interface with a CT scanner | Same | N/A |
| Feature | MEDRAD Stellant CT | MEDRAD Stellant CT Injection | Rationale for Change |
| | Injection System as
cleared in K082905
(Predicate) | System with Certegra
Workstation K173773
(Proposed) | |
| Indications for Use | The MEDRAD Stellant CT
Injection System is intended
for the specific purpose of
injecting intravenous
contrast media 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. | Product name updated;
reference to saline added
for clarity. |
| Single or Dual Syringe
System | Available in both single or
dual syringe injector head
model. | Dual syringe model only | Only dual syringe head
model available on
Stellant with Certegra
Workstation. |
| Volume Range | 1 to 200 ml (for 200 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
Limit (PSI/kPa) | Choice of 50/345, 100/689,
150/1034, 200/1379,
250/1724, 300/2068,
325/2241 | Choice of 50/345, 100/689,
150/1034, 200/1379, 225/1551,
250/1724, 300/2068, 325/2241 | Option of 225 PSI/1551
kPa added to dropdown
menu for user
convenience. |
| Protocol Memory | 32 protocols of up to 6
phases each | 250 protocols of up to 6 phases
each | Customer convenience of
ability to store additional
protocols. |
| Protocol Programming
Parameters | Flow rate and volume
(system calculates duration) | Flow rate, volume and/or
duration | Added functionality for
user to program by any
two of three parameters.
System calculates the
third. |
| Parametric Data Output
/ Informatics
Compatibility | None | Yes | Data output and
informatics compatibility
added for customer
convenience. |
| Injection History Memory | None | Unlimited | Customer convenience of
ability to access injection
history. |
| Control Room Unit | VxWorks-based display
control unit | Windows-based Workstation | Current technology;
informatics accessory
compatibility. |
| Information Display
(Control Room) | Color LCD | Same | N/A |
| Programming Keys
(Control Room) | Software-generated via an
LCD touch
screen | Same | N/A |
| Retract Control | Manual and Automatic | Same | N/A |
| Feature | MEDRAD Stellant CT
Injection System as
cleared in K082905
(Predicate) | MEDRAD Stellant CT Injection
System with Certegra
Workstation K173773
(Proposed) | Rationale for Change |
| Check for Air
Confirmation | Operator visual inspection;
user confirmed | Same | N/A |
| Start/Stop Switch (Hand
Switch) | Start, Stop and Pause
functionality | Same | N/A |
| Pressure Graph | Yes | Same | N/A |
| Syringe Sensing | Optical | Same | N/A |
| Autoload | Yes | Same | N/A |
| Auto
Dock/Retract/Advance | Yes; user-selectable auto-
dock and advance; user-
selectable auto-retract | Same | N/A |
| Protocol Lock / Remote
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 Stellant
FLEX and Stellant with
Certegra Workstation to
allow for more than one
user-defined timed
notification. |
| Reminders | None | 1 to 300 s in 1 s increments | Reminders are user-
defined timing
notifications generated
during the injection
sequence. Expanded
capability from single
purpose Scan Delay to
allow for more than one
user-defined timed
notification from the start
of the injection. |
| Syringe Heat Maintainer | Yes | Same | N/A |
| Syringe Heat Maintainer
Range | 95 degrees F +/- 9 degrees
(35 degrees C +/- 5 degrees) | Same | N/A |
| P3T Functionality | Includes P3T Cardiac, P3T
PA and P3T Abdomen
functionality | Same | N/A |
| 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, and
abdominal aorta | Same | N/A |
| Feature | MEDRAD Stellant CT
Injection System as
cleared in K082905
(Predicate) | MEDRAD Stellant CT Injection
System with Certegra
Workstation K173773
(Proposed) | Rationale for Change |
| P3T PA Indications | 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. | Same | N/A |
| P3T Abdomen
Indications | P3T Abdomen is indicated
for use with CT imaging of
abdominal organs (i.e., liver,
pancreas, kidneys). | Same | N/A |
| P3T User Interface | When licensed, the user can
opt to use the P3T software
accessories for any given
injection. The user is
required to confirm or
change the suggested
protocol before beginning an
injection. | Same | N/A |
| Imaging System
Interface (ISI) -
Functionality | Yes. The ISI module option
is indicated for the specific
purpose of allowing an
injector to interface with a
CT scanner. | Same | N/A |
| Connect.CT
Functionality | Yes. The Connect.CT
application is indicated for
the specific purpose of
allowing the injector to
interface with a CT scanner. | Same | N/A |

9

10

11

Table 2. Comparison of Fluid Delivery Features and Performance Specifications in MEDRAD Stellant CT Injection System as cleared in K082905 (Predicate) and MEDRAD Stellant CT Injection System with Certegra Workstation K173773 (Proposed).

12

13

14

Table 3 Comparison of MEDRAD Stellant CT Injection System Syringe Kits and Connector Tubing as cleared in K063090 (Predicate) and Stellant FLEX CT Injection System Syringe Kits K173773 (Proposed).

| | Feature | MEDRAD Stellant Syringe
Kits & Connector Tubing as
cleared in K063090
(Predicate) | MEDRAD Stellant FLEX
Syringe Kits & Connector
Tubing K173773
(Proposed) | Rationale for Change |
|--------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | 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. | 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. | Consistency of Stellant
FLEX syringe kit
indications for use
statement with Stellant
FLEX CT Injection
System. No change to
intent of indications for
use. |
| Construction | Injector
compatibility | MEDRAD Stellant CT
Injection System, MEDRAD
Stellant CT Injection System
with Certegra Workstation | MEDRAD Stellant FLEX CT
Injection System with Certegra
Workstation | Stellant FLEX syringe
interface modified to
accommodate 2D
barcode and reader. |
| | Syringe Volume
(contrast) | 200 ml | Choice of 150 ml or 200 ml | Smaller Stellant FLEX
syringe offered for
customer value. |
| | Syringe Volume
(saline) | 200 ml | Choice of 150 ml or 200 ml | Smaller Stellant FLEX
syringe offered for
customer value. |
| | Syringe Barrel
Syringe Barrel
Lubrication | PET
Silicone | Same
Same | N/A
N/A |
| Materials | Plunger Support
Ring | Polycarbonate | Same | N/A |
| | Plunger Cover | Polyisoprene with carbon
black colorant | Polypropylene and TPV with
new colorant | (Current) Design updated
for cost optimization.

15

Table 4 Comparison of MEDRAD Stellant CT Injection System Syringe Kits as cleared in K063090 (Predicate) and the MEDRAD Stellant CT Injection System Syringe Kits K173773 (Proposed)

| Feature | | MEDRAD Stellant Syringe
Kits as cleared in
K063090 (Predicate) | MEDRAD Stellant Syringe Kits
K173773 (Proposed) | Rationale for Change |
|---------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------|
| | | | | |
| Indications for Use | | 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. | Same | N/A |
| Construction | Injector
compatibility | MEDRAD Stellant CT
Injection System, MEDRAD
Stellant CT Injection
System with Certegra
Workstation | Same | N/A |
| | Syringe Volume
(contrast) | 200 ml | Same | N/A |
| | Syringe Volume
(saline) | 200 ml | Same | N/A |
| | Syringe Barrel | PET | Same | N/A |
| Materials | Syringe Barrel
Lubrication | Silicone | Same | N/A |
| | Plunger Support
Ring | Polycarbonate | Same | N/A |
| | Plunger Cover | Polyisoprene with carbon
black colorant | Polypropylene and TPV (same
black colorant as predicate) | Design updated for cost
optimization. |
| | Dust Caps | Polypropylene | Same | N/A |
| | Spikes | ABS | Same | N/A |
| | Packaging Type,
Material | Tyvek lid covering
polystyrene tray | Same | N/A |
| Biol | Sterilization | Ethylene Oxide | E-Beam | Updated mode of
sterilization; SAL is |

16

| Feature | MEDRAD Stellant Syringe
Kits as cleared in
K063090 (Predicate) | MEDRAD Stellant Syringe Kits
K173773 (Proposed) | Rationale for Change | |
|---------------------------------------|------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------|------|
| | | | unchanged. | |
| | Performance | Sterility Assurance
Level (SAL) | 10-6 | Same |
| | | Pyrogenicity | Non-Pyrogenic Fluid Path | Same |
| | | Latex Content | Not made with natural
rubber latex | Same |
| | DEHP | No | Same | N/A |
| Pressure Rating | 400 psi (2410 kPa) | Same | N/A | |
| Syringe Sensing
and Identification | Labeling, grooves at bottom
of barrel to be optically
identified | Same | N/A | |
| Fluid Detection | Clear syringe, FluiDots
indicators | Same | N/A | |

Table 5 Comparison of MEDRAD Stellant Connector Tubing as cleared in K063090 (Predicate) and MEDRAD Stellant Connector Tubing K173773 (Proposed)

| Feature | MEDRAD Stellant Syringe Kits
& Connector Tubing as
cleared in K063090 (Predicate) | MEDRAD Stellant Connector
Tubing K173773 (Proposed) | Rationale for Change |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Description | Low pressure
connector tube assembly offered
in two configurations - one for
dual syringe injection (with T-
connector), one for single
syringe injection (without
T-connector) | Same | N/A |
| Pressure Rating | 400 psi (2410 kPa) | Same | N/A |
| Tubing Length | 60" | Same | N/A |
| Tubing material | PVC | Same | N/A |
| T-connector
material | Polycarbonate | Same | N/A |
| Packaging
Materials, Type | Tyvek membrane, polyethylene
pouch | Same | N/A |
| Sterilization | Ethylene Oxide | Ethylene Oxide when packaged
standalone; E-beam when
packaged in Stellant Syringe Kits;
E-beam when packaged in
Stellant FLEX Syringe Kits | Alternative modes of
sterilization used when
packaged in syringe kits;
SAL is unchanged. |
| Sterility Assurance
Level (SAL) | 10-6 | Same | N/A |
| Pyrogenicity | Non-Pyrogenic Fluid Path | Same | N/A |
| Latex Content | Not made with natural rubber
latex | Same | N/A |
| DEHP | Yes | No | Removal of DEHP. |

17

Performance Data:

The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant CT Injection System with Certegra Workstation, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing share common design elements with the predicate MEDRAD Stellant CT Injection System, the predicate MEDRAD Stellant Syringe Kits, and the predicate MEDRAD Stellant Connector Tubing. Complete bench testing was performed on all design changes unique to the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and MEDRAD Stellant FLEX Syringe Kits. Likewise, complete bench testing was performed on all design changes unique to the MEDRAD Stellant CT Injection System with Certegra Workstation and MEDRAD Stellant Syringe Kits. Where bench testing on shared elements of the design existed from the predicate MEDRAD Stellant CT Injection System, the MEDRAD Stellant Syringe Kits, and from similar devices, performance requirements and test data were analyzed and leveraged. The combined bench test results and analysis results confirm that the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant CT Injection System with Certegra Workstation, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing meet product specification and performance requirements.

The following testing was successfully completed:

. Device performance testing included verification of the system disposable filling and preparation, protocol management, fluid delivery—both sequential and simultaneous, flow rates, volumes, and pressures. Testing also verified that the device was not affected by environmental conditions such as atmospheric conditions and handling. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
. Disposables performance testing included verification of the syringe and connector tubing mechanical functions and pressure capabilities (ISO 594), and packaging (ISO 11607-1). Testing was performed using aged samples that had been sterilized and with samples that had been subjected to shipping conditions (ASTM D4169). All testing passed and the demonstrated product performance met all prior established acceptance criteria.
. Biocompatibility testing was conducted on the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing to verify that these devices meet the requirements of ISO 10993-1:2009. Based on guidance of ISO 10993-1:2009, Table A.1, the following test program was selected for an externally communicating, indirect blood path, limited contact (