(71 days)
Not Found
No
The document describes a software-controlled injection system that allows users to program injection parameters. While it mentions "compute individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration for individualized dosing," this is described as a computation based on inputs, not a learning or adaptive process characteristic of AI/ML. There are no explicit mentions of AI, ML, or related concepts like neural networks or training data.
No
The device is indicated for injecting contrast media or saline for diagnostic studies in computed tomography (CT) applications, not for treating any medical condition.
No
The device is an injection system used to administer contrast media or saline for diagnostic studies in CT applications. It facilitates the diagnostic process but does not, by itself, diagnose. The P3T software accessories compute individual contrast injection protocols and scan timing to improve the consistency of individualized injection protocols, not to make a diagnosis.
No
The device description explicitly states it is a "software-controlled medical device" and describes hardware components like syringes and tubing, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described devices (MEDRAD Stellant CT Injection Systems, Syringe Kits, Connector Tubing, and associated software) are used for the injection of contrast media or saline into the human body during CT procedures. They are tools for administering substances into the patient, not for analyzing samples from the patient.
- Intended Use: The stated intended use is for "injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications." This clearly describes an in-vivo procedure (within the living body), not an in-vitro test (outside the living body).
The devices are accessories and components of a CT injection system, which is used to enhance the visibility of structures during a diagnostic imaging procedure. They do not perform any diagnostic testing on biological samples.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DXT
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 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 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
CT
Anatomical Site
cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, 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)
Verification and validation testing was conducted to assess the impact of the Workstation on the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and the MEDRAD Stellant CT Injection System with Certegra Workstation. The following testing was successfully completed:
- Device performance testing included verification of fluid delivery, 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.
- 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.
- 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 MEDRAD 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 MEDRAD 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 device 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 was performed per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," and confirmed that the injection systems meet their cleaning and disinfection requirements.
All test results demonstrate that the design and materials of the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and the MEDRAD Stellant CT Injection System with Certegra Workstation meet the established performance criteria and will perform as intended. The results of the design verification and validation, including human factors engineering evaluation, demonstrate that the subject devices are substantially equivalent to their predicate devices.
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.
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
§ 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.
0
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.
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 2018.11.01 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
2
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)
| 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) 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) |
|---|
| ------------------------------------------------- |
| X 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
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: (412) 406-3780 | |
| Email: lisa.ewing@bayer.com | |
| 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 |
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 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.
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 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
Injection System with
Certegra Workstation as
cleared in K173773
(Predicate) | MEDRAD Stellant FLEX CT
Injection System with
Certegra Workstation
K182273 (Proposed) | Rationale for Change | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indications for Use | The MEDRAD Stellant FLEX
CT Injection System with
Certegra Workstation,
including Stellant FLEX CT
Syringe Kits and Connector
Tubing, is indicated for the
specific purpose of injecting
intravenous contrast media
or saline into humans for
diagnostic studies in
computed tomography (CT)
applications. | Same | N/A | |
| Single or Dual Syringe
System | Dual syringe | Same | N/A | |
| Volume Range | 1 to 200 ml or 1 to 150 ml
(depending on 200 ml or 150
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,
225/1551, 250/1724,
300/2068, 325/2241 | Same | N/A | |
| Protocol Memory | 250 protocols of up to 6
phases each | Same | N/A | |
| Protocol Programming
Parameters | Flow rate, volume and/or
duration | Same | N/A | |
| Parametric Data Output
/ Informatics
Compatibility | Yes | Same | N/A | |
| Injection History Memory | Unlimited | Same | N/A | |
| Control Room Unit | Windows-based Workstation
with separate hardware
components | Windows-based
Workstation with integrated
hardware components | Integration of hardware
components for aesthetic
improvement, modular
design and serviceability.
No impact on safety and
effectiveness. | |
| Information Display
(Control Room) | Color LCD | Same | N/A | |
| Programming Keys
(Control Room) | Software-generated via an
LCD resistive touch screen | Software-generated via an
LCD capacitive touch screen | Touch screen calibration not
required for capacitive touch
screen. No impact on safety | |
| Feature | MEDRAD Stellant FLEX CT
Injection System with
Certegra Workstation as
cleared in K173773
(Predicate) | MEDRAD Stellant FLEX CT
Injection System with
Certegra Workstation
K182273 (Proposed) | Rationale for Change | |
| Programming Keys
(Scan Room) | Dedicated keys on injector
head | 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 (Barcode) | 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 | |
| Reminders | 1 to 300 s in 1 s increments | Same | N/A | |
| 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 | |
| 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 | |
| Feature | MEDRAD Stellant FLEX CT
Injection System with
Certegra Workstation as
cleared in K173773
(Predicate) | MEDRAD Stellant FLEX CT
Injection System with
Certegra Workstation
K182273 (Proposed) | Rationale for Change | |
| 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
Injection System with
Certegra Workstation as
cleared in K173773
(Predicate) | MEDRAD Stellant CT
Injection System with
Certegra Workstation
K182273 (Proposed) | Rationale for Change | |
| Indications for Use | 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. | Same | N/A | |
| Single or Dual Syringe
System | Dual syringe | Same | N/A | |
| 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,
225/1551, 250/1724,
300/2068, 325/2241 | Same | N/A | |
| Protocol Memory | 250 protocols of up to 6
phases each | Same | N/A | |
| Protocol Programming
Parameters | Flow rate, volume and/or
duration | Same | N/A | |
| Parametric Data Output
/ Informatics
Compatibility | Yes | Same | N/A | |
| Injection History Memory | Unlimited | Same | N/A | |
| Control Room Unit | Windows-based Workstation
with separate hardware
components | Windows-based
Workstation with integrated
hardware components | Integration of hardware
components for aesthetic
improvement, modular
design and serviceability.
No impact on safety and
effectiveness. | |
| Information Display
(Control Room) | Color LCD | Same | N/A | |
| Programming Keys
(Control Room) | Software-generated via an
LCD resistive touch screen | Software-generated via an
LCD capacitive touch screen | Touch screen calibration not
required for capacitive touch
screen. No impact on safety
and effectiveness. | |
| Programming Keys
(Scan Room) | Dedicated keys on injector
head | Same | N/A | |
| Retract Control | Manual and Automatic | Same | N/A | |
| Feature | MEDRAD Stellant CT
Injection System with
Certegra Workstation as
cleared in K173773
(Predicate) | MEDRAD Stellant CT
Injection System with
Certegra Workstation
K182273 (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 | |
| Reminders | 1 to 300 s in 1 s increments | Same | N/A | |
| 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 | |
| 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 | |
| Feature | MEDRAD Stellant CT
Injection System with
Certegra Workstation as
cleared in K173773
(Predicate) | MEDRAD Stellant CT
Injection System with
Certegra Workstation
K182273 (Proposed) | Rationale for Change | |
| 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 FLEX
Syringe Kits as cleared in
K173773 (Predicate) | MEDRAD Stellant FLEX
Syringe Kits K182273
(Proposed) | Rationale for Change | |
| Indications for Use | The MEDRAD Stellant FLEX
CT Injection System with
Certegra Workstation,
including Stellant FLEX CT
Syringe Kits and Connector
Tubing, is indicated for the
specific purpose of injecting
intravenous contrast media
or saline into humans for
diagnostic studies in
computed tomography (CT)
applications. | Same | N/A | |
| Injector
compatibility | MEDRAD Stellant FLEX CT
Injection System with
Certegra Workstation | Same | N/A | |
| Syringe Volume
(contrast) | Choice of 150 ml or 200 ml | Same | N/A | |
| Syringe Volume
(saline) | Choice of 150 ml or 200 ml | Same | N/A | |
| Syringe Barrel | PET | Same | N/A | |
| Syringe Barrel
Lubrication | Silicone | Same | N/A | |
| Plunger Support
Ring | Polycarbonate | Same | N/A | |
| Plunger Cover | Polypropylene and TPV with
new colorant | Same | N/A | |
| Dust Caps | Polypropylene | Same | N/A | |
| Spikes | ABS | Same | N/A | |
| Packaging Type,
Material | Tyvek lid covering
polystyrene tray | Same | N/A | |
| Sterilization | E-Beam | Same | N/A | |
| 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 | No | Same | N/A | |
| Pressure Rating | 400 psi (2410 kPa) | Same | N/A | |
| Syringe Sensing
and Identification | Labeling, 2D barcode | Same | N/A | |
| Fluid Detection | Clear Syringe, FluiDots and
Beacon indicators | Same | N/A | |
| Feature | MEDRAD Stellant Syringe Kits as cleared in K173773 (Predicate) | MEDRAD Stellant Syringe Kits K182273 (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 | Polypropylene and TPV (same black colorant as predicate) | Same | N/A |
| | Dust Caps | Polypropylene | Same | N/A |
| | Spikes | ABS | Same | N/A |
| | Packaging Type, Material | Tyvek lid covering polystyrene tray | Same | N/A |
| | Sterilization | E-Beam | Same | N/A |
| Biological | 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 | No | Same | N/A |
| Performance | 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 |
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Table 2. Comparison of Fluid Delivery Features and Performance Specifications in MEDRAD Stellant CT Injection System with Certegra Workstation as cleared in K17373 (Predicate) and MEDRAD Stellant CT Injection System with Certegra Workstation K182273 (Proposed)
510(k) Summary Page 8 of 15 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and MEDRAD Stellant CT Injection System with Certegra Workstation
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13
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Table 3. Comparison of Stellant FLEX CT Injection System Syringe Kits as cleared in K173773 (Predicate) and Stellant FLEX CT Injection System Syringe Kits K182273 (Proposed)
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Table 4. Comparison of MEDRAD Stellant Syringe Kits as cleared in K173773 (Predicate) and MEDRAD Stellant Syringe Kits K182273 (Proposed)
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| Table 5. Comparison of MEDRAD Stellant Connector Tubing as cleared in K173773 (Predicate) and MEDRAD Stellant | |||
|---|---|---|---|
| Connector Tubing K182273 (Proposed) | |||
| Feature | MEDRAD Stellant | ||
| Connector Tubing as | |||
| cleared in K173773 | |||
| (Predicate) | MEDRAD Stellant Connector | ||
| Tubing K182273 (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 when
packaged standalone; E-
beam when packaged in
Stellant Syringe Kits; E-beam
when packaged in Stellant
FLEX Syringe Kits | Same | N/A |
| 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 | No | Same | N/A |
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Performance Data:
Verification and validation testing was conducted to assess the impact of the Workstation on the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and the MEDRAD Stellant CT Injection System with Certegra Workstation. The following testing was successfully completed:
- Device performance testing included verification of fluid delivery, 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.
- . 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.
- . 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 MEDRAD 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 MEDRAD 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 device 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 was performed per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," and confirmed that the injection systems meet their cleaning and disinfection requirements.
All test results demonstrate that the design and materials of the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and the MEDRAD Stellant CT Injection System with Certegra Workstation meet the established performance criteria and will perform as intended. The results of the design verification and validation, including human factors engineering evaluation, demonstrate that the subject devices are substantially equivalent to their predicate devices.
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes.
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Clinical Testing:
No clinical testing was required or performed to support this Special 510(k) Premarket Notification.
Conclusion:
Bayer Medical Care Inc. considers the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation to be substantially equivalent to the predicate device, the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation cleared in K173773. Similarly, Bayer Medical Care Inc. considers the MEDRAD Stellant CT Injection System with Certegra Workstation to be substantially equivalent to the predicate device, the MEDRAD Stellant CT Injection System with Certegra Workstation, also cleared in K173773. This conclusion is based upon the same indications for use, energy type, principle of operation, and graphical user interface, in addition to having similar technological characteristics, particularly with regard to similarities in functional design, usability and workflow, and fundamental scientific technology. The differences between the proposed devices and the predicate devices do not introduce new issues of safety and effectiveness.