(71 days)
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.
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.
The provided text describes a 510(k) premarket notification for contrast injection systems. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving the efficacy of a new, novel technology with extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering verification and validation, as well as human factors testing, to confirm that a modified device performs as safely and effectively as its predicate.
Here's an breakdown of the information requested, based on the provided text, and an explanation of why some fields are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a precise "table of acceptance criteria" with numerical outcomes in the way a clinical study would for diagnostics. Instead, it describes categories of testing and the general outcome that "All testing passed and the demonstrated product performance met all prior established acceptance criteria." The acceptance criteria are implicitly tied to the performance specifications of the predicate device and relevant industry standards.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Device Performance Testing | Verification of fluid delivery, flow rates, volumes, and pressures. Tested for impact of environmental conditions (atmospheric, handling). |
| Safety and Compatibility Testing | 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. |
| Reliability Testing | Statistical methods used to demonstrate capability to sequentially and repeatedly meet system performance requirements. Verified no degradation to performance when injection system and Informatics processes were run simultaneously (for both FLEX and standard Stellant systems). |
| Simulated Use and Human Factors Testing | Device and disposables used in a simulated clinical environment to validate clinical user needs per EN 62366-1: 2015 and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Cleaning and Disinfection | Performed per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "verification and validation testing" including "device performance testing," "safety and compatibility testing," and "reliability testing." These are typically engineering tests.
- Sample Size: The specific sample sizes for these engineering tests (e.g., number of injection cycles, number of units tested) are not stated in the provided 510(k) summary. These details would typically be found in the full test reports submitted to the FDA, not in the summary.
- Data Provenance: This is not a clinical study in the typical sense; the data provenance refers to internal engineering test results. The document does not specify a country of origin for the data (it's presumed to be from the manufacturer's testing facilities). The tests are prospective in the sense that they were designed and executed to validate the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept (experts establishing ground truth for a test set) is generally applicable to AI/ML or diagnostic image analysis studies. For a device like an angiographic injector, "ground truth" is established by engineering specifications, calibration standards, and adherence to recognized safety and performance standards. No experts for "ground truth" establishment in the context of clinical interpretation or diagnosis are mentioned or relevant here.
4. Adjudication Method for the Test Set
Not applicable for engineering and performance validation of a mechanical/software device like an injector. Adjudication methods (e.g., 2+1, 3+1) are for human interpretation of data, typically in diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating the impact of a diagnostic aid (e.g., AI) on human reader performance. This device is an angiographic injector system, not a diagnostic aid. The documentation explicitly states: "No clinical testing was required or performed to support this Special 510(k) Premarket Notification."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
This question is typically for AI/ML diagnostic algorithms. While the device has software components (e.g., P3T, ISI, Connect.CT), their "performance" is about controlling mechanical injection parameters or facilitating interface, not interpreting medical data in a standalone diagnostic capacity. The engineering tests implicitly evaluate the "standalone" performance of the system functions against their specifications.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Specifications: Pre-defined ranges and tolerances for parameters like flow rate, volume, pressure, fill speed, etc.
- Industry Standards: Compliance with standards like IEC 60601-1 (medical electrical equipment safety), EMC requirements, and EN 62366-1:2015 (human factors).
- Predicate Device Performance: The underlying assumption is that the modified device must perform equivalently to the predicate device, which itself met established safety and performance criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML model that requires a "training set." The development of the device involved traditional engineering design and iterative testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established
As explained above, this is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment process in that context.
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November 1, 2018
Bayer Medical Care Inc. Lisa Ewing Deputy Director, Global Regulatory Strategy 1 Bayer Drive Indianola, Pennsylvania 15051
Re: K182273
Trade/Device Name: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 28, 2018 Received: October 1, 2018
Dear Lisa Ewing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (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
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Indications for Use
510(k) Number (if known) K182273
Device Name
MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD® Stellant FLEX Syringe Kits, MEDRAD® Stellant CT Injection System with Certegra Workstation, MEDRAD® Stellant Syringe Kits, MEDRAD® Stellant Connector Tubing
Indications for Use (Describe)
MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation
The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant FLEX Syringe Kits
The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant CT Injection System with Certegra Workstation
The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant Syringe Kits
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
MEDRAD® Stellant Connector Tubing
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Indications for Use
510(k) Number (if known) K182273
Device Name
P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
Indications for Use (Describe)
P3T Cardiac
P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T PA
P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T Abdomen
P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).
ISI
The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.
Connect.CT
The Connect. CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| 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."
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Image /page/4/Picture/1 description: The image shows the logo for Bayer. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are in a dark blue color. The wordmark is surrounded by a circular design with two colors. The top half of the circle is green, and the bottom half is blue.
510(k) Summary
| Submitter: | Bayer Medical Care Inc. |
|---|---|
| 1 Bayer Drive | |
| Indianola, PA 15051 | |
| Contact Person: | Lisa A. Ewing |
| Deputy Director, Global Regulatory Strategy, Device New Product | |
| Development | |
| Phone: (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 |
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Device Description: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration. Refer to the Comparison to Predicate Device section for additional information regarding device functions, specifications, etc.
MEDRAD Stellant CT Injection System with Certegra Workstation
The MEDRAD Stellant CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration. Refer to the Comparison to Predicate Device section for additional information regarding device functions, specifications, etc.
Personalized Patient Protocol Technology (P3T)
The Stellant P3T software accessories compute individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration for individualized dosing, and for increasing the consistency of individualized injection protocols among clinicians.
Imaging System Interface (ISI)
The ISI module options allow an injector to interface with a CT scanner.
Connect.CT
The Connect.CT application allows an injector to interface with a CT scanner.
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Indications for Use:
MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation
The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant FLEX Syringe Kits
The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant CT Injection System with Certegra Workstation
The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant Syringe Kits
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD Stellant Injectors.
MEDRAD® Stellant Connector Tubing
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
P3T Cardiac
P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T PA
P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
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P3T Abdomen
P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).
ાટા
The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.
Connect.CT
The Connect.CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.
Comparison to the Predicate Device:
The fundamental scientific technology, principle of operation and 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.
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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 CTInjection System withCertegra Workstation ascleared in K173773(Predicate) | MEDRAD Stellant FLEX CTInjection System withCertegra WorkstationK182273 (Proposed) | Rationale for Change | |
|---|---|---|---|---|
| Indications for Use | The MEDRAD Stellant FLEXCT Injection System withCertegra Workstation,including Stellant FLEX CTSyringe Kits and ConnectorTubing, is indicated for thespecific purpose of injectingintravenous contrast mediaor saline into humans fordiagnostic studies incomputed tomography (CT)applications. | Same | N/A | |
| Single or Dual SyringeSystem | Dual syringe | Same | N/A | |
| Volume Range | 1 to 200 ml or 1 to 150 ml(depending on 200 ml or 150ml 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 PressureLimit (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 6phases each | Same | N/A | |
| Protocol ProgrammingParameters | Flow rate, volume and/orduration | Same | N/A | |
| Parametric Data Output/ InformaticsCompatibility | Yes | Same | N/A | |
| Injection History Memory | Unlimited | Same | N/A | |
| Control Room Unit | Windows-based Workstationwith separate hardwarecomponents | Windows-basedWorkstation with integratedhardware components | Integration of hardwarecomponents for aestheticimprovement, modulardesign and serviceability.No impact on safety andeffectiveness. | |
| Information Display(Control Room) | Color LCD | Same | N/A | |
| Programming Keys(Control Room) | Software-generated via anLCD resistive touch screen | Software-generated via anLCD capacitive touch screen | Touch screen calibration notrequired for capacitive touchscreen. No impact on safety | |
| Feature | MEDRAD Stellant FLEX CTInjection System withCertegra Workstation ascleared in K173773(Predicate) | MEDRAD Stellant FLEX CTInjection System withCertegra WorkstationK182273 (Proposed) | Rationale for Change | |
| Programming Keys(Scan Room) | Dedicated keys on injectorhead | Same | N/A | |
| Retract Control | Manual and Automatic | Same | N/A | |
| Check for AirConfirmation | Operator visual inspection;user confirmed | Same | N/A | |
| Start/Stop Switch (HandSwitch) | Start, Stop and Pausefunctionality | Same | N/A | |
| Pressure Graph | Yes | Same | N/A | |
| Syringe Sensing | Optical (Barcode) | Same | N/A | |
| Autoload | Yes | Same | N/A | |
| AutoDock/Retract/Advance | Yes; user-selectable auto-dock and advance; user-selectable auto-retract | Same | N/A | |
| Protocol Lock / RemoteArming | 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 MaintainerRange | 95 degrees F +/- 9 degrees(35 degrees C +/- 5degrees) | Same | N/A | |
| P3T Functionality | Includes P3T Cardiac, P3TPA, and P3T Abdomenfunctionality | Same | N/A | |
| P3T Cardiac Indications | P3T Cardiac is indicated foruse with CT Angiography ofthe cardiac structures,coronary arteries, chambersof the heart, pulmonaryvasculature, thoracic, andabdominal aorta. | Same | N/A | |
| P3T PA Indications | P3T PA is indicated for usewith CT Angiography of thecardiac structures, coronaryarteries, chambers of theheart, pulmonaryvasculature, thoracic, andabdominal aorta. | Same | N/A | |
| P3T AbdomenIndications | P3T Abdomen is indicatedfor use with CT imaging ofabdominal organs (i.e., liver,pancreas, kidneys). | Same | N/A | |
| Feature | MEDRAD Stellant FLEX CTInjection System withCertegra Workstation ascleared in K173773(Predicate) | MEDRAD Stellant FLEX CTInjection System withCertegra WorkstationK182273 (Proposed) | Rationale for Change | |
| P3T User Interface | When licensed, the user canopt to use the P3T softwareaccessories for any giveninjection. The user isrequired to confirm orchange the suggestedprotocol before beginning aninjection. | Same | N/A | |
| Imaging SystemInterface (ISI) -Functionality | Yes. The ISI module optionis indicated for the specificpurpose of allowing aninjector to interface with aCT scanner. | Same | N/A | |
| Connect.CTFunctionality | Yes. The Connect.CTapplication is indicated forthe specific purpose ofallowing the injector tointerface with a CT scanner | Same | N/A | |
| Feature | MEDRAD Stellant CTInjection System withCertegra Workstation ascleared in K173773(Predicate) | MEDRAD Stellant CTInjection System withCertegra WorkstationK182273 (Proposed) | Rationale for Change | |
| Indications for Use | The MEDRAD Stellant CTInjection System withCertegra Workstation isindicated for the specificpurpose of injectingintravenous contrast mediaor saline into humans fordiagnostic studies incomputed tomography (CT)applications. | Same | N/A | |
| Single or Dual SyringeSystem | Dual syringe | Same | N/A | |
| Volume Range | 1 to 200 ml (for 200 mlsyringe 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 PressureLimit (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 6phases each | Same | N/A | |
| Protocol ProgrammingParameters | Flow rate, volume and/orduration | Same | N/A | |
| Parametric Data Output/ InformaticsCompatibility | Yes | Same | N/A | |
| Injection History Memory | Unlimited | Same | N/A | |
| Control Room Unit | Windows-based Workstationwith separate hardwarecomponents | Windows-basedWorkstation with integratedhardware components | Integration of hardwarecomponents for aestheticimprovement, modulardesign and serviceability.No impact on safety andeffectiveness. | |
| Information Display(Control Room) | Color LCD | Same | N/A | |
| Programming Keys(Control Room) | Software-generated via anLCD resistive touch screen | Software-generated via anLCD capacitive touch screen | Touch screen calibration notrequired for capacitive touchscreen. No impact on safetyand effectiveness. | |
| Programming Keys(Scan Room) | Dedicated keys on injectorhead | Same | N/A | |
| Retract Control | Manual and Automatic | Same | N/A | |
| Feature | MEDRAD Stellant CTInjection System withCertegra Workstation ascleared in K173773(Predicate) | MEDRAD Stellant CTInjection System withCertegra WorkstationK182273 (Proposed) | Rationale for Change | |
| Check for AirConfirmation | Operator visual inspection;user confirmed | Same | N/A | |
| Start/Stop Switch (HandSwitch) | Start, Stop and Pausefunctionality | Same | N/A | |
| Pressure Graph | Yes | Same | N/A | |
| Syringe Sensing | Optical | Same | N/A | |
| Autoload | Yes | Same | N/A | |
| AutoDock/Retract/Advance | Yes; user-selectable auto-dock and advance; user-selectable auto-retract | Same | N/A | |
| Protocol Lock / RemoteArming | 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 MaintainerRange | 95 degrees F +/- 9 degrees(35 degrees C +/- 5degrees) | Same | N/A | |
| P3T Functionality | Includes P3T Cardiac, P3TPA and P3T Abdomenfunctionality | Same | N/A | |
| P3T Cardiac Indications | P3T Cardiac is indicated foruse with CT Angiography ofthe cardiac structures,coronary arteries, chambersof the heart, pulmonaryvasculature, thoracic, andabdominal aorta. | Same | N/A | |
| P3T PA Indications | P3T PA is indicated for usewith CT Angiography of thecardiac structures, coronaryarteries, chambers of theheart, pulmonaryvasculature, thoracic, andabdominal aorta. | Same | N/A | |
| P3T AbdomenIndications | P3T Abdomen is indicatedfor use with CT imaging ofabdominal organs (i.e., liver,pancreas, kidneys). | Same | N/A | |
| P3T User Interface | When licensed, the user canopt to use the P3T softwareaccessories for any giveninjection. The user isrequired to confirm orchange the suggestedprotocol before beginning aninjection | Same | N/A | |
| Feature | MEDRAD Stellant CTInjection System withCertegra Workstation ascleared in K173773(Predicate) | MEDRAD Stellant CTInjection System withCertegra WorkstationK182273 (Proposed) | Rationale for Change | |
| Imaging SystemInterface (ISI) -Functionality | Yes. The ISI module optionis indicated for the specificpurpose of allowing aninjector to interface with aCT scanner. | Same | N/A | |
| Connect.CTFunctionality | Yes. The Connect.CTapplication is indicated forthe specific purpose ofallowing the injector tointerface with a CT scanner. | Same | N/A | |
| Feature | MEDRAD Stellant FLEXSyringe Kits as cleared inK173773 (Predicate) | MEDRAD Stellant FLEXSyringe Kits K182273(Proposed) | Rationale for Change | |
| Indications for Use | The MEDRAD Stellant FLEXCT Injection System withCertegra Workstation,including Stellant FLEX CTSyringe Kits and ConnectorTubing, is indicated for thespecific purpose of injectingintravenous contrast mediaor saline into humans fordiagnostic studies incomputed tomography (CT)applications. | Same | N/A | |
| Injectorcompatibility | MEDRAD Stellant FLEX CTInjection System withCertegra 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 BarrelLubrication | Silicone | Same | N/A | |
| Plunger SupportRing | Polycarbonate | Same | N/A | |
| Plunger Cover | Polypropylene and TPV withnew colorant | Same | N/A | |
| Dust Caps | Polypropylene | Same | N/A | |
| Spikes | ABS | Same | N/A | |
| Packaging Type,Material | Tyvek lid coveringpolystyrene tray | Same | N/A | |
| Sterilization | E-Beam | Same | N/A | |
| Sterility AssuranceLevel (SAL) | 10-6 | Same | N/A | |
| Pyrogenicity | Non-Pyrogenic Fluid Path | Same | N/A | |
| Latex Content | Not made with natural rubberlatex | Same | N/A | |
| DEHP | No | Same | N/A | |
| Pressure Rating | 400 psi (2410 kPa) | Same | N/A | |
| Syringe Sensingand Identification | Labeling, 2D barcode | Same | N/A | |
| Fluid Detection | Clear Syringe, FluiDots andBeacon 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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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 StellantConnector Tubing ascleared in K173773(Predicate) | MEDRAD Stellant ConnectorTubing K182273 (Proposed) | Rationale for Change |
| Description | Low pressureconnector tube assemblyoffered in two configurations- one for dual syringeinjection (with T-connector),one for single syringeinjection (withoutT-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 whenpackaged standalone; E-beam when packaged inStellant Syringe Kits; E-beamwhen packaged in StellantFLEX 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 rubberlatex | 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.
§ 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.