(248 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.
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.
MEDRAD Stellant CT Injection System with Certegra Workstation: The MEDRAD Stellant CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection svstem, it is designed to allow a user to fill disposable svringes to perform an injection with a user-programmed volume, flow rate and/or duration.
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.
The provided document is a 510(k) premarket notification for a medical device: the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and associated components. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as for a PMA. Therefore, the device performance is evaluated against established engineering specifications and verified through various forms of bench testing, rather than clinical efficacy measures.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a quantitative, pass/fail table format directly tied to an AI or algorithm's performance. Instead, it discusses the general performance requirements and outcomes of various engineering tests. The "reported device performance" is consistently stated as "All testing passed and the demonstrated product performance met all prior established acceptance criteria."
General categories of acceptance criteria (implicit from testing performed) and reported outcomes:
| Category of Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device performance (filling, protocol management, fluid delivery, flow rates, volumes, pressures) | Passed, met all prior established acceptance criteria. |
| Environmental conditions (atmospheric, handling) | Passed, met all prior established acceptance criteria. |
| Disposables mechanical functions (syringe, tubing, pressure capabilities per ISO 594) | Passed, met all prior established acceptance criteria. |
| Disposables packaging (per ISO 11607-1) | Passed, met all prior established acceptance criteria. |
| Biocompatibility (per ISO 10993-1:2009 for cytotoxicity, hemocompatibility, sensitization, irritation, acute systemic toxicity, materials mediated pyrogen) | Passed, met the requirements. |
| Sterilization (per ISO 11137-1, -2, -3 to SAL of 10^-6) | Passed, met all prior established acceptance criteria. |
| Safety and Compatibility (configurations, circuitry, IEC 60601-1, EMC, electrical safety, communication/control failure detection, programming keys, sensors, safe operation) | Passed, met all prior established acceptance criteria. |
| Shelf-life and shipping (4-year aging for disposables, transit/storage for injector system per ISTA 2A) | Passed, met all prior established acceptance criteria. |
| Reliability (sequential/repeated performance, no degradation with simultaneous processes) | Passed, met all prior established acceptance criteria. |
| Simulated Use and Human Factors (clinical user needs, per EN 62366-1:2015 and FDA Guidance) | Passed, demonstrated no new or different questions of safety or effectiveness. |
| Cleaning and disinfection (per FDA Guidance) | Passed, systems meet requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes various bench tests and simulated use tests rather than studies involving patient data or clinical test sets in the context of an AI/algorithm. Therefore, information regarding "sample size used for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" is not applicable in the way it would be for AI/algorithm performance studies.
The testing involved:
- Bench testing: Performed on design changes unique to the proposed devices and on shared elements, leveraging existing data from predicate devices. Specific sample sizes for mechanical tests (e.g., number of syringes tested for pressure) are not detailed but are implied to be sufficient for engineering verification.
- Aged samples and samples subjected to shipping conditions were used for disposables performance testing.
- Biocompatibility testing was done on the Kits and Tubing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a 510(k) submission for an injection system and accessories, relying on demonstrating substantial equivalence through engineering and simulated use testing, the concept of "ground truth" established by human experts (like radiologists for image analysis) is not directly applicable in the typical sense for AI/algorithm evaluation.
The "ground truth" for the performance tests would be the established engineering specifications and safety requirements, which are set by scientific and regulatory standards (e.g., ISO, IEC, ASTM) and internal design requirements. Human factors testing involved "simulated clinical environment" and validated "clinical user needs," implying input from clinical professionals, but specific numbers or qualifications are not provided.
4. Adjudication Method for the Test Set
Since there is no "test set" in the context of human interpretation of medical data, an "adjudication method" (like 2+1 or 3+1 for resolving disagreements) is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical testing was required or performed to support this Traditional 510(k) Premarket Notification." Therefore, an MRMC comparative effectiveness study was not done. The device is not an AI/algorithm where human reader improvement with assistance would be measured.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device (an angiographic injector and its accessories) is a hardware and software system used with a human operator, not a standalone algorithm for diagnosis or image analysis. The "P3T software accessories compute individual contrast injection protocols and scan timing," which can be considered an algorithmic component, but its performance is verified as part of the overall system's functional design and accuracy in delivering specified parameters, not as a standalone diagnostic algorithm. The testing confirms that this software functions correctly within the system.
7. The Type of Ground Truth Used
The ground truth for this device's performance evaluation is based on:
- Engineering specifications and design requirements: These define the expected performance parameters (e.g., flow rate range, volume range, pressure limits, sterilization level).
- International standards and regulations: Such as ISO 594, ISO 11607-1, ISO 10993-1:2009, ISO 11137-1, IEC 60601-1, ASTM D4169, EN 62366-1:2015, and FDA Guidances. These standards establish acceptable performance thresholds for medical devices, particularly regarding safety, biocompatibility, and functionality.
8. The Sample Size for the Training Set
As this is a hardware medical device with supporting software for controlling injections, and not an AI/ML algorithm that requires a "training set" of data to learn from, this concept is not applicable.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set in the context of AI/ML, the question of how its ground truth was established is not applicable. The device's "P3T software" calculates injection protocols based on "patient characteristics, scanner parameters and contrast concentration," which are pre-defined inputs and rules, not learned from a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 17, 2018
Bayer Medical Care Inc. Lisa Ewing Deputy Director, Global Regulatory Strategy 1 Bayer Drive Indianola, Pennsylvania 15051
Re: K173773
Trade/Device Name: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation. MEDRAD Stellant Syringe Kits. MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT, IZQ Dated: July 19, 2018 Received: July 20, 2018
Dear Lisa Ewing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael John -S 2018.08.17 12:34:14 -04'00'
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173773
Device Name
MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD® Stellant FLEX Syringe Kits, MEDRAD® Stellant CT Injection System with Certegra Workstation, MEDRAD® Stellant Syringe Kits, MEDRAD® Stellant Connector Tubing
Indications for Use (Describe)
MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation
The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant FLEX Syringe Kits
The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant CT Injection System with Certegra Workstation
The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant Syringe Kits
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
MEDRAD® Stellant Connector Tubing
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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Indications for Use
510(k) Number (if known) K173773
Device Name
P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
Indications for Use (Describe)
P3T Cardiac
P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T PA
P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T Abdomen
P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).
ISI
The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.
Connect.CT
The Connect. CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
| Submitter: | Bayer Medical Care Inc.1 Bayer DriveIndianola, PA 15051 |
|---|---|
| Contact Person: | Lisa A. EwingDeputy Director, Global Regulatory Strategy, Device New ProductDevelopmentPhone: (412) 406-3780Email: lisa.ewing@bayer.com |
| Date Prepared: | August 15, 2018 |
| Device Trade Name: | MEDRAD® Stellant FLEX CT Injection System with CertegraWorkstationMEDRAD® Stellant FLEX Syringe KitsMEDRAD® Stellant CT Injection System with Certegra WorkstationMEDRAD® Stellant Syringe KitsMEDRAD® Stellant Connector TubingP3T CardiacP3T PAP3T AbdomenISIConnect.CT |
| Common Name: | Angiographic Injector and Syringe |
| Classification Name: | Injector and Syringe, Angiographic [21 CFR 870.1650] |
| Product Code: | DXT, IZQ |
| Classification: | Class II |
| Primary Predicate Device: | The subject device is substantially equivalent to the followingdevices:Injector System – MEDRAD Stellant CT Injector System with P3TCardiac K082905 |
| Secondary Predicate Device: | Syringe Kit – MEDRAD Stellant CT Injector System with ExtravasationDetection System Accessory, K063090 |
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Device Description: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration. Refer to the Comparison to Predicate Device section for additional information regarding device functions, specifications, etc.
MEDRAD Stellant CT Injection System with Certegra Workstation
The MEDRAD Stellant CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection svstem, it is designed to allow a user to fill disposable svringes to perform an injection with a user-programmed volume, flow rate and/or duration. Refer to the Comparison to Predicate Device section for additional information regarding device functions, specifications, etc.
Personalized Patient Protocol Technology (P3T)
The Stellant P3T software accessories compute individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration for individualized dosing, and for increasing the consistency of individualized injection protocols among clinicians.
Imaging System Interface (ISI)
The ISI module options allow an injector to interface with a CT scanner.
Connect.CT
The Connect.CT application allows an injector to interface with a CT scanner.
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Indications for Use:
MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation
The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant FLEX Syringe Kits
The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant CT Injection System with Certegra Workstation
The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant Syringe Kits
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD Stellant Injectors.
MEDRAD® Stellant Connector Tubing
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
P3T Cardiac
P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T PA
P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
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P3T Abdomen
P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).
ાટા
The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.
Connect.CT
The Connect.CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.
Comparison to the Predicate Device:
The fundamental scientific technology, principle of operation and intended use/indications for use of the proposed devices are unchanged from the predicate devices, the MEDRAD Stellant CT Injection System cleared in K082905 and the MEDRAD Stellant Syringe Kits cleared in K063090. Additionally, the proposed injection systems (MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and MEDRAD Stellant CT Injection System with Certegra Workstation) and the predicate Stellant CT Injection System share similarities in functional design, performance specifications and materials.
The tables below provide a detailed comparison of the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation to the predicate MEDRAD Stellant CT Injection System, the MEDRAD Stellant CT Injection System with Certegra Workstation to the predicate MEDRAD Stellant CT Injection System, the MEDRAD Stellant FLEX Syringe Kits to the predicate MEDRAD Stellant Syringe Kits, the MEDRAD Stellant Syringe Kits to the predicate MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing to the predicate MEDRAD Stellant Connector Tubing.
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Table 1. Comparison of Fluid Delivery Features and Performance Specifications in MEDRAD Stellant CT Injection System as cleared in K082905 (Predicate) and MEDRAD Stellant FLEX CT Injection System with Certegra Workstation K173773 (Proposed).
| Feature | MEDRAD Stellant CTInjection System ascleared in K082905(Predicate) | MEDRAD Stellant FLEXCT Injection Systemwith CertegraWorkstation K173773(Proposed) | Rationale for Change |
|---|---|---|---|
| Indications for Use | The MEDRAD Stellant CTInjection System isintended for the specificpurpose of injectingintravenous contrast mediainto humans for diagnosticstudies in computedtomography (CT)applications. | The MEDRAD StellantFLEX CT InjectionSystem with CertegraWorkstation, includingStellant FLEX CTSyringe Kits andConnector Tubing, isindicated for the specificpurpose of injectingintravenous contrastmedia or saline intohumans for diagnosticstudies in computedtomography (CT)applications. | Product name updated;references to Stellant FLEXsyringe kits and connector tubing,as well as saline, added forclarity. |
| Single or Dual SyringeSystem | Available in both single ordual syringe injector headmodel. | Dual syringe model only | Only dual syringe head modelavailable on Stellant FLEX. |
| Volume Range | 1 to 200 ml (for 200 mlsyringe size) | 1 to 200 ml or 1 to 150ml (depending on 200 mlor 150 ml syringe size) | Consistency with offered syringevolumes. |
| 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, 200/1379,250/1724, 300/2068,325/2241 | Choice of 50/345,100/689, 150/1034,200/1379, 225/1551,250/1724, 300/2068,325/2241 | Option of 225 PSI/1551 kPaadded to dropdown menu foruser convenience. |
| Protocol Memory | 32 protocols of up to 6phases each | 250 protocols of up to 6phases each | Customer convenience of abilityto store additional protocols. |
| Protocol ProgrammingParameters | Flow rate and volume(system calculatesduration) | Flow rate, volume and/orduration | Added functionality for user toprogram by any two of threeparameters. System calculatesthe third. |
| Parametric Data Output/ InformaticsCompatibility | None | Yes | Data output and informaticscompatibility added for customerconvenience. |
| Injection History Memory | None | Unlimited | Customer convenience of abilityto access injection history. |
| Control Room Unit | VxWorks-based display | Windows-based | Current technology; informatics |
| Feature | MEDRAD Stellant CTInjection System ascleared in K082905(Predicate) | MEDRAD Stellant FLEXCT Injection Systemwith CertegraWorkstation K173773(Proposed) | Rationale for Change |
| Information Display(Control Room) | Color LCD | Same | N/A |
| Programming Keys(Control Room) | Software-generated via anLCD touchscreen | 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 | Optical (Barcode) | Different technology required forencoding additional syringeinformation. |
| 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 |
| Scan Delay | 1 to 300 s in 1 s increments | None | Scan Delay with Reminders onStellant FLEX to allow for morethan one user-defined timednotification. |
| Reminders | None | 1 to 300 s in 1 sincrements | Reminders are user-definedtiming notifications generatedduring the injection sequence.Expanded capability from singlepurpose Scan Delay to allow formore than one user-definedtimed notification from the start ofthe injection. |
| 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 indicatedfor use with CTAngiography of the cardiacstructures, coronaryarteries, chambers of theheart, pulmonaryvasculature, thoracic, and | Same | N/A |
| Feature | MEDRAD Stellant CTInjection System ascleared in K082905(Predicate) | MEDRAD Stellant FLEXCT Injection Systemwith CertegraWorkstation K173773(Proposed) | Rationale for Change |
| P3T PA Indications | P3T PA is indicated for usewith CT Angiography of thecardiac structures,coronary arteries,chambers of the heart,pulmonary vasculature,thoracic, and abdominalaorta. | 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 usercan opt to use the P3Tsoftware accessories forany given injection. Theuser is required to confirmor change the suggestedprotocol before beginningan injection. | Same | N/A |
| Imaging SystemInterface (ISI) -Functionality | Yes. The ISI moduleoption is indicated for thespecific purpose of allowingan injector to interface witha CT 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 CT | MEDRAD Stellant CT Injection | Rationale for Change |
| Injection System ascleared in K082905(Predicate) | System with CertegraWorkstation K173773(Proposed) | ||
| Indications for Use | The MEDRAD Stellant CTInjection System is intendedfor the specific purpose ofinjecting intravenouscontrast media into humansfor diagnostic studies incomputed tomography (CT)applications. | The MEDRAD Stellant CTInjection System with CertegraWorkstation is indicated for thespecific purpose of injectingintravenous contrast media orsaline into humans fordiagnostic studies in computedtomography (CT) applications. | Product name updated;reference to saline addedfor clarity. |
| Single or Dual SyringeSystem | Available in both single ordual syringe injector headmodel. | Dual syringe model only | Only dual syringe headmodel available onStellant with CertegraWorkstation. |
| 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, 200/1379,250/1724, 300/2068,325/2241 | Choice of 50/345, 100/689,150/1034, 200/1379, 225/1551,250/1724, 300/2068, 325/2241 | Option of 225 PSI/1551kPa added to dropdownmenu for userconvenience. |
| Protocol Memory | 32 protocols of up to 6phases each | 250 protocols of up to 6 phaseseach | Customer convenience ofability to store additionalprotocols. |
| Protocol ProgrammingParameters | Flow rate and volume(system calculates duration) | Flow rate, volume and/orduration | Added functionality foruser to program by anytwo of three parameters.System calculates thethird. |
| Parametric Data Output/ InformaticsCompatibility | None | Yes | Data output andinformatics compatibilityadded for customerconvenience. |
| Injection History Memory | None | Unlimited | Customer convenience ofability to access injectionhistory. |
| Control Room Unit | VxWorks-based displaycontrol unit | Windows-based Workstation | Current technology;informatics accessorycompatibility. |
| Information Display(Control Room) | Color LCD | Same | N/A |
| Programming Keys(Control Room) | Software-generated via anLCD touchscreen | Same | N/A |
| Retract Control | Manual and Automatic | Same | N/A |
| Feature | MEDRAD Stellant CTInjection System ascleared in K082905(Predicate) | MEDRAD Stellant CT InjectionSystem with CertegraWorkstation K173773(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 |
| Scan Delay | 1 to 300 s in 1 s increments | None | Scan Delay withReminders on StellantFLEX and Stellant withCertegra Workstation toallow for more than oneuser-defined timednotification. |
| Reminders | None | 1 to 300 s in 1 s increments | Reminders are user-defined timingnotifications generatedduring the injectionsequence. Expandedcapability from singlepurpose Scan Delay toallow for more than oneuser-defined timednotification from the startof the injection. |
| Syringe Heat Maintainer | Yes | Same | N/A |
| Syringe Heat MaintainerRange | 95 degrees F +/- 9 degrees(35 degrees C +/- 5 degrees) | 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 |
| Feature | MEDRAD Stellant CTInjection System ascleared in K082905(Predicate) | MEDRAD Stellant CT InjectionSystem with CertegraWorkstation K173773(Proposed) | Rationale for Change |
| 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 |
| 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 |
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Table 2. Comparison of Fluid Delivery Features and Performance Specifications in MEDRAD Stellant CT Injection System as cleared in K082905 (Predicate) and MEDRAD Stellant CT Injection System with Certegra Workstation K173773 (Proposed).
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Table 3 Comparison of MEDRAD Stellant CT Injection System Syringe Kits and Connector Tubing as cleared in K063090 (Predicate) and Stellant FLEX CT Injection System Syringe Kits K173773 (Proposed).
| Feature | MEDRAD Stellant SyringeKits & Connector Tubing ascleared in K063090(Predicate) | MEDRAD Stellant FLEXSyringe Kits & ConnectorTubing K173773(Proposed) | Rationale for Change | |
|---|---|---|---|---|
| Indications for Use | The contents of this packageare intended to be used inthe delivery of contrast mediaor saline. They are indicatedfor single-use on one patientonly with MEDRAD StellantInjectors. | The MEDRAD Stellant FLEX CTInjection System with CertegraWorkstation, including StellantFLEX CT Syringe Kits andConnector Tubing, is indicatedfor the specific purpose ofinjecting intravenous contrastmedia or saline into humans fordiagnostic studies in computedtomography (CT) applications. | Consistency of StellantFLEX syringe kitindications for usestatement with StellantFLEX CT InjectionSystem. No change tointent of indications foruse. | |
| Construction | Injectorcompatibility | MEDRAD Stellant CTInjection System, MEDRADStellant CT Injection Systemwith Certegra Workstation | MEDRAD Stellant FLEX CTInjection System with CertegraWorkstation | Stellant FLEX syringeinterface modified toaccommodate 2Dbarcode and reader. |
| Syringe Volume(contrast) | 200 ml | Choice of 150 ml or 200 ml | Smaller Stellant FLEXsyringe offered forcustomer value. | |
| Syringe Volume(saline) | 200 ml | Choice of 150 ml or 200 ml | Smaller Stellant FLEXsyringe offered forcustomer value. | |
| Syringe BarrelSyringe BarrelLubrication | PETSilicone | SameSame | N/AN/A | |
| Materials | Plunger SupportRing | Polycarbonate | Same | N/A |
| Plunger Cover | Polyisoprene with carbonblack colorant | Polypropylene and TPV withnew colorant | (Current) Design updatedfor cost optimization.(FLEX) Stellant FLEXcolorant added forbeacon fluid detectiontechnology. | |
| Dust Caps | Polypropylene | Same | N/A | |
| Spikes | ABS | Same | N/A | |
| Packaging Type,Material | Tyvek lid coveringpolystyrene tray | Same | N/A | |
| Biological | Sterilization | Ethylene Oxide | E-Beam | Updated mode ofsterilization; SAL isunchanged. |
| 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 | |
| Feature | MEDRAD Stellant SyringeKits & Connector Tubing ascleared in K063090(Predicate) | MEDRAD Stellant FLEXSyringe Kits & ConnectorTubing K173773(Proposed) | Rationale for Change | |
| Performance | Pressure Rating | 400 psi (2410 kPa) | Same | N/A |
| Syringe Sensingand Identification | Labeling, grooves at bottomof barrel to be opticallyidentified | Labeling, 2D barcode | Barcode added tosyringe barrel includeadditional syringeidentification | |
| Fluid Detection | Clear syringe, FluiDotsindicators | Clear Syringe, FluiDots andBeacon indicators | Beacon indicator addedto Stellant FLEX syringeas an additional fluiddetection method. |
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Table 4 Comparison of MEDRAD Stellant CT Injection System Syringe Kits as cleared in K063090 (Predicate) and the MEDRAD Stellant CT Injection System Syringe Kits K173773 (Proposed)
| Feature | MEDRAD Stellant SyringeKits as cleared inK063090 (Predicate) | MEDRAD Stellant Syringe KitsK173773 (Proposed) | Rationale for Change | |
|---|---|---|---|---|
| Indications for Use | The contents of thispackage are intended to beused in the delivery ofcontrast media or saline.They are indicated forsingle-use on one patientonly with MEDRAD StellantInjectors. | Same | N/A | |
| Construction | Injectorcompatibility | MEDRAD Stellant CTInjection System, MEDRADStellant CT InjectionSystem with CertegraWorkstation | 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 BarrelLubrication | Silicone | Same | N/A |
| Plunger SupportRing | Polycarbonate | Same | N/A | |
| Plunger Cover | Polyisoprene with carbonblack colorant | Polypropylene and TPV (sameblack colorant as predicate) | Design updated for costoptimization. | |
| Dust Caps | Polypropylene | Same | N/A | |
| Spikes | ABS | Same | N/A | |
| Packaging Type,Material | Tyvek lid coveringpolystyrene tray | Same | N/A | |
| Biol | Sterilization | Ethylene Oxide | E-Beam | Updated mode ofsterilization; SAL is |
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| Feature | MEDRAD Stellant SyringeKits as cleared inK063090 (Predicate) | MEDRAD Stellant Syringe KitsK173773 (Proposed) | Rationale for Change | |
|---|---|---|---|---|
| unchanged. | ||||
| Performance | Sterility AssuranceLevel (SAL) | 10-6 | Same | |
| Pyrogenicity | Non-Pyrogenic Fluid Path | Same | ||
| Latex Content | Not made with naturalrubber latex | Same | ||
| DEHP | No | Same | N/A | |
| Pressure Rating | 400 psi (2410 kPa) | Same | N/A | |
| Syringe Sensingand Identification | Labeling, grooves at bottomof barrel to be opticallyidentified | Same | N/A | |
| Fluid Detection | Clear syringe, FluiDotsindicators | Same | N/A |
Table 5 Comparison of MEDRAD Stellant Connector Tubing as cleared in K063090 (Predicate) and MEDRAD Stellant Connector Tubing K173773 (Proposed)
| Feature | MEDRAD Stellant Syringe Kits& Connector Tubing ascleared in K063090 (Predicate) | MEDRAD Stellant ConnectorTubing K173773 (Proposed) | Rationale for Change |
|---|---|---|---|
| Description | Low pressureconnector tube assembly offeredin two configurations - one fordual syringe injection (with T-connector), one for singlesyringe injection (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-connectormaterial | Polycarbonate | Same | N/A |
| PackagingMaterials, Type | Tyvek membrane, polyethylenepouch | Same | N/A |
| Sterilization | Ethylene Oxide | Ethylene Oxide when packagedstandalone; E-beam whenpackaged in Stellant Syringe Kits;E-beam when packaged inStellant FLEX Syringe Kits | Alternative modes ofsterilization used whenpackaged in syringe kits;SAL is unchanged. |
| 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 | Yes | No | Removal of DEHP. |
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Performance Data:
The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant CT Injection System with Certegra Workstation, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing share common design elements with the predicate MEDRAD Stellant CT Injection System, the predicate MEDRAD Stellant Syringe Kits, and the predicate MEDRAD Stellant Connector Tubing. Complete bench testing was performed on all design changes unique to the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and MEDRAD Stellant FLEX Syringe Kits. Likewise, complete bench testing was performed on all design changes unique to the MEDRAD Stellant CT Injection System with Certegra Workstation and MEDRAD Stellant Syringe Kits. Where bench testing on shared elements of the design existed from the predicate MEDRAD Stellant CT Injection System, the MEDRAD Stellant Syringe Kits, and from similar devices, performance requirements and test data were analyzed and leveraged. The combined bench test results and analysis results confirm that the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant CT Injection System with Certegra Workstation, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing meet product specification and performance requirements.
The following testing was successfully completed:
- . Device performance testing included verification of the system disposable filling and preparation, protocol management, fluid delivery—both sequential and simultaneous, flow rates, volumes, and pressures. Testing also verified that the device was not affected by environmental conditions such as atmospheric conditions and handling. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
- . Disposables performance testing included verification of the syringe and connector tubing mechanical functions and pressure capabilities (ISO 594), and packaging (ISO 11607-1). Testing was performed using aged samples that had been sterilized and with samples that had been subjected to shipping conditions (ASTM D4169). All testing passed and the demonstrated product performance met all prior established acceptance criteria.
- . Biocompatibility testing was conducted on the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing to verify that these devices meet the requirements of ISO 10993-1:2009. Based on guidance of ISO 10993-1:2009, Table A.1, the following test program was selected for an externally communicating, indirect blood path, limited contact (< 24 h) device:
- Cytotoxicity o
- Hemocompatibility o
- . Hemolysis
- O Sensitization
- o Irritation / Intracutaneous Reactivity
- Acute Systemic Toxicity o
- l Acute Systemic Injection
- l Materials Mediated Pyrogen
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- Sterilization conditions have been validated on the syringe and connector tubing kits in accordance with ISO 11137-1, ISO 11137-2 and ISO 11137-3 to provide a Sterility Assurance Level of 106. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
- Safety and Compatibility testing included verification of configurations and specifications, circuitry, compliance with IEC 60601-1 and EMC requirements, electrical safety controls, ability to detect failures in communication and controls, programming keys, and sensors, and safe operation. All testing passed and the demonstrated product performance demonstrated met all prior established acceptance criteria.
- . Shelf-life and shipping testing included verification that the system performance was not affected by four-year aging and shelf-life (for disposable syringes and connector tubing) and packaged transit and storage (ISTA 2A, for the injector system). All testing passed and the demonstrated performance met all prior established acceptance criteria.
- Reliability testing was performed using statistical methods to demonstrate the capability to sequentially and repeatedly meet system performance requirements. Testing verified there was no degradation to performance when the Stellant FLEX CT Injection System with Certegra Workstation and Informatics processes were run simultaneously. Similarly, testing verified there was no degradation to performance when the Stellant CT Injection System with Certegra Workstation and Informatics processes were run simultaneously. All testing passed and the demonstrated performance met all prior established acceptance criteria.
- Simulated Use and Human Factors testing was performed by using the injector systems and disposables in a simulated clinical environment to validate the clinical user needs were met by the design per EN 62366-1: 2015 and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." Testing demonstrated that no new or different questions of safety or effectiveness were raised.
- . Cleaning and disinfection vas performed per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," and confirmed that the injection systems meets their cleaning and disinfection requirements.
All test results demonstrate that the design and materials of the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant CT Injection System with Certegra Workstation, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing meet 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.
Clinical Testing:
No clinical testing was required or performed to support this Traditional 510(k) Premarket Notification.
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Conclusion:
Bayer considers the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, the MEDRAD Stellant FLEX Syringe Kits, the MEDRAD Stellant CT Injection System with Certegra Workstation, the MEDRAD Stellant Syringe Kits, and the MEDRAD Stellant Connector Tubing to be substantially equivalent to the predicate devices, the MEDRAD Stellant CT Injection System cleared in K082905 and the Stellant Syringe Kits cleared in K063090. This conclusion is based upon the devices having the same intended use, energy type and principle of operation, and having similar technological characteristics, particularly with regard to similarities in functional design, software features, usability and workflow, materials and fundamental scientific technology.
§ 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.