(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.
§ 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.