(142 days)
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures.
The Cathlab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution.
The Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing:
- (1) communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices,
- (2) communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface,
- (3) interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.
The basis for this 510(k) submission is a modification of the family of legally marketed GE angiographic, fluoroscopic X-ray systems devices to expand their indications for use regarding the generic integration interfaces for other imaging / data medical devices used in interventional and surgical cathlab environments and cleared/approved for commercial distribution.
Same time with the intended use/indications for use expansion we introduce the Integrated Vivid E9 solution. The Vivid E9 (BT12 version) integrates with Innova IGS 520, Innova IGS 530, and Innova IGS 540 systems, integration consisting in displaying the Vivid E9 system screen on Innova IGS Large Display Monitor solution.
For the Innova IGS Vivid E9 integration we apply the specific qualifications criteria and processes described in the section "Determination of Substantial Equivalence" below.
This document describes the 510(k) summary for the GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers solutions.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document focuses on integration capabilities and does not present a typical table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or image quality scores for a diagnostic AI device. Instead, the "acceptance criteria" are related to the safety and functionality of integrating the system with other medical devices.
| Acceptance Criteria (from "Determination of Substantial Equivalence" section) | Reported Device Performance/Compliance |
|---|---|
| Integration of 3rd party systems: | Evaluated for electrical and electromagnetic safety. |
| - Shall be "FDA cleared/approved device" | The integration relies on the fact that integrated devices are already FDA cleared/approved. |
| - Shall comply with one or more generic integration interfaces offered by the GE angiographic, fluoroscopic X-ray systems. | Demonstrated compliance through internal testing (see "Quality Assurance Measures"). |
| - Integration of devices shall be safe and effective and shall not raise different questions of safety and effectiveness than the predicate device(s). | Quality Assurance Measures Applied to Development: |
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
The device and its applications/accessories comply with voluntary standards and applicable performance standards for radiation-emitting products. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "testing" described is primarily system integration and safety verification. The document does not specify a number of integrated devices or test scenarios.
- Data Provenance: Not applicable. The testing described is internal engineering verification and validation, not based on patient data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Number of Experts: Not applicable. Ground truth as typically understood for diagnostic AI devices (e.g., disease presence) is not established in this submission. The "ground truth" here is compliance with safety, performance, and integration standards, which is assessed through engineering tests and regulatory requirements.
- Qualifications of Experts: Not specified, but implied to be qualified GE Healthcare engineers and regulatory personnel involved in the design, development, and testing of the system.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of human reader adjudication for this device, as it is related to system integration and functional performance rather than diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- Effect Size of Human Readers with/without AI assistance: Not applicable, as this submission is not about the diagnostic accuracy of AI in interpreting images or the impact on human reader performance. It concerns the integration of existing cleared/approved devices and the X-ray system.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The "Cathlab Frontiers solutions" are described as communication protocols and interfaces that simplify workflow and integrate imaging/data devices. The "performance" described pertains to the system's ability to integrate safely and effectively, not to a standalone diagnostic algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" used for this submission is compliance with regulatory standards, engineering specifications, and safety requirements. It's established through internal testing (risk analysis, requirements reviews, design reviews, various levels of verification, and validation) and confirmation that integrated third-party devices are already FDA-cleared/approved.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This submission does not involve a machine learning algorithm that requires a training set in the typical sense. The "Cathlab Frontiers solutions" are integration functionalities based on defined communication protocols and interfaces.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a machine learning algorithm mentioned in this submission.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.