(89 days)
The angiographic X-ray systems are indicated for use 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 proposed device, Discovery IGS 730 is an X-ray angiographic system with a 30cm detector size. The proposed device introduces a new fixed C arm positioner that will be the basis of the Discovery IGS X-ray angiographic systems platform. The proposed device will be offered with 2 product configurations, Interventional and OR configuration. The indications for use are expanded to include image-guided surgical procedures and open surgery procedures for the OR configuration of the product. The X-ray tube, the collimator, the X-ray power unit, the flat panel, the X-ray control and image processing chain are the same as the GE Innova systems.
Here's an analysis of the GE Discovery IGS 730 510(k) submission, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not include explicit acceptance criteria or a direct comparison to reported device performance metrics for the Discovery IGS 730. Instead, it relies on the principle of substantial equivalence to predicate devices. The "performance" claimed is that the Discovery IGS 730 is "as safe and effective as its predicates devices, and its performances to be substantially equivalent to the predicate devices."
The submission focuses on non-clinical verification and validation tests to ensure the system functions as intended and meets safety and performance standards equivalent to existing approved devices. The specific metrics for "acceptance criteria" are implied to be conformance with:
- Functional requirements for angiographic and fluoroscopic X-ray systems.
- Safety standards detailed in Section 9 of the premarket submission (not provided here).
- Performance capabilities comparable to the predicate devices (K111209: INTEGRATED INNOVA - SSI SYSTEM OPTION GE Medical Systems and K090745: Siemens Artis Zee).
Since no specific numerical performance criteria are listed, a table comparing them directly isn't possible from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission states, "The subject of this premarket submission, Discovery IGS 730, did not require clinical studies to support substantial equivalence in the intended clinical environment." Therefore, there was no clinical test set for performance evaluation in the context of human data.
- Data Provenance: Not applicable for a clinical test set. The verification and validation tests performed were non-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. As no clinical studies were performed, there was no "ground truth" derived from expert review of clinical data. The "ground truth" for non-clinical testing would be the device's design specifications and regulatory requirements, verified through engineering tests.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The submission explicitly states, "The subject of this premarket submission, Discovery IGS 730, did not require clinical studies to support substantial equivalence in the intended clinical environment." Therefore, no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Partially applicable, but not for "algorithm only" in the modern sense. While this isn't an AI/algorithm-focused device, the non-clinical verification and validation tests essentially assess the device's standalone performance against its design specifications and safety requirements. However, this is not an "algorithm-only" study as typically understood for AI devices. It's a system-level performance evaluation.
7. Type of Ground Truth Used
- Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" was established by design specifications, pre-defined performance criteria, and adherence to voluntary standards (as mentioned in Section 9 of the submission). These would include technical specifications for imaging quality, radiation dose, mechanical stability, and software functionality, validated through various engineering and simulated use tests.
8. Sample Size for the Training Set
- Not applicable. This device is a traditional X-ray angiographic system, not an AI or machine learning device that utilizes a "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model.
Summary of Device Acceptance:
The GE Discovery IGS 730 was accepted based on substantial equivalence to legally marketed predicate devices (K111209 and K090745). This determination was supported by non-clinical verification and validation tests, which demonstrated that the new device met the same functional, safety, and performance standards as its predecessors. The submission emphasizes that the Discovery IGS 730 uses the "same fundamental scientific technology" as its predicate devices, introducing a new fixed C-arm positioner and expanding indications for use to include image-guided surgical procedures. No new clinical studies were deemed necessary to support this claim of substantial equivalence.
§ 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.