(90 days)
The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body.
Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations.
This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance.
Exclusion: This system is not recommended for Mammography.
Contraindication: Exposure of X-Ray should be avoided during pregnancy.
The Cardiovascular Angiography system is designed to perform fluoroscopic & digital radiographic studies and are used in interventional examinations. This system covers the complete range of angiographic applications, cardiac angiography, neuroangiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography and digital radiographic/ fluoroscopic procedures. The following components are configured to create the Cardiovascular Angiography system:
-
- Floor mounted C-arm (Altima FDX Adv) or Ceiling Mounted C-Arm (Proxima FDX) or Mobile C-Arm (Digiscan FDX-VXXYY), X-ray tube assembly and Solid State X-Ray image detector
-
- Patient Table
-
- Ceiling suspended display(s)
-
- Footswitch for releasing radiation
-
- Control console for controlling the stand, patient table, collimator and imaging system.
The provided FDA 510(k) summary for the "Cardiovascular Angiography System" focuses on demonstrating substantial equivalence to predicate and reference devices, rather than establishing acceptance criteria and providing detailed study results in the manner typically seen for novel AI/ML devices.
This submission is for an X-ray imaging system, not an AI/ML powered device, so the typical AI/ML-specific study components like "number of experts used to establish ground truth" or "MRMC comparative effectiveness study" are not applicable in this context. The evaluation here is based on technical specifications, non-clinical performance testing, and adherence to recognized industry standards.
Here's an analysis based on the provided document, framed within your request:
Acceptance Criteria and Device Performance (for an X-ray system)
The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to legally marketed predicate devices and compliance with established performance standards for X-ray systems. The "reported device performance" is primarily presented as meeting or being comparable to these standards and the predicate device's specifications.
Table of Acceptance Criteria and Reported Device Performance
Since this is a traditional 510(k) for an X-ray system, the "acceptance criteria" are not framed as specific performance metrics of an AI algorithm (e.g., AUC, sensitivity/specificity targets). Instead, they are based on established safety and performance characteristics of such medical devices as outlined in relevant standards and predicate device comparisons. The document indicates that the device meets these, making it "substantially equivalent."
| Category | Acceptance Criteria (Implied / Standard-Based) | Reported Device Performance (as stated in document) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate/reference devices. | "Essentially the same as the predicate with respect to indication and intended use." (Table 3) |
| X-Ray Generator Type | Microprocessor-controlled, high frequency converter generator, comparable to predicate/reference. | "Microprocessor-controlled, high frequency converter generator." (Table 3) "Same as Predicate device" (Table 3 justification) |
| X-Ray Generator Power Rating | Comparable performance to predicate (Allura Xper FD: 100KW) or sufficient to meet exposure requirements (Reference Ziehm Vision RFD: 30KW, 25KW). | Subject Device: XGEN-100CV: 100KW, XGEN-80CV: 80KW, XGEN-65CV: 65KW, XGEN-40CV: 40KW, XGEN-27CV: 27KW. "Similar (SE #1)" and "Sufficient to meet the fluoroscopic and digital radiographic exposure requirements and have higher maximum power output as compare to Reference device." (SE#1 & #2 Discussion) |
| Digital Radiographic Mode (mA & kV) | Comparable ranges to predicate/reference. | Subject Device: 1-1000 mA, 40-125 kV. "Same as Predicate device" (Table 3 justification) |
| Fluoroscopic Mode (mA, kV, fps) | Comparable ranges to predicate/reference, including pulsed fluoroscopy. | Subject Device: Pulsed 200 mA max, 40-125 kV, Up to 30 fps. "Same as Predicate device" (Table 3 justification) |
| Automatic Brightness Stabilization (ABS) Control | Presence of ABS. | "Yes" (Table 3) "Same" (Table 3 justification) |
| X-Ray Tube Features (Type, Heat Storage, Focal Spot, Anode Angle) | Comparable to predicate/reference, with differences not introducing new safety concerns. | "Rotating Anode." Various specific values for heat storage, focal spot size, and anode angle for different optional tubes. "Similar (SE #3)", with a note that differences "do not change or add new potential safety risks." (SE#3 Discussion) |
| Solid State X-Ray Image Detectors (Type, Active Area, Pixel Matrix, DQE, MTF, A/D Conversion, Pixel Pitch) | Detectors either previously cleared by FDA or technology comparable to predicate/reference and compliant with SSXI guidance. Differences should not raise safety/effectiveness concerns. | Various specific values for different optional detectors. "Same as Reference device," "Similar (SE #4)," or "Same as Predicate device," depending on the specific parameter and detector. Differences are not deemed to affect safety or effectiveness. (SE#4 Discussion) |
| Imaging Mode Functionality | Standard imaging modes (Pulsed Fluoroscopy, Digital Spot). | "Pulsed Fluoroscopy" and "Digital Spot." "Same" (Table 3 justification) |
| Video Storage Type & PACS Interface | Standard storage options (HDD, USB, CD/DVD-RW) and networking (DICOM conformance, Ethernet/WLAN). | "Internal HDD drive, USB, CD/DVD-RW drive," "Yes" for DICOM conformance, "Ethernet or WLAN" for PACS. "Same" (Table 3 justifications) |
| Safety Compliance | Conformance to relevant IEC standards (e.g., 60601-1, 60601-1-2, 60601-1-3, 60601-2-43, 60601-2-54, 62304, 62366-1, 14971, 60825-1) and 21 CFR Federal Performance Standards (1020.30, 1020.32, 1040.10). | Certified conformance explicitly stated. "Non-clinical verification test results demonstrate that the Cardiovascular Angiography system complies with the aforementioned international and FDA recognized consensus standards and FDA guidance documents." (Performance Testing, Section 13) |
Study Details (for an X-ray system, not AI/ML)
-
Sample Size Used for the Test Set and Data Provenance:
- This document describes "non-clinical performance testing" and "bench testing." It does not specify a "test set" in the context of patient data or images as would be seen for AI/ML validation.
- The "testing" refers to technical evaluations of the system's components and overall functionality against engineering specifications and industry standards.
- There is no mention of patient data (retrospective or prospective) for performance evaluation. The data provenance (country of origin) is not applicable or stated for this type of technical performance testing.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth for an AI/ML algorithm (e.g., disease presence) is not being established here. The "truth" is whether the system performs according to its design specifications and relevant safety/performance standards. This is determined through engineering and compliance testing.
-
Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- Not applicable. Adjudication methods are relevant for human reader studies, particularly in AI/ML performance evaluation where ground truth might be derived from expert consensus.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an X-ray imaging device, not an AI-assisted diagnostic tool. No human reader studies are described.
-
If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
- Not applicable, as this is not an AI/ML algorithm.
-
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the adherence to established engineering specifications, safety standards (e.g., IEC 60601 series), and the functional equivalence to predicate devices, verified through non-clinical bench testing. There is no biological or clinical ground truth like pathology or outcomes data used to establish device performance in this type of submission.
-
The Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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.