(65 days)
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform:
· Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures,
· Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally:
- · The Azurion series can be used in a hybrid Operation Room.
· The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
The Azurion series R1.2 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion series R1.2 interventional fluoroscopic X-ray system include:
- Real-time image visualization of patient anatomy during procedures ●
- Imaging techniques and tools to assist interventional procedures ●
- Post processing functions after interventional procedures o
- Storage of reference/control images for patient records ●
- Compatibility to images of other modalities via DICOM o
- Built in radiation safety controls ●
This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures.
The Azurion series R1.2 is available in a comparable set of configurations for monoplane models as the currently marketed and predicate devices Allura Xper R9.
Configurations are composed of detector type. (monoplane) geometry, table type and available image processing. The monoplane (single C-arm) and biplane (dual arm) systems are categorized into X-ray systems and the configurations are differentiated by the following features:
- 12 inch Flat detector (FD12)
- 15 inch Flat detector (FD15)
- 20 inch Flat detector (FD20) ●
Additionally, identical to the predicate devices, all configurations of the Azurion series R1.2 can be used in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.
Here's an analysis of the provided text regarding the Azurion series R1.2 device, focusing on acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes the Azurion series R1.2 as an interventional fluoroscopic X-ray system intended for image guidance and cardiac imaging applications. It indicates that the device's performance is demonstrated through its compliance with various international and FDA-recognized consensus standards and guidance documents, as well as software verification and non-clinical validation testing. However, the document does not explicitly state specific, quantifiable acceptance criteria (e.g., "minimum resolution of X lp/mm," "contrast-to-noise ratio of Y"). Instead, it focuses on demonstrating equivalence to a predicate device and compliance with established standards.
Therefore, the "acceptance criteria" can be inferred as successful completion of the listed tests and compliance with the relevant standards, aiming for performance that is "substantially equivalent" to the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance (as stated) |
|---|---|
| Compliance with IEC 62304 (Medical device software – Software life cycle processes) | Demonstrated compliance. |
| Compliance with ISO 14971 (Medical devices – Application of risk management to medical devices) | Demonstrated compliance. |
| Compliance with IEC 60601-2-28 (Basic safety and essential performance of X-ray tube assemblies for medical diagnosis) | Demonstrated compliance. |
| Compliance with IEC 60601-2-43 (Safety of X-Ray equipment for interventional procedures) | Demonstrated compliance. |
| Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | Demonstrated compliance. |
| Compliance with FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices | Demonstrated compliance. |
| Successful Software verification testing (functional, non-functional requirements, performance, reliability, safety, risk control measures) | "Results demonstrated that all executed tests were passed." |
| Successful Non-clinical validation testing (intended use, commercial claims, service, user needs, effectiveness of safety measures, instructions for use) | "Non-clinical validation testing has been performed to cover the intended use, commercial claims, service, user needs, effectiveness of safety measures and instructions for use." (Implies successful completion, as the conclusion is substantial equivalence) |
| Substantial Equivalence to predicate device Allura Xper R9 in terms of Indications for Use, Technological Characteristics, Non-clinical performance testing, and Safety and Effectiveness. | "The Azurion series R1.2 is substantially equivalent to the currently marketed predicate device Allura Xper R9 in terms of indications for use, technological characteristics and safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or image datasets. The performance validation is based on:
- Software verification testing: Performed to cover system-level requirements and risk control measures. The "sample size" here would refer to the number of software test cases, which is not provided.
- Non-clinical validation testing: Performed to cover intended use, claims, user needs, etc. The "sample size" is not specified here either, as this refers to device-level validation activities rather than a dataset.
- Lack of clinical study data: The document explicitly states: "The Azurion series R1.2 did not require clinical study data since substantial equivalence to the currently marketed predicate device Allura Xper R9 was demonstrated..."
Therefore, there is no information about a "test set" sample size or data provenance in the sense of patient data or images used for algorithmic performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical study data or image-based test set with ground truth is mentioned for the Azurion series R1.2 in this document, there is no information regarding experts used to establish ground truth or their qualifications. The device is evaluated for substantial equivalence based on technical specifications and non-clinical testing.
4. Adjudication Method for the Test Set
As there is no mention of a clinical test set or human interpretation of images requiring ground truth adjudication, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission explicitly states that clinical study data was not required.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is an X-ray imaging system, not an AI algorithm designed for standalone diagnostic interpretation. Its "performance" is inherently tied to producing images for human interpretation and guiding procedures. Therefore, the concept of a "standalone" algorithmic performance study as typically understood for AI/CAD devices does not directly apply here. The software verification and non-clinical validation assess the system's operational integrity and image generation capabilities.
7. Type of Ground Truth Used
Given the nature of the device (an X-ray imaging system) and the emphasis on non-clinical testing and substantial equivalence, the "ground truth" for its evaluation would primarily involve:
- Technical specifications and engineering standards: Compliance with IEC, ISO, and FDA guidance documents serves as a form of "ground truth" that the device meets defined safety and performance benchmarks.
- Predicate device features and performance: The Allura Xper R9 serves as the primary "ground truth" reference for substantial equivalence, meaning the Azurion series R1.2 is evaluated against the established and cleared performance and safety profile of the predicate device.
- Internal functional requirements: Software verification tests against defined functional and non-functional requirements.
There is no mention of pathology, expert consensus on patient images, or outcomes data being used as ground truth in this 510(k) summary.
8. Sample Size for the Training Set
No information is provided about a training set. This device is an imaging system, not an AI/ML algorithm that would typically require a training set of data. While the device may incorporate image processing algorithms (like ClarityIQ), the document doesn't detail their development or any associated training sets.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of this device's submission, there is no information on how its ground truth would have been established.
§ 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.