(74 days)
The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
The NES Reprocessed Visions PV .018 Digital IVUS Catheter utilizes a cylindrical ultrasound transducer array close to the distal tip to radiate acoustic energy into the surrounding tissue. By using the information gathered from the ultrasonic echoes, the device can generate real-time images of the coronary and peripheral vessels.
The NES Reprocessed Visions PV .018 Digital IVUS Catheter tracks over a 0.018" (0.46mm) guide wire by through an internal lumen. Approximately 31 cm from the catheter tip is a guidewire port for the exiting guidewire. The NES Reprocessed Visions PV .018 Digital IVUS Catheter is introduced into the vascular system percutaneously or via surgical cutdown.
The NES Reprocessed Visions PV .018 Digital IVUS Catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. If connect to another system, the catheter will not operate.
The NES Reprocessed Visions PV .018 Digital IVUS Catheter is intended to be reprocessed one (1x) time.
The provided FDA 510(k) clearance letter and summary for K250592 describes a reprocessed medical device, the NES Reprocessed Visions PV .018 Digital IVUS Catheter. This document does not detail acceptance criteria or the study that proves the device meets AI/Machine Learning performance standards, as it is a traditional medical device (an Intravascular Ultrasound Catheter) and not an AI-enabled device.
Therefore, many of the requested categories regarding AI model performance, ground truth establishment, expert adjudication, MRMC studies, and training/test set sizes are not applicable to this submission.
However, I can extract the relevant information regarding the device's functional and safety testing as described in the 510(k) summary, which serves as the "study" proving the device meets its acceptance criteria for a reprocessed medical device.
Summary of Device Acceptance Criteria and Performance (for a Reprocessed Medical Device, not AI)
The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a reprocessed version of a predicate device. The acceptance criteria and "study" proving the device meets these criteria focus on demonstrating that reprocessing does not compromise the device's safety and effectiveness compared to the original device. The "study" involves various bench and laboratory tests.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that "The test methods, requirements and acceptance criteria used for the .018 IVUS are the same used in cleared K200195 (reprocessed .014 IVUS)." It also indicates that there are "no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation." This implies that the acceptance criteria are met if the reprocessed device performs comparably to a new device (or the predicate reprocessed device K200195) across all specified tests.
| Acceptance Criteria Category | Specific Tests/Requirements | Reported Device Performance (as implied by clearance) |
|---|---|---|
| Safety | Cleaning Validation | Meets validation requirements |
| Sterilization Validation | Meets validation requirements | |
| Biocompatibility Testing | Meets biocompatibility standards | |
| Transducer Thermal Testing | Meets thermal output specifications | |
| Drying Validation | Meets validation requirements | |
| Packaging Validation | Meets validation requirements | |
| Functional/Performance | Visual Inspection | Passes visual inspection |
| Dimensional Verification | Within specified dimensional tolerances | |
| Simulated Use | Performs as expected in simulated use conditions | |
| Mechanical Characteristics | Meets mechanical strength and integrity specifications | |
| System Compatibility | Compatible with Volcano s5 Series or CORE Series Systems | |
| Image Acuity | Provides images with sufficient clarity and resolution | |
| Transducer Acoustic Output | Within safe and effective acoustic output limits | |
| Flushing Adapter Compatibility | Compatible with relevant flushing adapters | |
| Surface Property Testing | Meets specified surface property requirements |
Note: The document states that the "NES Reprocessed Visions PV .018 Digital IVUS Catheter is as safe and effective as the predicate devices described herein," which is the overarching conclusion of meeting all acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test, but standard for device validations. For a reprocessed device, this would typically involve a statistically significant number of reprocessed units across multiple reprocessing cycles.
- Data Provenance: The tests are described as "Bench and laboratory testing," implying controlled, experimental data generated specifically for this submission. There is no mention of patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- N/A: As this is a traditional medical device (not an AI/ML device), expert establishment of ground truth in the context of image interpretation or diagnostic accuracy is not relevant. The "ground truth" for the device's performance would be established by validated test methods and engineering specifications.
4. Adjudication Method for the Test Set
- N/A: Adjudication is typically relevant for subjective assessments (e.g., in AI or clinical studies). For bench and lab testing of a physical device, performance is measured against objective, predetermined specifications rather than requiring expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- N/A: An MRMC study is relevant for evaluating the impact of AI on human reader performance. This device is an IVUS catheter and does not involve AI assistance for image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: This question pertains to AI algorithm performance. This device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Performance Standards: The "ground truth" for this device's performance is compliance with established engineering specifications, safety standards (e.g., sterilization, biocompatibility), and functional performance benchmarks (e.g., image acuity, acoustic output) that are deemed equivalent to the original predicate device. This is determined through objective bench and laboratory testing.
8. The Sample Size for the Training Set
- N/A: No training set is applicable as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- N/A: Not applicable.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).