(51 days)
The Visions® PV.014P RX 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 the cerebral vessels.
The Visions® PV.014P RX 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 PV . 014P RX Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the Catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.
The term RX has been added to the PV.014P Catheter to identify it as a rapid exchange catheter. The rapid exchange feature has not changed from the currently marketed PV.014P Catheter. Volcano is adding the term RX to the name to clearly identify the catheter as rapid exchange.
The PV . 014P RX Catheter utilizes an internal lumen that allows the catheter to track over a 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the Catheter tip. The device is introduced either percutaneously or via surgical cut down into the vascular system.
The PV . 014P RX Catheter may be used with the Volcano s5™. Volcano CORE Mobile, and Volcano CORE imaging systems. The device is designed to work with Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.
The modified PV.014P Catheter (PV.014P RX) has a stiffer core to help improve device deliverability. The stiffer core wire provides increased "pushability" while maintaining the same trackability as the currently marketed PV.014P Catheter. In order to increase "pushability", the size of the core within the proximal shaft of the catheter was made with a larger OD. The proximal end was increased while keeping the distal end diameter the same. The modified PV.014P Catheter (PV.014P RX) with stiffer core utilizes the same current manufacturing processes, equipment and materials as the currently marketed device.
The provided document is a 510(k) summary for the Volcano Visions® PV.014P RX Digital IVUS Catheter. This device is an intravascular ultrasound (IVUS) catheter, which is a diagnostic tool used to visualize the internal structure of blood vessels.
The 510(k) in question is for a modification to an existing device (Visions® PV.014P Catheter) specifically, "The modified PV.014P Catheter (PV.014P RX) has a stiffer core to help improve device deliverability." Therefore, the "study" described is primarily focused on demonstrating that this modification does not negatively impact the safety or effectiveness of the device compared to the predicate device, rather than proving the device meets novel acceptance criteria for a new type of device.
Given this context, some of the requested information (like expert consensus for ground truth on images, MRMC studies, or training set details for an AI algorithm) are not applicable to this type of device modification submission. The "acceptance criteria" here are largely related to bench testing performance to ensure functional equivalence and safety.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance testing to ensure the modified device is substantially equivalent to the predicate. The "acceptance criteria" are implied by the successful completion of these tests and demonstrating no statistically significant difference or acceptable performance compared to known standards or product specifications.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Cross and Re-Cross Force (No statistically significant difference from predicate) | "The results demonstrated that there is no statistically significant difference between the subject device and control device for Cross/Re-Cross..." |
| Insertion and Recovery (Trackability) Force (No statistically significant difference from predicate) | "... and Insertion/Recovery (Trackability)." |
| Buckling (Acceptable rigidity) | "The results demonstrated acceptable rigidity of the catheter." (Conducted in accordance with FDA's Guidance Document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers") |
| Signal Processing / Image Quality (No change in imaging) | "The results demonstrated that the change did not affect imaging." (Quantitative and qualitative image assessment performed). |
2. Sample Size and Data Provenance
- Sample size used for the test set: Not explicitly stated for each test (Cross/Re-Cross, Insertion/Recovery, Buckling, Signal Processing). The language "The results demonstrated..." suggests sufficient testing was performed, but specific numbers are not provided in this summary.
- Data Provenance: The tests are non-clinical bench tests. The data is generated internally by the manufacturer (Volcano Corporation) in a controlled laboratory environment. The country of origin of the data is implied to be the US, where Volcano Corporation is based. The data is prospective, generated specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of experts: Not applicable. For this type of device modification, the ground truth is established through physical measurements and comparisons against engineering specifications and the predicate device's performance, not human expert consensus on images.
- Qualifications of experts: Not applicable in the context of image interpretation. The "experts" would be the engineers and quality control personnel performing the bench tests.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable. This is not a study involving subjective human interpretation that would require an adjudication process. It's a series of objective physical and performance measurements.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC study: No, an MRMC comparative effectiveness study was not conducted. This is not an AI-assisted diagnostic device where human reader performance is being evaluated. The device is purely a diagnostic imaging catheter whose modification impacts physical properties (stiffness, deliverability), not directly human diagnostic accuracy.
6. Standalone (Algorithm Only) Performance
- Standalone performance: Not applicable. This is not a software algorithm, but a physical medical device. The "performance data" refers to its mechanical and imaging capabilities.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission is based on:
- Engineering specifications and standards: e.g., acceptable rigidity for buckling according to FDA guidance.
- Bench test measurements: Direct quantitative measurements of forces, dimensions, and image characteristics.
- Comparison to predicate device: The key "ground truth" is that the modified device's performance metrics are either statistically equivalent to the predicate or meet established safety thresholds.
8. Sample Size for the Training Set
- Training set size: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How Ground Truth for the Training Set was Established
- Ground truth for training set: Not applicable (as above).
§ 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).