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The Visions PV .035 catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels.

The Visions PV .035 ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Visions PV .035 Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The Visions PV .035 Catheter is introduced percutaneously or via surgical cutdown into the vascular system, and is designed to track over 0.035"-0.038" (0.89-0.97mm) guide wires.

The catheter body has markers 1 cm apart along the working length. There are 25 radiopaque (RO) markers on the distal end of the catheter, starting 1 cm from the imaging plane, with the 25th RO marker overlapping the distal-most wide inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle, with wider marks indicating 5 cm intervals.

A lubricious GlyDx® hydrophilic coating is applied externally to a distal portion of the catheter. The Visions® PV .035 Catheter, catalog number 88901, catheters may only be used with the In-Vision Imaging System, Volcano s5™ or Volcano s5i™ imaging systems, or later systems. This catheter will not operate if connected to any other imaging system.

The provided text describes a 510(k) submission for the Volcano Visions® PV .035 Digital IVUS Catheter. This is a premarket notification for a medical device redesign, aiming to demonstrate substantial equivalence to a legally marketed predicate device. As such, the document does not contain a study designed to prove the device meets acceptance criteria in the way a clinical trial or performance study would.

Instead, the submission focuses on demonstrating that the redesigned device is as safe and effective as the predicate device by comparing their intended use, principles of operation, and design elements, and ensuring that design changes do not negatively impact performance. The "acceptance criteria" here are implicitly related to maintaining the performance and safety standards established by the predicate device and relevant regulations.

Here's an analysis based on the provided text, highlighting what is included and what is not typically part of a 510(k) submission for a device modification of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of "acceptance criteria" for clinical performance with corresponding "reported device performance" in the context of a new efficacy study. The device is a diagnostic imaging catheter, and its performance is judged against its ability to display vascular morphology and provide dimensional measurements, similar to its predicate.

The main "performance" data presented is the Acoustic Output Reporting Table for Track 3 (Page 4). This table details physical acoustic parameters of the transducer, which are critical safety and performance characteristics for ultrasound devices.

The implied acceptance criteria for these acoustic outputs are that they fall within the established safety guidelines for diagnostic ultrasound devices (e.g., MI < 1.3, TI < 1.0 for non-ophthalmic use as per FDA guidance). The reported values (e.g., MI of 0.0162) are extremely low, indicating a very safe acoustic profile.

Other "acceptance criteria" would relate to mechanical properties, biocompatibility, sterilization, and shelf life, which are mentioned as having been "performed/will be performed" to prove the materials and manufacturing processes are safe. Specific numerical acceptance criteria for these tests are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical "test set" with a specific sample size. As a 510(k) for a device redesign primarily focused on changes to the catheter body and materials, the submission relies on non-clinical testing (e.g., biocompatibility, mechanical durability, acoustic output measurements, sterilization validation).

Therefore, there is no human patient data test set or provenance described in this submission summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Since there is no clinical "test set" or ground truth based on patient data, there are no medical experts (e.g., radiologists) involved in establishing ground truth for such a study in this document. The "experts" involved would be engineers and scientists performing the non-clinical tests and regulatory specialists ensuring compliance.

4. Adjudication Method for the Test Set

Not applicable, as there is no clinical "test set" or human review of images that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study would compare human reader performance with and without AI assistance for tasks like image interpretation. The Visions® PV .035 Digital IVUS Catheter is a diagnostic imaging device (hardware), not an AI-based image analysis software.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is an imaging catheter that provides raw image data. It does not contain a standalone algorithm for automated analysis without human input.

7. The Type of Ground Truth Used

For the safety and performance aspects reported, the "ground truth" is derived from:

• Physical measurements: Acoustic output parameters (MI, pr.3, W0, fc, etc.) are measured using standardized test methods and equipment.
• Material specifications: Biocompatibility testing assesses material safety against established standards.
• Mechanical and electrical engineering tests: To ensure the catheter's structural integrity, tracking capability, and electrical safety.
• Sterilization and packaging validation: To confirm the device remains sterile and functional over its shelf life.

There is no pathology, expert consensus on patient images, or outcomes data used as ground truth in this particular 510(k) summary for a redesign. The primary "ground truth" for the device's overall safety and effectiveness is its substantial equivalence to the predicate device, which has already demonstrated safety and effectiveness in the market.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm.

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