(196 days)
The 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 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 Visions® PV .018 Digital IVUS 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 Visions® PV .018 catheter utilizes an internal lumen that allows the catheters to track over a 0.018" (0.46 mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The PV .018 catheters are introduced either percutaneously or via surgical cut down into the vascular system.
The Visions® PV .018 catheter may only be used with Volcano imaging systems, such as the Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheter will not operate if connected to any other imaging system.
The provided text describes a 510(k) premarket notification for the Volcano Visions PV .018 Digital IVUS Catheter. This is a medical device submission, and the focus of the performance data is on demonstrating substantial equivalence to a predicate device, rather than proving a new diagnostic algorithm meets specific acceptance criteria based on human performance. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not directly applicable or available in this type of document.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document states that "All bench testing was successfully completed and met the pre-determined acceptance criteria." However, the specific quantitative acceptance criteria and detailed reported performance values for each test are not provided in this summary. The document only lists the categories of tests performed.
| Test Category | Acceptance Criteria (Not Detailed) | Reported Device Performance |
|---|---|---|
| Shelf Life | Met pre-determined specifications | Successfully completed |
| Floppy Tip Tensile Testing | Met pre-determined specifications | Successfully completed |
| ESL Tensile Testing | Met pre-determined specifications | Successfully completed |
| Signal Processing | Met pre-determined specifications | Successfully completed |
| Biocompatibility: | Successfully completed for all listed tests | |
| - Cytotoxicity | Met pre-determined specifications | Passed |
| - Sensitization | Met pre-determined specifications | Passed |
| - Intracutaneous Reactivity | Met pre-determined specifications | Passed |
| - Systemic Toxicity | Met pre-determined specifications | Passed |
| - Pyrogenicity | Met pre-determined specifications | Passed |
| - ASTM Hemolysis | Met pre-determined specifications | Passed |
| - Partial Thromboplastin Time | Met pre-determined specifications | Passed |
| - In vivo Thromboresistance | Met pre-determined specifications | Passed |
| - C3a Complement Activation | Met pre-determined specifications | Passed |
| - SC5-b Complement Activation | Met pre-determined specifications | Passed |
| - Bacterial Endotoxins (LAL) | Met pre-determined specifications | Passed |
| - LEAP Latex Elisa for Antigenic Protein | Met pre-determined specifications | Passed |
| - Platelet and Leukocyte Counts | Met pre-determined specifications | Passed |
| - Chemical Characterization | Met pre-determined specifications | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Non-clinical device testing" and "Bench testing" and "Biocompatibility testing." These refer to laboratory tests on the device itself, not clinical data from patients. Therefore, terms like "sample size for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this submission focused on device modifications and substantial equivalence through bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "test set" here refers to the device itself under various laboratory conditions (e.g., tensile strength, signal processing, biocompatibility assays), not a diagnostic algorithm or image analysis requiring expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no clinical "test set" requiring human adjudication mentioned in the document. The testing described is non-clinical bench testing.
5. 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
This is not applicable. The device is an Intravascular Ultrasound (IVUS) Catheter, not an AI-powered diagnostic system. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the clinical sense. For the non-clinical tests, the "ground truth" would be established by validated measurement methods and a comparison to predetermined engineering and biocompatibility specifications. For example, a tensile strength test would have a "ground truth" based on the material's known properties and established engineering standards.
8. The sample size for the training set
This is not applicable. This document describes a physical medical device. There is no mention of a "training set" as it would pertain to an AI algorithm.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set for an AI algorithm mentioned, the establishment of ground truth for such a set is irrelevant to this submission.
Summary of the Device and Submission Context:
The Volcano Visions® PV .018 Digital IVUS Catheter is designed for evaluating vascular morphology. The 510(k) submission (K150442) relates to modifications made to an existing predicate device (Visions F/X Model 82700). The performance data provided is entirely non-clinical, focusing on bench testing to confirm the physical and functional integrity of the modified device and biocompatibility testing to ensure its safety for human contact. The key assertion is that these modifications do not alter the intended use or fundamental scientific technologies, and the device remains substantially equivalent to the predicate. The document does not contain information about algorithmic performance, clinical study results with human readers, or patient-level ground truth data, as these are typically not required for this type of 510(k) clearance based on substantial equivalence to an existing device after minor modifications.
§ 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).