(66 days)
The Visions® PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the 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 .035 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 and dimensional measurements from the image.
The Visions® PV .035 Digital IVUS 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 Digital IVUS 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 marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-to-middle, with wider marks indicating 5 cm intervals.
A lubricious hydrophilic coating is applied externally to a distal portion of the catheter. The Visions® PV .035 Digital IVUS Catheter, catalog number 88901, may only be used with the In-Vision Imaging System, Volcano s5" Series and CORE " Series of Systems. This catheter will not operate if connected to any other imaging system.
Based on the provided text, the device in question is the Volcano Visions® PV .035 Digital IVUS Catheter.
However, the document states that "Volcano Corporation made minor revisions to the instructions for use for the Visions® PV.035 Digital IVUS Catheter. These edits include revisions to contraindication section and other editorial changes to improve and streamline the overall IFU. There is no change to the current device design, specifications, indications, and/or any other characteristics."
Therefore, the provided document does not contain information about studies to prove acceptance criteria for a new device or a modified device with changes to design or specifications. Instead, it refers to a literature search conducted to support minor modifications to the contraindication sections, implying that the device's fundamental performance characteristics were already established by a previous submission (K121273 - the predicate device).
Given this, I cannot fully complete all sections of your request as the information is not present in the provided text. I will address the parts that can be inferred or explicitly stated.
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "There is no change to the current device design, specifications, indications, and/or any other characteristics." This indicates that the performance criteria and reported performance remain the same as the predicate device (Visions® PV .035 Digital IVUS Catheter, K121273). The current submission focuses on minor revisions to the instructions for use, specifically contraindications. Therefore, no new performance data or acceptance criteria related to device function are presented.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document for device performance. This submission focuses on IFU revisions and refers to predicate device performance. | Not specified in this document for device performance. This submission focuses on IFU revisions and refers to predicate device performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set data was generated or submitted for device performance as there were no changes to device design or specifications. A "literature search was carried out to support minor modifications to the contraindication sections," but details on sample size or provenance of that literature are not provided.
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)
Not applicable. No new test set requiring ground truth establishment was conducted for device performance. The literature search was used to evaluate contraindications, but details on expert involvement or qualifications are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication was conducted for device performance.
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
Not applicable. The device is a diagnostic intravascular catheter, not an AI-assisted interpretation device. No MRMC studies or AI assistance are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a diagnostic intravascular catheter; it is used by a human operator and does not operate as a standalone algorithm for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for device performance validation in this submission. The literature search supported modifications to contraindications, implying a review of existing medical knowledge, potentially including outcomes data or expert opinions from published studies, but this is not a "ground truth" for a new performance study.
8. The sample size for the training set
Not applicable. No new training set for an algorithm was used or described.
9. How the ground truth for the training set was established
Not applicable. No new training set for an algorithm was used or described.
§ 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).