(263 days)
The Reprocessed Visions PV .035 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. The Visions PV .035 ultrasound imaging 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 Reprocessed 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 catheter is introduced percutaneously or via surgical cutdown into the vascular system, and it is designed to track over 0.035"-.038" (0.89-0.97mm) guide wires.
The catheter has body markers 1 cm apart along the working length. There are 25 radiopaque markers on the distal end of the catheter, starting 1cm 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.
The Visions PV .035 catheters may only be used with Volcano s5 Series and CORE Series of Systems.
A hydrophilic coating is applied externally to a distal portion of the catheter.
This document is not a study that proves a device meets acceptance criteria, but rather a 510(k) Premarket Notification by Innovative Health, LLC for a reprocessed medical device, the Reprocessed Visions PV .035 Digital IVUS Catheter.
In the context of reprocessed devices, the primary goal of the 510(k) submission is to demonstrate substantial equivalence to a predicate (new) device, not to showcase novel performance or "AI" capabilities. The "acceptance criteria" here are largely related to demonstrating that the reprocessed device performs as safely and effectively as the original, new device, and that the reprocessing process itself is robust.
Therefore, many of the requested points regarding AI, MRMC studies, specific performance metrics, and training data are not applicable to this type of submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical performance results in the way a new device with novel functionality might. Instead, it demonstrates substantial equivalence by confirming that the reprocessed device maintains the same functional and safety characteristics as the predicate device after reprocessing.
The "acceptance criteria" for this device would broadly be:
- Biocompatibility identical to the new device.
- Cleaning effectiveness to remove contaminants.
- Sterilization effectiveness.
- Functional performance (visual, dimensional, simulated use) equivalent to the new device.
- Mechanical characteristics equivalent to the new device.
- Hydrophilic coating integrity maintained.
- System compatibility with existing Volcano systems.
- Packaging integrity maintained.
The "reported device performance" is the successful completion of these tests, leading to the conclusion of substantial equivalence.
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 states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Visions PV .035 Catheter."
- Sample Size: The specific number of reprocessed catheters used for each type of testing (biocompatibility, cleaning, sterilization, functional, mechanical, packaging) is not specified in the provided text.
- Data Provenance: The testing was conducted in a "bench and laboratory" setting, indicating controlled laboratory conditions rather than patient data. The country of origin is not specified but implicitly within the US, given the FDA submission. This is prospective testing of reprocessed devices.
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 question is not applicable to this submission. The "ground truth" for a reprocessed device like this is the performance and safety profile of the original, new device, and the successful validation of the reprocessing steps to ensure equivalence. This doesn't involve expert readers or diagnostic accuracy assessments in the traditional sense. The evaluations are primarily engineering and scientific tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic decisions, and not in the bench/laboratory testing described for this reprocessed device.
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 question is not applicable. This device is an Intravascular Ultrasound (IVUS) catheter, a imaging tool, and the submission is for a reprocessed version of it. It does not involve Artificial Intelligence (AI) or human-in-the-loop performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device does not contain an algorithm or AI for standalone performance assessment. It's a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this reprocessed device is established by demonstrating that its performance and safety characteristics after reprocessing are equivalent to those of the predicate (new) device. This is assessed through:
- Physical and chemical testing: Biocompatibility, material integrity, cleaning efficacy.
- Functional testing: Visual inspection, dimensional verification, simulated use (e.g., tracking over guide wires), mechanical characteristics (e.g., tensile strength, kink resistance), hydrophilic coating performance.
- Sterilization validation: Ensuring sterility assurance level.
There is no "expert consensus" on diagnostic findings, pathology, or outcomes data involved in this specific submission for substantial equivalence of a reprocessed device.
8. The sample size for the training set
This question is not applicable. This device is a reprocessed physical medical device, not an AI/machine learning algorithm. Therefore, there is no training set in the computational sense.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this type of device.
§ 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).