(144 days)
The Vein360 Reprocessed Visions PV .018 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 Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional anglographic procedures to provide an image of the vessel lumen and wall structures. The catheter is designed for use on adult patients (greater than 21 years of age).
The Vein360 Reprocessed Visions PV .018 Digital IVUS catheter (subject device) is a reprocessed single use device. After clinical use of the Visions PV .018 Digital IVUS Catheter (Manufactured by Philips), the IVUS catheter is shipped to Vein360 per established Vein360 instructions. Upon receipt, the subject device is cleaned, inspected, functionally tested, packaged and sterilized using ethylene oxide (EO) qas.
The subject device is an intravascular imaging catheter containing an ultrasound transducer located at the distal end of the catheter. This transducer utilizes a 64element cylindrical array that radiates acoustic energy into the surrounding tissue and detects subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.
The subject device utilizes an internal lumen that allows the catheter to track over the 0.018"(0.46mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The subject device is introduced percutaneously or via surgical cutdown into the vascular system.
The catheter's working length is 135 cm and includes three (3) non-radiopaque positioning markers. The subject device maintains all mechanical and electrical properties of the predicate device after reprocessing operations.
The subject device may only be used with Volcano s5 Series, CORE, and IntraSight imaging systems.
The subject device is packaged with a flushing tool that is equivalent to the predicate and is used for flushing the device's lumen with heparinized normal saline.
The subject device can only be reprocessed once and is permanently marked to indicate it has been reprocessed.
The provided documents describe the Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter. This device is a reprocessed single-use device, and the submission's goal is to demonstrate its substantial equivalence to the original, unused version of the same product. The acceptance criteria and the study that proves the device meets these criteria are primarily focused on the reprocessing aspects and ensuring the reprocessed device performs identically to the new device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details various validation studies and performance testing conducted to demonstrate that the reprocessed device maintains the same performance characteristics as the predicate device. The acceptance criteria essentially infer that the reprocessed device must pass these tests, demonstrating identical or equivalent performance to the predicate.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Cleaning Validation | All physical soil removed under minimum operating conditions. |
| Drying Validation | Successful completion (implied to meet predefined standards for dryness). |
| Sterilization Validation | Successful completion (implied to achieve sterility assurance level). |
| Endotoxin Test Method Validation | Successful validation (implied to ensure no pyrogenic contaminants). |
| Biocompatibility | Successful completion (implied to meet biocompatibility standards for patient contact). |
| Performance Validation | All tests (Simulated Use, Dimensional Integrity, Mechanical Integrity, Electrical Integrity, Electrical Safety, Acoustic Output, Image Quality, System Compatibility) successfully completed. The reprocessed device demonstrated to be substantially equivalent to the predicate device in terms of form, fit, and function. |
| Packaging Validation | Successful completion (implied to ensure product integrity and sterility until use). |
| Reprocessing Cycle Limit | Validated for one reprocessing cycle. Devices taken out of service after maximum cycles or if reprocessed by others. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test set. It mentions that "subject devices were clinically used and then soiled with artificial test soil" for cleaning validation and performance validation. This indicates a prospective approach for the testing, where devices were intentionally reprocessed and then tested. The country of origin of the data is not specified, but given the FDA submission, it implicitly aligns with U.S. regulatory standards.
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 section is not applicable as the evaluation of this medical device (a reprocessed IVUS catheter) is based on technical performance testing and validation, not on interpretations or diagnoses by medical experts to establish a "ground truth" for a diagnostic task. The "ground truth" here is the original specifications and performance of the new device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the reasons stated above. Adjudication methods are typically used in clinical studies involving interpretation of medical images or data by multiple experts.
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 section is not applicable. The device is an Intravascular Ultrasound (IVUS) catheter, which is a diagnostic tool, not an AI-assisted diagnostic system. No MRMC study involving human readers and AI assistance was conducted or described in the provided text. The study focuses purely on the physical and functional performance of the reprocessed device compared to the original.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section 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.)
The 'ground truth' for this submission is the original design specifications and established performance characteristics of the new, unused predicate device (Visions® PV .018 Digital IVUS Catheter - K150442). The studies aimed to prove that the reprocessed device adheres to these same performance standards after reprocessing. This is evidenced by statements like: "Electro-mechanical performance testing was performed to demonstrate that the reprocessing operations did not adversely affect the predicate device's form, fit, or function."
8. The sample size for the training set
This section is not applicable. The evaluation of this device does not involve a "training set" in the context of machine learning or AI models. The testing described is for physical device validation.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
§ 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).