(60 days)
The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014P RX (014R), Eagle Eye Platinum RX, and Eagle Eve Platinum ST RX Digital IVUS catheters are all 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. These devices are not currently indicated for use in the cerebral vessels.
The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014p RX (014R), Eagle Eye Platinum RX, and Eagle Eye Platinum ST RX RX Digital IVUS catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
The subject devices are reprocessed single use devices. After clinical use of the predicate devices (Manufactured by Philips), the devices are shipped to Vein360 per established Vein360 instructions. Upon receipt, the subject devices are cleaned, inspected, hydrophilic coated, functionally tested, packaged, and sterilized using ethylene oxide (EO) gas.
The subject devices are rapid exchange intravascular imaging catheters containing an ultrasound transducer located at the distal end of the catheter. This transducer utilizes a 64-element 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 coronary and peripheral vessels.
The subject devices utilize an internal lumen that allows the catheter to track over the 0.014" (0.36mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The subject devices are introduced percutaneously or via surgical cutdown into the vascular system.
Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.
The subject devices may only be used with Volcano s5 Series or CORE Series 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 devices are reprocessed once and permanently marked to indicate it has been reprocessed by Vein360.
This document describes the Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (85910P, 014R), and Vein360 Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, and Vein360 Reprocessed Eagle Eye Platinum ST RX Digital IVUS Catheter. This device is a reprocessed single-use intravascular imaging catheter.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" for each performance test in a quantitative manner. Instead, it states that "results of performance testing demonstrate the subject devices are substantially equivalent to the predicate devices which are safe and effective for their intended use." This implies that the acceptance criteria for each test was to match or not degrade from the performance of the original predicate devices.
| Performance Test Category | Reported Device Performance (Implied Acceptance Criteria) |
|---|---|
| Cleaning Validation | Demonstrated removal of all physical soil under minimum operating conditions. (Acceptance: No residual soil after cleaning) |
| Drying Validation | (Not explicitly detailed, but implied to be sufficient for proper reprocessing) |
| Sterilization Validation | (Not explicitly detailed, but implied to achieve sterility; Ethylene Oxide (EO) gas) |
| Endotoxin Test Method Validation | (Not explicitly detailed, but implied to meet endotoxin limits) |
| Biocompatibility | (Not explicitly detailed, but implied to be non-toxic and biocompatible after reprocessing) |
| Performance Validation | Reprocessing operations did not adversely affect the predicate device's form, fit, or function. |
| - Simulated Use | (Implied: Device functions as expected in simulated clinical scenarios) |
| - Dimensional Integrity | (Implied: Dimensions remain within specifications after reprocessing) |
| - Mechanical Integrity | (Implied: Mechanical strength and functionality are maintained after reprocessing) |
| - Cross / re-cross Testing | (Implied: Catheter can be advanced and withdrawn through vessels appropriately) |
| - Electrical Integrity | (Implied: Electrical components function correctly after reprocessing) |
| - Electrical Safety | (Implied: Device remained electrically safe after reprocessing) |
| - Hydrophilic Coating Integrity | (Implied: Coating remained intact and functional) |
| - Acoustic Output | (Implied: Acoustic output remained within specifications for image generation) |
| - Image Quality | (Implied: Image quality remained comparable to the predicate device) |
| - System Compatibility | (Implied: Subject devices function correctly with Volcano s5 Series or CORE Series imaging systems) |
| Packaging Validation | (Not explicitly detailed, but implied to maintain device integrity and sterility until use) |
| Reprocessing Cycles | Validated for one reprocessing cycle. (Acceptance: Device retains performance after one reprocessing cycle.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test set. It mentions "subject devices were clinically used and then soiled with artificial test soil" for cleaning and performance validation. However, the number of devices, cases, or specific data points for these tests is not provided.
- Data Provenance: The devices are "reprocessed single use devices" that were "after clinical use of the predicate devices (Manufactured by Philips)". This indicates that the initial data (the predicate devices themselves) came from clinical use, and then the reprocessed devices were subjected to further testing. The geographical origin of the initial clinical use data is not specified, but the reprocessing company is based in the US (Ohio). The tests conducted are prospective in the sense that they are performed on reprocessed devices to demonstrate their continued performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be focused on physical, electrical, and imaging characteristics compared to baseline (predicate device) performance, rather than an interpretation of medical images by human experts.
4. Adjudication Method:
Since no experts were mentioned for establishing ground truth, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for AI-powered diagnostic tools where human interpretation is a key component. This submission relates to the reprocessing of physical medical devices.
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. This device is an IVUS catheter, a physical device that generates images, not an AI algorithm itself. The imaging system (Volcano s5 Series or CORE Series) has its own algorithms, but the study focuses on the reprocessed catheter's ability to produce comparable images.
7. Type of Ground Truth Used:
The ground truth used for assessing the reprocessed device's performance is the original performance and specifications of the predicate (unreprocessed) devices. The studies aimed to demonstrate that the reprocessed devices maintained "form, fit, or function" comparable to the new predicate devices. This includes:
- Physical measurements (dimensional integrity, mechanical integrity)
- Functional performance (simulated use, cross/re-cross, electrical integrity, acoustic output, image quality)
- Safety parameters (cleaning efficacy, sterility, endotoxin levels, biocompatibility, electrical safety)
For cleaning validation, the "ground truth" was the absence of physical soil, demonstrated objectively.
8. Sample Size for the Training Set:
This is not applicable as the device is a physical, reprocessed IVUS catheter, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no mention of a training set for an AI algorithm.
§ 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).