(29 days)
The Reverse Medical® Corporation MVP® Micro Vascular Plug System is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Reverse Medical® MVP® Micro Vascular Plug System consists of a micro vascular occlusion plug that is attached to a composite delivery wire and is intended to be delivered to the treatment site through a catheter. The MVP occlusion plug is a selfexpandable, ovoid-shaped frame made from nitinol and incorporates a PTFE cover over the proximal portion of the ovoid. The plug device is secured at both ends with platinum marker bands. The proximal marker band is attached to a delivery wire that is used to push the plug device through a commercially available catheter to the intended treatment site. After satisfactory deployment of the plug device at the treatment site, the implant is detached from the delivery wire by rotating the wire counter clockwise.
The provided document describes the acceptance criteria and a study demonstrating that the Reverse Medical® MVP® Micro Vascular Plug System, with modifications, meets these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Dimensional Inspection | Successfully passed acceptance criteria. |
| Visual Inspection | Successfully passed acceptance criteria. |
| Microcatheter Compatibility: | |
| - Flexibility within microcatheter | Successfully passed acceptance criteria. |
| - Delivery wire kinking assessment | Successfully passed acceptance criteria. |
| - Multiple deployments and withdrawals | Successfully passed acceptance criteria. |
| - Force required to deploy and retract device | Successfully passed acceptance criteria. |
| Detachment Evaluations: | |
| - Number of turns required to detach | Successfully passed acceptance criteria. |
| - Torque strength of detachment junction | Successfully passed acceptance criteria. |
| Galvanic Corrosion per ASTM G71 | Successfully passed acceptance criteria. |
| MRI Compatibility per ASTM F-2503 | Successfully passed acceptance criteria. |
| Package Integrity and Shelf-life | Successfully passed acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices or tests) used for each individual performance test. It broadly states that "All testing was performed on units that were sterilized and met all inspection criteria."
The data provenance is prospective, as the tests were conducted specifically to evaluate the modified devices. The tests were conducted by Reverse Medical Corporation, presumably in the United States, given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The performance tests described are primarily engineering and technical evaluations of the device's physical properties and functionality, not clinical studies requiring expert ground truth for interpretation like image analysis or diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The performance tests are objective measurements against defined product specifications and industry standards, not subjective assessments requiring adjudication by 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
No, an MRMC comparative effectiveness study was not done. This submission is for modifications to a mechanical vascular embolization device, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a mechanical medical implant and does not involve any algorithms.
7. The Type of Ground Truth Used
The ground truth used for the performance tests consists of pre-defined product specifications, engineering standards (e.g., ASTM G71, ASTM F-2503), and acceptance criteria established by Reverse Medical Corporation. These are objective benchmarks against which the device's physical and functional performance is measured.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reason as point 8.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).