(92 days)
The Reverse Medical Micro Vascular Plug (MVP-7, MVP-9) System is intended for use 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 text describes a 510(k) premarket notification for the Reverse Medical Micro Vascular Plug (MVP-7 & MVP-9) and outlines the basis for determining substantial equivalence to predicate devices. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.
The document primarily focuses on demonstrating that the modified MVP-7 and MVP-9 devices are substantially equivalent to their predicate devices (MVP-3Q, MVP-5Q, MVP-3, and MVP-5) based on their intended use, design, materials, principle of operation, and overall technological characteristics.
Instead of a specific clinical study with detailed acceptance criteria and performance metrics, it lists a series of non-clinical performance tests conducted to verify the design changes. These tests primarily address the physical and mechanical aspects of the device and its compatibility with delivery systems.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding "reported device performance" values for clinical outcomes. The performance tests listed are primarily non-clinical assessments.
| Acceptance Criteria (Implied from tests) | Reported Device Performance (Summary from text) |
|---|---|
| Dimensional Accuracy | All units met all inspection criteria |
| Visual Inspection | All units met all inspection criteria |
| Catheter Compatibility | Demonstrated within "Simulated Use Vascular Model" |
| Flexibility within catheter | Tested and met criteria (implies satisfactory performance) |
| Delivery wire kinking assessment | Tested and met criteria (implies satisfactory performance) |
| Multiple deployments and withdrawals through catheter | Tested and met criteria (implies satisfactory performance) |
| Force required to deploy and retract device within catheter | Tested and met criteria (implies satisfactory performance) |
| Detachment Evaluations | Tested and met criteria (implies satisfactory performance) |
| Number of turns required to detach implant | Tested and met criteria (implies satisfactory performance) |
| Torque strength of detachment junction | Tested and met criteria (implies satisfactory performance) |
| Galvanic Corrosion | Tested per ASTM G71 (implies satisfactory performance) |
| MRI Compatibility | Tested per ASTM F-2503 (implies satisfactory performance) |
2. Sample size used for the test set and the data provenance
The document does not specify human clinical "test set" sample sizes, as the performance tests described are non-clinical tests performed on "units that were sterilized and met all inspection criteria." Data provenance is from in-house non-clinical testing by Reverse Medical Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests described are engineering/material performance tests, not clinical evaluations requiring expert interpretation of ground truth in the context of diagnostic or interventional efficacy.
4. Adjudication method for the test set
Not applicable for non-clinical engineering tests.
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. This is not an AI-assisted diagnostic or interventional device, but a physical vascular embolization device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the specifications and standards of the tests themselves (e.g., dimensional requirements, force measurements, compliance with ASTM standards for corrosion and MRI compatibility).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The "units" for testing refer to manufactured devices.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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).