(204 days)
The Reverse Medical™ Micro Vascular Plug (MVP™) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.
The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.021" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 1.5 – 3.0mm. The proximal marker band attaches to a delivery wire that pushes through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set – 275 cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP).
This document is a 510(k) Summary for the Reverse Medical MVP™ Micro Vascular Plug System, which focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain a study that establishes acceptance criteria for specific device performance metrics in the way a clinical trial or a detailed performance study with defined endpoints would. Instead, it relies on non-clinical data (biocompatibility, sterilization, and bench-top testing) to show that the device performs as intended and is comparable to predicate devices.
Therefore, many of the requested sections (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission, as it's not a clinical effectiveness study of an AI/ML device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a table for biocompatibility tests, which acts as acceptance criteria for the biological safety of the materials. It also lists various design verification tests (bench-top testing) that were performed, indicating that "All tests performed passed successfully." However, specific numerical acceptance criteria and reported performance values for each of these mechanical/performance tests are not provided in this summary.
| Test Type | Acceptance Criteria (Stated) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic |
| Kligman Maximization Sensitization Test | Non-Sensitizing | Non-Sensitizing |
| Intracutaneous Injection | Non-Irritant | Non-Irritant |
| Systemic Injection | Non-Toxic | Non-Toxic |
| Material-Mediated Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic |
| Genotoxicity/Mutagenicity | Non-Mutagenic | Non-Mutagenic |
| In Vitro Mouse Lymphoma Assay | Non-Mutagenic | Non-Mutagenic |
| In Vivo Mouse Lymphoma | Non-Mutagenic | Non-Mutagenic |
| Hemolysis | Non-Hemolytic | Non-Hemolytic |
| Complement Activation C3a and SC5ba-9 | No greater biological response than corresponding control | No greater biological response than corresponding control |
| Inactivated Partial Thromboplastin Time | Minimal, passed acceptance criteria | Non-activator, passed acceptance criteria |
| Platelet and Leukocyte Counts | No range or acceptable level established (Test Articles) | (No specific numeric result; assumed within acceptable range for testing) |
| Muscle Implantation | Passed acceptance criteria (4 and 13 week) | Intramuscular Implantation- 4 and 13 week, passed acceptance criteria |
| Design Verification (Bench-Top Testing) | ||
| Visual Inspection | (Implied to meet specifications) | Passed successfully |
| Dimensional Inspection | (Implied to meet specifications) | Passed successfully |
| Tensile Strength | (Implied to meet specifications) | Passed successfully |
| USP Particulate | (Implied to meet specifications) | Passed successfully |
| Radial Force | (Implied to meet specifications) | Passed successfully |
| Microcatheter Compatibility | (Implied to meet specifications) | Passed successfully |
| Detachment Time | (Implied to meet specifications) | Passed successfully |
| Torque Strength | (Implied to meet specifications) | Passed successfully |
| Plug Foreshortening | (Implied to meet specifications) | Passed successfully |
| Nickel Release | (Implied to meet specifications) | Passed successfully |
| Corrosion Resistance | (Implied to meet specifications) | Passed successfully |
| Flow Occlusion/Reduction | (Implied to meet specifications) | Passed successfully |
| Magnetic Resonance Compatibility | (Implied to meet specifications) | Passed successfully |
| Labeling | (Implied to meet specifications) | Passed successfully |
| Packaging | (Implied to meet specifications) | Passed successfully |
| Shelf Life | (Implied to meet specifications) | Passed successfully |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ | Validated to provide SAL of 10⁻⁶ |
| Biocompatibility | (As detailed above) | Passed successfully |
| Detachment Box and Cable Set | (Implied to meet specifications) | Passed successfully |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for individual bench tests; generally involves representative samples of manufactured devices.
- Data Provenance: Not explicitly stated, but all testing described is non-clinical (bench-top, in vitro/ex vivo lab testing, and animal testing for biocompatibility). Given the company location (Irvine, CA), it's highly likely this testing was conducted in the US or by US-based contractors, but this is not explicitly stated as "country of origin for data." All data is prospective insofar as it was generated specifically for this 510(k) submission, not gathered from past clinical procedures.
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)
- Not applicable. This is a medical device 510(k) for a physical implant, not an AI/ML diagnostic device requiring expert interpretation for ground truth. Ground truth for these tests is based on objective measurements, chemical analysis, and standardized biological observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Ground truth is established through laboratory test protocols, not physician adjudication.
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 device is a physical implant, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility: Ground truth is established by standardized biological assays and observation of biological responses, compared against control samples where relevant.
- For design verification: Ground truth is established by engineering specifications, objective physical measurements (e.g., tensile strength, dimensions, detachment time), and functional tests (e.g., flow occlusion in a mock vessel).
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. As above, no machine learning training set is involved.
§ 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).