(33 days)
The Reverse Medical Micro Vascular Plug (MVP-5) 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 (0.027" 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 3.0 -5.0mm. The proximal marker band attaches to a delivery wire that pushes the device 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).
The provided document is a 510(k) summary for the Reverse Medical MVP™ Micro Vascular Plug System (MVP-5). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness through clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, the information requested in the prompt, particularly points 1, 2, 3, 4, 5, 6, 7, 8, and 9, which relate to studies proving a device meets acceptance criteria (as typically defined for diagnostic or effectiveness claims), is not directly applicable to this 510(k) submission.
This 510(k) demonstrates the MVP-5's safety and effectiveness by comparing it to an existing predicate device (Reverse Medical MVP-3 System, K123803) based on:
- Non-Clinical Data: Biocompatibility testing and Design Verification (bench-top testing).
- Performance and Design Equivalence: Showing that the new device's materials, specifications, performance, and intended use are substantially equivalent to the predicate, and that any differences do not raise new questions of safety or effectiveness.
Here's how the provided information relates to the prompt's categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied for Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Non-Cytotoxic, Non-Sensitizing, Non-Irritant, Non-Toxic, Non-Pyrogenic, Non-Mutagenic, Non-Hemolytic, Minimal Complement Activation, Non-Activator (Thromboplastin Time), Passed Muscle Implantation |
| Sterilization Assurance Level (SAL) | 10⁻⁶ (validated per ANSI/AAMI/ISO 11135) |
| Physical & Mechanical Properties | All bench-top tests passed successfully (Visual, Dimensional, Tensile Strength, USP Particulate, Radial Force, Microcatheter Compatibility, Detachment Time, Torque Strength, Plug Foreshortening, Nickel Release, Corrosion Resistance, Flow Occlusion/Reduction, Magnetic Resonance Compatibility, Labeling, Packaging, Shelf Life, Detachment Box and Cable Set) |
| Intended Use | Obstruct or reduce the rate of blood flow in the peripheral vasculature (Equivalent to predicate) |
| Method of Placement | Delivery wire through a 0.027" ID microcatheter (Similar to predicate's 0.021" ID) |
| Radiopaque markers | Platinum marker bands at each end (Equivalent to predicate) |
| Proximal End Configuration | Proximal marker band and attachment for pusher wire (Equivalent to predicate) |
| Detachment System | Electrolytic (Equivalent to predicate) |
| Battery Operated | Yes (Equivalent to predicate) |
Note: The "acceptance criteria" here are implicitly the successful passing of each test and demonstrated equivalence to the predicate device, as per 510(k) requirements.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical trial data with human subjects. The tests performed are non-clinical (bench-top and biocompatibility). The sample sizes for these tests are not provided in this summary.
- Data Provenance: Non-clinical (laboratory testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was a non-clinical submission. No "ground truth" was established by experts for a test set of patient data, as would be the case for diagnostic or AI algorithm evaluations.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is mentioned.
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 vascular plug, not a diagnostic imaging device or an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of clinical "ground truth" for diagnostic evaluation. For non-clinical tests, the "ground truth" is established by standard laboratory methods and validated test protocols (e.g., ISO standards for biocompatibility, engineering specifications for mechanical properties).
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not an algorithm or AI system that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of Study Type
The study described is a non-clinical design verification and biocompatibility study, supplemented by a comparison to a legally marketed predicate device. The primary goal was to establish substantial equivalence for the purpose of 510(k) clearance, not to demonstrate clinical efficacy against specific acceptance criteria in a human population. The "acceptance criteria" are the successful passing of established laboratory and bench-top tests, and the demonstration that the device's characteristics and performance are comparable to the predicate.
§ 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).