(80 days)
The MegaVac Mechanical Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- The non-surgical removal of thrombi from synthetic grafts.
- Use in temporary blood vessel/graft occlusion.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft
- Catheter placement over a guidewire
The MegaVac Mechanical Thrombectomy System consists of two single-use devices, the MegaVac Catheter with SafeSeal technology and a ThromboWire clot retractor, for intravascular mechanical thrombectomy, occlusion, aspiration and embolectomy. The MegaVac Catheter with SafeSeal technology utilizes a silicone coated nitinol braided funnel that expands to occlude antegrade blood flow proximal to the target work zone creating a static environment in which to perform the intervention, while also centering and securing the catheter tip position within the vessel. The MegaVac catheter's large-mouth funnel and inner diameter allows for strong aspiration while easily being able to pass the ThromboWire and other lesion disruptive or therapeutic devices through it. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle can serve to gather and pull matter towards and through the MegaVac catheter during aspiration.
The provided document is a 510(k) Summary for the MegaVac Mechanical Thrombectomy System. This regulatory submission primarily focuses on establishing substantial equivalence to predicate devices based on design, function, materials, sterilization, and in vitro testing. It does not contain information about clinical studies (comparative effectiveness or standalone), sample sizes for test or training sets for AI devices, expert qualifications for ground truth establishment, or adjudication methods, as these are typically associated with performance evaluations of AI/ML-based devices or clinical trials rather than a 510(k) submission for a traditional medical device demonstrating substantial equivalence through bench testing.
Therefore, many of the requested details related to AI device performance evaluation are not present in this document.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements." However, specific numerical acceptance criteria for each test are not provided. The table below lists the tests performed and the general statement about meeting acceptance criteria.
| Test Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Functional, Dimensional and Mechanical Testing | Occlusion | Met acceptance criteria and pre-determined product specifications |
| Aspiration | Met acceptance criteria and pre-determined product specifications | |
| Trackability over guidewire | Met acceptance criteria and pre-determined product specifications | |
| Retraction | Met acceptance criteria and pre-determined product specifications | |
| Handle stroke | Met acceptance criteria and pre-determined product specifications | |
| Leakage | Met acceptance criteria and pre-determined product specifications | |
| Tensile | Met acceptance criteria and pre-determined product specifications | |
| Diameters, length | Met acceptance criteria and pre-determined product specifications | |
| Component compatibility (obturator/Thrombowire) | Met acceptance criteria and pre-determined product specifications | |
| Biocompatibility Testing | In accordance with 10993-1 for external communicating device in contact with circulating blood with limited exposure time ( |
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).