(78 days)
The Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
The Merci Microcatheter is indicated for use in the selected placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.
Like the predicate device, the Merci® Retriever consists of a flexible, Nitinol core wire with shaped loops at the distal end. A radiopaque coil covers the tip allowing visualization under fluoroscopy.
The shaped loops of the Retriever are deployed distal to the thrombus or foreign body through the Microcatheter. The Retriever and Microcatheter are pulled back to engage the thrombus or foreign body in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the Microcatheter are then removed from the body.
The provided text describes the "Modified Merci® Retriever" and "Merci® Microcatheter" devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against predefined acceptance criteria.
While the document states, "All devices met the required specifications for the completed tests" under the "Testing Summary" section, it does not elaborate on what these specifications (acceptance criteria) were or what "tests" were performed.
Therefore, I cannot provide the requested information.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).