(27 days)
Aneuroplastic® is indicated for the reinforcing and encapsulating of cerebral aneurysms.
Aneuroplastic® is a self-curing methylmethacrylate (MMA) resin for reinforcing and encapsulating cerebral aneurysms. The following modifications are being made: A change is being made to the formulation of the liquid component and the Instructions for Use (IFU) is being updated.
This document is a 510(k) summary for a medical device (Aneuroplastic®) and an FDA clearance letter. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The 510(k) submission process for this type of device (Methyl Methacrylate (MMA) for reinforcing and encapsulating cerebral aneurysms) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with acceptance criteria.
Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory classification, intended use, and the basis for substantial equivalence, which is typically through demonstrating similar technological characteristics to existing devices.
§ 882.5030 Methyl methacrylate for aneurysmorrhaphy.
(a)
Identification. Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip.(b)
Classification. Class II (performance standards).