(303 days)
CES Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the neurovasculature for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas and other vascular lesions of the brain, spinal cord and spine.
The CES Vascular Occlusion System consists of straight and shaped CES Pushable Coils (made from platinum alloy and synthetic fibers) and the CES Coil Pusher (with two radiopaque tip markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" I.D.
I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text from the 510(k) summary for the CES Vascular Occlusion System does not contain information about specific performance acceptance criteria or details of a study designed to demonstrate meeting those criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, sterilization, and indications for use. It lists predicate devices and their 510(k) numbers, and indicates that "All applicable biocompatibility tests were successfully performed on the CES Pushable Coils." However, it does not state what the acceptance criteria for these tests were, nor does it provide any quantitative performance data from a specific study that would demonstrate the device meets any defined acceptance criteria for effectiveness or safety beyond biocompatibility.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).