(488 days)
The Detachable Silicone Balloon (DSB) is intended for artificial embolization of the internal carotid artery in the presence of certain intracranial aneurysms in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.
The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.
This is not an AI/ML device, therefore, the mentioned acceptance criteria and studies are not applicable.
The Detachable Silicone Balloon (DSB) is a medical device for artificial embolization. Device testing included biocompatibility testing and functional bench testing. Functional bench testing included cycle testing, rupture testing, pressure-volume testing, detachment force testing, inflation-deflation cycle rate testing, and catheter insertion valve testing. The results of these tests demonstrated the DSB to be safe for its intended use.
This device was determined to be substantially equivalent to predicate devices based on intended use, materials, manufacturing, design parameters, method of delivery, and method of deployment.
§ 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).