(23 days)
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). An "introducer sheath" covers the microcoil and DPU and is attached to a re-sheathing tool
I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for the Micrus Microcoil Delivery System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.
The information provided primarily covers:
- Device Description and Intended Use: The Micrus MicroCoil Delivery System is for endovascular embolization of intracranial aneurysms.
- Comparison to Predicate Devices: The submission argues that the device, with its new introducer sheath and re-sheathing tool, is substantially equivalent to previously cleared Micrus Microcoil Systems based on intended use, design, materials, and method of construction.
- Conclusion: The submission concludes substantial equivalence based on design, materials, function, intended use comparison, and "non-clinical testing." However, the details of this non-clinical testing are not provided.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
§ 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).