(37 days)
The MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus Presidio 18-System Microcoil consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Presidio 18-System Microcoil is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.017" and 0.021." The coils are available in spherical shapes and are available in various diameters and lengths: Coil lengths range from 30 to 50 centimeters. Coil diameters range from 8 to 20 millimeters. Micrus Presidio 18-System Microcoils are fabricated from the same diameter platinum alloy wire as used in the Cerecyte 18 system platinum Microcoils, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The Microcoils are subjected to the same thermal treatments for primary and secondary shaping processes. The addition of Presidio 18-System Microcoil to the Cerecyte 18-System line means these 18-System Microcoils will be identical to the current CE Marked / FDA Cleared Cerecyte 18-System with only a single point of difference (length). The platinum alloy wire will match the diameter of all Micrus Microcoil 18 Systems (Platinum only and Cerecyte). The catalog number for Presidio-18 is PC4. The 18 System Presidio Microcoils maintain the same design features as all the current Microcoil Systems. Compared with the current design, size 18 Presidio Microcoil Systems have: The same intended use Connect to the same connecting cables. Detach using the same Detachment Control Box. It is important to reiterate, the Micrus Presidio-18 MicroCoils are identical to the current FDA cleared Micrus Cerecyte-18 MicroCoils except for length
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification for the Micrus Presidio-18 MicroCoil System, which focuses on establishing substantial equivalence to previously cleared predicate devices.
The key points from the provided text are:
- Device: Micrus Presidio-18 MicroCoil System
- Intended Use: Endovascular embolization of intracranial aneurysms.
- Predicate Devices: Micrus MicroCoil System, Cerecyte-18 (K053160), MicroVention MicroPlex Complex 3D (K012145), Micrus MicroCoil Delivery System (K002056).
- Basis for Equivalence: The Presidio-18 MicroCoil सिस्टमs are described as "identical to the current FDA cleared Micrus Cerecyte-18 MicroCoils except for length." This suggests that the substantial equivalence argument relies on the similarity of design, materials, manufacturing processes, and intended use with an already cleared device, rather than new performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence based on prior device characteristics.
§ 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).