(322 days)
The Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery.
The Frontier Devices Neuro System consists of titanium bone plates and screws of various shapes and sizes. The plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Plates are 0.4 and 0.6 mm thick and come in a variety of shapes and sizes that are designed for cranial closure applications. The shapes and corresponding sizes include: Straight plates 9-12mm long (1x1, 2x2, 5 and 7 holes), Box plates 10mm x 10mm to 16mm x 16mm (4 hole), X-plate 8mm x 8mm (4 hole), Y-plate 16mm long (6 and 8 holes), Double Y-plate 18mm to 21mm long (6 and 8 hole), Strut plate 24 and 35mm long (6 and 8 hole). The burr hole covers are are made from unalloyed titanium that conforms to the ASTM F67 standard. They are 0.4 and 0.6 mm thick and are circular in shape with equi-spaced drill holes around the circumference. The burr hole covers have two basic shapes. The burr hole cover for shunt has a segment of the circular burr hole cover missing which is where a shunt device is placed. The other burr hole cover is a complete circle. The corresponding sizes include: Burr hole covers 12mm to 24mm diameter, Burr hole covers for shunt 12mm to 24mm diameter. The mesh is made from unalloyed titanium that conforms to ASTM F67 standard. They are 0.4 and 0.6mm thick and rectangular in shape, 90mm x 120mm. The screws are self-drilling screws that do not require a pre-drilled pilot hole and are made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Screws are 1.5 to 1.8 mm in diameter and range in length from 3 to 6 mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Frontier Devices Neuro Closure System:
Summary of Device Performance and Acceptance Criteria
This 510(k) submission for the Frontier Devices Neuro Closure System (K100205) describes a medical device seeking substantial equivalence to predicate devices, rather than establishing entirely new performance criteria. Therefore, the "acceptance criteria" are primarily based on demonstrating similarity to existing, legally marketed devices.
The performance testing focused on demonstrating that the new device performs similarly to the predicate devices and meets relevant safety standards for its materials.
| Acceptance Criteria Category | Reported Device Performance (Frontier Devices Neuro Closure System) |
|---|---|
| Material Composition | Plates made from unalloyed titanium (ASTM F67). Screws made from titanium alloy, Ti-6Al-4V (ASTM F136). |
| Material Biocompatibility/Safety | Endotoxin levels |
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).