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The Vycor Viewsite Brain Access System (VBAS) is intended to provide for access and allow for visualization of the surgical field during brain and spine surgery.

The Vycor Medical Surgical Access System (VBAS) includes a family of retractor devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spinal region. The subject device is comprised of the modified version of the predicate device cleared under #K060973 together with the optional Alignment clip (A)C component. The models designated with post characters "AC" includes the Alignment Clip ("AC") included separately in the packaging. This is available for all models other than the 6mm size. The AC may be optionally attached to aid in centering third party navigational and image guided system ("IGS") pointers or probes ("pointer"). Like the predicate, the subject device consists of an introducer and port. The port and introducer are packaged assembled and ready for use. Upon insertion of the device, the introducer is removed and the port is left in place. The introducer has a length greater than the port. The smooth and soft tapered introducer works to spread apart the brain or other portions of delicate tissue. Upon removal of the introducer, the port provides a hollow working channel allowing the surgeon access to the target tissues. The AC optional component was designed to make the VBAS easier to use with IGS by enabling the IGS pointer to be centered and held in place: - . Designed to accommodate a range of commonly-used pointers - . Securely clips onto the VBAS device when used - Provides insertion direction to center the pointer in the device and ensure vertical alignment - Provides locking mechanism to securely hold the pointer in place and therefore enable the pointer and VBAS to be one integrated unit freeing up one of the surgeon's hands