Search Results

The SURGIVISIO medical device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis or articulation structures are visualized.

The Surgivisio system is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures. The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls. The mobile C-arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal ends of the 'C'. The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling. The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.

The MR Compatible Ventricular Cannula is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. The device is intended for "single patient use only."

The Cannula has a stepped distal tip with a 30 cm rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. Soft this in areets the lumen in the center portion and at the distal end where it terminates at a female luer fitting. The fluid containing central lumen is manufactured from non-reactive silica. The cannula will be marketed in the following sizes: 16 ga Ventricular Cannula, .008" ID x 4ft; 16 ga Ventricular Cannula. .008" ID x 10ft; 14 ga Ventricular Cannula, .021" ID x 4ft; 14 ga Ventricular Cannula, .021" ID x 10ft.

The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion. The System is intended for use only with 1.5 Tesla MRI scanners.

The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame Accessory Kit, the SMARTFrame Handcontroller, and the MR Neuro Procedure Drape. The MR Neuro Procedure Drape was cleared for market via a separate 510(k) notice (K091343). The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the burr hole as called out in the trajectory planning software. The SMARTFrame is an adjustable trajectory frame that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MR images, makes changes, and confirms with subsequent MR images. The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) that meet the physician's desired imaging quality.

The MRI Neuro Surgical Drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MRI imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.

The MRI Procedure Drape is composed of urethane film, polyethylene EVA copolymer film and polypropylene nonwoven material, creating a sterile barrier for a surgical procedure. The construction includes a suspension system that allows the clear film area to move with the patient as they are moved in and out of the MRI scanner bore.

The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

The Head Fixation Arc and Table Base is designed to immobilize the patients head during the surqical procedure. It has secondary design intent to provide mounting method for the headcoil and optional camera system. The patient's head is positioned inside the headcoil and attached rigidly to the Head Fixation Arc. The patients head never touches the head coil.