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The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

The Arcus Head Fixation Frame is a re-usable, non-sterile device designed to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets. It consists of a Ring that secures the patient's skull with skull pins, a Base that secures the Ring, and Posts that hold Fixation Screws. The device is secured to the scanner table. It is designed for use with specific Siemens MRI Scanners. The device is MR Conditional and contains brass inserts and titanium pin tips.

The V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.

The V-TAG™ device is a single-use, skull-mounted, rigid trajectory array guide used in stereotactic surgical procedures. The V-TAG can be manipulated to provide a wide range of surgical trajectories into the head. An image-quided neuronavigational system loaded with a stereotactic surgical plan is used to align the V-TAG to the planned trajectory; once aligned, the V-TAG is securely locked to provide a stable instrument guide. After positioning of the V-TAG, magnetic resonance imaging (MRI) is used to confirm alignment with the planned trajectory. Adjustment of the V-TAG may be performed in the MRI scanner to refine or change the trajectory based on updated intraoperative imaging. Intracranial placement of a neurosurgical device or surgical instrument using the V-TAG device is only to be performed after MRI confirmation of the trajectory.

The MR Compatible Aspiration System is used for controlled aspiration of blood, cystic components of tumors, abscess, colloid cysts, and cerebrospinal fluid using a manual syringe during surgery of the Ventricle System or Cerebrum.

The MCA Kit is an accessory to the cleared ClearPoint System (K171257). The MCA Kit consists of a MCA device guide, guide sheath, stylet, depth stops, cannula (with attached tube) and adapter. The MCA Kit is designed to aid a physician in the removal of specific tissue or fluid types from the brain during image guided surgery. It is MR safe, as all materials are non-metallic. The MCA Kit is comprised of single use only, sterile-packaged disposable components that are packaged together.

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, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Thumbwheel Extension. The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the traiectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the quidance and fixation for neurosurqical 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 MRI 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) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. MRI Interventions also supplies an optional head fixation frame that can be used with the ClearPoint System. The ClearPoint Workstation includes the following: 1. ClearPoint Workstation Software (for trajectory planning and monitoring) 2. Laptop Computer The hardware components of the current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following: 1. SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole) a. Marking Grid b. Marking Tool 2. SMARTFrame Pack (SMARTFrame or SMARTFrame XG) a. SMARTFrame ("ATF") with Base b. Centering Device and Wharen Centering Guide c. Dock d. Device Lock (2 different diameters) e. Screwdriver f. Roll Lock Screw and Washer 3. Rescue Screws (Extra Titanium Screws) 4. Thumbwheel Extension 5. Accessory Kit a. Peel-away Sheath b. Stylet c. Lancet d. Depth Stop e. Ruler 6. Scalp Mount Base 7. Guide Tubes and Device Guide Packs (Guide Cannulas) In addition, the ClearPoint System is used with the following separately cleared or Class I, 510(k)exempt products: SmartTip MRI Hand Drill and Drill Bit Kit MRI Neuro Procedure Drape, with Marker Pen and Cover SmartFrame MR Fiducial Camera Fiberscope Accessory Kit

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, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices. The user should consult the "Navigational Accuracy" section of the User's Guide to assess if the accuracy of the system is suitable for their needs.

The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid (previously cleared under K100836), the SMARTFrame™ MRI-Guided Trajectory Frame (K100836), the SMARTFrame™ Accessory Kit (K100836) and the SMARTFrame™ Thumbwheel Extension. 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 allow for trajectory feedback when the physician views the MRI 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. MRI Interventions also supplies an optional head fixation frame that can be used with the ClearPoint System. The ClearPoint Workstation includes the following: 1. ClearPoint Workstation Software (for trajectory planning and monitoring) 2. Laptop Computer The hardware components of the ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following: 1. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole) a. Marking Grid b. Marking Tool 2. SMARTFrame Pack a. SMARTFrame (adjustable trajectory frame ("ATF") to guide and hold the neurosurgical tools, includes fiducials, Targeting Cannula, & titanium screws) b. Centering Device c. Dock d. Device Lock (2 different diameters) e. Screwdriver 3. Rescue Screws (Extra Titanium Screws) 4. Thumbwheel Extension 5. Accessory Pack a. Peel away sheath b. Stylet c. Lancet d. Depth Stop e. Ruler 6. Scalp Mount Base 7. Guide Tube and Device Guide Packs (Guide Cannulas)

The MRII Cranial Drill and Accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The MRII Cranial Drill and Accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.

The MRII Cranial Drill and accessories is composed of the MR Compatible Hand Drill and Drill Bit Kits, packaged separately and found substantially equivalent in K 122456. The packaging is identical to that of the predicate device. The MRII Cranial Drill is wrapped in CSR and then sealed in a Tyvek pouch. The Drill Bit Kits are packaged in a sealed tray within a sealed Tyvek pouch.

The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during the 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 and 3.0 Tesla MRI scanners.

The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Hand Controller. The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) 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 MRI 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. MRI Interventions also supplies an optional head fixation frame and imaging coil(s) that can be used with the ClearPoint System. The ClearPoint Workstation includes the ClearPoint Workstation Software (for trajectory planning and monitoring) and a Laptop Computer. The hardware components of the ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the SMARTGrid Pack (Marking Grid, Marking Tool), SMARTFrame Pack (SMARTFrame or SMARTFrame XG, Centering Tool, Wharen Centering Guide, Dock, Device Lock, Screwdriver, Roll Lock Screw and Washer), Rescue Screws, Hand Controller and Thumbwheel Extension, Accessory Pack (Peel-away Sheath, Stylet, Lancet, Depth Stop, Ruler), Scalp Mount Base, Guide Tube and Device Guide Packs (Guide Cannulas), SmartTip MRI Hand Drill and Drill Bit Kit, SmartTwist MRII Hand Drill and 4.5mm/6.0mm Drill Guide, MRI Neuro Procedure Drape, with Marker Pen and Cover, and SmartFrame MR Fiducial.

The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during the 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 and 3.0 Tesla MRI scanners.

The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Hand Controller. The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software. The SMARTFrame is an Adjustable Traiectory Frame (ATF) that provides the quidance 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 MRI 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. MRI Interventions also supplies an optional head fixation frame and imaging coil(s) that can be used with the ClearPoint System. The ClearPoint Workstation includes the following: 1. ClearPoint Workstation Software (for trajectory planning and monitoring) 2. Laptop Computer The hardware components of the ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following: 1. SMARTGrid Pack (interacts with the software to determine the desired location of the burr hole) a. Marking Grid b. Marking Tool 2. SMARTFrame Pack (SMARTFrame or SMARTFrame XG) a. SMARTFrame ("ATF") with Base b. Centering Tool c. Dock d. Device Lock (2 different diameters) e. Screwdriver f. Roll Lock Screw and Washer 3. Rescue Screws (Extra Titanium Screws) 4. Hand Controller (for use with the ATF) and Thumbwheel Extension 5. Accessory Pack a. Peel-away Sheath b. Stylet c. Lancet d. Depth Stop e. Ruler 6. Scalp Mount Base 7. Guide Tube and Device Guide Packs (Guide Cannulas) 8. SmartTip MRI Hand Drill and Drill Bit Kit 9. MRI Neuro Procedure Drape, with Marker Pen and Cover 10. MR Camera Fiberscope Accessory Kit 11. SmartFrame MR Fiducial

The SmartTwist™ MRII Hand Drill and accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.

The SmartTwist MRII Hand Drill is a hand held manual drill with a 3:1 gear ration. It is intended for use with the drill kit accessory kits SmartTip Drill Kits for a 3.2mm, 4.5mm and 6.0mm drill bit, with lancet, depth stop and ruler.

The VarioGuide Drill Kit used in conjunction with BrainLab's VarioGuide is intended for creating an access point in the skull during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."

The VarioGuide Drill Kit is a set of components that work in conjunction with the VarioGuide and each other to guide a drill bit along a desired trajectory to make an access hole in the skull. The components that comprise the VarioCuide Drill Kit are a Drill Guide, a 3.4mm Drill Bit, a Lancet, two Depth Stops and a Device Guide. The Drill Guide is made from Peek and has a 316L Stainless Steel tip which is pressed into the Drill Guide body. The Drill Guide Tip has two unique features. First, the tip has a double-chamfered edge which allows the unique into the bone and that also prevents the tip from bending over. The second feature is windows that allow drilled material to exit through the tip and thus prevents the drill bit from binding. The Drill Guide is used to constrain the prevents access bal access hole creation to a predetermined to assult the unit on unring. 316L Stainless Steel and is used to create an access hole through the skull. The Drill Bit tip is designed so that the amount of drill walk at the start of drilling is limited. This feature also helps Drill Bit to maintain its trajectory. The Lancet is made from 316L Stainless Steel and has a sharp point at the distal end to allow the Lancet to pierce the Dura and/or Pia. The Lancet has a reduced section (0.60)" long) which allows the Lancet to pass through the skull without any wall interference. The Depth Stops are made from 316L Stainless Steel and are used in conjunction with the Drill Bit and Lancet to set the desired depth. The Device Guide is made from Peek and is used to guide an instrument (such as a catherer) on a predetermined path. The Device Guide is available in two sizes, 0.075" for the small and 0.085" for the large.