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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 an operating room environment and in conjunction with MR and/or CT imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization of segmentable brain structures from a set of loaded MR images. 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) (asleep or awake) lead placement. When used in an MRI environment, the system is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.

The updated ClearPoint Software Version 3.0 introduces modifications to support a new clinical workflow using intraoperative CT imaging when compared to the previous ClearPoint Software Version 2.2 (K233243). The ClearPoint System described in this submission is essentially identical from a technological standpoint to the cleared predicate device described in K233243 (ClearPoint System version 2.2). As mentioned above, since the prior clearance, the company has implemented software features to enable usage of the ClearPoint System during CT-guided procedures, in addition to MR-guided procedures supported in the predicate device. The hardware components are unchanged from the device described in K233243 and minor changes were made to the indications for use. The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid Planning Grid, the SMARTFrame 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 trajectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the guidance and fixation for neurosurgical tools. The image-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 intraoperatively acquired images, makes changes and confirms with subsequent image acquisitions. Optionally, the ClearPoint System can be used with any head fixation frame to immobilize the patient's head with respect to the scanner table. ClearPoint Neuro also supplies an optional head fixation frame 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 current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile and include the SMARTGrid Planning Grid (Marking Grid, Marking Tool), SMARTFrame Pack (SMARTFrame or SMARTFrame XG, Centering Device and Wharen Centering Guide, Dock, Device Lock, Screwdriver, Roll Lock Screw and Washer), Rescue Screws (Extra Titanium Screws), Thumbwheel Extension, Accessory Kit (Peel-away Sheath, Stylet, Lancet, Depth Stop, Ruler), Scalp Mount Base, and Guide Tubes and Device Guide Packs (Guide Cannulas). In addition, the ClearPoint System is used with the 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, and SmartFrame Fiducial.

The ClearPoint Array System (Version 1.2) 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 in conjunction with MR imaging. The ClearPoint Array System (Version 1.2) 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 ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape. The ClearPoint Array Workstation includes the following: 1. ClearPoint Array Workstation Software (for trajectory planning and monitoring) 2. Laptop Computer The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories, and are listed below. They are all single use devices provided sterile. Beyond the changes described above, there have been no modifications to the hardware compared to the last cleared version of the device (K214040). 1. SMARTFrame Array Pack a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter, Tracker Rod) b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and titanium standoff pins) c. Entry Point Locator d. Targeting Stem e. Centering Device f. Dock g. Device Lock (2 different diameters) h. Screwdriver i. 2.1-mm Guide Tube j. 4.5 Center Drill Guide k. 4.5 Offset Drill Guide l. 3.4-mm Drill Reducer Tube m. Center Insertion Guide n. Offset Insertion Guide 2. SmartFrame Array Thumb Wheel Extension Set for the trajectory frame. 3. SmartFrame Array Guide Tube Kit a. 1.7-mm Guide Tube b. 0.5-mm Guide Tube and Device Lock c. 3.1-mm Guide Tube and Device Lock d. SmartFrame Array Guide Tubes (sold separately) e. 7.9mm Center and Offset Device Guides f. 5.4mm Center and Offset Device Guides Common Components to the ClearPoint System are listed below. These components have not been modified since their clearance (K214040, K200097, K100836, K091343). 1. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole) (K100836) a. Marking Grid b. Marking Tool 2. Accessory Pack (K200097) a. Peel away sheath b. Stylet c. Depth Stop d. Ruler 3. MRI Neuro Procedure Drape (K091343)

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 ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI Guided Planning Grid, the SMARTFrame™ MRI-Guided Traiectory 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 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 frame allows for trajectory feedback when the physician views the MRI images, makes changes and confirms with subsequent MR images. The modified ClearPoint Software is used to provide stereotactic quidance for the insertion of one or more devices into the brain within a magnetic resonance imaging (MRI) environment, using hardware provided by ClearPoint Neuro, Incorporated. The software will guide the end user through a set of discrete workflow steps for identifying localization hardware mounted onto the patient, planning one or more trajectory paths into the brain, quiding the alignment of one or more stereotactic frames along each of the planned trajectories, and monitoring the insertion of one of more devices into the brain. The software also supports workflow for creating pre-operative plans prior to carrying out the intraoperative procedure. The software will be installed on a physical laptop computer situated inside the MRI Suite during the intra-operative procedure. There, it will be used in conjunction with a MRI scanner, the SMARTFrame adjustable trajectory frame (ATF), and associated disposable hardware kits provided by ClearPoint Neuro to guide the user through the insertion of one or more devices into the brain. Throughout the procedure, in instances where specific scans are required, the software application will prescribe scan plane parameters detailing the position and angulation of a desired image acquisition necessary to proceed with the workflow. In these cases, users are required to enter the parameters prescribed by the software manually on the MRI scanner console to carry out the appropriate image acquisition. 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. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint System.

ClearPoint Maestro™ Brain Model is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MR images. This software is intended to automate the process of identifying, labelling, and quantifying the volume and shape of brain structures visible in MRI images.

The ClearPoint Maestro™ Brain Model provides automated image processing of brain structures from T1-weighted MR images. Specifically, the device automates the manual process of identifying, labeling, and quantifying the volume and shape of subcortical structures to simplify the workflow for MRI segmentation. The ClearPoint Maestro™ Brain Model consists of the following key functional modules. - DICOM Read Module . - Segmentation Module ● - Visualization Module ● - . Exporting Module The segmented brain structures are color coded and overlayed onto the MR images or be displayed as 3-D triangular mesh representation. The viewing capabilities of the device also provides anatomic orientation labels (left, right, inferior, superior, anterior, posterior), image slice selection, standard image manipulation such as contrast adjustment, rotation, zoom, and the ability to adjust the transparency of the image overlay. The output from ClearPoint Maestro™ Brain Model can also exported as a report in PDF format. The report also provides a comparison of segmented volume to normative values of brain structures based on reference data.

The ClearPoint® Array 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 ® Array 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 ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape. A pre-alignment may be used when it is desired to obtain an approximate alignment using a Surgical Navigation System prior to performing final alignment and device placement in the MR Scanner using real-time MR Images. Pre-alignment using an SNS is not intended to provide accurate stereotactic placement. The final alignment and insertion must be performed using real-time MR images with ClearPoint Array software prior to inserting a device in the brain. The SMARTGrid™ MRI-Guided Planning Grid 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™ Array MRI-Guided Trajectory Frame is an adjustable trajectory frame that provides the quidance and fixation for neurosurgical tools. MRI visible fluids in the Targeting Stem along with the fiducial markers in the frame allows for trajectory feedback when the physician views the MR images, makes changes and confirms the subsequent MR images. The ClearPoint Array 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. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint Array System. The ClearPoint System Array Workstation includes the following: 1. ClearPoint Workstation Software (for trajectory planning and monitoring) 2. Laptop Computer The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories. They are all single use devices that are provided sterile. They include the following: 1 SMARTFrame Array Pack a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter and Tracker Rod) b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and support pins) c. Entry Point Locator d. Targeting Stem e. Centering Device f. Dock g. Device Lock (2 different diameters) h. Screwdriver i. 2.1-mm Guide Tube j. 4.5 Center Drill Guide k. 4.5 Offset Drill Guide l. 3.4-mm Drill Reducer Tube m. Center Insertion Guide n. Offset Insertion Guide 2 SmartFrame Array Thumb Wheel Extension Set for the trajectory frame 3 SmartFrame Array Guide Tube Kit a. 1.7-mm Guide Tube b. 2.5-mm Guide Tube and Device Lock c. 3.2-mm Guide Tube and Device Lock 4 SmartFrame Array Guide Tubes (sold seperately) a. 7.9mm Center and Offset Device Guides b. 5.4mm Center and Offset Device Guides Common components to ClearPoint System include: 1. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole): a. Marking Grid b. Marking Tool 2. Accessory pack: a. Peel away sheath b. Stylet c. Depth Stop d. Ruler 3. MRI Neuro Procedure Drape

The ClearPoin® Array 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® Array System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insettion 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 ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape. A pre-alignment may be used when it is desired to obtain an approximate alignment using a Surgical Navigation System prior to performing final alignment and device placement in the MR Scanner using real-time MR Images. Pre-alignment using an SNS is not intended to provide accurate stereotactic placement. The final alignment and insertion must be performed using real-time MR images with ClearPoint Array software prior to inserting a device in the brain. The SMARTGrid™ MRI-Guided Planning Grid 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™ Array MRI-Guided Trajectory Frame is an adjustable trajectory frame that provides the quidance and fixation for neurosurgical tools. MRI visible fluids in the Targeting Stem along with the fiducial markers in the frame allows for trajectory feedback when the physician views the MR images, makes changes and confirms the subsequent MR images. The ClearPoint Array 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. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint Array System. The ClearPoint System Array Workstation includes the following: 1. ClearPoint Workstation Software (for trajectory planning and monitoring) 2. Laptop Computer The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories. Some of the accessories are common components with the ClearPoint System (K200079). They are all single use devices that are provided sterile. They include the following: 1 SMARTFrame Array Pack a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter and Tracker Rod) b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and support pins) c. Entry Point Locator d. Targeting Stem e. Centering Device f. Dock q. Device Lock (2 different diameters) h. Screwdriver i. 2.1-mm Guide Tube j. Center Drill Guide k. Offset Drill Guide 1. 3.4-mm Drill Reducer Tube m. Center Insertion Guide n. Offset Insertion Guide 2 SmartFrame Array Thumb Wheel Extension Set for the trajectory frame 3 SmartFrame Array Guide Tube Kit a. 1.7-mm Guide Tube b. 2.5-mm Guide Tube and Device Lock c. 3.2-mm Guide Tube and Device Lock Common components to ClearPoint System include: 1. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole) a. Marking Grid b. Marking Tool 2. Accessory pack a. Peel away sheath b. Stylet c. Depth Stop d. Ruler 3. MRI Neuro Procedure Drape