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The Bone Anchor is intended to be used with commercially available stereotactic systems for intracranial and neurosurgical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.

The Bone Anchor is a single-use device for temporary short-term fixation of surgical tools or accessories during a single surgical procedure. The Bone Anchor may be used during image-guided or MR interventional procedures. This device is not intended to create a seal or barrier from potential infection and has not been tested for long-term (>24 hours) use. The Bone Anchor components are listed below along with their function: - Bone Anchor (Skull Device) A device that is inserted into the Skull that is used . to hold an instrument or accessory in place after is it inserted to the desired position. Part of the Skull Fixation Device protrudes from the Skull. - Bone Anchor Driver (Driver) An optional device used to position the Skull . Fixation Device into the skull. - Bone Anchor Silicone Seal A device within the Bone Anchor which is . compressed against the inserted instrument or accessory when the Cap is tightened, thereby holding the instrument or accessory in place. - Bone Anchor Cap A device which connects to the Bone Anchor and, when . tightened, compresses the Silicone Seal against the inserted instrument or accessory. - . Bone Anchor Cover - An optional device which is placed over the Cap when inserting a flexible instrument or other accessory and can be locked into place on the Cap to secure the accessory.

The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction.

The SmartFrame OR is a hardware-only precision trajectory aiming device for procedures conducted entirely in the traditional operating room and in conjunction with commercially available optical navigation systems such as Medtronic Stealth Station S8, or functionally equivalent optical navigation systems. The SmartFrame OR Stereotactic System tower consists of three assemblies. The reference bracket arm attaches to the skull mount and the trajectory aiming tower is attached to the mount once it is affixed to the patient skull. The ring assembly of the base is attached to the patient's skull. The socket assembly fits over the two retaining blocks on the ring assembly and is secured with the tower thumbscrews. The SmartFrame OR Kit consists of the following Components: - 1x SmartFrame OR Tower ● - 1x Device Guide, 2.1mm - 1x Centering Ring ● - 1x Dock ● - 1x Lock - 1x Lock (2.1mm) ● - 1x SNS Thumb Wheel Extension ● - . 1x Thumb Screw Pack The plastic tower assembly is designed to provide multi-directional orientation adjustments to the Device Guide, which is a guide tube encased in the center of the tower assembly. The Device Guide has a 14-gauge central lumen through which a peel away sheath can be placed and oriented. The tower, when attached to the base assembly, provides adjustments in the roll, pitch, x, and y directions by turning the appropriate thumb wheels. The thumb wheels on the SMARTFrame are used to maneuver the Device Guide by either direct or indirect physician contact.

The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

The ClearPoint Bone Screw Fiducials are titanium bone screw fiducials that provide fixed reference points during neurosurgical procedures. The ClearPoint Bone Screw Fiducial Kit is provided sterile and is composed of the following: - 5x - ClearPoint Bone Screw Fiducials - 1x Bone Screw Fiducial holder - 1x Screwdriver The Bone Screw Fiducial is made of titanium and comprised of a threaded portion that is screwed into a patient's skull and a non-threaded, exposed length that protrudes from the patient's head. The head contains a feature for compatibility with a T8 Torx screwdriver and small divot positioned at the center of the spherical head which is used to center the pointer tip of a navigation tool. The Bone Screw Holder is intended to assist in holding the Bone Screw Fiducials securely to the screwdriver during anchoring. This is accomplished by allowing the screwdriver to mate with the Bone Screw Fiducial without the Bone Screw Fiducial separating from the assembly therefore allowing it to be anchored to the skull.

The ClearPointer is intended to be used in conjunction with the SmartFrame OR System and a compatible stereotactic optical navigation system for patient registration and navigation.

The ClearPointer Optical Navigation Wand is an optical tracker intended to be used with the SmartFrame OR Stereotactic System and ClearPoint Bone Screw Fiducials, both of which are subject of pending 510(k) submission. The ClearPointer is used in conjunction with a Medtronic StealthStation Navigation System to align the SmartFrame OR tower to the desired target. It is composed of 4 optical spheres and utilizes a sphere positional geometry that is recognizable by the Medtronic StealthStation S8 Optical navigation System. It is equipped with a Pointer attachment to allow for image registration and entry point location. The Pointer Attachment can also be removed from the Optical Tracker component, so that the Tracker can be mounted to a SmartFrame OR. The SmartFrame OR Hardware Kit is provided with the following components: - 1x ClearPointer™ ● - 1x Pointer Attachment ● - 1x Reference Array Bracket Arm ● - 1x Torx Screwdriver ● - 10x Reflective Spheres

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. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization and quantification 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 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 updated ClearPoint Software Version 2.2 integrates the ClearPoint Neuro Maestro Brain Model software (K213645) into the previous ClearPoint Software Version 2.1 (K222519). The ClearPoint Maestro™ Brain Model product is a stand-alone software application for automatic labeling, visualization, and quantification of segmentable brain structures from a set of MRI images and has been incorporated into the ClearPoint System software. The ClearPoint System described in this submission is essentially identical from a technological standpoint to the cleared predicate device described in K222519 (ClearPoint System). As mentioned above, since the prior clearance, the company has integrated the Maestro Brain Model into the software of the predicate device. Specifically, the company has released an updated version of software 2.1, which was part of the last clearance, and has now been upgraded to software 2.2. 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 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 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) (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. 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 and 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 Each of the above packs is sold separately and is intended to be used with the ClearPoint Workstation. Each of the components has been described in detail in previous submissions. The ClearPoint System described in this 510(k) is a modification to the company's cleared ClearPoint System (K222519).