Who is the manufacturer of CLEARPOINT SYSTEM?

Surgivision, Inc. filed the 510(k) submission for CLEARPOINT SYSTEM (K100836).

What is the FDA product code for CLEARPOINT SYSTEM?

ORR. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for CLEARPOINT SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CLEARPOINT SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CLEARPOINT SYSTEM

Q: What are the predicate devices for CLEARPOINT SYSTEM?

Navigus II MR Trajectory Guide (K012719); Philips Medical Systems software package for the Achieva, Intera and Panorama MR Systems (K063559).

K100836 · Surgivision, Inc. · ORR · Jun 16, 2010 · Neurology

Device Facts

Record ID	K100836
Device Name	CLEARPOINT SYSTEM
Applicant	Surgivision, Inc.
Product Code	ORR · Neurology
Decision Date	Jun 16, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

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.

Device Story

ClearPoint System provides stereotactic guidance for neurosurgical procedures within 1.5T MRI environment. System components include workstation laptop with planning/navigation software, SMARTGrid planning grid, SMARTFrame trajectory frame, handcontroller, and procedure drape. Physician uses workstation to plan trajectories based on MR images; SMARTFrame provides mechanical guidance and fixation for surgical instruments. MRI-visible fluids in targeting cannula and fiducial markers in frame base allow real-time trajectory feedback via MR imaging. System enables frameless stereotaxy; supports bilateral procedures. Used by neurosurgeons and MRI technicians in MRI suite. Output consists of visual guidance on workstation display, assisting surgeon in precise placement of biopsy needles, catheters, or electrodes. Benefits include accurate, image-guided delivery of instruments to target sites within brain, potentially improving procedural precision.

Clinical Evidence

No clinical trials on human subjects. Evidence consists of bench testing and cadaver studies. Accuracy testing in skull phantom demonstrated targeting error <1.5mm, comparable to Navigus II MR. Cadaver study compared workflow and accuracy against Navigus II MR, showing comparable performance and user ratings. Safety testing evaluated image distortion, force/torque, and RF heating in 1.5T MRI, confirming MRI conditional status per ASTM F2503.

Technological Characteristics

System includes workstation laptop, SMARTGrid, SMARTFrame, and accessories. Materials: polymer base with titanium screws. Sensing/actuation: mechanical trajectory frame with MRI-visible fiducial markers. Energy: MRI-compatible. Connectivity: standalone workstation. Sterilization: ethylene oxide. Software: planning and navigation.

Indications for Use

Indicated for stereotactic guidance during neurological procedures including biopsies, catheter, and electrode insertion in patients requiring such interventions within a 1.5T MRI environment.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

Navigus II MR Trajectory Guide (K012719)
Philips Medical Systems software package for the Achieva, Intera and Panorama MR Systems (K063559)

Related Devices

K160434 — ClearPoint System · Mri Interventions, Inc. · Mar 17, 2016
K171257 — ClearPoint System · Mri Interventions, Inc. · Oct 20, 2017
K142505 — ClearPoint System · Mri Interventions, Inc. · Oct 21, 2015
K202575 — ClearPoint Array System · ClearPoint Neuro, Inc. · Jan 22, 2021
K200079 — ClearPoint System and Accessories · Mri Interventions, Inc. · Feb 13, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ K100836 P. 1 of 7 # 510(k) SUMMARY SURGIVISION, INC.'S CLEARPOINT SYSTEM # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 Phone: 202.637.5600 Fax: 202.637.5910 Contact Person: John J. Smith, M.D., J.D. Date Prepared: June 16, 2010 #### Name of Device and Name/Address of Sponsor ClearPoint System™ SurgiVision, Inc. 5 Musick Irvine, CA 92618 ### Common or Usual Name Neurological Stereotaxic Instrument #### Classification 21 C.F.R. §882.4560 #### Predicate Devices Image-Guided Neurologics, Inc. Navigus II MR Trajectory Guide (K012719) Philips Medical Systems software package for the Achieva, Intera and Panorama MR Systems (K063559) ### Intended Use / Indications for Use 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 {1}------------------------------------------------ K100836 P. 2 of 7 used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion. The System is intended for use only with 1.5 Tesla MRI scanners. ### Technological Characteristics 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. See the table below for a detailed comparison of the technological characteristics of the ClearPoint System and those of the predicate devices. {2}------------------------------------------------ RGIVISION, INC.'S CLEARPOINT SYSTEM - SUBSTANTIAL EQUIVALENCE COMPARISON | Characteristic | SurgiVision ClearPoint System | Navigus II MR (K012719) | Software package cleared with the Achieva, Intera and Panorama MR Systems (K063559) | |------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | 21 CFR 882.4560 | HAW 21 CFR 882.4560 | LNH 21 CFR 892.1000 | | Classification Regulation | Neurological Stereotaxic Instrument | Neurological Stereotaxic Instrument | Magnetic Resonance Diagnostic Device | | Indications for Use | 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 NAVIGUS II MR Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. This device will provide accurate delivery of devices or instruments to target sites 3mm and larger. | The ACHIEVA, INTERA and PANORAMA 1.0T Release 2.5-series are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis. In addition the Achieva, Intera and Panorama 1.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user. | | Brief Device Description | System includes planning and navigation software (ClearPoint Workstation, MRI only) designed to work with hardware, the ClearPoint SMARTFrame and accessories. Overall System is not specific to any particular neurosurgical procedure. | The NAVIGUS II MR Trajectory Guide is a stereotactic frame that is intended to be used in conjunction with MR scanner software. Device is not specific to any particular neurosurgical procedure. | The update to the Philips System software includes the following features. • Rapid Locus is a post-processing software package intended for use to support the use of interventional coils and MR stereo-tactic localization devices to perform MR- guided interventional procedures. Using information from MR images regarding the coordinates of a user- specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the | | Characteristic | SurgiVision ClearPoint System | Navigus II MR (K012719) | Software package cleared with the Achieva, Intera and Panorama MR Systems (K063559) | | Principal Operator Use Location | Neurosurgeon / MRI Technician MRI Suite | Neurosurgeon MRI Suite | targeted region of interest, such as a lesion or suspected lesion. The Achieva, Intera and Panorama 1.0T systems can be used for imaging during interventional procedures when performed with MR-compatible devices such as in- room display and MR-safe biopsy needles. | | Operating Principle | Stereotaxic guiding and fixation device, planning software | Stereotaxic guiding & fixation device | Neurosurgeon / MRI Technician MRI Suite Can be used for planning and implementation of neuro-interventional procedures in conjunction with stereotactic frames, such as the Navigus II MR | | "Frameless" stereotaxy | Yes | Yes | N/A | | MRI Compatible? | Yes | Yes | N/A | | Software Facilitates Placement and Trajectory of Surgical Devices | Yes | N/A | Yes | | Software Features | Software features include: ● pan ● zoom (also: zoom to point, zoom to region, zoom all viewports) ● window width/level adjustment ● greylevel invert (negative image) ● measure lines ● viewport resize ● viewport maximize / restore (toggle between current layout and 1x1 layout of selected viewport) ● viewport drag (drag from one viewport to another to switch contents) ● reset ● show/hide annotations | N/A | Software features include: ● pan ● zoom (also: zoom to point, zoom to region, zoom all viewports) ● window width/level adjustment ● greylevel invert (negative image) ● measure lines ● viewport resize ● viewport maximize / restore (toggle between current layout and 1x1 layout of selected viewport) ● viewport drag (drag from one viewport to another to switch contents) ● reset ● show/hide annotations | | Characteristic | SurgiVision ClearPoint System | Navigus II MR (K012719) | Software package cleared with the Achieva, Intera and Panorama MR Systems (K063559) | | Hardware Facilitates Trajectory and Temporary Fixation of Neurosurgical Devices | Yes | Yes | N/A | | • crosshair controls - toggle show/hide | • crosshair controls - toggle show/hide | | | | Materials (body contacting) | Polymer Base with titanium screws into skull | Polymer Base with titanium screws into skull | N/A | | Range of motion | +/- 26 degrees roll, +/-33 degrees pitch | 25 degrees angular, 360 degrees rotation | N/A | | Burr Hole Size | 14mm | 14mm | N/A | | Bilateral option | Yes | Yes | N/A | | Fiducial markers | Yes | No | N/A | | Multi-lumen spacing | 2.5 degrees variable | 3mm fixed | N/A | | Targeting lumen integral with frame | Yes | No | N/A | | Remote frame and targeting control | Yes | No | N/A | | Bone screws | 3 | 3 | N/A | | Optional screw sites | Yes | Yes | N/A | | Single Use | Yes | Yes | N/A | | Sterilized | Yes | Yes | N/A | | Devices supplied by Mfr in addition to the head mount | Marking Grid, Sheath, Stylet, Multiple diameter Guide Tubes, (2) Stop, Dock, Depth Stop, Hand Controller | MultiLumen Insert, Bridge (Centered & Offset), Fluid Stem, Titanium Stylet, Depth Stop, 3 Peel Away Introducer Sheath (1.5mm I.D.), Multiple diameter Guide Tubes | N/A | K100836 P. 3 of 7 {3}------------------------------------------------ K100836 P-4 of 7 . {4}------------------------------------------------ K100836 P. 5 of 7 {5}------------------------------------------------ K100836 P. 6 of 7 ### Consensus Standards The ClearPoint System complies with the following recognized consensus standards: - NEMA PS 3.1 3.18 (2008) Digital Imaging and Communications in Medicine . (DICOM) Set. - AAMI/ANSI/ISO 10993-1 Biological evaluation of medical devices Part 1: . Evaluation and testing. - ANSI/AAMI/ISO 1135-1 Sterilization of health care products Ethylene oxide -. Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices. ### Performance Data SurgiVision has conducted software validation testing, as well as accuracy and safety testing of the ClearPoint System in multiple models and settings. In all instances, the device functioned as intended and targeting accuracy observed was as expected. This testing is described in detail below. #### ClearPoint System Accuracy Testing ## MRI Test Device Accuracy Testing This study was intended to demonstrate that a known pre-determined target in a phantom can be localized by the distal tip of a Test Device representative of the devices to be used with the ClearPoint System. The system software went through all procedural steps during this testing with the exception of the Marking Grid / Burr Hole location. This study demonstrated that the SMARTFrame can deliver a simulated device to the same X, Y, and Z coordinates as the Stylet/Sheath, and can deliver a simulated device to the projected X, Y, and Z coordinates without Stylet/Sheath confirmation. Finally, testing with actual medical devices (instead of simulated devices) had the same results. # System Accuracy Comparison in a Skull Phantom - Navigus II MR vs. ClearPoint System The goal of this comparison testing was to obtain accuracy results for the ClearPoint System using a skull phantom, and to compare those results with data previously obtained for the predicate Navigus II MR (also known as the "NeXframe MR") device using the same model system. The system software went through all steps during this testing with the exception of the Marking Grid / Burr Hole location. It was concluded that the ClearPoint System is at least as accurate as the NeXframe MR (used in conjunction with software on a cleared MRI scanner) in terms of radial error and depth error when placing a device at a target site in a simulated head/brain phantom. {6}------------------------------------------------ K100836 P. 7 of 7 # System Accuracy Comparison in a Cadaver - Navigus II MR vs. ClearPoint System A cadaver study was performed to compare the Navigus II MR ("NeXframe MR"), used in conjunction with software on a cleared MRI scanner, and the ClearPoint System for work flow performance and accuracy. The objective of the study was to perform procedures using the NeXframe MR and the ClearPoint System to access targets in a cadaver head. This testing demonstrated that the ClearPoint System was at least comparable to the NeXframe MR (used in conjunction with software on a cleared MRI scanner) in terms of both accuracy and user ratings on a variety of procedure-related assessments. ### Conclusions These test results demonstrate that the targeting accuracy of the ClearPoint System is as good as the Navigus II MR, when used in conjunction with MRI scanner software. The results support the safe and effective use of the ClearPoint System to guide a device to a brain target with an error less than 1.5mm. ## ClearPoint System Safety Testing Relevant components of the ClearPoint System were evaluated for interactions with the electromagnetic fields in an MRI suite. Specifically, the following interactions of the device components were evaluated: (1) image distortion; (2) force and torque; and (3) RF heating. With regard to image distortion, force and RF heating, the company conducted verification testing to ensure that the subject device components did not interfere with MR images and confirm their safety when used in conjunction with a 1.5T MRI scanner. The company concluded that the ClearPoint System is MRI Conditional as defined by ASTM F2503. The analysis and measurements performed by the company demonstrated that the presence of the ClearPoint System components do not expose a patient to added risk from the electromagnetic fields in a 1.5T MRI system. ### Substantial Equivalence The ClearPoint System is as safe and effective as the Navigus II MR Trajectory Guide used in conjunction with MRI scanner software, such as the software package cleared with the Philips Medical Systems' Achieva, Intera and Panorama MR Systems. The ClearPoint System has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the ClearPoint System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the ClearPoint System is as safe and effective as the predicate devices. Thus, the ClearPoint System is substantially equivalent. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Surgivision, Inc. c/o John J. Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 JUN 1 6 2010 Re: K100836 Trade/Device Name: Clearpoint System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ORR, LNH Dated: March 23, 2010 Received: March 24, 2010 Dear Mr. Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {8}------------------------------------------------ Page 2 - John J. Smith, M.D., J.D. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Qina Stumph f Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health . Enclosure {9}------------------------------------------------ Indications for Use Statement K100836 510(k) Number (if known): Device Name: SurgiVision, Inc. ClearPoint System™ Indications for Use: 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. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use. (Per 21 CFR 801.109) (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K100836 Page **_ of _**