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 Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ClearPoint System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy (Radial/Depth Error)	"targeting accuracy observed was as expected" and "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"
Targeting Error	"error less than 1.5mm"
Functionality	"the device functioned as intended"
Safety (MRI Compatibility)	Device is "MRI Conditional as defined by ASTM F2503" with no added patient risk from electromagnetic fields, evidenced by verification testing for image distortion, force/torque, and RF heating.
Workflow Performance	"at least comparable to the NeXframe MR... in terms of both accuracy and user ratings on a variety of procedure-related assessments."

2. Sample Sizes and Data Provenance

Test Set Sample Size:
- MRI Test Device Accuracy Testing: Not explicitly stated, but implies multiple tests were conducted with a "Test Device representative of the devices to be used."
- System Accuracy Comparison in a Skull Phantom: Not explicitly stated, but involved the ClearPoint System and the predicate Navigus II MR/NeXframe MR.
- System Accuracy Comparison in a Cadaver: One cadaver was used.
Data Provenance: The studies were internal validation studies conducted by SurgiVision, Inc., using phantoms and a cadaver. No information is provided regarding country of origin or whether it was retrospective or prospective in the context of clinical patient data, as these were pre-clinical validation studies.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. The studies described are technical performance assessments against pre-defined targets (phantoms) or comparisons to a predicate device in a cadaver, rather than diagnostic assessments requiring expert interpretation.

4. Adjudication Method (Test Set)

The document does not describe a formal adjudication method for ground truth in the test set. For the phantom studies, the ground truth was presumably the known pre-determined target or the expected performance based on the predicate device. For the cadaver study, it involved comparing the ClearPoint System's performance against the predicate Navigus II MR, likely using objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text refers to comparative effectiveness studies against a predicate device (Navigus II MR) and its performance, and user ratings on procedure-related assessments by a user, but not an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance assessment was conducted for the device's accuracy and functionality. The "ClearPoint System Accuracy Testing" and "System Accuracy Comparison in a Skull Phantom" sections describe tests of the system's ability to precisely position instruments and achieve targeting accuracy. These tests are focused on the device's inherent mechanical and software performance.

7. Type of Ground Truth Used

For Accuracy Testing:
- MRI Test Device Accuracy Testing: A "known pre-determined target in a phantom."
- System Accuracy Comparison in a Skull Phantom: Comparison against data previously obtained for the predicate Navigus II MR/NeXframe MR using the same model system. The predicate device's performance would serve as a de-facto ground truth or benchmark, assuming its accuracy had been previously established.
- System Accuracy Comparison in a Cadaver: Comparison against the predicate Navigus II MR/NeXframe MR's performance in accessing targets in a cadaver head.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for a "training set." The studies described are validation studies for the device's performance against established benchmarks or a predicate, not studies involving an AI or machine learning model that requires a dedicated training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI or machine learning model is mentioned in the provided text. The device is a "Neurological Stereotaxic Instrument" with associated software, not explicitly an AI-driven diagnostic or treatment planning system that would typically have a training set.

Summary

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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

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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

See the table below for a detailed comparison of the technological characteristics of the ClearPoint System and those of the predicate devices.

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RGIVISION, INC.'S CLEARPOINT SYSTEM - SUBSTANTIAL EQUIVALENCE COMPARISON

Characteristic	SurgiVision ClearPoint System	Navigus II MR (K012719)	Software package cleared with theAchieva, Intera and Panorama MRSystems (K063559)
Product Code	21 CFR 882.4560	HAW21 CFR 882.4560	LNH21 CFR 892.1000
Classification Regulation	Neurological Stereotaxic Instrument	Neurological Stereotaxic Instrument	Magnetic Resonance Diagnostic Device
Indications for Use	The ClearPoint System is intended toprovide stereotactic guidance for theplacement and operation of instruments ordevices during planning and operation ofneurological procedures within the MRIenvironment and in conjunction with MRimaging. The ClearPoint System isintended as an integral part of proceduresthat have traditionally used stereotacticmethodology. These procedures includebiopsies, catheter and electrode insertion.The System is intended for use only with1.5 Tesla MRI scanners.	The NAVIGUS II MR Trajectory Guide isintended to provide stereotactic guidancefor the placement and operation ofneurological procedures within the MRIenvironment and in conjunction with MRimaging. The Trajectory Guide is intendedas an integral part of procedures that havetraditionally used stereotactic methodology.These procedures include biopsies, catheterand electrode introduction. This device willprovide accurate delivery of devices orinstruments to target sites 3mm and larger.	The ACHIEVA, INTERA andPANORAMA 1.0T Release 2.5-seriesare magnetic resonance diagnosticdevices that produce cross-sectionalimages, spectroscopy images and/orspectra in any orientation of the internalstructure of the whole body. Theseimages when interpreted by a trainedphysician, yield information that mayassist in diagnosis. In addition theAchieva, Intera and Panorama 1.0Tdevices provide capabilities to performinterventional procedures in the head,body and extremities, which may befacilitated by MR techniques, such asreal time imaging. Such procedures mustbe performed with MR compatibleinstrumentation as selected and evaluatedby the clinical user.
Brief Device Description	System includes planning and navigationsoftware (ClearPoint Workstation, MRIonly) designed to work with hardware, theClearPoint SMARTFrame and accessories.Overall System is not specific to anyparticular neurosurgical procedure.	The NAVIGUS II MR Trajectory Guide is astereotactic frame that is intended to beused in conjunction with MR scannersoftware.Device is not specific to any particularneurosurgical procedure.	The update to the Philips Systemsoftware includes the following features.• Rapid Locus is a post-processingsoftware package intended for use tosupport the use of interventionalcoils and MR stereo-tacticlocalization devices to perform MR-guided interventional procedures.Using information from MR imagesregarding the coordinates of a user-specified region of interest, andfiducial coordinates, the softwareprovides an automatic calculation ofthe location and depth of the
Characteristic	SurgiVision ClearPoint System	Navigus II MR (K012719)	Software package cleared with theAchieva, Intera and Panorama MRSystems (K063559)
Principal OperatorUse Location	Neurosurgeon / MRI TechnicianMRI Suite	NeurosurgeonMRI Suite	targeted region of interest, such as alesion or suspected lesion.The Achieva, Intera and Panorama1.0T systems can be used forimaging during interventionalprocedures when performed withMR-compatible devices such as in-room display and MR-safe biopsyneedles.
Operating Principle	Stereotaxic guiding and fixation device,planning software	Stereotaxic guiding & fixation device	Neurosurgeon / MRI TechnicianMRI SuiteCan be used for planning andimplementation of neuro-interventionalprocedures in conjunction withstereotactic frames, such as the NavigusII MR
"Frameless" stereotaxy	Yes	Yes	N/A
MRI Compatible?	Yes	Yes	N/A
Software FacilitatesPlacement and Trajectoryof Surgical Devices	Yes	N/A	Yes
Software Features	Software features include:● pan● zoom (also: zoom to point, zoom toregion, zoom all viewports)● window width/level adjustment● greylevel invert (negative image)● measure lines● viewport resize● viewport maximize / restore (togglebetween current layout and 1x1layout of selected viewport)● viewport drag (drag from oneviewport to another to switchcontents)● reset● show/hide annotations	N/A	Software features include:● pan● zoom (also: zoom to point, zoomto region, zoom all viewports)● window width/level adjustment● greylevel invert (negative image)● measure lines● viewport resize● viewport maximize / restore(toggle between current layout and1x1 layout of selected viewport)● viewport drag (drag from oneviewport to another to switchcontents)● 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 FacilitatesTrajectory andTemporary Fixation ofNeurosurgical Devices	Yes	Yes	N/A
• crosshair controls - toggleshow/hide	• crosshair controls - toggleshow/hide
Materials (bodycontacting)	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 integralwith frame	Yes	No	N/A
Remote frame andtargeting 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 inaddition to the headmount	Marking Grid, Sheath, Stylet, Multiplediameter Guide Tubes, (2) Stop, Dock,Depth Stop, Hand Controller	MultiLumen Insert, Bridge (Centered &Offset), Fluid Stem, Titanium Stylet, DepthStop, 3 Peel Away Introducer Sheath(1.5mm I.D.), Multiple diameter GuideTubes	N/A

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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.

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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.

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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.

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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

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Indications for Use Statement

K100836 510(k) Number (if known):

Device Name: SurgiVision, Inc. ClearPoint System™

Indications for Use:

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 _

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).