(60 days)
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:
- ClearPoint Workstation Software (for trajectory planning and monitoring)
- 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:
- SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole)
a. Marking Grid
b. Marking Tool - 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 - Rescue Screws (Extra Titanium Screws)
- Thumbwheel Extension
- Accessory Kit
a. Peel-away Sheath
b. Stylet
c. Lancet
d. Depth Stop
e. Ruler - Scalp Mount Base
- 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).
The provide document primarily focuses on the substantial equivalence of the ClearPoint System (Software Version 2.2) to its predicate device (ClearPoint System Software Version 2.1) and the integration of functionalities from another cleared device (ClearPoint Maestro Brain Model K213645). While it mentions "Accuracy testing" and "acceptance criteria," the level of detail provided is insufficient to fully answer all aspects of your request, particularly regarding specific performance metrics for the integrated Maestro Brain Model functionalities, the study design for establishing ground truth, or details of multi-reader studies.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document mentions "Accuracy testing was performed to confirm that modifications included in ClearPoint System 2.2 did not cause any unexpected changes in the accuracy specifications of the software, with successful results." The Table 2, "ClearPoint System Accuracy Specifications," appears to represent the device's demonstrated performance against an underlying (but unstated) acceptance criterion for accuracy.
| Acceptance Criterion (Inferred from Predicate Claims) | Reported Device Performance (ClearPoint System Software Version 2.2) |
|---|---|
| Positional Error (e.g., within a certain range like ±1.5 mm @ ≤125mm, as stated in the comparison table for Targeting Accuracy) | Positional Error (mm) |
| Mean (X,Y,Z): 0.14, 0.16, 0.56 | |
| Std. Dev.: 0.37, 0.54, 0.57 | |
| 99% CI: 0.44, 0.60, 0.10 | |
| Angular Error (e.g., within a certain angular tolerance) | Angular Error (deg.) |
| Mean: 0.32° | |
| Std. Dev.: 0.17° | |
| 99% CI: 0.46° |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for "Accuracy testing" or for the validation of the Maestro Brain Model functionalities. It broadly states "ClearPoint Neuro performed extensive Non-Clinical Verification Testing." No information on data provenance (country of origin, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Workflow for verifying the brain structure segmentation results" for the Maestro Brain Model functionality, which implies a human review process, but no specifics are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the integration of an existing cleared software and ensuring the overall system's accuracy specifications are maintained. The AI component (automatic segmentation of brain structures) is integrated, but its comparative effectiveness with human readers is not detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone validation of the "Maestro Brain Model" functionality was likely already done as part of its original 510(k) clearance (K213645). The current submission states, "The inclusion of the Maestro Brain Model functionalities incorporates the functions of a standalone software product that has previously been subject of a cleared 510(k), (K213645)."
While the specific standalone performance metrics for K213645 are not reproduced in this document, the fact that it was a "stand-alone software application for automatic labeling, visualization, and quantification of segmentable brain structures" implies that its performance as an algorithm-only component was evaluated during its initial clearance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used. For "Accuracy testing" related to positional and angular error, it typically involves phantom studies or precisely measured landmarks. For the brain structure segmentation, the "Maestro Brain Model" clearance (K213645) would have established its own ground truth, likely involving expert-drawn segmentations or anatomical atlases. The current submission only refers to the pre-existing clearance.
8. The sample size for the training set
The document does not provide any information regarding the sample size for the training set for any of the software's components, including the Maestro Brain Model.
9. How the ground truth for the training set was established
The document does not provide any information on how the ground truth for the training set was established. This information would typically be part of the original 510(k) submission for the Maestro Brain Model (K213645), which is referenced as a predicate, but not detailed here.
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November 27, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ClearPoint Neuro Inc. Brennan Sullivan Regulatory Affairs Manager 120 S. Sierra Avenue, Suite 100 Solana Beach, California 92075
Re: K233243
Trade/Device Name: ClearPoint System (Software Version 2.2) Regulation Number: 21 CFR 882.4560 Regulation Name: Neurological Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, QIH Dated: September 28, 2023 Received: September 28, 2023
Dear Brennan Sullivan:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Image /page/1/Picture/6 description: The image shows the name "Adam D. Pierce -S" in large, bold font. To the right of the name, there is a digital signature that also says "Adam D. Pierce -S". The signature includes the date "2023.11.27" and the time "13:25:33-05'00'".
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233243
Device Name
ClearPoint System (Software Version 2.2)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
A. Device Information
| Category | Comments |
|---|---|
| Sponsor: | ClearPoint Neuro, Inc.6349 Paseo Del LagoCarlsbad, CA 92011 |
| Correspondent ContactInformation: | Brennan Sullivan120 S. Sierra Ave.Solana Beach, CA 92075617-678-1028bsullivan@clearpointneuro.com |
| Device Common Name: | Neurological Stereotactic Instrument |
| Device Regulation & Name: | Neurological Stereotaxic Instrument, 21CFR882.4560 |
| Classification & Product Code: | Class IIHAW |
| 510(k) Number: | K233243 |
| Device Proprietary Name: | ClearPoint System Software Version 2.2 |
Primary Predicate Device Information:
| Predicate Device: | ClearPoint System (v2.1) |
|---|---|
| Predicate Device Manufacturer: | ClearPoint Neuro, Inc. |
| Predicate Device Common Name: | Neurological Stereotactic Instrument |
| Predicate Device Premarket Notification # | K222519 |
| Predicate Device Classification & Name | Neurological Stereotaxic Instrument, |
| 21CFR 882.4560 | |
| Predicate Device Classification &Product Code: | Class IIHAW |
Additional Predicate Device Information:
| Predicate Device: | ClearPoint Maestro Brain Model |
|---|---|
| Predicate Device Manufacturer: | ClearPoint Neuro, Inc. |
| Predicate Device Common Name: | System, Image Processing,Radiological |
| Predicate Device Premarket Notification # | K213645 |
| Predicate Device Classification & Name | Medical Imaging Management andProcessing System, 21CFR 892.2050 |
| Predicate Device Classification &Product Code: | Class IIQIH |
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B. Date Summary Prepared
November 27, 2023
C. Description of Device
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:
-
- ClearPoint Workstation Software (for trajectory planning and monitoring)
-
- 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:
-
- SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole)
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ClearPoint Neuro, Inc.
ClearPoint System Software Version 2.2
- Marking Grid a.
- b. Marking Tool
-
- 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)
- Screwdriver e.
- f. Roll Lock Screw and Washer
-
- Rescue Screws (Extra Titanium Screws)
-
- Thumbwheel Extension
-
- Accessory Kit
- a. Peel-away Sheath
- b. Stylet
- c. Lancet
- d. Depth Stop
- e. Ruler
-
- Scalp Mount Base
-
- 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).
D. 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. 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 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.
{7}------------------------------------------------
E. Comparison of Technological Characteristics
ClearPoint System (Software Version 2.2) is substantially equivalent to the previously cleared ClearPoint System (Software Version 2.1) (K222519). The subject device's hardware is identical in design and technological characteristics. The differences between the proposed and predicate devices are modifications to the software to include additional tunctionality that has been previously cleared in the ClearPoint Neuro Maestro 510(k) (K213645).
Both the proposed and predicate ClearPoint Systems are 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. Specifically, the following modifications have been made in ClearPoint Software Version 2.2:
- . Integration of Maestro Brain Model functionalities:
- O Optional automatic segmentation of anatomical cortical and subcortical structures at user request.
- o Visualization of brain structure segmentations overlaid semi-transparently onto 2D views of any registered scan.
- Visualization of brain structure segmentations as polygon models embedded in the o scene in 3D views of any registered scan.
- o Computation of volume measurements corresponding to each segmented brain structure.
- O Workflow for verifying the brain structure segmentation results.
- o Summarizing brain structure volume measurements in a clinical procedure report.
- Full compatibility with Windows 11 Operating System ●
- Ability to load color DICOM images stored with RGB Photometric Interpretation. ●
- . Capabilities to display images in either Neurological or Radiological viewing orientation within the application viewports according to user preference.
- . Ability to express anatomical coordinate values and associated landmarks relative to an origin point at either the mid-commissure (MCP) point or posterior commissure (PC) point.
- A new set of measurement graphic tool improvements ●
- Some workflow-specific optimizations which provide more efficient and generalized software workflow.
- Translating the software user interface to support nine additional languages.
These modifications were made as part of continuous product improvement efforts. Specifically, the modifications allow for enhanced functionality and compatibility of the ClearPoint System. The inclusion of the Maestro Brain Model functionalities incorporates the functions of a standalone software product that has previously been subject of a cleared 510(k), (K213645). These changes have been verified and validated and do not raise any different questions of safety or effectiveness.
{8}------------------------------------------------
- Optional automatic segmentation of anatomical cortical and subcortical structures at user ● request.
- Visualization of brain structure segmentations overlaid semi-transparently onto 2D views of any registered scan.
- Visualization of brain structure segmentations as polygon models embedded in the scene ● in 3D views of any registered scan.
- Computation of volume measurements corresponding to each segmented brain structure. ●
- Workflow for verifying the brain structure segmentation results.
- . Summarizing brain structure volume measurements in a clinical procedure report.
These changes to the ClearPoint System 2.1 Software have been validated and do not impact the safety or efficacy of the device. A substantial equivalence chart comparing the similarities and differences between the ClearPoint System and its predicate device is provided below. The primary differences between the proposed ClearPoint System 2.2 and the predicate are the incorporation of the functionality of an additional 510(k)-cleared device and additional minor differences in the technological characteristics between the Proposed device and the predicate do not raise different questions of safety or efficacy.
| Characteristic | Proposed ClearPoint System(v2.2) | Primary PredicateClearPoint System (v2.1)K222519 | Reference PredicateClearPoint MaestroK213645 |
|---|---|---|---|
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 892.2050 |
| Product Code | HAW | HAW | QIH |
| Indications for Use | The ClearPoint System is intended toprovide stereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedures within theMRI environment and in conjunctionwith MR imaging. During planning,the system is intended to providefunctionality for the automaticidentification, labeling, visualizationand quantification of segmentablebrain structures from a set of loadedMR images. The ClearPoint Systemis intended as an integral part ofprocedures that have traditionallyused stereotactic methodology.These procedures include biopsies,catheter and electrode insertionincluding deep brain stimulation(DBS) lead placement. The Systemis intended for use only with 1.5 and | The ClearPoint System is intended toprovide stereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedures within theMRI environment and in conjunctionwith MR imaging. The ClearPointSystem is intended as an integral partof procedures that have traditionallyused stereotactic methodology.These procedures include biopsies,catheter and electrode insertionincluding deep brain stimulation(DBS) lead placement. The Systemis intended for use only with 1.5 and3.0 Tesla MRI scanners and MRconditional implants and devices. | ClearPoint Maestro™ BrainModel is intended forautomatic labeling,visualization, volumetric andshape quantification ofsegmentable brain structuresfrom a set of MR images.This software is intended toautomate the process ofidentifying, labelling, andquantifying the volume andshape of brain structuresvisible in MRI images. |
| 3.0 Tesla MRI scanners and MRconditional implants and devices. | |||
| Environment | MRI Suite | MRI Suite | MRI Suite |
| SMARTGrid Pack | MRI Planning Grid & Markingtool | MRI Planning Grid & Markingtool | NA |
| SMARTFramePack | SmartFrame XG, Scalp MountBase, Bone Screws, Stand-OffPins, Screwdriver, CenteringTool, Wharen Centering Guide(packaged and sold separately),Dock and Lock, Roll Lock Screwwith Washer, Rescue Screws(packaged separately) | SmartFrame XG, Scalp MountBase, Bone Screws, Stand-OffPins, Screwdriver, CenteringTool, Wharen Centering Guide(packaged and sold separately),Dock and Lock, Roll LockScrew with Washer, RescueScrews (packaged separately) | NA |
| Hand Controller | Thumbwheel Extension(Light Hand Controller) | Thumbwheel Extension (LightHand Controller) | NA |
| Accessory pack | Peel away sheath, Lancet, Stylet,Depth stop, ruler | Peel away sheath, Lancet, Stylet,Depth stop, ruler | NA |
| Drill Guides | 4.5 mm & 6.0 mm | 4.5 mm & 6.0 mm | NA |
| Targeting CannulaID | 0.0825" | 0.0825" | NA |
| Targeting CannulaMaterial | Ultem and PEEK | Ultem and PEEK | NA |
| Guide Tube/DeviceGuide/Drill GuideID | Drill Guide ID: 4.5 mm(included in SmartFrame Pack)Drill Guide Tube ID: 3.4 mm(included in SmartFrame Pack)Guide Tube ID: 3.2 mmGuide Tube ID: 2.5 mmGuide Tube ID: 2.1 mmGuide Tube ID: 1.7 mm | Drill Guide ID: 4.5 mm(included in SmartFrame Pack)Drill Guide Tube ID: 3.4 mm(included in SmartFrame Pack)Guide Tube ID: 3.2 mmGuide Tube ID: 2.5 mmGuide Tube ID: 2.1 mmGuide Tube ID: 1.7 mm | NA |
| Targeting Accuracy | ± 1.5 mm @ ≤125mm | ± 1.5 mm @ ≤125mm | NA |
| Packaging | Sterile, Sealed Tray, InsideSterile Tyvek Pouch (WharenCentering Guide and Drill andDevice Guides are Sterile in adouble Tyvek Pouch Without aTray; Wharen Centering GuidePackaging includes PVC) | Sterile, Sealed Tray, InsideSterile Tyvek Pouch (WharenCentering Guide and Drill andDevice Guides are Sterile in adouble Tyvek Pouch Without aTray; Wharen Centering GuidePackaging includes PVC) | NA |
| Software | Version 2.2 | Version 2.1 | Version 1.0 |
| Operating System | Windows 10, Windows 11 | Windows 10 | Windows 10 |
| ProgrammingLanguages | Visual C#Visual C++ | Visual C#Visual C++ | C++Qt |
| VisualizationSoftware Toolkit | Fovia HDVR® | Fovia HDVR® | Visualization Toolkit(VTK) |
| VisualizationFeatures | Display of MR and CT images in reformatted (MPR) and 3D views.Cross-reference line display with current plane intersection correlation point indication | Display of MR and CT images in reformatted (MPR) and 3D views.Cross-reference line display with current plane intersection correlation point indication | Display of MR images in reformatted (MPR) and 3D views.Cross-reference line display with current plane intersection |
| ClearPoint Neuro, Inc. | K233243 | ||
| ClearPoint System Software Version 2.2 | Page 7 of 10 | ||
| Display of 2D annotations and overlays on rendered images General interactive tools (e.g., pan, zoom, width/level, etc.) 3D display of hardware models of the SMARTGrid and SMARTFrame along with volumetric image sets | Display of 2D annotations and overlays on rendered images General interactive tools (e.g., pan, zoom, width/level, etc.) 3D display of hardware models of the SMARTGrid and SMARTFrame along with volumetric image sets | correlation point indication Display of 2D annotations and overlays on rendered images General interactive tools (e.g., pan, zoom, width/level, etc.) | |
| DICOM Toolkit | MergeCOM-3 Dicom Toolkit® | MergeCOM-3 Dicom Toolkit® | Insight Toolkit (ITK) |
| DICOM Features | Transfer of images from MR scanner through network (TCP/IP) Browse/load images from media/local storage Configuration and testing of image transfer from scanner to workstation Load enhanced/compressed DICOM images Load color DICOM images that are stored with RGB Photometric Interpretation | Transfer of images from MR scanner through network (TCP/IP) Browse/load images from media/local storage Configuration and testing of image transfer from scanner to workstation Load enhanced/compressed DICOM images | Browse/load images from media/local storage Load enhanced / compressed DICOM images Export bitmask of segmented brain structures in DICOM format |
| Image RegistrationFramework | Insight Toolkit (ITK) | Insight Toolkit (ITK) | NA |
| ImageFusion/Registration | Ability to automatically register/fuse MR-to-MR and MR-to-CT images acquired in different frames of reference Ability to seed automatic registration/fusion based on an initial input transform Slider control used to set the relative weight of the two blended image volumes Tools for reviewing the accuracy of registration and manual override capabilities | Ability to automatically register/fuse MR-to-MR and MR-to-CT images acquired in different frames of reference Ability to seed automatic registration/fusion based on an initial input transform Slider control used to set the relative weight of the two blended image volumes Tools for reviewing the accuracy of registration and manual override capabilities | NA |
| Volume of InterestDefinition | Ability to define and visualize 3D structures within a loaded image set Tools for defining 3D volumes of interest manually Display and computation of volume interest measurements (e.g., total volume, volume overlap) | Ability to define and visualize 3D structures within a loaded image set Tools for defining 3D volumes of interest manually Display and computation of volume interest measurements (e.g., total volume, volume overlap) | NA |
| ClearPoint System Software Version 2.2 | Page 8 of 10 | ||
| ImageSegmentationAlgorithm | Algorithm to automaticallyidentify anterior commissure(AC) and posteriorcommissure (PC) locationswithin the brain. Thisalgorithm has the sameimplementation as in thepredicate device. Algorithms to automaticallylocate and identify markinggrid, targeting framecomponents, cannula, anddevice tip. These algorithmshave the sameimplementation as in thepredicate device. Automated measurement ofbrain tissue volumes andstructures. This algorithmhas the sameimplementation as thepredicate device. Automatic segmentation andquantification of brainstructures using proprietaryshape-constrainedsegmentation algorithms.These algorithms have thesame implementation as thepredicate device. | Algorithm to automaticallyidentify anterior commissure(AC) and posteriorcommissure (PC) locationswithin the brain.Algorithms to automaticallylocate and identify markinggrid, targeting framecomponents, cannula, anddevice tip. | Automatedmeasurement of braintissue volumes andstructures.Automaticsegmentation andquantification of brainstructures usingproprietary shape-constrainedsegmentationalgorithms. |
| Scan PlaneParameters | Geometric computations todisplay position and orientationof prescribed scan planeparameters for Siemens, Philips,and GE MR scannermanufacturers. | Geometric computations todisplay position and orientationof prescribed scan planeparameters for Siemens, Philips,and GE MR scannermanufacturers. | NA |
| HardwareAdjustmentComputations | Computations used to indicaterequired frame adjustmentsneeded to adjust cannula todesired trajectory. Thesecomputations are the same as inthe predicate device | Computations used to indicaterequired frame adjustmentsneeded to adjust cannula todesired trajectory | NA |
| Low-Level MathLibrary | Low-level math utilities used forgeometric computations. Theseutilities are the same as in thepredicate device | Low-level math utilities used forgeometric computations. | Identical |
| Workflow | Optional workflow for initiatingan automatic segmentation ofbrain structures from a loadedMR scan and visualizing /verifying the results. | No ability to perform automaticsegmentation of brain structuresfrom a loaded MR scan. | Optional workflow forinitiating an automaticsegmentation of brainstructures from a loadedMR scan and |
| visualizing/verifying theresults. | |||
| Visualize segmented brainstructures as overlays on anyscan loaded into the application | No ability to visualize segmentedbrain structures | Visualize segmentedbrain structures asoverlays on a referencescan loaded into theapplication | |
| Output volumetricmeasurements corresponding toeach segmented brain structure | No ability to present volumemeasurements for segmentedbrain structures | Output volumetricmeasurementscorresponding to eachsegmented brain structure |
Table 1: Side-by-side comparison of ClearPoint System (Software Version 2.2) with Predicate Device
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ClearPoint System Software Version 2,2
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F. Summary of Supporting Data
ClearPoint Neuro performed extensive Non-Clinical Verification Testing to evaluate the safety and performance of the software components of ClearPoint System (Software Version 2.2). The following software verification testing was performed:
- Automated Verification ●
- Integrated System Verification
- Localization Verification ●
- Regression Test Verification ●
- Manual Testing .
The results of all testing met the acceptance criteria and demonstrated that the proposed ClearPoint System (Software Version 2.2) complies with all design specifications and performs as expected.
G. Discussion of Performance Data
Accuracy testing was performed to confirm that modifications included in ClearPoint System 2.2 did not cause any unexpected changes in the accuracy specifications of the software, with successful results. Table 2 outlines the demonstrated accuracy specifications of ClearPoint System.
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| Performance Validation | Positional Error (mm) | Angular Error (deg.) | ||||
|---|---|---|---|---|---|---|
| ClearPoint System | Mean (X,Y,Z) | Std. Dev. | 99% CI | Mean | Std. Dev. | 99% CI |
| 0.14 | 0.37 | 0.44 | 0.32° | 0.17° | 0.46° | |
| 0.16 | 0.54 | 0.60 | ||||
| 0.56 | 0.57 | 0.10 |
Table 2: ClearPoint System Accuracy Specifications
H. Conclusion
The subject ClearPoint System (Version 2.2) and the predicate ClearPoint System (Version 2.1) have similar indications for use, technological characteristics, and principles of operation. In addition, the minor differences in the ClearPoint Version 2.2 Software do not alter the fundamental clinical purpose or present different questions of safety or effectiveness as compared to the ClearPoint System 2.1 predicate. Thus, the ClearPoint System Version 2.2 Software is substantially equivalent to the ClearPoint System 2.1 (K222519).
§ 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).