(58 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 an operating room environment and in conjunction with MR and/or CT imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization of segmentable brain structures from a set of loaded MR images. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (DBS) (asleep or awake) lead placement. When used in an MRI environment, the system is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.
The updated ClearPoint Software Version 3.0 introduces modifications to support a new clinical workflow using intraoperative CT imaging when compared to the previous ClearPoint Software Version 2.2 (K233243). The ClearPoint System described in this submission is essentially identical from a technological standpoint to the cleared predicate device described in K233243 (ClearPoint System version 2.2). As mentioned above, since the prior clearance, the company has implemented software features to enable usage of the ClearPoint System during CT-guided procedures, in addition to MR-guided procedures supported in the predicate device. The hardware components are unchanged from the device described in K233243 and minor changes were made to the indications for use.
The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid Planning Grid, the SMARTFrame Trajectory Frame, the SMARTFrame Accessory Kit and the SMARTFrame Thumbwheel Extension. The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the guidance and fixation for neurosurgical tools. The image-visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the intraoperatively acquired images, makes changes and confirms with subsequent image acquisitions. Optionally, the ClearPoint System can be used with any head fixation frame to immobilize the patient's head with respect to the scanner table. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint System. The ClearPoint Workstation includes the ClearPoint Workstation Software (for trajectory planning and monitoring) and a Laptop Computer. The hardware components of the current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile and include the SMARTGrid Planning Grid (Marking Grid, Marking Tool), SMARTFrame Pack (SMARTFrame or SMARTFrame XG, Centering Device and Wharen Centering Guide, Dock, Device Lock, Screwdriver, Roll Lock Screw and Washer), Rescue Screws (Extra Titanium Screws), Thumbwheel Extension, Accessory Kit (Peel-away Sheath, Stylet, Lancet, Depth Stop, Ruler), Scalp Mount Base, and Guide Tubes and Device Guide Packs (Guide Cannulas). In addition, the ClearPoint System is used with the separately cleared or Class I, 510(k) exempt products: SmartTip MRI Hand Drill and Drill Bit Kit, MRI Neuro Procedure Drape, with Marker Pen and Cover, and SmartFrame Fiducial.
The provided document (K243657) is a 510(k) Premarket Notification for the ClearPoint System (Software Version 3.0), which is a stereotaxic instrument. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the non-clinical testing performed.
Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, addressing each point as much as possible:
1. A table of acceptance criteria and the reported device performance
The document provides accuracy specifications in tables:
Table 1: ClearPoint System Accuracy Specifications - MRI Guidance (Unchanged from predicate)
| 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 |
Note: The table layout in the original document for MRI accuracy is a bit unusual with duplicated rows for positional error, and it's not explicitly labelled as "acceptance criteria." However, it presents the validated performance.
Table 2: ClearPoint System Accuracy Specifications - CT Guidance (New for v3.0)
| Precision ME (mm) | Accuracy RMS (mm) | Accuracy Max (mm) | |
|---|---|---|---|
| X | 0.1 | 0.17 | 0.3 |
| Y | 0.1 | 0.17 | 0.3 |
| Z | 0.1 | 0.17 | 0.3 |
| Roll | 0.1° | 0.17° | 0.3° |
| Pitch | 0.1° | 0.17° | 0.3° |
| Yaw | 0.1° | 0.17° | 0.3° |
| Positional Error (mm) | Trajectory Angle Error (Degrees) | ||||
|---|---|---|---|---|---|
| Mean | Standard Deviation | 99% CI Upper Bound | Mean | Standard Deviation | 99% CI Upper Bound |
| 0.81 | 0.49 | 0.93 | 0.31 | 0.23 | 0.37 |
Explicit Acceptance Criteria (from "Targeting Accuracy" row in Table 3 comparison):
- Targeting Accuracy: ± 1.5 mm @ ≤125mm (This appears to be the primary specified acceptance criterion for overall targeting accuracy, presumably applying across both MRI and CT guidance given its placement in the general comparison table).
Reported Device Performance:
- MRI Guidance: Positional Error (99% CI) 0.44 mm, 0.60 mm, 0.10 mm. Angular Error (99% CI) 0.46°. These values are well within the ± 1.5 mm overall targeting accuracy.
- CT Guidance: Positional Error (99% CI Upper Bound) 0.93 mm. Trajectory Angle Error (99% CI Upper Bound) 0.37°. These values are also well within the ± 1.5 mm overall targeting accuracy.
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 states:
- "Accuracy testing was performed using an MRI scanner to confirm that modifications included in the ClearPoint System 3.0 did not cause any unexpected changes in the accuracy specifications of the software, with successful results."
- "Additionally, accuracy testing was performed in a CT scanner to validate the CT-guided clinical workflow that is new to the ClearPoint 3.0 software and establish new ground-truth accuracy specifications."
However, the document does not specify the sample size for either the MRI or CT accuracy test sets.
The data provenance is also not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of accuracy testing for a stereotaxic device, these are typically phantom-based, prospective tests conducted in a controlled lab or clinical environment, rather than patient data studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention human experts for establishing ground truth for the accuracy tests. The accuracy testing described appears to be technical validation against a known physical ground truth (e.g., phantom measurements), as is common for stereotaxic instrument validation. Therefore, expert consensus on images is not relevant for this type of accuracy assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the accuracy testing described is a technical validation against a physical ground truth, not a study evaluating human interpretation or a scenario requiring adjudication.
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 MRMC comparative effectiveness study or any evaluation of human readers (even though the device has "automatic identification, labeling, visualization" of structures). The testing detailed is primarily focused on the system's technical accuracy in guidance, not on AI assistance for human image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the accuracy testing described in Section 6, "Non-Clinical Testing," and detailed in Tables 1 and 2, represents standalone (algorithm only) performance testing against a technical ground truth. It evaluates the system's precision and accuracy in positional and angular measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the accuracy tests appears to be physical measurements from a phantom or test setup, given the context of "Positional Error" and "Angular Error" in millimeters and degrees. The document refers to "establish new ground-truth accuracy specifications" in relation to the CT testing, implying a precise, measurable standard. This is typical for the technical validation of stereotaxic guidance systems.
8. The sample size for the training set
The document does not specify a sample size for a "training set." The ClearPoint System 3.0 software introduces features like "automatic identification, labeling, visualization, and quantification of segmentable brain structures" and "Algorithms to automatically locate and identify marking grid, targeting frame components, cannula, and device tip from both MR and CT image sets." While these imply the use of machine learning or advanced algorithms that would require training data, the submission focuses on the validation of these features' accuracy, not on the details of their development (including training data specifics).
9. How the ground truth for the training set was established
Since the document does not discuss a training set, there is no information provided on how its ground truth was established. For the algorithms processing anatomical structures or hardware components, the ground truth for training data would typically involve manually annotated medical images by qualified personnel (e.g., radiologists, neurosurgeons, or trained annotators under expert supervision).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the date January 24, 2025. The text is written in a clear, sans-serif font. The date is presented in a standard format, with the month, day, and year clearly indicated. The text is horizontally aligned and evenly spaced.
ClearPoint Neuro, Inc. Brennan Sullivan Regulatory Affairs Manager 120 S. Sierra Ave., Suite 100 Solana Beach, California 92075
Re: K243657
Trade/Device Name: ClearPoint System (Software Version 3.0) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 26, 2024 Received: November 27, 2024
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 (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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
{1}------------------------------------------------
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).
Your device is also subject to, among other requirements, the Quality System (OS) 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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
{2}------------------------------------------------
assistance/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).
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Adam D. Pierce -S, and the date of the signature is 2025.01.24. The time of the signature is 12:36:19 -05'00'. The image also includes the word 'Sincerely,'.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K243657
Device Name ClearPoint System (Software Version 3.0)
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 an operating room environment and in conjunction with MR and/or CT imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization of segmentable brain structures from a set of loaded MR images. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (DBS) (asleep or awake) lead placement. When used in an MRI environment, the system is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) Summary for the ClearPoint Neuro ClearPoint 3.0 Software (per 21CFR 807.87)
1. SUBMITTER/510(K) HOLDER
ClearPoint Neuro, Inc. 6349 Paseo Del Lago Carlsbad, CA 92011 Contact Person: Brennan Sullivan Telephone: 617-678-1028
Date Prepared: January 24, 2025
2. DEVICE INFORMATION
| Name of Device: | ClearPoint System 3.0 Software |
|---|---|
| Common or Usual Name: | ClearPoint System |
| Classification: | Neurological Stereotaxic Instrument, 21CFR 882.4560 |
| Regulatory Class: | Class II |
| Product Code | HAW |
3. PREDICATE DEVICES
| • ClearPoint Software Version 2.2 | K233243 |
|---|---|
| • ClearPoint Software Version 2.1 | K222519 |
4. DEVICE DESCRIPTION
The updated ClearPoint Software Version 3.0 introduces modifications to support a new clinical workflow using intraoperative CT imaging when compared to the previous ClearPoint Software Version 2.2 (K233243). The ClearPoint System described in this submission is essentially identical from a technological standpoint to the cleared predicate device described in K233243 (ClearPoint System version 2.2). As mentioned above, since the prior clearance, the company has implemented software features to enable usage of the ClearPoint System during CT-guided procedures, in addition to MR-guided procedures supported in the predicate device. The hardware components are unchanged from the device described in K233243 and minor changes were made to the indications for use.
The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid Planning Grid, the SMARTFrame Trajectory Frame, the SMARTFrame Accessory Kit and the SMARTFrame Thumbwheel Extension. The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the guidance and fixation for neurosurgical tools.
{5}------------------------------------------------
The image-visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the intraoperatively acquired images, makes changes and confirms with subsequent image acquisitions.
Optionally, the ClearPoint System can be used with any head fixation frame to immobilize the patient's head with respect to the scanner table. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint System.
The ClearPoint Workstation includes the 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 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)
- SMARTFrame ("ATF") with Base a.
- b. Centering Device and Wharen Centering Guide
- c. Dock
- d. Device Lock
- e. Screwdriver
- Roll Lock Screw and Washer f.
-
- Rescue Screws (Extra Titanium Screws)
-
- Thumbwheel Extension
-
- Accessory Kit
- a. Peel-away Sheath
- b. Stylet
- c. Lancet
- d. Depth Stop
- Ruler e.
-
- 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
{6}------------------------------------------------
- SmartFrame Fiducial ●
Each of the above packs is sold separately and is intended to be used with the ClearPoint System. 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 (K233243).
5. 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 an operating room environment and in conjunction with MR and/or CT imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization, 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) (asleep or awake) lead placement. When used in an MRI environment, the system is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.
6. NON-CLINICAL TESTING
ClearPoint Neuro performed extensive Non-Clinical Verification Testing to evaluate the safety and performance of the software components of ClearPoint System (Software Version 3.0). The following software verification testing was performed:
- Automated Verification
- Integrated System Verification using Magnetic Resonance Imaging ●
- Regression Test Verification ●
- Manual Testing
- Accuracy Verification using Computed Tomography Imaging
The results of all testing met the acceptance criteria and demonstrated that the proposed ClearPoint System (Software Version 3.0) complies with all design specifications and performs as expected.
Accuracy testing was performed using an MRI scanner to confirm that modifications included in the ClearPoint System 3.0 did not cause any unexpected changes in the accuracy specifications of the software, with successful results. Additionally, accuracy testing was performed in a CT scanner to validate the CT-guided clinical workflow that is new to the ClearPoint 3.0 software and establish new ground-truth accuracy specifications. Table 1 outlines the demonstrated accuracy specifications of ClearPoint System using MRI guidance and is unchanged with respect to the predicate device. Table 2 outlines the demonstrated accuracy specifications of ClearPoint System with CT image-guidance.
{7}------------------------------------------------
| 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 |
| Variable | Precision ME (mm) | Accuracy RMS (mm) | Accuracy Max (mm) |
|---|---|---|---|
| X | 0.1 | 0.17 | 0.3 |
| Y | 0.1 | 0.17 | 0.3 |
| Z | 0.1 | 0.17 | 0.3 |
| Roll | 0.1° | 0.17° | 0.3° |
| Pitch | 0.1° | 0.17° | 0.3° |
| Yaw | 0.1° | 0.17° | 0.3° |
| Positional Error (mm) | Trajectory Angle Error (Degrees) | ||||
|---|---|---|---|---|---|
| Mean | Standard Deviation | 99% CI Upper Bound | Mean | Standard Deviation | 99% CI Upper Bound |
| 0.81 | 0.49 | 0.93 | 0.31 | 0.23 | 0.37 |
Table 2: ClearPoint System Accuracy Specifications - CT
7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
ClearPoint System (Version 3.0) is substantially equivalent to the previously cleared ClearPoint System (Version 2.2) (K233243) and the reference device StealthStation Cranial Software, v3.1.5 (K231976). The subject device's hardware is identical in design and technological characteristics to the predicate device. The differences between the proposed and predicate devices are modifications to the software to enable its use during CT-guided neurosurgical procedures.
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 in conjunction with MR imaging. The primary technological differences between the subject ClearPoint 3.0 and ClearPoint 2.2 predicate device are the following:
- Introduction of a full set of software modifications to support a clinical workflow ● using intraoperative CT imaging
- Introduction of the ability to automatically segment ClearPoint System hardware components from CT images (i.e., marking grid, frame markers, targeting cannula, inserted device)
- Introduction of a new set of image fusion tool improvements ●
- Introduction a set of tools and features to improve the clinical workflow post device ● insertion
- Obsolescence of product features that have very limited usage clinically. ●
- Introduction of the ability to visualize adjustable frame tower and initial frame adjustments prior to frame mounting
- Minor user interface updates for continuous improvement and product rebranding
These modifications allow for enhanced functionality and compatibility of the ClearPoint System. These changes have been verified and validated and do not raise any different questions of safety or effectiveness and the subject device is substantially equivalent to the predicate.
{8}------------------------------------------------
A substantial equivalence chart comparing the similarities and differences between the ClearPoint System and its predicate devices is provided below.
{9}------------------------------------------------
| Characteristic | Proposed ClearPoint System (v3.0) | Primary PredicateClearPoint System (v2.2) K233243 | Secondary PredicateStealthStation Cranial Software K231976 |
|---|---|---|---|
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | HAW | HAW | HAW |
| 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 anoperating room environment and inconjunction with MR and/or CTimaging. During planning, the system isintended to provide functionality for theautomatic identification, labeling,visualization, and quantification ofsegmentable brain structures from a set ofloaded MR images. The ClearPoint Systemis intended as an integral part of proceduresthat have traditionally used stereotacticmethodology. These procedures includebiopsies, catheter and electrode insertionincluding deep brain stimulation (DBS)(asleep or awake) lead placement. Whenused in an MRI environment, the system isintended for use only with 1.5 and 3.0 TeslaMRI scanners and MR Conditionalimplants and devices. | 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. During planning, the system isintended to provide functionality for theautomatic identification, labeling.visualization and quantification ofsegmentable brain structures from a set ofloaded MR images. The ClearPointSystem is intended as an integral part ofprocedures that have traditionally usedstereotactic methodology. Theseprocedures include biopsies, catheter andelectrode insertion including deep brainstimulation (DBS) lead placement. TheSystem is intended for use only with 1.5and 3.0 Tesla MRI scanners and MRconditional implants and devices. | The StealthStation System, with StealthStation Cranialsoftware, is intended to aid in precisely locating anatomicalstructures in either open or percutaneous neurosurgicalprocedures. The system is indicated for any medical conditionin which reference to a rigid anatomical structure can beidentified relative to images of the anatomy. This can include,but is not limited to, the following cranial procedures (includingstereotactic frame-based and stereotactic frame alternatives-based procedures):Cranial biopsies (including stereotactic) Deep brain stimulation (DBS) lead placement Depth electrode placement Tumor resections Craniotomies/Craniectomies Skull Base Procedures Transsphenoidal Procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF leak repair Pediatric Ventricular Catheter Placement General Ventricular Catheter Placement |
| Environment | MRI Suite and Operating Roomenvironment | MRI Suite | MRI Suite and Operating Room environment |
| Imaging Modalities | Magnetic Resonance Imaging (MRI)Computed Tomography (CT) | Magnetic Resonance Imaging (MRI) | Computed Tomography (CT)Magnetic Resonance Imaging (MRI)Nuclear Medicine |
| SMARTGrid Pack | NA | Planning Grid & Marking tool | NA |
| SMARTFrame Pack | SmartFrame XG, Skull Mount Base,Scalp Mount Base, Bone Screws,Stand-Off Pins, Screwdriver,Centering Tool, Wharen CenteringGuide (packaged and sold separately),Dock and Lock, Roll Lock Screw withWasher, Rescue Screws (packagedseparately) | SmartFrame XG, Skull Mount Base,Scalp Mount Base, Bone Screws,Stand-Off Pins, Screwdriver,Centering Tool, Wharen CenteringGuide (packaged and sold separately),Dock and Lock, Roll Lock Screwwith Washer, Rescue Screws(packaged separately) | NA |
| Hand Controller | Thumbwheel Extension (LightHand Controller) | Thumbwheel Extension (Light HandController) | 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 , 5.4 mm, & 6.0 mm | 4.5 mm, 5.4 mm, & 6.0 mm | NA |
| Targeting Cannula | ID0.0825"Materials:Ultem and PEEK | ID0.0825"Materials:Ultem and PEEK | NA |
| Guide TubeInstrumentsCompatible (mm) | 1.24 - 1.80 | 1.24 - 1.80 | NA |
| Device GuideInstrumentCompatibility (mm) | 2.1 - 5.4 | 2.1 - 5.4 | NA |
| Targeting Accuracy | $\pm$ 1.5 mm @ ≤125mm | $\pm$ 1.5 mm @ ≤125mm | Under representative worst-case configuration,theStealthStation® System with StealthStation CranialSoftware, hasdemonstrated performance in 3Dpositional accuracy with a mean error $\le$ 2.0 mm and intrajectory angle accuracy with a mean error $\le$ 2.0 degrees |
| Packaging | Sterile, Sealed Tray/Pouch | Sterile, Sealed Tray/Pouch | NA |
| Software | Version 3.0 | Version 2.2 | 3.1.5 |
| Operating System | Microsoft Windows OperatingSystem | Microsoft Windows OperatingSystem | Microsoft Windows Operating System |
| ProgrammingLanguages | Visual C#Visual C++ | Visual C#Visual C++ | C++ |
| Visualization Features | ● Display of MR images inreformatted (MPR) and 3D views.● Cross-reference line display withcurrent plane intersectioncorrelation point indication. | ● Display of MR images inreformatted (MPR) and 3D views.● Cross-reference line display withcurrent plane intersectioncorrelation point indication. | Ultrasound Video In, Ultrasound Overlay, 3D, 2DAnatomic Orthogonal, Trajectory 1 and 2, TargetGuidance, Trajectory Guidance, Probes Eye, LookAhead, Microscope Injection, Video Input |
| 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. Ability to display CT images in reformatted (MPR) and 3D views. | 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. Ability to display CT images in reformatted (MPR) and 3D views. | ||
| DICOM Features | Retrieval of images from MR/CT 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 Single image DICOM Export (local) | Retrieval 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 | Network Connectivity CD, DVD, USB DICOM Import DICOM Export |
| Image Fusion/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 | Exam-to-Exam Registration: Identity Merge Registration, Manual Merge Registration and Automatic Merge Registration.Patient Registration: PointMerge registration, Tracer registration, Touch-N-Go registration, StealthAiR registration, O-arm registration, Stereotactic Localizer Registration and StarFix Bone Anchor Registration |
| Spherical region-of-interest tools to define regions to consider for automatic registration/fusion | |||
| LocalizationTechnology | Magnetic Resonance Imaging (MRI) Computed Tomography (CT) | Magnetic Resonance Imaging (MRI) | Optical (infra-red) Electromagnetic Mechanical based stereotactic |
| Planning Features | Ability to create one or more trajectory paths (entry and target selection) Advanced visualization using multiple viewing layouts and viewing planes Viewport crosshair correlation capabilities Display graphic annotations representing trajectory paths Display trajectory point distances and trajectory depth measurements Compare two selected image series side-by-side Display segmented brain regions overlaid on loaded image sets. Visualize 3D frame mount positions and frame tower angulation | Ability to create one or more trajectory paths (entry and target selection) Advanced visualization using multiple viewing layouts and viewing planes Viewport crosshair correlation capabilities Display graphic annotations representing trajectory paths Display trajectory point distances and trajectory depth measurements. Compare two selected image series side-by-side Display segmented brain regions overlaid on loaded image sets. Visualize 3D frame mount positions | Plan Entry and Target Selection 3D Model BuildingAdvanced Visualization Create Patient Based Anatomical Coordinate Space Stereotactic Frame Settings Brain Atlas: Schaltenbrand-Wahren Atlas with Talairach Grid StarFix Designer Annotations |
| Help/TroubleshootingTools | User Manual available on workstation. Status message indications/warnings with ability to show specific troubleshooting instructions. User visible software log so that previously displayed status messages (and troubleshooting instructions) can be re-visited throughout the course of a procedure. | User Manual available on workstation. Status message indications/warnings with ability to show specific troubleshooting instructions. User visible software log so that previously displayed status messages (and troubleshooting instructions) can be re-visited throughout the course of a procedure. | N/A |
| Image SegmentationAlgorithms | Algorithm to automatically identify anterior commissure (AC) and posterior commissure (PC) locations within the brain. Algorithms to automatically locate and identify marking grid, targeting frame components, cannula, and device tip from both MR and CT image sets. Automated measurement of brain tissue volumes and structures from MR images. Automatic segmentation and quantification of brain structures using proprietary shape-constrained segmentation algorithms from MR images. | Algorithm to automatically identify anterior commissure (AC) and posterior commissure (PC) locations within the brain. Algorithms to automatically locate and identify marking grid, targeting frame components, cannula, and device tip from MR image sets. Automated measurement of brain tissue volumes and structures from MR images. Automatic segmentation and quantification of brain structures using proprietary shape-constrained segmentation algorithms from MR images. | N/A |
| MRI Scan PlaneParameters | Geometric computations to display position and orientation of prescribed scan plane parameters for Siemens, Philips, and GE MR scanner manufacturers. | Geometric computations to display position and orientation of prescribed scan plane parameters for Siemens, Philips, and GE MR scanner manufacturers. | N/A |
| Hardware AdjustmentComputations | Computations used to indicate required frame adjustments needed to adjust targeting cannula to desired trajectory. | Computations used to indicate required frame adjustments needed to adjust targeting cannula to desired trajectory. | N/A |
| Low-Level MathLibrary | Low-level math utilities used for geometric computations. | Low-level math utilities used for geometric computations. | N/A |
| Workflow | Support for pre-surgical and intraoperative surgical workflows using MR and CT image guidance | Support for pre-surgical and intraoperative surgical workflow using MR image guidance | Support for Pre-surgical and intraoperative surgical workflows using optical / electromagnetic localization technology. |
Table 3: Side-by-side comparison of ClearPoint System (Software Version 3.0) with Predicate Devices
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
§ 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).