(58 days)
No
The document mentions "automatic identification, labeling, visualization of segmentable brain structures" but does not explicitly state that AI or ML is used for this functionality. The "Mentions AI, DNN, or ML" field is "Not Found".
No
The device is intended for stereotactic guidance and placement of instruments, not for direct treatment of disease or conditions.
No
The ClearPoint System is intended for stereotactic guidance during neurological procedures, specifically for instrument placement and operation, not for diagnosing conditions. While it assists in identifying brain structures from images, this functionality is for procedural planning, not disease diagnosis.
No
The device description explicitly states that the ClearPoint System is comprised of both a workstation laptop with software and hardware components, including the SMARTGrid, SMARTFrame, and various accessories.
Based on the provided information, the ClearPoint System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within an operating room environment." This describes a system used in vivo (within a living organism) for surgical guidance, not for testing samples in vitro (outside of a living organism).
- Device Description: The description details hardware components like frames, cannulas, and software for trajectory planning and monitoring, all of which are used directly on or with the patient during a surgical procedure.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ClearPoint System does not perform any such analysis on biological samples.
The ClearPoint System is a surgical guidance system that utilizes medical imaging (MR and CT) to assist physicians in performing neurological procedures.
N/A
Intended Use / Indications for Use
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within 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.
Product codes (comma separated list FDA assigned to the subject device)
HAW
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. 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)
a. SMARTFrame ("ATF") with Base
b. Centering Device and Wharen Centering Guide
c. Dock
d. Device Lock
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 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR and/or CT imaging.
Anatomical Site
neurological procedures within an operating room environment; brain structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance Validation - ClearPoint System (MRI):
Positional Error (mm): Mean (X,Y,Z) 0.14, Std. Dev. 0.37, 99% CI 0.44
Trajectory Angle Error (deg.): Mean 0.32°, Std. Dev. 0.17°, 99% CI 0.46°
ClearPoint System Accuracy Specifications - CT:
Variable:
X: Precision ME (mm) 0.1, Accuracy RMS (mm) 0.17, Accuracy Max (mm) 0.3
Y: Precision ME (mm) 0.1, Accuracy RMS (mm) 0.17, Accuracy Max (mm) 0.3
Z: Precision ME (mm) 0.1, Accuracy RMS (mm) 0.17, Accuracy Max (mm) 0.3
Roll: Precision ME (mm) 0.1°, Accuracy RMS (mm) 0.17°, Accuracy Max (mm) 0.3°
Pitch: Precision ME (mm) 0.1°, Accuracy RMS (mm) 0.17°, Accuracy Max (mm) 0.3°
Yaw: Precision ME (mm) 0.1°, Accuracy RMS (mm) 0.17°, Accuracy Max (mm) 0.3°
Positional Error (mm): Mean 0.81, Standard Deviation 0.49, 99% CI Upper Bound 0.93
Trajectory Angle Error (Degrees): Mean 0.31, Standard Deviation 0.23, 99% CI Upper Bound 0.37
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
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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)
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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 Predicate
ClearPoint System (v2.2) K233243 | Secondary Predicate
StealthStation 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 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. | 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. | The StealthStation System, with StealthStation Cranial
software, is intended to aid in precisely locating anatomical
structures in either open or percutaneous neurosurgical
procedures. The system is indicated for any medical condition
in which reference to a rigid anatomical structure can be
identified relative to images of the anatomy. This can include,
but is not limited to, the following cranial procedures (including
stereotactic 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 Room
environment | 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 Centering
Guide (packaged and sold separately),
Dock and Lock, Roll Lock Screw with
Washer, Rescue Screws (packaged
separately) | SmartFrame XG, Skull Mount Base,
Scalp Mount Base, Bone Screws,
Stand-Off Pins, Screwdriver,
Centering Tool, Wharen Centering
Guide (packaged and sold separately),
Dock and Lock, Roll Lock Screw
with Washer, Rescue Screws
(packaged separately) | NA |
| Hand Controller | Thumbwheel Extension (Light
Hand Controller) | Thumbwheel Extension (Light Hand
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 , 5.4 mm, & 6.0 mm | 4.5 mm, 5.4 mm, & 6.0 mm | NA |
| Targeting Cannula | ID
0.0825"
Materials:
Ultem and PEEK | ID
0.0825"
Materials:
Ultem and PEEK | NA |
| Guide Tube
Instruments
Compatible (mm) | 1.24 - 1.80 | 1.24 - 1.80 | NA |
| Device Guide
Instrument
Compatibility (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,
the
StealthStation® System with StealthStation Cranial
Software, has
demonstrated performance in 3D
positional accuracy with a mean error $\le$ 2.0 mm and in
trajectory 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 Operating
System | Microsoft Windows Operating
System | Microsoft Windows Operating System |
| Programming
Languages | Visual C#
Visual C++ | Visual C#
Visual C++ | C++ |
| Visualization Features | ● Display of MR 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
correlation point indication. | Ultrasound Video In, Ultrasound Overlay, 3D, 2D
Anatomic Orthogonal, Trajectory 1 and 2, Target
Guidance, Trajectory Guidance, Probes Eye, Look
Ahead, 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 | | |
| Localization
Technology | 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 Building
Advanced Visualization Create Patient Based Anatomical Coordinate Space Stereotactic Frame Settings Brain Atlas: Schaltenbrand-Wahren Atlas with Talairach Grid StarFix Designer Annotations |
| Help/Troubleshooting
Tools | 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 Segmentation
Algorithms | 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 Plane
Parameters | 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 Adjustment
Computations | 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 Math
Library | 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
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