(84 days)
No
The summary describes a stereotactic guidance system based on physical frames, software for planning and visualization, and MR imaging feedback. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Rapid Locus" software is described as a post-processing package, not explicitly using AI/ML.
No.
The device provides stereotactic guidance for instrument placement during neurological procedures, but it does not directly treat a disease or condition itself.
No
Explanation: The ClearPoint System is described as providing "stereotactic guidance for the placement and operation of instruments or devices" during neurological procedures within the MRI environment. It is used for "biopsies, catheter and electrode insertion," which are interventional procedures, not diagnostic ones. The system aids in guiding tools, not in making a diagnosis.
No
The device description explicitly lists multiple hardware components (workstation laptop, SMARTGrid, SMARTFrame, SMARTFrame Accessory Kit, SMARTFrame Handcontroller, MR Neuro Procedure Drape) in addition to the workstation software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ClearPoint System's Intended Use: The ClearPoint System is intended for stereotactic guidance during neurological procedures within the MRI environment. It is used to guide the placement and operation of instruments or devices within the patient's body (in vivo), not to analyze specimens outside the body (in vitro).
- Device Description: The components of the system (workstation, frames, handcontroller, drape) are all designed for physical guidance and positioning during surgery, not for laboratory analysis of biological samples.
- Lack of Specimen Handling: There is no mention of the ClearPoint System being used to collect, prepare, or analyze any biological specimens.
The ClearPoint System is a surgical guidance system used in conjunction with medical imaging (MRI) for interventional 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 the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion. The System is intended for use only with 1.5 Tesla MRI scanners.
Product codes
ORR, LNH
Device Description
The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame Accessory Kit, the SMARTFrame Handcontroller, and the MR Neuro Procedure Drape. The MR Neuro Procedure Drape was cleared for market via a separate 510(k) notice (K091343).
The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the burr hole as called out in the trajectory planning software. The SMARTFrame is an adjustable trajectory frame that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MR images, makes changes, and confirms with subsequent MR images. The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) that meet the physician's desired imaging quality.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
Brain / Head (Neurological procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeon / MRI Technician
MRI Suite
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
Not Found
Summary of Performance Studies
MRI Test Device Accuracy Testing
Study Type: Accuracy Testing
Sample Size: Not specified
Key Results: Demonstrated that a known pre-determined target in a phantom can be localized by the distal tip of a Test Device representative of the devices to be used with the ClearPoint System. Showed the SMARTFrame can deliver a simulated device to the same X, Y, and Z coordinates as the Stylet/Sheath, and to projected coordinates without Stylet/Sheath confirmation. Testing with actual medical devices had the same results.
System Accuracy Comparison in a Skull Phantom - Navigus II MR vs. ClearPoint System
Study Type: Accuracy Comparison Testing
Sample Size: Not specified
Key Results: Concluded that the ClearPoint System is at least as accurate as the NeXframe MR (used in conjunction with software on a cleared MRI scanner) in terms of radial error and depth error when placing a device at a target site in a simulated head/brain phantom.
System Accuracy Comparison in a Cadaver - Navigus II MR vs. ClearPoint System
Study Type: Cadaver Study
Sample Size: Not specified
Key Results: Demonstrated that the ClearPoint System was at least comparable to the NeXframe MR (used in conjunction with software on a cleared MRI scanner) in terms of both accuracy and user ratings on a variety of procedure-related assessments.
ClearPoint System Safety Testing
Study Type: Safety Testing (evaluating interactions with electromagnetic fields in MRI suite)
Sample Size: Not specified
Key Results: Evaluated image distortion, force and torque, and RF heating. Verification testing ensured device components did not interfere with MR images and confirmed safety when used with a 1.5T MRI scanner. Concluded that the ClearPoint System is MRI Conditional as defined by ASTM F2503, and its components do not expose a patient to added risk from electromagnetic fields in a 1.5T MRI system.
Overall Conclusion: The targeting accuracy of the ClearPoint System is as good as the Navigus II MR, when used in conjunction with MRI scanner software. The results support the safe and effective use of the ClearPoint System to guide a device to a brain target with an error less than 1.5mm.
Key Metrics
Targeting accuracy error less than 1.5mm.
Predicate Device(s)
Image-Guided Neurologics, Inc. Navigus II MR Trajectory Guide (K012719), Philips Medical Systems software package for the Achieva, Intera and Panorama MR Systems (K063559)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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510(k) SUMMARY SURGIVISION, INC.'S CLEARPOINT SYSTEM
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 Phone: 202.637.5600 Fax: 202.637.5910 Contact Person: John J. Smith, M.D., J.D.
Date Prepared: June 16, 2010
Name of Device and Name/Address of Sponsor
ClearPoint System™
SurgiVision, Inc. 5 Musick Irvine, CA 92618
Common or Usual Name
Neurological Stereotaxic Instrument
Classification
21 C.F.R. §882.4560
Predicate Devices
Image-Guided Neurologics, Inc. Navigus II MR Trajectory Guide (K012719) Philips Medical Systems software package for the Achieva, Intera and Panorama MR Systems (K063559)
Intended Use / Indications for Use
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally
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used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion. The System is intended for use only with 1.5 Tesla MRI scanners.
Technological Characteristics
The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame Accessory Kit, the SMARTFrame Handcontroller, and the MR Neuro Procedure Drape. The MR Neuro Procedure Drape was cleared for market via a separate 510(k) notice (K091343).
The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the burr hole as called out in the trajectory planning software. The SMARTFrame is an adjustable trajectory frame that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MR images, makes changes, and confirms with subsequent MR images.
The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) that meet the physician's desired imaging quality.
See the table below for a detailed comparison of the technological characteristics of the ClearPoint System and those of the predicate devices.
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RGIVISION, INC.'S CLEARPOINT SYSTEM - SUBSTANTIAL EQUIVALENCE COMPARISON
| Characteristic | SurgiVision ClearPoint System | Navigus II MR (K012719) | Software package cleared with the
Achieva, Intera and Panorama MR
Systems (K063559) |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | 21 CFR 882.4560 | HAW
21 CFR 882.4560 | LNH
21 CFR 892.1000 |
| Classification Regulation | Neurological Stereotaxic Instrument | Neurological Stereotaxic Instrument | Magnetic Resonance Diagnostic Device |
| Indications for Use | The ClearPoint System is intended to
provide stereotactic guidance for the
placement and operation of instruments or
devices during planning and operation of
neurological procedures within the MRI
environment and in conjunction with MR
imaging. The ClearPoint System is
intended as an integral part of procedures
that have traditionally used stereotactic
methodology. These procedures include
biopsies, catheter and electrode insertion.
The System is intended for use only with
1.5 Tesla MRI scanners. | The NAVIGUS II MR Trajectory Guide is
intended to provide stereotactic guidance
for the placement and operation of
neurological procedures within the MRI
environment and in conjunction with MR
imaging. The Trajectory Guide is intended
as an integral part of procedures that have
traditionally used stereotactic methodology.
These procedures include biopsies, catheter
and electrode introduction. This device will
provide accurate delivery of devices or
instruments to target sites 3mm and larger. | The ACHIEVA, INTERA and
PANORAMA 1.0T Release 2.5-series
are magnetic resonance diagnostic
devices that produce cross-sectional
images, spectroscopy images and/or
spectra in any orientation of the internal
structure of the whole body. These
images when interpreted by a trained
physician, yield information that may
assist in diagnosis. In addition the
Achieva, Intera and Panorama 1.0T
devices provide capabilities to perform
interventional procedures in the head,
body and extremities, which may be
facilitated by MR techniques, such as
real time imaging. Such procedures must
be performed with MR compatible
instrumentation as selected and evaluated
by the clinical user. |
| Brief Device Description | System includes planning and navigation
software (ClearPoint Workstation, MRI
only) designed to work with hardware, the
ClearPoint SMARTFrame and accessories.
Overall System is not specific to any
particular neurosurgical procedure. | The NAVIGUS II MR Trajectory Guide is a
stereotactic frame that is intended to be
used in conjunction with MR scanner
software.
Device is not specific to any particular
neurosurgical procedure. | The update to the Philips System
software includes the following features.
• Rapid Locus is a post-processing
software package intended for use to
support the use of interventional
coils and MR stereo-tactic
localization devices to perform MR-
guided interventional procedures.
Using information from MR images
regarding the coordinates of a user-
specified region of interest, and
fiducial coordinates, the software
provides an automatic calculation of
the location and depth of the |
| Characteristic | SurgiVision ClearPoint System | Navigus II MR (K012719) | Software package cleared with the
Achieva, Intera and Panorama MR
Systems (K063559) |
| Principal Operator
Use Location | Neurosurgeon / MRI Technician
MRI Suite | Neurosurgeon
MRI Suite | targeted region of interest, such as a
lesion or suspected lesion.
The Achieva, Intera and Panorama
1.0T systems can be used for
imaging during interventional
procedures when performed with
MR-compatible devices such as in-
room display and MR-safe biopsy
needles. |
| Operating Principle | Stereotaxic guiding and fixation device,
planning software | Stereotaxic guiding & fixation device | Neurosurgeon / MRI Technician
MRI Suite
Can be used for planning and
implementation of neuro-interventional
procedures in conjunction with
stereotactic frames, such as the Navigus
II MR |
| "Frameless" stereotaxy | Yes | Yes | N/A |
| MRI Compatible? | Yes | Yes | N/A |
| Software Facilitates
Placement and Trajectory
of Surgical Devices | Yes | N/A | Yes |
| Software Features | Software features include:
● pan
● zoom (also: zoom to point, zoom to
region, zoom all viewports)
● window width/level adjustment
● greylevel invert (negative image)
● measure lines
● viewport resize
● viewport maximize / restore (toggle
between current layout and 1x1
layout of selected viewport)
● viewport drag (drag from one
viewport to another to switch
contents)
● reset
● show/hide annotations | N/A | Software features include:
● pan
● zoom (also: zoom to point, zoom
to region, zoom all viewports)
● window width/level adjustment
● greylevel invert (negative image)
● measure lines
● viewport resize
● viewport maximize / restore
(toggle between current layout and
1x1 layout of selected viewport)
● viewport drag (drag from one
viewport to another to switch
contents)
● reset
● show/hide annotations |
| Characteristic | SurgiVision ClearPoint System | Navigus II MR (K012719) | Software package cleared with the Achieva, Intera and Panorama MR Systems (K063559) |
| Hardware Facilitates
Trajectory and
Temporary Fixation of
Neurosurgical Devices | Yes | Yes | N/A |
| • crosshair controls - toggle
show/hide | • crosshair controls - toggle
show/hide | | |
| Materials (body
contacting) | Polymer Base with titanium screws into skull | Polymer Base with titanium screws into skull | N/A |
| Range of motion | +/- 26 degrees roll, +/-33 degrees pitch | 25 degrees angular, 360 degrees rotation | N/A |
| Burr Hole Size | 14mm | 14mm | N/A |
| Bilateral option | Yes | Yes | N/A |
| Fiducial markers | Yes | No | N/A |
| Multi-lumen spacing | 2.5 degrees variable | 3mm fixed | N/A |
| Targeting lumen integral
with frame | Yes | No | N/A |
| Remote frame and
targeting control | Yes | No | N/A |
| Bone screws | 3 | 3 | N/A |
| Optional screw sites | Yes | Yes | N/A |
| Single Use | Yes | Yes | N/A |
| Sterilized | Yes | Yes | N/A |
| Devices supplied by Mfr in
addition to the head
mount | Marking Grid, Sheath, Stylet, Multiple
diameter Guide Tubes, (2) Stop, Dock,
Depth Stop, Hand Controller | MultiLumen Insert, Bridge (Centered &
Offset), Fluid Stem, Titanium Stylet, Depth
Stop, 3 Peel Away Introducer Sheath
(1.5mm I.D.), Multiple diameter Guide
Tubes | N/A |
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Consensus Standards
The ClearPoint System complies with the following recognized consensus standards:
- NEMA PS 3.1 3.18 (2008) Digital Imaging and Communications in Medicine . (DICOM) Set.
- AAMI/ANSI/ISO 10993-1 Biological evaluation of medical devices Part 1: . Evaluation and testing.
- ANSI/AAMI/ISO 1135-1 Sterilization of health care products Ethylene oxide -. Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices.
Performance Data
SurgiVision has conducted software validation testing, as well as accuracy and safety testing of the ClearPoint System in multiple models and settings. In all instances, the device functioned as intended and targeting accuracy observed was as expected. This testing is described in detail below.
ClearPoint System Accuracy Testing
MRI Test Device Accuracy Testing
This study was intended to demonstrate that a known pre-determined target in a phantom can be localized by the distal tip of a Test Device representative of the devices to be used with the ClearPoint System. The system software went through all procedural steps during this testing with the exception of the Marking Grid / Burr Hole location. This study demonstrated that the SMARTFrame can deliver a simulated device to the same X, Y, and Z coordinates as the Stylet/Sheath, and can deliver a simulated device to the projected X, Y, and Z coordinates without Stylet/Sheath confirmation. Finally, testing with actual medical devices (instead of simulated devices) had the same results.
System Accuracy Comparison in a Skull Phantom - Navigus II MR vs. ClearPoint System
The goal of this comparison testing was to obtain accuracy results for the ClearPoint System using a skull phantom, and to compare those results with data previously obtained for the predicate Navigus II MR (also known as the "NeXframe MR") device using the same model system. The system software went through all steps during this testing with the exception of the Marking Grid / Burr Hole location.
It was concluded that the ClearPoint System is at least as accurate as the NeXframe MR (used in conjunction with software on a cleared MRI scanner) in terms of radial error and depth error when placing a device at a target site in a simulated head/brain phantom.
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System Accuracy Comparison in a Cadaver - Navigus II MR vs. ClearPoint System
A cadaver study was performed to compare the Navigus II MR ("NeXframe MR"), used in conjunction with software on a cleared MRI scanner, and the ClearPoint System for work flow performance and accuracy. The objective of the study was to perform procedures using the NeXframe MR and the ClearPoint System to access targets in a cadaver head. This testing demonstrated that the ClearPoint System was at least comparable to the NeXframe MR (used in conjunction with software on a cleared MRI scanner) in terms of both accuracy and user ratings on a variety of procedure-related assessments.
Conclusions
These test results demonstrate that the targeting accuracy of the ClearPoint System is as good as the Navigus II MR, when used in conjunction with MRI scanner software. The results support the safe and effective use of the ClearPoint System to guide a device to a brain target with an error less than 1.5mm.
ClearPoint System Safety Testing
Relevant components of the ClearPoint System were evaluated for interactions with the electromagnetic fields in an MRI suite. Specifically, the following interactions of the device components were evaluated: (1) image distortion; (2) force and torque; and (3) RF heating. With regard to image distortion, force and RF heating, the company conducted verification testing to ensure that the subject device components did not interfere with MR images and confirm their safety when used in conjunction with a 1.5T MRI scanner.
The company concluded that the ClearPoint System is MRI Conditional as defined by ASTM F2503. The analysis and measurements performed by the company demonstrated that the presence of the ClearPoint System components do not expose a patient to added risk from the electromagnetic fields in a 1.5T MRI system.
Substantial Equivalence
The ClearPoint System is as safe and effective as the Navigus II MR Trajectory Guide used in conjunction with MRI scanner software, such as the software package cleared with the Philips Medical Systems' Achieva, Intera and Panorama MR Systems. The ClearPoint System has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the ClearPoint System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the ClearPoint System is as safe and effective as the predicate devices. Thus, the ClearPoint System is substantially equivalent.
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgivision, Inc. c/o John J. Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
JUN 1 6 2010
Re: K100836
Trade/Device Name: Clearpoint System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ORR, LNH Dated: March 23, 2010 Received: March 24, 2010
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - John J. Smith, M.D., J.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Qina Stumph f
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health .
Enclosure
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Indications for Use Statement
K100836 510(k) Number (if known):
Device Name: SurgiVision, Inc. ClearPoint System™
Indications for Use:
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion. The System is intended for use only with 1.5 Tesla MRI scanners.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use.
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number K100836
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