(175 days)
No
The summary describes a stereotactic guidance system based on physical components (frames, grids, cannulas) and software for trajectory planning and monitoring. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The performance studies focus on mechanical accuracy and clinical outcomes based on traditional stereotactic methods.
No.
The ClearPoint System is intended for stereotactic guidance and placement of instruments or devices during neurological procedures, not for providing a therapeutic effect itself.
No
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during neurological procedures. It is a navigational and surgical guidance system, not a device used to diagnose a medical condition.
No
The device description explicitly lists multiple hardware components, including the SMARTGrid, SMARTFrame, and various accessories, in addition to the workstation software and laptop.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- ClearPoint System's Function: The ClearPoint System is a surgical guidance system used during neurological procedures within the MRI environment. It helps physicians plan and execute the placement of instruments or devices within the brain. It does not analyze biological samples.
The device description and intended use clearly indicate its role in surgical navigation and guidance, not in the analysis of in vitro specimens.
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, 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 user should consult the "Navigational Accuracy" section of the User's Guide to assess if the accuracy of the system is suitable for their needs.
Product codes
ORR, HAW
Device Description
The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid (previously cleared under K100836), the SMARTFrame™ MRI-Guided Trajectory Frame (K100836), the SMARTFrame™ Accessory Kit (K100836) and the SMARTFrame™ Thumbwheel Extension.
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 allow for trajectory feedback when the physician views the MRI images, makes changes, and confirms with subsequent MR images.
The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) that meet the physician's desired imaging quality. MRI Interventions 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 ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:
- SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole)
a. Marking Grid
b. Marking Tool - SMARTFrame Pack
a. SMARTFrame (adjustable trajectory frame ("ATF") to guide and hold the neurosurgical tools, includes fiducials, Targeting Cannula, & titanium screws)
b. Centering Device
c. Dock
d. Device Lock (2 different diameters)
e. Screwdriver - Rescue Screws (Extra Titanium Screws)
- Thumbwheel Extension
- Accessory Pack
a. Peel away sheath
b. Stylet
c. Lancet
d. Depth Stop
e. Ruler - Scalp Mount Base
- Guide Tube and Device Guide Packs (Guide Cannulas)
Each of the above packs is sold separately. Each is intended to be used with the ClearPoint Workstation. 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 (K122456/K151536)
- MRI Neuro Procedure Drape, with Marker Pen and Cover (K091343)
- SmartFrame MR Fiducial (510(k)-exempt Accessory)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
Neurological procedures (head/brain)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Literature and registry data demonstrating that the ClearPoint System accurately positions DBS leads in more than 500 patients demonstrates safe and effective use for the new indications. The registry data included data from 35 institutions currently using the ClearPoint System in practice. Accuracy placement data were available on 1,259 procedures, 828 of which were for DBS lead placement.
Results from the company's bench accuracy tests demonstrated that the mean error across device configurations was below 1mm, with the highest standard deviation being 0.45mm and the highest 99% confidence limit being 1.52mm. Angular errors were all below 1°, with the highest standard deviation being 0.55° and the highest 99% confidence limit being 1.40°. These observed values are all below the 2mm and 2° accuracy limits for a stereotaxic device intended for general neurological use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bench Accuracy Tests:
Mean error: below 1mm
Highest standard deviation (error): 0.45mm
Highest 99% confidence limit (error): 1.52mm
Angular errors: all below 1°
Highest standard deviation (angular error): 0.55°
Highest 99% confidence limit (angular error): 1.40°
Targeting Accuracy: ± 1.5mm @ ≤ 125mm
Predicate Device(s)
Reference Device(s)
K100836, K122456/K151536, K091343
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 20, 2017
MRI Interventions, Inc. % John Smith, MD JD Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004
Re: K171257
Trade/Device Name: ClearPoint System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ORR, HAW Dated: September 21, 2017 Received: September 21, 2017
Dear Dr. 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, 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.
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education (DICE) 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,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171257
Device Name ClearPoint System
Indications for Use (Describe)
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. 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 user should consult the "Navigational Accuracy" section of the User's Guide to assess if the accuracy of the system is suitable for their needs.
| 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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3
510(k) SUMMARY
MRI Intervention, Inc.'s ClearPoint Device
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: September 21, 2017
Name of Device and Name/Address of Sponsor
ClearPoint System™
MRI Interventions, Inc. 5 Musick Irvine, CA 92618
Common or Usual Name:
Neurological Stereotaxic Instrument
Classification
21 C.F.R. §882.4560
Product Code
ORR, HAW
Predicate Device
MRI Interventions, Inc. ClearPoint System (K160434)
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, 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 user should consult the "Navigational Accuracy" section of the User's Guide to assess if the accuracy of the system is suitable for their needs.
4
Technological Characteristics
The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid (previously cleared under K100836), the SMARTFrame™ MRI-Guided Trajectory Frame (K100836), the SMARTFrame™ Accessory Kit (K100836) and the SMARTFrame™ Thumbwheel Extension.
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 allow for trajectory feedback when the physician views the MRI images, makes changes, and confirms with subsequent MR images.
The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) that meet the physician's desired imaging quality. MRI Interventions 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 ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:
-
- SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole)
- a. Marking Grid
- b. Marking Tool
-
- SMARTFrame Pack
-
a. SMARTFrame (adjustable trajectory frame ("ATF") to guide and hold the neurosurgical tools, includes fiducials, Targeting Cannula, & titanium screws)
-
b. Centering Device
-
c. Dock
-
d. Device Lock (2 different diameters)
-
e. Screwdriver
-
- Rescue Screws (Extra Titanium Screws)
-
- Thumbwheel Extension
5
-
- Accessory Pack
- a. Peel away sheath
- b. Stylet
- c. Lancet
- d. Depth Stop
- e. Ruler
-
- Scalp Mount Base
-
- Guide Tube and Device Guide Packs (Guide Cannulas)
Each of the above packs is sold separately. Each is intended to be used with the ClearPoint Workstation. 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 (K122456/K151536) ●
- MRI Neuro Procedure Drape, with Marker Pen and Cover (K091343)
- SmartFrame MR Fiducial (510(k)-exempt Accessory) ●
The primary purpose of this 510(k) notice is to expand the indications of the device to explicitly include use with the positioning of deep brain stimulator ("DBS") leads. In addition, since the ClearPoint System's last clearance (K160434), an additional locking slot below the top slot in the SmartFrame XG Targeting Cannula ("TC") Support has been added to allow users to retract the TC while the removable support cap is in place. There are now three total locking slots on the TC Support. The software has also been updated to version 1.6.2.
The table below presents a detailed comparison of the technological characteristics of the ClearPoint System and those of the predicate device.
| | ClearPoint System (Predicate)
K160434 | ClearPoint System (Subject) |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | ORR, HAW | ORR, HAW |
| Intended Use | The ClearPoint System is intended to
provide stereotactic guidance and
operation of instruments or devices
during the 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 and 3.0 Tesla MRI scanners. | The ClearPoint System is intended to
provide stereotactic guidance and
operation of instruments or devices during
the 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, including
deep brain stimulation (DBS) lead
placement. The System is intended for use
only with 1.5 and 3.0 Tesla MRI scanners.
The user should consult the "Navigational
Accuracy" section of the User's Guide to
assess if the accuracy of the system is
suitable for their needs. |
| | ClearPoint System (Predicate)
K160434 | ClearPoint System (Subject) |
| Environment | MRI Suite | MRI Suite |
| Sterilization | EO 10-6 SAL | EO 10-6 SAL |
| SmartGrid
Pack | MRI Planning Grid & Marking Tool | MRI Planning Grid & Marking Tool |
| SmartFrame
Pack | SmartFrame XG, Scalp Mount Base, Bone
Screws, Scalp Mount Base, 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, Scalp Mount Base,
Bone Screws, Scalp Mount Base,
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) |
| Hand Controller | Thumbwheel Extension (Light Hand
Controller) | Thumbwheel Extension (Light Hand
Controller) |
| Accessory Kit | Peel-away Sheath, Lancet, Stylet, Depth
Stop, Ruler | Peel-away Sheath, Lancet, Stylet, Depth
Stop, Ruler |
| Drill Guides | 4.5mm & 6.0mm | 4.5mm & 6.0mm |
| Targeting
Cannula ID | 0.0825" | 0.0825" |
| Targeting
Cannula
Material | Ultem and PEEK | Ultem and PEEK |
| Guide Tube /
Device Guide /
Drill Guide ID | 0.0938, 0.141, 0.191, 0.250" | 0.0938, 0.141, 0.191, 0.250" |
| Guide Tube/
Device Guide /
Drill Guide
Material | Ultem | Ultem |
| Packaging | Sterile, Sealed Tray, Inside
Sterile Tyvek Pouch
(Wharen Centering Guide and Drill and
Device Guides are Sterile in a double
Tyvek Pouch Without a Tray; Wharen
Centering Guide Packaging includes
PVC) | Sterile, Sealed Tray, Inside
Sterile Tyvek Pouch
(Wharen Centering Guide and Drill and
Device Guides are Sterile in a double
Tyvek Pouch Without a Tray; Wharen
Centering Guide Packaging includes
PVC) |
| Targeting
Accuracy | $\pm$ 1.5mm @ $\leq$ 125mm | $\pm$ 1.5mm @ $\leq$ 125mm |
| Software | 1.6 | 1.6.2 |
Summary of the Technological Characteristics of the Device Compared to the Predicate Device
6
Performance Data
Literature and registry data demonstrating that the ClearPoint System accurately positions DBS leads in more than 500 patients demonstrates safe and effective use for the new indications. The registry data included data from 35 institutions currently using the ClearPoint System in practice. Accuracy placement data were available on 1,259 procedures, 828 of which were for DBS lead placement.
7
Results from the company's bench accuracy tests demonstrated that the mean error across device configurations was below 1mm, with the highest standard deviation being 0.45mm and the highest 99% confidence limit being 1.52mm. Angular errors were all below 1°, with the highest standard deviation being 0.55° and the highest 99% confidence limit being 1.40°. These observed values are all below the 2mm and 2° accuracy limits for a stereotaxic device intended for general neurological use.
Substantial Equivalence
The ClearPoint System is as safe and effective as the predicate ClearPoint System (K160434). The ClearPoint System has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate device. Thus the ClearPoint System that is the subject of this submission is substantially equivalent to the previously cleared ClearPoint System.