(63 days)
No
The document describes a stereotactic guidance system for neurological procedures using MR imaging. While it involves software for trajectory planning and monitoring, there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The testing focuses on accuracy and verification of software modifications, not on the performance of an AI/ML algorithm.
No
The device provides stereotactic guidance for instrument placement during neurological procedures, but it does not directly treat or provide therapy itself. Instruments or devices that perform the therapeutic action (e.g., DBS leads) are placed using this system.
No
The ClearPoint Array System (Version 1.2) is intended to provide stereotactic guidance for the placement and operation of instruments or devices during neurological procedures. It is a surgical guidance system, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description explicitly lists multiple hardware components, including a laptop computer, trajectory frames, scalp mounts, and various surgical accessories, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 the MRI in conjunction with MR imaging." This describes a surgical guidance system used in vivo (within the living body) during a medical procedure.
- Device Description: The components listed are hardware and software designed for surgical planning and guidance, such as trajectory frames, guide tubes, and planning software. These are tools used to assist a surgeon during a procedure, not to analyze biological samples in vitro.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases. This device does not perform any such analysis of biological samples.
The ClearPoint Array System is a surgical guidance system.
N/A
Intended Use / Indications for Use
The ClearPoint Array System (Version 1.2) 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 in conjunction with MR imaging. The ClearPoint Array System (Version 1.2) 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.
Product codes
HAW
Device Description
The ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape. The ClearPoint Array Workstation includes the following:
-
- ClearPoint Array Workstation Software (for trajectory planning and monitoring)
-
- Laptop Computer
The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories, and are listed below. They are all single use devices provided sterile. Beyond the changes described above, there have been no modifications to the hardware compared to the last cleared version of the device (K214040).
-
- SMARTFrame Array Pack
- SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter, Tracker Rod)
- SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and titanium standoff pins)
- Entry Point Locator
- Targeting Stem
- Centering Device
- Dock
- Device Lock (2 different diameters)
- Screwdriver
- 2.1-mm Guide Tube
- 4.5 Center Drill Guide
- 4.5 Offset Drill Guide
- 3.4-mm Drill Reducer Tube
- Center Insertion Guide
- Offset Insertion Guide
-
- SmartFrame Array Thumb Wheel Extension Set for the trajectory frame.
-
- SmartFrame Array Guide Tube Kit
- 1.7-mm Guide Tube
- 0.5-mm Guide Tube and Device Lock
- 3.1-mm Guide Tube and Device Lock
- SmartFrame Array Guide Tubes (sold separately)
- 7.9mm Center and Offset Device Guides
- 5.4mm Center and Offset Device Guides
Common Components to the ClearPoint System are listed below. These components have not been modified since their clearance (K214040, K200097, K100836, K091343).
-
- SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole) (K100836)
- Marking Grid
- Marking Tool
-
- Accessory Pack (K200097)
- Peel away sheath
- Stylet
- Depth Stop
- Ruler
-
- MRI Neuro Procedure Drape (K091343)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
neurological procedures (brain)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-Clinical Verification Testing was performed to evaluate the safety and performance of the software components. Testing included: Automated Verification, Integrated System Verification, Localization Verification, and Regression Test Verification. All results met acceptance criteria. Accuracy testing was performed to confirm that modifications did not cause unexpected changes in accuracy specifications. The demonstrated accuracy specifications for the ClearPoint Array System are:
- Positional Error (mm): Mean (x,y,z) 0.78, Std. Dev. 0.39, 99% CI 1.14 (first row); 1.52, 0.46, 1.94 (second row); -1.41, 0.73, -2.08 (third row).
- Angular Error (deg.): Mean 0.67°, Std. Dev. 0.14°, 99% CI 0.85°.
Key Metrics
Positional Error (mm): Mean (x,y,z) 0.78, Std. Dev. 0.39, 99% CI 1.14 (first row); 1.52, 0.46, 1.94 (second row); -1.41, 0.73, -2.08 (third row).
Angular Error (deg.): Mean 0.67°, Std. Dev. 0.14°, 99% CI 0.85°.
Targeting Accuracy:
§ 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
September 15, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ClearPoint Neuro, Inc. Brennan Sullivan Regulatory Affairs Manager 5 Musick Irvine, California 92618
Re: K232102
Trade/Device Name: ClearPoint Array System (Version 1.2) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 18, 2023 Received: August 18, 2023
Dear Brennan Sullivan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Adam D. Pierce -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Adam D. Pierce -S" followed by the date "2023.09.15" and the time "16:20:45 -04'00'". The text on the right side of the image indicates that the document was digitally signed by Adam D. Pierce on September 15, 2023.
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
2
Indications for Use
510(k) Number (if known) K232102
Device Name ClearPoint Array System (Version 1.2)
Indications for Use (Describe)
The ClearPoint Array System (Version 1.2) 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 in conjunction with MR imaging. The ClearPoint Array System (Version 1.2) 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary for the ClearPoint Neuro ClearPoint Array System (Version 1.2)
1. SUBMITTER/510(K) HOLDER
ClearPoint Neuro, Inc. 5 Musick Irvine, CA 92618 Contact Person: Mary McNamara-Cullinane Telephone: 508-446-1830
Date Prepared: August 18, 2023
2. DEVICE INFORMATION
| Name of Device: | ClearPoint Array System (Version 1.2) |
|---|---|
| Common or Usual Name: | ClearPoint Array System |
| Classification: | Neurological Stereotaxic Instrument, 21CFR 882.4560 |
| Regulatory Class: | Class II |
| Product Code | HAW |
3. PREDICATE DEVICES
| • ClearPoint Array System 1.1 Software | K214040 |
|---|---|
| ---------------------------------------- | --------- |
- ClearPoint Array System 1.0 Software K202575 ●
4. DEVICE DESCRIPTION
The ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape. The ClearPoint Array Workstation includes the following:
-
- ClearPoint Array Workstation Software (for trajectory planning and monitoring)
-
- Laptop Computer
The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories, and are listed below. They are all single use devices provided sterile. Beyond the changes described above, there have been no modifications to the hardware compared to the last cleared version of the device (K214040).
-
- SMARTFrame Array Pack
4
- SMARTFrame Array (adjustable trajectory frame to guide and hold the a. neurosurgical tools, includes Probe Adapter, Tracker Rod)
- SMARTFrame Array Scalp Mount Base (includes fiducials, titanium b. screws, and titanium standoff pins)
- Entry Point Locator C.
- Targeting Stem d.
- Centering Device e.
- t. Dock
- Device Lock (2 different diameters) g.
- Screwdriver h.
- i. 2.1-mm Guide Tube
- i. 4.5 Center Drill Guide
- k. 4.5 Offset Drill Guide
- 3.4-mm Drill Reducer Tube 1.
- m. Center Insertion Guide
- n. Offset Insertion Guide
-
- SmartFrame Array Thumb Wheel Extension Set for the trajectory frame.
- SmartFrame Array Guide Tube Kit 3.
- a. 1.7-mm Guide Tube
- b. 0.5-mm Guide Tube and Device Lock
- 3.1-mm Guide Tube and Device Lock C.
- d. SmartFrame Array Guide Tubes (sold separately)
- 7.9mm Center and Offset Device Guides e.
- f. 5.4mm Center and Offset Device Guides
Common Components to the ClearPoint System are listed below. These components have not been modified since their clearance (K214040, K200097, K100836, K091343).
-
- SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole) (K100836)
- a. Marking Grid
- b. Marking Tool
-
- Accessory Pack (K200097)
- a. Peel away sheath
- b. Stylet
- c. Depth Stop
- d. Ruler
-
- MRI Neuro Procedure Drape (K091343)
న. INTENDED USE
The ClearPoint® Array System (Version 1.2) 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® Array System (Version 1.2) 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
5
placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.
NON-CLINICAL TESTING 6.
ClearPoint Neuro performed extensive Non-Clinical Verification Testing to evaluate the safety and performance of the software components of ClearPoint Array System (Version 1.2). The following software verification testing was performed:
- Automated Verification ●
- Integrated System Verification ●
- Localization Verification
- Regression Test Verification
The results of all testing met the acceptance criteria and demonstrated that the modified ClearPoint Array Software complies with all design specifications and performs as expected.
Accuracy testing was performed to confirm that modifications included in ClearPoint Array 1.2 did not cause any unexpected changes in the accuracy specifications of the software, with successful results. Table 5-1 outlines the demonstrated accuracy specifications of ClearPoint Array System.
| Performance
| Validation | Positional Error (mm) | Angular Error (deg.) | ||||
|---|---|---|---|---|---|---|
| ClearPoint | ||||||
| Array System | Mean | |||||
| (x,y,z) | Std. Dev. | 99% CI | Mean | Std. Dev. | 99% CI | |
| 0.78 | 0.39 | 1.14 | 0.67° | 0.14° | 0.85° | |
| 1.52 | 0.46 | 1.94 | ||||
| -1.41 | 0.73 | -2.08 |
Table 5-1: ClearPoint Array Accuracy Specifications
Cl = confidence interval
7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The technological characteristics of the Array 1.2 Software are essentially identical to the predicates. The purpose of this Special 510(k) is to incorporate an update to the ClearPoint Array software. In addition to the functions of the predicate device, the ClearPoint Array System (Version 1.2) software includes the following modifications:
- . Support for parallel trajectory planning and realization using the guide channels of the ClearPoint Array® frame, such that devices can be inserted using guide channel positions without the need to adjust the frame angulation between insertions. This feature set includes:
- Ability to define one or more parallel trajectory paths corresponding to o physical guide channels on the frame.
6
- Capabilities to visualize the pre-mount orientation of the frame base(s) o needed to achieve the parallel trajectories corresponding to the guide channel positions.
- Prescription of adjustments needed to align the frame(s) along any parallel o traiectory path.
- Instructions for inserting device(s) along one or more parallel trajectory o paths.
- . Improved trajectory definition and review tools, including the ability to visualize pre-operatively planned trajectories in a three-dimensional scene, ability to modify target/entry points using coordinate values and ability to copy previously defined trajectory paths.
- Image visualization and rendering performance improvements. ●
- . Improved automatic fusion of image sets that are acquired in different frames of reference.
- A new set of interactive viewport tools which provide a richer functional toolset . offering.
- Translating the software user interface to support nine additional languages. ●
There have been no modifications to any of the hardware components of the predicate device. In addition, the minor differences in the newer software version do not alter the fundamental clinical purpose or present different questions of safety or effectiveness as compared to the predicate. The final software version has been fully validated. Thus, the ClearPoint Array System (version 1.2) is substantially equivalent to the ClearPoint Array System (K214040).The ClearPoint Array System (version 1.2) is substantially equivalent to the predicate The ClearPoint Array System (K214040) because the subject device raises no new issues of safety and effectiveness, meets all test specifications, and the non-clinical testing performed demonstrates that the subject devices is as effective, and performs as well as the predicate device. A side-by-side comparison of the subject device to the predicate can be found below in Table 5-2.
| Characteristic | Proposed ClearPoint Array System (v1.2) | ClearPoint Array System (v1.1)
K214040 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Classification | 21 C.F.R. § 882.4560 | 21 C.F.R. § 882.4560 |
| Product Code | HAW | HAW |
| Indications for Use | The ClearPoint® Array 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® Array 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 | Identical |
| | MR Conditional implants and devices. | |
| Environment | MRI Suite or OR | Identical |
| SMARTGrid Pack | MRI Planning Grid & Marking tool. | Identical |
| SMARTFrame Pack | SMARTFrame Array Adjustable Trajectory Frame, Scalp
Mount Base, Entry Point Locator, Targeting Stem, Centering
Device, Dock, Device Lock,
screwdriver, 2.1-mm Guide Tube, Center Drill Guide, Offset
Drill Guide, 3.4-mm Drill Reducer Tube, Center Insertion
Guide, Offset Insertion Guide | Identical |
| Hand Controller | Thumbwheel Extension | Identical |
| Accessory pack | Peel away sheath, Stylet, Depth stop, ruler | Identical |
| Drill Guides | Drill Guide, 4.5-mm (included in SMARTFrame Pack) | Identical |
| Targeting Cannula ID | No ID, Targeting Stem is completely fluid-filled | Identical |
| Targeting Cannula Material | PEEK | Identical |
| Guide Tube/Device Guide/Drill Guide ID | Drill Guide ID: 4.5 mm (included in
SmartFrame Pack)
Drill Guide Tube ID: 3.4 mm (included in
SmartFrame Pack)
Guide Tube ID: 3.2 mm
Guide Tube ID: 2.5 mm
Guide Tube ID: 2.1 mm
Guide Tube ID: 1.7 mm | Identical |
| Targeting Accuracy | ≤ 2.0 mm | Identical |
| Packaging | SMARTFrame Array Pack: PETG Tray with sealed Tyvek
Lid inside of a Sealed Mylar-Tyvek Pouch
SMARTFrame Array Thumbwheel
Extension:
PETG Tray sealed in a Double Mylar-Tyvek Pouch
SMARTFrame Array Guide Tube Kit:
Sealed Double Mylar-Tyvek Pouches | Identical |
| Software | Version 1.2 | Version 1.1 |
| Operating System | Windows 10, Windows 11 | Windows 10 |
| Programming Languages | Visual C#
Visual C++ | Identical |
| Visualization Software Toolkit | Fovia HDVR® | Identical |
| DICOM Toolkit | MergeCOM-3 Dicom Toolkit® | Identical |
| Image Registration Framework | Insight Toolkit (ITK) | CCR
NeuroTargeting
Registration
Library |
Table 5-2: Side-by-side comparison of ClearPoint Array 1.2 Software with Parent Device
7
8
8. CONCLUSIONS
The ClearPoint Array System (Version 1.2) is as safe and effective as the predicate device. The ClearPoint Array System (Version 1.2) has the same indications for use, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the subject device and its predicate devices raise no new issues of safety or effectiveness. Thus, the ClearPoint Array System (Version 1.2) is substantially equivalent to the predicate device.