ClearPoint Array System

K202575 · ClearPoint Neuro, Inc. · HAW · Jan 22, 2021 · Neurology

Device Facts

• Record ID: K202575
• Device Name: ClearPoint Array System
• Applicant: ClearPoint Neuro, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jan 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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 MR Conditional implants and devices.

Device Story

ClearPoint Array System provides stereotactic guidance for neurosurgical procedures within MRI environments. System inputs include real-time MR images and trajectory planning data. Components include workstation laptop with planning software, SMARTGrid MRI-guided planning grid, and SMARTFrame Array trajectory frame. Physician uses workstation to plan trajectories; SMARTGrid assists in burr hole positioning; SMARTFrame Array provides guidance and fixation for surgical tools. MRI-visible fluids in targeting stem and fiducial markers in frame provide trajectory feedback via MR imaging. System allows for pre-alignment using surgical navigation systems, followed by final alignment and insertion under real-time MR guidance. Output is visual trajectory feedback on workstation monitor, enabling precise instrument placement. Used in MRI suites or OR by neurosurgeons. Benefits include real-time visualization and accurate stereotactic placement of neurosurgical tools, potentially improving procedural outcomes.

Clinical Evidence

Bench testing only. Navigational accuracy validation performed; mean positional error 0.78mm (x), 1.52mm (y), -1.41mm (z) with 99% CI. Angular error mean 0.67°. Biocompatibility testing (ISO 10993-1) for SMARTFrame Array Base showed no cytotoxicity, irritation, sensitization, systemic toxicity, or pyrogenicity.

Technological Characteristics

Materials: PEEK (targeting cannula), titanium (screws). Energy: MRI-guided (1.5T/3.0T). Form factor: Adjustable trajectory frame with discrete positional adjustment. Connectivity: Workstation-based. Sterilization: EO (10^-6 SAL). Software: Trajectory planning and monitoring.

Indications for Use

Indicated for patients undergoing neurological procedures requiring stereotactic guidance, including biopsies, catheter placement, and deep brain stimulation (DBS) lead placement. Intended for use with 1.5T and 3.0T MRI scanners and MR-conditional implants.

Regulatory Classification

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.

Predicate Devices

• ClearPoint System and Accessories (K200079)

Submission Summary (Full Text)

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January 22, 2021

ClearPoint Neuro, Inc. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004

Re: K202575

Trade/Device Name: ClearPoint Array System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 23, 2020 Received: December 23, 2020

Dear John 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. 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

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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) 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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

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

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510(k) Number (if known)

K202575

Device Name

ClearPoint Array System

Indications for Use (Describe)

The ClearPoin® 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 insettion 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)

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

#### ClearPoint Neuro Inc.'s ClearPoint Array System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared ClearPoint Neuro Inc.

5 Musick

### Irvine, CA 92618

Phone: [phone] Facsimile: (49) 900-6834 Contact Person: Peter Piferi, C.O.O Date Prepared: January 22, 2021

Name of Device: ClearPoint Array System

Common or Usual Name: ClearPoint Array System

Classification Name: Neurological Stereotaxic Instrument, 21 CFR 882.4560

Regulatory Class: Class II

Product Code: HAW

#### Predicate Devices

ClearPoint System and Accessories (K200079)

### Intended Use / 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 MR Conditional implants and devices.

## 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.

A pre-alignment may be used when it is desired to obtain an approximate alignment using a Surgical Navigation System prior to performing final alignment and device placement in the MR Scanner using real-time MR Images. Pre-alignment using an SNS is not intended to provide accurate stereotactic placement. The final alignment and insertion must be performed using real-time MR images with ClearPoint Array software prior to inserting a device in the brain. The SMARTGrid™ MRI-Guided Planning Grid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software.

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The SMARTFrame™ Array MRI-Guided Trajectory Frame is an adjustable trajectory frame that provides the quidance and fixation for neurosurgical tools. MRI visible fluids in the Targeting Stem along with the fiducial markers in the frame allows for trajectory feedback when the physician views the MR images, makes changes and confirms the subsequent MR images. The ClearPoint Array 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) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint Array System.

The ClearPoint System Array Workstation includes the following:

- 1. ClearPoint Workstation Software (for trajectory planning and monitoring)
- 2. Laptop Computer

The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories. Some of the accessories are common components with the ClearPoint System (K200079). They are all single use devices that are provided sterile. They include the following:

- 1 SMARTFrame Array Pack
- a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter and Tracker Rod)
- b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and support pins)
- Entry Point Locator C.
- d. Targeting Stem
- e. Centering Device
- f. Dock
- Device Lock (2 different diameters) q.
- h. Screwdriver
- i. 2.1-mm Guide Tube
- j. Center Drill Guide
- Offset Drill Guide k.
- 1. 3.4-mm Drill Reducer Tube
- m. Center Insertion Guide
- n. Offset Insertion Guide
- 2 SmartFrame Array Thumb Wheel Extension Set for the trajectory frame
- 3 SmartFrame Array Guide Tube Kit
- a. 1.7-mm Guide Tube
- b. 2.5-mm Guide Tube and Device Lock
- c. 3.2-mm Guide Tube and Device Lock

Common components to ClearPoint System include:

- 1. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole)
- a. Marking Grid

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- b. Marking Tool
- 2. Accessory pack
- a. Peel away sheath
- b. Stylet
- c. Depth Stop
- d. Ruler
- 3. MRI Neuro Procedure Drape

# Technological Characteristics

The purpose of the 510(k) is to modify the SmartFrame Array by:

- 1. Material change and addition of small geometric features on the Adjustable Trajectory Frame (ATF) and Scalp Mount Base.
- 2. Replacing the ATF's continuous X-Y adjustment with a discrete positional adjustment.
- 3. Modification of the targeting cannula material and construction.
- 4. Providing a passive guide and rod with the ATF that allows users to insert a surgical navigation system Probe or Universal Tracker and be held in the ATF.
- 5. Minor updates to device packaging.
- 6. Software modifications for:
- New workflow options, user interface, image alignment methods. ●
- Introduction of new software tools for volume of interest comparison. .

| Classification | ClearPoint System (Predicate)<br>K200079 | ClearPoint Array System (Subject) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 21 C.F.R. § 882.4560 | 21 C.F.R. § 882.4560 |
| Product code | HAW | HAW |
| Intended Use | The ClearPoint® System is intended to<br>provide stereotactic guidance for the<br>placement and operation of instruments<br>or devices during planning and<br>operation of neurological procedures<br>within the MRI environment and in<br>conjunction with MR imaging. The<br>ClearPoint® Array System is intended<br>as an integral part of procedures that<br>have traditionally used stereotactic<br>methodology. These procedures<br>include biopsies, catheter and electrode | The ClearPoint® Array System is<br>intended to provide stereotactic<br>guidance for the placement and<br>operation of instruments or devices<br>during planning and operation of<br>neurological procedures within the MRI<br>environment and in conjunction with MR<br>imaging. The ClearPoint® Array System<br>is intended as an integral part of<br>procedures that have traditionally used<br>stereotactic methodology. These<br>procedures include biopsies, catheter |
| | insertion including deep brain<br>stimulation (DBS) lead placement. The<br>System is intended for use only with 1.5<br>and 3.0 Tesla MRI scanners and MR<br>Conditional implants and devices. | and electrode insertion including deep<br>brain stimulation (DBS) lead placement.<br>The System is intended for use only<br>with 1.5 and 3.0 Tesla MRI scanners<br>and MR Conditional implants and<br>devices. |
| Environment | MRI Suite | MRI Suite or OR |
| 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 Adjustable Trajectory<br>Frame with Targeting Cannula, Skull<br>Mount Base, Screwdriver, Dock, Device<br>Lock, Centering Ring | SMARTFrame Array Adjustable<br>Trajectory Frame, Scalp Mount Base,<br>Entry Point Locator, Targeting Stem,<br>Centering Device, Dock, Device Lock,<br>screwdriver, 2.1-mm Guide Tube,<br>Center Drill Guide, Offset Drill Guide,<br>3.4-mm Drill Reducer Tube, Center<br>Insertion Guide, Offset Insertion Guide |
| Hand Controller | Thumbwheel Extension | Thumbwheel Extension |
| Accessory pack | Peel away sheath, Stylet, Depth stop,<br>ruler | Peel away sheath, Stylet, Depth stop,<br>ruler |
| Drill Guides | Drill Guide, 3.4-mm<br>Drill Guide, 4.5-mm<br>Drill Guide, 6.0-mm | Drill Guide, 4.5-mm (included in<br>SMARTFrame Pack) |
| Targeting Cannula ID | .083" (2.1 mm) | No ID, Targeting Stem is completely<br>fluid-filled |
| Targeting Cannula<br>Material | Ultem and PEEK | PEEK |
| Guide Tube/Device<br>Guide/Drill Guide ID | Drill Guide ID: 4.5 mm<br>Drill Guide ID: 6.0 mm<br>Device/Drill Guide ID: 3.4 mm<br>Device Guide ID: 3.2 mm<br>Device Guide ID: 2.5 mm<br>Device Guide ID: .093"<br>Guide Tube ID: 1.7 mm | Drill Guide ID: 4.5 mm (included in<br>SmartFrame Pack)<br>Drill Guide Tube ID: 3.4 mm (included in<br>SmartFrame Pack)<br>Guide Tube ID: 3.2 mm<br>Guide Tube ID: 2.5 mm<br>Guide Tube ID: 2.1 mm<br>Guide Tube ID: 1.7 mm |
| Packaging | SMARTFrame Pack: PETG Tray with<br>sealed Tyvek Lid inside of a Sealed<br>Mylar-Tyvek Pouch | SMARTFrame Array Pack: PETG Tray<br>with sealed Tyvek Lid inside of a Sealed<br>Mylar-Tyvek Pouch |
| | Thumbwheel Extension: PETG Tray<br>sealed in a Double Mylar-Tyvek Pouch | SMARTFrame Array Thumbwheel<br>Extension: PETG Tray sealed in a<br>Double Mylar-Tyvek Pouch |
| | Guide Tubes and Drill Guides: Sealed<br>Double Mylar-Tyvek Pouches | SMARTFrame Array Guide Tube Kit:<br>Sealed Double Mylar-Tyvek Pouches |
| Targeting Accuracy | ≤ 1.5 mm | ≤ 2.0 mm |
| Software | ClearPoint 2.0.x | ClearPoint Array 1.0.x |

# Summary of Technological Characteristics of the Device Compared to the Predicate Device

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## Biocompatibility

All patient contacting components remain the same as the predicate ClearPoint System except for the SMARTFrame Array Base. For this reason, biocompatibility was only performed on the SMARTFrame Array Base. The SmartFrame Lite Base was found to be biocompatible per ISO 10993-1 as summarized below.

| Test Description | Results | Pass/Fail |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Cytotoxicity<br>ISO 10993-5 | The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity). | Pass |
| Irritation<br>ISO 10993-11 | There was no erythema and no edema observed on the skin of the animals treated with the Saline and Sesame Oil extracts. For both test article extracts, the Primary Irritation Index was calculated to be 0.0 and the irritation response was categorized as negligible. | Pass |
| Sensitization<br>ISO 10993-11 | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. | Pass |
| Systemic Toxicity ISO 10993-11 | There was no mortality or evidence of systemic toxicity form the extracts injected into mice. Each test article extract met the requirements of the study. | Pass |
| Material Mediated<br>Pyrogenicity<br>ISO 10993-11 | The total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP requirements. The test article met the requirements for the absence of pyrogens. | Pass |

## Performance Data

The modifications implemented in ClearPoint Array System were conducted in conformance with the company's design control procedures. Design inputs provided the requirements for the respective product specifications. Design Verification and Validation was performed relative to these specifications and with acceptable results. These tests included verification of physical, performance, and safety requirements, as well as benchtop accuracy testing. The navigational accuracy validation values are presented in the table below.

| Performance<br>Validation | Positional Error (mm) | | | Angular Error (deg.) | | |
|----------------------------|-----------------------|-----------|--------|----------------------|-----------|--------|
| ClearPoint<br>Array System | Mean<br>(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 | | | |

*Cl = confidence interval

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Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the ClearPont Array System functions as intended and is substantially equivalent to the legally marketed ClearPoint System.

#### Substantial Equivalence

The modifications implemented in ClearPoint Array System were conducted in conformance with the company's design control procedures. Performance testing established the substantial equivalence of the ClearPoint Array System to the predicate ClearPoint System, including design verification testing.

The ClearPoint Array System has the same intended use and similar indications for use, technological characteristics and principles of operation as the predicate ClearPoint System. The minor differences in the workflow and usability do not raise new and different questions of safety and effectiveness.

#### Conclusions

The ClearPoint Array System has the same intended use and similar indications for use, technological characteristics and principles of operation as the predicate ClearPoint System. The differences between the ClearPoint Array System and the predicate raise no new issues of safety and effectiveness. Thus, the ClearPoint Array System is substantially equivalent to the previously cleared ClearPoint System.