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.

Device Description

The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Hand Controller.

The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software. The SMARTFrame is an Adjustable Traiectory Frame (ATF) that provides the quidance 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 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 and imaging coil(s) 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 (SMARTFrame or SMARTFrame XG)
a. SMARTFrame ("ATF") with Base
b. Centering Tool
c. Dock
d. Device Lock (2 different diameters)
e. Screwdriver
f. Roll Lock Screw and Washer
Rescue Screws (Extra Titanium Screws)
Hand Controller (for use with the ATF) and 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)
SmartTip MRI Hand Drill and Drill Bit Kit
MRI Neuro Procedure Drape, with Marker Pen and Cover
MR Camera Fiberscope Accessory Kit
SmartFrame MR Fiducial

AI/ML Overview

The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Targeting Accuracy	Less than 1.5 mm at ≤ 125 mm

2. Sample Size and Data Provenance:

Test Set Sample Size: The document repeatedly mentions "a cadaver study" and "a water phantom" for accuracy testing. No specific number for the cadaver or water phantom samples is provided.
Data Provenance: The studies appear to be conducted by the manufacturer, MRI Interventions, Inc., in a controlled testing environment, rather than being derived from patient data or clinical trials in specific countries. The testing methodology suggests a lab-based, pre-clinical assessment.

3. Number of Experts and Qualifications:

The document does not mention the use of experts to establish ground truth for the test set. The validation seems to rely on physical measurements and technical verification rather than human interpretation or expert consensus.

4. Adjudication Method:

No adjudication method is mentioned as the ground truth establishment for the test set does not involve human interpretation requiring adjudication.

5. MRMC Comparative Effectiveness Study:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a stereotactic guidance system, not an AI diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance:

The performance described is for the device itself (hardware and software working together to achieve targeting accuracy). However, the "standalone" context for AI usually refers to algorithm-only performance without human input. In this case, the ClearPoint System is the standalone device providing guidance. The accuracy testing detailed assesses the device's ability to achieve its intended targeting without human "correction" during the measurement of accuracy. The system's performance is independently verified, as the outcome (targeting accuracy) is a direct measure of the system's output.

7. Type of Ground Truth Used:

The ground truth for the accuracy testing was established through physical measurements and phantom studies. Specifically, a water phantom and a cadaver study were used to measure the deviation of the device's guided trajectory from the intended target. This is a form of measurement ground truth.

8. Sample Size for the Training Set:

The document describes a hardware and software system for stereotactic guidance. It does not explicitly mention a "training set" in the context of machine learning or AI model development. The software capabilities are described more as an integral part of the system's function (e.g., trajectory planning and monitoring) rather than a continuously learning AI. Therefore, a traditional "training set" as understood in AI validation is not applicable or explicitly mentioned.

9. How Ground Truth for Training Set Was Established:

As a traditional "training set" is not explicitly mentioned or applicable to the device's description, the method for establishing its ground truth is not detailed. The software's development likely followed standard software engineering verification and validation processes against pre-defined specifications and requirements, rather than through a machine learning training paradigm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2015

MRI Interventions. Inc. % John J. Smith, MD, JD Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Re: K142505

Trade/Device Name: ClearPoint System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, ORR Dated: September 22, 2015 Received: September 22, 2015

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

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Page 2 - John J. Smith, MD, JD

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 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,

Carlos L. Pena -SFD/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142505

Device Name ClearPoint System

Indications for Use (Describe)

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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510(k) Summary K142505

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the MRII ClearPoint System.

1. Company Making the Submission:

Name of Owner:	MRI Interventions, Inc.
Address:	5 MusickIrvine, CA 92618
Telephone:	949-900-6833
Fax:	949-900-6834
Contact:	Pete Piferi
E-mail:	ppiferi@mriinterventions.com
Date Prepared:	October 21, 2015

2. Device Name:

Common Name:	Neurological StereotaxicInstrument
Proprietary Name:	ClearPoint System
Classification Name:	Stereotaxic Instrument
Regulatory Class:	II
Regulation Number:	21 C.F.R. § 882.4560
Product Code:	ORR, HAW

3. Predicate Device:

MRII ClearPoint System, K1111073

4. Device Description:

The ClearPoint Workstation includes the following:

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1. ClearPoint Workstation Software (for trajectory planning and monitoring)
1. 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:

1. SMARTGrid Pack (interacts with the software to determine the desired location of the burr hole)
- a. Marking Grid
- b. Marking Tool
1. SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
- a. SMARTFrame ("ATF") with Base
- b. Centering Tool
- c. Dock
- d. Device Lock (2 different diameters)
- e. Screwdriver
- Roll Lock Screw and Washer f.
1. Rescue Screws (Extra Titanium Screws)
1. Hand Controller (for use with the ATF) and Thumbwheel Extension
1. Accessory Pack
- a. Peel-away Sheath
  - b. Stylet
  - c. Lancet
  - d. Depth Stop
  - e. Ruler
1. Scalp Mount Base
1. Guide Tube and Device Guide Packs (Guide Cannulas)
1. SmartTip MRI Hand Drill and Drill Bit Kit
1. MRI Neuro Procedure Drape, with Marker Pen and Cover
1. MR Camera Fiberscope Accessory Kit
1. SmartFrame MR Fiducial

Each of the above packs is sold separately. Each is intended to be used with the ClearPoint Workstation.

5. Indications for Use:

The ClearPoint System is intended to provide stereotactic quidance 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.

6. Comparison of the Technological Characteristics of the Device with the Predicate Device:

Modifications to the predicate ClearPoint System are as follows:

a) The Scalp Mount is a modified base for the existing ClearPoint ATF allowing attachment through the scalp to the skull instead of directly to the skull via a relatively large incision.
b) The SMARTFrame XG is a modified tower of the ClearPoint ATF allowing the exchange of Guide Cannulas, e.g. removal of the existing Guide Cannula and replacement with a Guide Cannula(s), allowing larger devices to be utilized in neurological procedures.

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Evolutionary changes within the ClearPoint System software. c)
d) Minor modifications of pre-existing accessories for the ClearPoint System.

	ClearPoint System	ClearPoint System (Modified)
	K111073
ClassificationProduct Code	21 CFR 882.4560ORR, HAW	21 CFR 882.4560ORR, HAW
Intended Use	The ClearPoint System is intended toprovide stereotactic guidance andoperation of instruments or devicesduring the planning and operation ofneurological procedures within theMRI environment and in conjunctionwith MR imaging. The ClearPointSystem is intended as an integral partof procedures that have traditionallyused stereotactic methodology.These procedures include biopsies,catheter and electrode insertion. TheSystem is intended for use only with1.5 and 3.0 Tesla MRI scanners.	The ClearPoint System is intended toprovide stereotactic guidance andoperation of instruments or devicesduring the planning and operation ofneurological procedures within theMRI environment and in conjunctionwith MR imaging. The ClearPointSystem is intended as an integral partof procedures that have traditionallyused stereotactic methodology.These procedures include biopsies,catheter and electrode insertion. TheSystem is intended for use only with1.5 and 3.0 Tesla MRI scanners.
Environment	MRI Suite	MRI Suite
Sterilization	EO 10-6 SAL	EO 10-6 SAL
SmartGridPack	MRI Planning Grid & Marking Tool	MRI Planning Grid & Marking Tool
SmartFramePack	SmartFrame ATF, Scalp Mount Base,Bone Screws, Screwdriver, CenteringTool, Dock and Lock, Roll Lock Screwwith Washer, Extra Titanium Screws	SmartFrame XG, Scalp Mount Base,Bone Screws, Scalp Mount Base,Screws, Stand-Off Pins, Screwdriver,Centering Tool, Dock and Lock, RollLock Screw with Washer, RescueScrews (packaged separately)
HandControllerAccessory Kit	Hand ControllerPeel-away Sheath, Stylet, DepthStop, Ruler	Thumbwheel Extension (Light HandController)Peel-away Sheath, Lancet, Stylet,Depth Stop, Ruler
TargetingCannula ID	0.0825"	0.0825"
TargetingCannulaMaterial	Ultem and PEEK	Ultem and PEEK
Guide Tube /Device GuideID	0.052, 0.068, 0.074"	0.0938 & 0.141"
Guide Tube /Device GuideMaterial	Ultem and PEEK	Ultem and PEEK
Guide Tube /Device GuideMaterialPackaging	Sterile, Sealed Tray, Inside SterileTyvek Pouch	Sterile, Sealed Tray, Inside SterileTyvek Pouch
TargetingAccuracy	$\pm$ 1.5mm @ ≤125mm	$\pm$ 1.5mm @ ≤125mm
Software	1.0	1.5

The Scalp Mount Base performs exactly the same function as the original SmartFrame Base, but is mounted through the patient's scalp to the skull instead of

MRI Interventions, Inc.

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directly to the scalp via a relatively large incision. The modification to the original Base was made to allow less invasive procedures to be performed with the SmartFrame.

The SmartFrame XG is a modification to the previously cleared SmartFrame ATF that is sold as a separate product. The need for the SmartFrame XG arose from physicians' desire to use ClearPoint and the SmartFrame for precision placement of MRI Compatible Biopsy Needles, Shunt Catheters for cyst drainage, and laser ablation catheters. The changes had no impact on use of the SmartFrame. The same Dock-and-Lock system used in the original SmartFrame ATF can be used with the SmartFrame XG. No software changes were necessary for the SmartFrame XG. The SmartFrame XG is fully interchangeable with all other SmartFrame components and accessories.

7. Performance Data:

The performance testing performed for the predicate ClearPoint System (K111073) is fully applicable to the modified ClearPoint System performance. Specifically, the following testing that was performed on the predicate device is fully applicable to the modified ClearPoint System:

Accuracy Testing, including MRI Device Accuracy Testing, System Accuracy . in a Water Phantom and System Accuracy in a Cadaver. These test results demonstrate the targeting accuracy of the predicate ClearPoint System (K111073) when used in conjunction with MRI scanner software. The results support the safe and effective use of the ClearPoint System to quide a device to a brain target with an error less than 1.5mm at ≤125mm.
ClearPoint System Safety Testing with 1.5T and 3.0T MRI scanners. .

In addition, the accuracy testing for the predicate ClearPoint System (K111073) was repeated for the modified ClearPoint System to validate a targeting accuracy for the ClearPoint System using the raised Scalp Mount frame. The results of this testing confirm the targeting accuracy of the device with an error less than 1.5mm at ≤125mm from the insertion point.

No additional sterility testing was performed. Additional biocompatibility tests were performed on the Device Guides as described below.

The ClearPoint System was modified in conformance with the company's design control procedures. Design inputs provided the requirements for the respective product specifications. Design Verification was performed relative to these specifications with acceptable results. Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the modified ClearPoint System functions as intended and is substantially equivalent to the legally marketed ClearPoint System. A summary of the performance testing that was conducted on the subject device is presented in the table below.

The risks of the modified ClearPoint System were further mitigated through labeling revisions to include a warning that end users should not use the system with instruments longer than 30cm in length, as the accuracy of the system has not been established with instruments longer than this length.

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Test	Test Method Summary	Results
Accuracy of Scalp MountBase	The Scalp Mount Base was tested using a waterphantom to verify system accuracy was maintained.	Pass
Accuracy of Large Bore ATFand Device Guide	A cadaver study was used to verify the accuracy ofthe Large Bore ATF and Device Guide.	Pass
Accuracy of SmartFrame XGand Device Guides	The SmartFrame XG and Device Guides wereverified to maintain accuracy using a photomappingdigitizer program and a cylindrical phantom test.	Pass
Accuracy of ClearPointComponents, Assembliesand System	Accuracy of the system under adverse and worstcase conditions evaluated to ensure Stylet locationwas maintained.	Pass
Targeting Cannula Aging	One- and two-year accelerated heat aging tests forthe Targeting Cannula	13-MonthShelf Life
Biocompatibility of DeviceGuide	Cytotoxicity Study Using ISO Elution Method & ISOSkin Irritation Study in Rabbits	Pass

Software Verification and Validation

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for industry and FDA Staff. "Guidance for the content of premarket Submission for software Contained in Medical Devices." The software for this device represents a moderate level of concern. The system conforms to the DICOM standard to allow the transfer of images from the MR scanner.

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.

8. Conclusions:

The modifications to the ClearPoint System were made in conformance with the company's design control procedures and the performance testing performed for the predicate ClearPoint System (K111073), including accuracy testing and safety testing, is fully applicable to the modified ClearPoint System. Additional accuracy testing was performed with the raised Scalp Mount base to confirm the accuracy of the modified device with an error less than 1.5mm at ≤125mm from the insertion point.

The modified ClearPoint System has the same intended use and indications for use and similar technologies characteristics and principles of operation as the predicate ClearPoint System. The minor technological differences between the modified ClearPoint System and its predicate ClearPoint System raise no new issues of safety and effectiveness. Thus the modifications are substantially equivalent to the previously cleared ClearPoint System.

Regulation Number and Section

§ 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).