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 Trajectory Frame (ATF) that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the 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 ClearPoint Workstation Software (for trajectory planning and monitoring) and a 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 SMARTGrid Pack (Marking Grid, Marking Tool), SMARTFrame Pack (SMARTFrame or SMARTFrame XG, Centering Tool, Wharen Centering Guide, Dock, Device Lock, Screwdriver, Roll Lock Screw and Washer), Rescue Screws, Hand Controller and Thumbwheel Extension, Accessory Pack (Peel-away Sheath, Stylet, Lancet, Depth Stop, Ruler), Scalp Mount Base, Guide Tube and Device Guide Packs (Guide Cannulas), SmartTip MRI Hand Drill and Drill Bit Kit, SmartTwist MRII Hand Drill and 4.5mm/6.0mm Drill Guide, MRI Neuro Procedure Drape, with Marker Pen and Cover, and SmartFrame MR Fiducial.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ClearPoint System, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance
Targeting Accuracy	± 1.5mm @ ≤ 125mm
Functionality of Wharen Centering Guide	Confirmed to hold Centering Tool and maintain selected entry point
Functionality of 4.5mm and 6.0mm Drill Guides	Acceptable results (functions as intended)
Compliance with Biological Evaluation	Adheres to AAMI/ANSI/ISO 10993-1
Compliance with Sterilization Process	Adheres to ANSI/AAMI/ISO 11135-1

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for test sets (e.g., number of phantom targets, physical products tested) for the functionality tests. The studies described are bench and phantom testing. Data provenance is implied to be from laboratory testing rather than human clinical data. The document does not provide information on the country of origin or whether the data was retrospective or prospective, as it pertains to bench and phantom testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the bench and phantom testing. The "ground truth" for these tests would likely be the known dimensions or positions in the phantom or bench setup.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods, as the tests performed are technical performance verification rather than clinical outcomes requiring expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench and phantom testing for device modifications, not a comparative clinical study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is a medical instrument system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply in the context of this 510(k) submission. The ClearPoint System requires a human operator for its intended use "to provide stereotactic guidance and operation of instruments or devices during the planning and operation of neurological procedures."

7. The Type of Ground Truth Used

For the performance data mentioned (Targeting Accuracy, functionality of new components):

Targeting Accuracy: The ground truth would be the known, precise target location within the phantom used for testing, typically established through precise measurement tools or engineering specifications.
Functionality of Wharen Centering Guide and Drill Guides: The ground truth would be the intended functional behavior and design specifications of these components as verified through engineering tests.

8. The Sample Size for the Training Set

The document does not mention any "training set" as it relates to machine learning or AI models. The ClearPoint System is a hardware/software system for surgical guidance, not an AI/ML device that requires training data in the typical sense.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of AI/ML, this question is not applicable to the provided document. The "training" for such a device would relate to the design and development processes for the hardware and software components, following engineering and quality system standards.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

March 24, 2016

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

Re: K160434 Trade/Device Name: ClearPoint System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW, ORR Dated: February 16, 2016 Received: February 16, 2016

Dear Dr. John Smith:

This letter corrects our substantially equivalent letter of March 17, 2016.

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 Actinclude 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/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 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 -S 同心

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160434

Device Name

ClearPoint System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:	March 15, 2016

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:	HAW, ORR

3. Predicate Device:

MRII ClearPoint System, K142505

4. Device Description:

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 Trajectory 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:

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

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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. Wharen Centering Guide
- d. Dock
- e. Device Lock (2 different diameters)
- f. Screwdriver
- Roll Lock Screw and Washer g.
Rescue Screws (Extra Titanium Screws) 5.
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
Guide Tube and Device Guide Packs (Guide Cannulas) 9.
1. SmartTip MRI Hand Drill and Drill Bit Kit
1. SmartTwist MRII Hand Drill and 4.5mm/6.0mm Drill Guide
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:

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

Modifications to the predicate ClearPoint System are as follows:

a) Addition of 4.5mm and 6.0mm Drill Guides that are compatible with the SmartFrame XG and can be used in place of the Targeting Cannula to facilitate the use of the cleared SmartTwist MRII Hand Drill (K151536) with the SmartFrame XG.

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b) Addition of the Wharen Centering Guide, an optional accessory designed to make the cleared Centering Tool (K100836) easier to use with the Scalp Mount Base. The use of this accessory is not required for proper use of the ClearPoint System, does not materially alter the clinical work flow, and does not change the intended use of the device. It can hold the Centering Tool in place and eliminate potential scalp movement during a) removing the lower pad of the Marking Grid, and b) during mounting of the Scalp Mount Base. Eliminating scalp movement during these steps will help ensure an accurate alignment of the SmartFrame to the entry point.

	ClearPoint SystemK142505	ClearPoint SystemModified
Classification	21 CFR 882.4560	21 CFR 882.4560
Product Code	HAW, ORR	HAW, ORR
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
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, Dock and Lock, RollLock Screw with Washer, RescueScrews (packaged separately)	SmartFrame XG, Scalp Mount Base,Bone Screws, Scalp Mount Base,Screws, Stand-Off Pins, Screwdriver,Centering Tool, Wharen CenteringGuide (packaged and soldseparately), Dock and Lock, Roll LockScrew with Washer, Rescue Screws(packaged separately)
Hand Controller	Thumbwheel Extension (Light HandController)	Thumbwheel Extension (Light HandController)
Accessory Kit	Peel-away Sheath, Lancet, Stylet,Depth Stop, Ruler	Peel-away Sheath, Lancet, Stylet,Depth Stop, Ruler
Drill Guides	Not included	4.5mm & 6.0mm
TargetingCannula ID	0.0825"	0.0825"
TargetingCannula Material	Ultem and PEEK	Ultem and PEEK
Guide Tube /Device Guide /Drill Guide ID	0.0938 & 0.141"	0.0938, 0.141, 0.191, 0.250"
Guide Tube /	Ultem	Ultem
	ClearPoint SystemK142505	ClearPoint SystemModified
Device Guide /Drill GuideMaterialPackaging	Sterile, Sealed Tray, Inside SterileTyvek Pouch	Sterile, Sealed Tray, Inside SterileTyvek Pouch(Wharen Centering Guide and Drilland Device Guides are Sterile in adouble Tyvek Pouch Without a Tray;Wharen Centering Guide Packagingincludes PVC)
TargetingAccuracy	$\pm$ 1.5mm @ ≤125mm	$\pm$ 1.5mm @ ≤125mm
Software	1.5

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7. Performance Data:

Bench and phantom testing confirmed that the Wharen Centering Guide can be used to help hold the Centering Tool in place and maintain the selected entry point. Design verification was performed on the 4.5mm and 6.0mm Drill Guides with acceptable results. The tests demonstrated that the modified ClearPoint System functions as intended and is substantially equivalent to the legally marketed device.

The ClearPoint System complies with the following recognized consensus standards:

AAMI/ANSI/ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing.
· ANSI/AAMI/ISO 11135-1 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 (K142505). 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).