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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

Device Description

The hardware and software components of the SurgiVision ClearPoint System. The hardware and software components of the SurgiVision ClearPoint System 37 are identical to the predicate device. The sole purpose of this 510(k) application is to expand the indications for the ClearPoint System to 3.0 Tesla MRI scanners. The ClearPoint System 3T is intended to provide trajectory planning, guidance and fixation of neurosurgical tools during minimally invasive stereotactic surgical procedures in the brain conducted in the MR suite. The System itself provides no therapeutic or diagnostic functionality. The ClearPoint Stereotactic System is comprised of two separate device groups, a hardware and a software group. The software group is known as the ClearPoint Workstation. It includes the following: ClearPoint Workstation Software (for trajectory planning and . monitoring) Laptop Computer . The hardware device group under the ClearPoint Stereotactic System umbrella is known as the SmartFrame and Accessories.

AI/ML Overview

Here's an analysis of the provided text regarding the SurgiVision ClearPoint System 3T, focusing on the acceptance criteria and the study proving it meets those criteria:

The K111073 submission for the ClearPoint System 3T is a 510(k) to expand the indications for use of the previously cleared ClearPoint System (K100836) to include 3.0 Tesla MRI scanners. Therefore, the primary "acceptance criterion" being evaluated is the device's performance and safety within the 3T MRI environment, specifically demonstrating it is substantially equivalent to the predicate device operating in a 1.5T environment.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compatibility with 3.0T MRI environment	Device functions as intended and is substantially equivalent to the predicate device in the 3T environment.
System Accuracy (in 3.0T environment)	Equivalent to ClearPoint System (predicate device, specified as ± 1.5mm).
Force Test Outcomes (in 3.0T environment)	Acceptable outcomes.
Torque Test Outcomes (in 3.0T environment)	Acceptable outcomes.
Heating Test Outcomes (in 3.0T environment)	Acceptable outcomes.
Image Artifacts (in 3.0T environment)	Acceptable outcomes.
B0 Field Test Outcomes (in 3.0T environment)	Acceptable outcomes.
MRI Conditional	ClearPoint SmartFrame and Accessories are MRI Conditional.

Details of the Study

Sample Size used for the test set and the data provenance:
- The document does not specify a "sample size" in terms of number of patients or cases. The testing described is bench testing only.
- Data Provenance: Not applicable in the context of patient data, as the tests were bench tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for bench testing is typically based on engineering specifications and metrology, not expert clinical consensus from patient data.
Adjudication method for the test set:
- Not applicable, as this was bench testing against engineering standards, not a clinical study requiring adjudication of expert interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or comparative effectiveness study was performed. The device, a neurological stereotaxic instrument, is a guidance system, not an AI-driven diagnostic or interpretative tool that would typically involve human readers or AI assistance in the way described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "testing" described is inherently standalone in nature, as it's bench testing of the system alone for its physical and functional characteristics (force, torque, heating, accuracy, etc.) within the 3T MRI environment. While the system is used with a human in the loop during surgery, the specific tests mentioned here evaluate the device's technical performance.
The type of ground truth used:
- Bench Test Ground Truth: Engineering specifications, physical measurements, and established safety standards for medical devices in an MRI environment (e.g., limits for heating, artifact generation, and system accuracy specifications from the predicate device).
The sample size for the training set:
- Not applicable. This device is a sterotactic guidance system; there is no mention of a machine learning component requiring a "training set" of data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this device.

Summary

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K111073

510(k) Summary

JUN 2 2 2 2011

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SurgiVision ClearPoint System 3T. ウ

Company Making the Submission: 1.

Name of Owner:	SurgiVision, Inc.
Address:	5 MusickIrvine, CA 92618
Telephone:	949-900-6833
Fax:	949-900-6834
Contact:	Edward Waddell
E-mail:	ewaddell@surgivision.com

2. Device Name:

Common Name:	Neurological StereotaxicInstrument
Proprietary Name:	ClearPoint System 3T
Classification:	II
Regulation Number:	21 CFR 882.4560
Product Code:	LNH, ORR

3. Predicate Device:

ClearPoint System, ruled substantially equivalent K100836 on June 16, 2010.

4. Intended Use Statement:

Description of Device: 5.

The hardware and software components of the SurgiVision ClearPoint System.

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37 are identical to the predicate device. The sole purpose of this 510(k) application is to expand the indications for the ClearPoint System to 3.0 Tesla MRI scanners. The ClearPoint System 3T is intended to provide trajectory planning, guidance and fixation of neurosurgical tools during minimally invasive stereotactic surgical procedures in the brain conducted in the MR suite. The System itself provides no therapeutic or diagnostic functionality.

The ClearPoint Stereotactic System is comprised of two separate device groups, a hardware and a software group. The software group is known as the ClearPoint Workstation. It includes the following:

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

The hardware device group under the ClearPoint Stereotactic System umbrella is known as the SmartFrame and Accessories.

Summary of the Technological Characteristics of the Device Compared 6. to the Predicate Device

	SurgiVisionClearPoint System 3T	Predicate Device:ClearPoint SystemK100836
Classification	21 CFR 882.4560	21 CFR 882.4560
Product Code	LNH, ORR	LNH, ORR
Intended Use	The ClearPoint System isintended to providestereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedureswithin the MRI environmentand in conjunction with MRimaging. The ClearPointSystem is intended as anintegral part of proceduresthat have traditionally usedstereotactic methodology.These procedures includebiopsies, catheter andelectrode insertion. TheSystem is intended for useonly with 1.5 and 3.0 TeslaMRI scanners.	The ClearPoint System isintended to providestereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedureswithin the MRI environmentand in conjunction with MRimaging. The ClearPointSystem is intended as anintegral part of proceduresthat have traditionally usedstereotactic methodology.These procedures includebiopsies, catheter andelectrode insertion. TheSystem is intended for useonly in 1.5 Tesla MRIscanners.

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510(k) (Traditional) Submission Section 5, 510(k) Summary

	SurgiVisionClearPoint System 3T	Predicate Device:ClearPoint SystemK100836
SoftwareVersion	ClearPoint 1.1	ClearPoint 1.1
Compatibilitywithenvironmentand otherdevices	1.5/3T MRI environment	1.5T MRI environment
SystemAccuracy	Equivalent to ClearPointSystem	$\pm$ 1.5mm

7. Testing:

Testing to applicable standards has been completed with acceptable outcomes. The following bench testing has been performed:

Testing addressed force, torque, heating, image artifacts, Bo and accuracy testing within the 3T environment, using ClearPoint 1.1 software and accessories, ruled substantially equivalent within K100836. These tests demonstrated that the ClearPoint System 3T functions as intended and is substantially equivalent to the legally marketed predicate ClearPoint System.

Non-clinical testing demonstrated the ClearPoint SmartFrame and Accessories as MRI Conditional.

8. Rx or OTC:

The Surgi Vision ClearPoint System 3T is an Rx prescription device per 21 CFR Part 801, Subpart D.

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9. Substantial Equivalence:

The SurgiVision ClearPoint System 3T is as safe and effective as the predicate ClearPoint System. The ClearPoint System 3T has the same intended uses and essentially identical indications, technological characteristics, and principles of operation as its predicate device. Performance data demonstrate that the ClearPoint system 3T is as safe and effective as the predicate ClearPoint System.

SurgiVision, Inc.
Edward Waddell

Edward Waddell Director of Regulatory Affairs

Date: Jun 17, 2011

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

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

Surgivision, Inc. c/o Mr. Edward Waddell Director, Regulatory 5 Musick Irvine, CA 92618

Re: K111073

Trade/Device Name: ClearPoint System 3T Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ORR, LNH Dated: April 15, 2011 Received: April 18, 2011

JUN 2 2 2011

Dear Mr. Waddell:

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 (reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Rekhmn. f

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement KI11073

510(k) Number (if known):

Device Name: SurgiVision, Inc. ClearPoint System™ 3T Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Con Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Per 21 CFR 801.109)

John Doucet

(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic, Neurological and Ear. Division of Throat Devices

K111073
510(k) Number

Page 1 Of 1

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).