BrightMatter Navigation System is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

Device Description

The subject device, BrightMatter Navigation system, is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. In particular, the device is suitable for neurosurgical cranial procedures. The planning functionality of the device is provided by an already cleared device, BrightMatter Planning (K140337). The remaining system provides a sequence of discrete workflow activities (or phases) that guide a surgeon through the process of data preparation for the surgical procedure. Then the device aids the surgeon in visualizing the location of the surgical tools relative to clinical images and physical location of the patient.

Following is a summary of steps involved in data preparation and registration of the patient's head position relative to pre-surgical clinical images:

Importing plan and imaging data
Reviewing and selecting a previously generated surgical plan
Optionally fusing (merging or co-registering) additional imaging data
Preparing and executing point-based registration

Following steps are provided as visualization tools during the execution of the surgical procedure:

Aid in visualizing location of the surgical site as planned by the surgeon (using BrightMatter Planning software, K140337)
For trajectory-centric procedures, help visualize insertion of tracked surgical tools by identifying location of surgical tool's position and orientation relative to clinical images and the surgical plan developed by the surgeon
Visualize location of tracked surgical tools after the intended target location has been reached

Key functional components of the subject device are an optical tracking sub-system, navigated surgical tools, custom software application and an external display. The navigated surgical tools are tracked using single-use passive reflective markers (K033621) that are attached to the surgical tools prior to each surgical procedure.

The surgical display and tracking camera are mounted on an Auxiliary Cart. The computer is housed in a Navigation Cart.

As with many systems in the OR, not all components need to be sterile during use. The only subcomponents that come in contact with the patient are the Pointing Tool, Port Reference Tool and Calibration Block. These tools fit in the limited contact duration category.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BrightMatter Navigation System v1.0, based on the provided FDA 510(k) document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Positional Error (Navigation Accuracy)	Less than 2 mm
Angular Error (Navigation Accuracy)	Less than 2 degrees
Cytotoxicity	Non-cytotoxic (0 score based on degree of cellular destruction)
Sensitization	Devices do not elicit sensitization response
Irritation/Intracutaneous Toxicity	Do not cause tissue irritation
Acute Systemic Toxicity (Rabbit Pyrogen)	Devices are non-pyrogenic
Acute Systemic Toxicity (Systemic Injection)	Device contact is non-toxic
Sterility Assurance Level (SAL)	≤ 10⁻⁶ (for end-user sterilizable components)

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

Sample Size for Test Set: Not explicitly stated as a number of "samples" in a traditional clinical sense. The accuracy testing was conducted using a "measurement phantom" that mimicked brain volume.
Data Provenance: The document does not specify the country of origin for the phantom data. The study was a non-clinical study, primarily involving engineering and system performance testing.

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

Number of Experts: Not applicable. The ground truth for the accuracy testing was established using a Coordinate Measurement Machine (CMM), which is a precision metrology instrument, not human experts.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established by CMM measurements, not human consensus requiring adjudication.

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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
Effect Size: Not applicable. The device is a navigation system for surgical guidance, not an AI diagnostic tool primarily evaluated by human reader performance on a diagnostic task.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the described accuracy testing (positional and angular error) is a form of standalone performance evaluation for the tracking and guidance algorithm. It assesses the device's inherent measurement capabilities without direct surgeon interaction in the measurement process (though it simulates surgical workflow via CT images of the phantom).

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the accuracy testing was established by Coordinate Measurement Machine (CMM) measurements on a measurement phantom. This provides high-precision physical measurements. In addition, for biocompatibility testing, established laboratory standards and measurement techniques were used to determine results.

8. The Sample Size for the Training Set

Sample Size for Training Set: The document does not provide information about a "training set" in the context of an AI/machine learning model. The BrightMatter Navigation System is described as using an "optical tracking sub-system" and software for guidance. It's not explicitly stated to be an AI/ML device in the sense of requiring a large training dataset for model development. The software development follows a standard Software Development Life Cycle.

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

Ground Truth for Training Set: Not applicable, as there's no explicit mention of a training set or AI/ML model training in the conventional sense. The "training" of such a system would typically involve calibrating the optical tracking hardware and validating the software algorithms against known physical parameters, where the "ground truth" would be the precisely known physical dimensions and positions.

Summary

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

April 2, 2015

Synaptive Medical Inc. Mr. Cameron Piron President Mars Center, South Tower, 101 College Street, Suite 200 Toronto, ON M5G 1L7 Canada

Re: K142024

Trade/Device Name: BrightMatter Navigation System v1.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: March 24, 2015 Received: March 30, 2015

Dear Mr. Piron,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/^

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) K142024

Device Name BrightMatter Navigation System v1.0

Indications for Use (Describe)

BrightMatter Navigation System is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

The system should be operated only by trained personnel such as surgeons and other clinic staff.

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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l. SUBMITTER

Synaptive Medical Inc. MaRS Centre, South Tower 101 College Street, Suite 200 Toronto, ON M5G 1L7 Canada

Contact Person: Cameron Piron President Telephone: 416-673-6679 Email: cameron.piron@synaptivemedical.com

Date Prepared: March 27, 2015

II. DEVICE

Name of Device: BrightMatter Navigation System v1.0 Common or Usual Name: Stereotaxic instrument Classification Name: Stereotaxic instrument (21 CFR 882.4560) Regulatory Class: II Product Code: HAW

III. PREDICATE DEVICE

Stryker Navigation System – Cranial Module by Stryker Corporation, K062640 Date cleared: December 14, 2006

IV. DEVICE DESCRIPTION

Following is a summary of steps involved in data preparation and registration of the patient's head position relative to pre-surgical clinical images:

Importing plan and imaging data
Reviewing and selecting a previously generated surgical plan
Optionally fusing (merging or co-registering) additional imaging data
Preparing and executing point-based registration

Following steps are provided as visualization tools during the execution of the surgical procedure:

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Aid in visualizing location of the surgical site as planned by the surgeon (using BrightMatter Planning software, K140337)
. For trajectory-centric procedures, help visualize insertion of tracked surgical tools by identifying location of surgical tool's position and orientation relative to clinical images and the surgical plan developed by the surgeon
Visualize location of tracked surgical tools after the intended target location has been reached

The surgical display and tracking camera are mounted on an Auxiliary Cart. The computer is housed in a Navigation Cart.

V. INDICATION FOR USE

The system should be operated only by trained personnel such as surgeons and other clinic staff.

The Indications for Use statement for BrightMatter Navigation System is identical to the predicate device with the exception that the subject device's statement does not enumerate specific supported clinical procedures. This difference does not affect the intended use of the subject device as a guidance system when the device is used as labeled. The safety and effectiveness of the subject device were established through verification and validation summarized below.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Design comparison summary: Both the subject device and the predicate device, Stryker Navigation System - Cranial Module, help develop a treatment plan is then used as input to image guided surgery. Both systems track the surgical tools using an optical 3D tracking system and the position and orientation of these tools are displayed relative to the clinical images of the patient. This information is used by the surgeon to guide the surgical instrument(s) to a target location designated by the surgeon. Both systems utilize a software sub-system that is workflow based. Hence, the overall design of the two systems are comparable. The only difference is that the subject device provides the additional capability of visualizing tractography information.

Biocompatibility summary: The subject device is comparable to the predicate device since the predicate device claims biocompatibility in its documentation and patient contacting parts of the subject device were tested per ISO 10993 and FDA Memo G95-1.

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Pointer Tool, Pointer Tool Tip and Port Reference Tool
Test	Results	Conclusions
Cytotoxicity: MEM ElutionGLP	0 score for based on degree ofcellular destruction	Non-cytotoxic
Sensitization: ISO GuineaPig MaximizationSensitization Test (GLP-2Extracts)	None of the animals showedsensitization response greater thanzero.	Devices do not elicitsensitization response
Irritation/IntracutaneousToxicity: ISOIntracutaneous IrritationTest (GLP-2Extracts)	No significant dermal reactions atinjected and control sites at 24, 48and 72 hrs.	Do not cause tissueirritation
Acute Systemic Toxicity:ISO Materials MediatedRabbit Pyrogen (GLP)	None of the animals had atemperature rise greater than or equalto 0.5 degrees.	Devices are non-pyrogenic.
Acute Systemic Toxicity:Acute Systemic InjectionTest	None of the tested animals showedclinical signs of toxicity	Device contact is non-toxic
Rabbit pyrogen test	Detected endotoxin level is less than0.005 EU/mL	Device is non-pyrogenic

Following is a summary of biocompatibility tests conducted for patient contacting parts:

Sterility summary: The subject device is comparable to the predicate device since the predicate device's navigation tools are sterilizable and the subject device's end-user sterilizable components have been tested per AAMI TIR30 and TIR12 and validation demonstrated an SAL of ≤10°.

Technology comparison: The predicate device utilizes active light sources on the surgical tool that are tracked using a stereoscopic camera while the subject device utilizes passive reflective markers on the surgical tools and the markers are illuminated by light sources located on the stereoscopic camera system. The accuracy of the subject device was characterized using a measurement phantom, Pointer Tool, Port Reference Tool and using point registration. Mean positional error was measured to be less than 2 mm and mean angular error was measured to be less than 2 degrees for both the tools. This performance was observed at the center and at the boundaries of the field of view of the tracking camera.

The predicate device supports video input from external microscope as an optional feature; however, the subject device does not provide this feature. The subject device provides visualization of tractography information as an additional modality, whereas, this capability is not provided by the predicate device. Since the latter two technologies are provided as optional features in the respective systems they are not intended to mitigate specific risks. Hence, these disparities do not introduce any new risks.

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VII. PERFORMANCE DATA

The following testing was conducted on BrightMatter Navigation system:

Tracking accuracy as positional error and angular error using a measurement phantom that mimicked the brain volume. Value of the measurement phantom was obtained using a Coordinate Measurement Machine (CMM) and used as truth data. CT image of the same phantom was used to simulate the clinical workflow during this measurement. The slice thickness of the CT image was 0.625 mm. Positional error was measured to be less than 2 mm and angular error was measured to be less than 2 degrees.
Software verification and validation testing for each requirement specification.
System integration testing using anatomical phantoms.
Safety testing using external test laboratories.

The following quality assurance measures were applied during development of the software component of the system:

. Software Development Life Cycle
Software Risk Assessment. ●
Risk Assessment of Off-the-Shelf (OTS) Software.
Software Configuration Management and Version Control.
. Software issue tracking and resolution.

Design Validation: Design validation was performed using the BrightMatter Navigation System in actual and simulated use settings. The results support substantial equivalence to the predicate device and demonstrate that the BrightMatter Navigation system is safe for its intended use.

Clinical Testing: This technology is not new, therefore a clinical study was not considered necessary prior to release.

VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the BrightMatter Navigation system should perform as intended in the specified use conditions. The non-clinical data demonstrate that the BrightMatter Navigation system device perform comparably to the predicate device that is currently marketed for the same intended use.

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).