Modus Nav 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. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

Device Description

The subject device, Modus Nav, is a modified version of its predicate, BrightMatter Guide with SurfaceTrace Registration. The system is a surgical planning and image guided surgical system that enables open or percutaneous computer-assisted cranial surgery. The system uses optical 3D tracking technology to display the location and orientation of tracked (also known as navigated) surgical instruments relative to the pre-operative scan images of the patient. The system consists of a software application installed on a computer, tracked surgical instruments, and accessories to enable the tracking of those instruments.

The planning functionality of the device is provided by an already cleared device called BrightMatter Plan 1.6.0 (K180394). The remaining functionality of the system can be broadly grouped into data preparation, registration and visualization of surqical tools. Data preparation and registration is performed during the initial stages of a surgical procedure and visualization of the tools is performed as needed during the surgical procedure.

General use of the system as an image guided surgical tool is composed of the following key steps:

. Equipment setup
. Plan selection and data preparation
Patient registration .
. Tool localization and visualization

An optical Tracking Camera provides the position and orientation of the tools with respect to the tracking origin. The navigated surgical tools are tracked using singleuse passive reflective markers (K033621) that are attached to the surgical tools prior to each surqical procedure. An external display can be used by the surgical staff if needed, given that the Tracking Camera mounted on a cart maintains a line of sight between the Cranial Reference and the Tracked Surqical Tools. Both the User Cart (also known as Navigation Cart) and Auxiliary Carts are placed outside the sterile field.

The primary purpose of this 510(k) submission is to introduce new navigated tools such as the Short Pointer, Shunt Stylet, and the corresponding Calibration Device. It also introduces new software features to support the navigation of these tools, the ability to navigate with Synaptive's Trackable Suction tools, and minor workflow improvements to facilitate the surgical procedure.

AI/ML Overview

The provided text describes the Modus Nav system, a surgical planning and image-guided surgical system for neurosurgical cranial procedures. Below is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided document.

Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (BrightMatter Guide with SurfaceTrace Registration) rather than setting specific clinical performance metrics with target values for new device features. The acceptance criteria are largely centered around functional verification, safety, and equivalence to the predicate.

Acceptance Criteria Category	Specific Activity/Test	Reported Device Performance/Documentation Result
Software Verification	Functional verification of integrated software system	Verified acceptance criteria for all SRS (Software Requirements Specifications) items have been met. Previous errors were tested and verified to no longer occur.
Algorithm Pipeline Verification	Automated performance verification of the core data processing facility (algorithm pipeline)	Performance verified using known data sets or 'truth data sets' to evaluate image processing pipeline and its outputs.
System Requirements Verification	Biocompatibility testing (Bacterial Endotoxins, Cytotoxicity, Irritation/Intracutaneous toxicity, Sensitization, Material-mediated pyrogenicity, Acute systemic toxicity, Hemocompatibility, Extractables)	All biocompatibility tests passed, demonstrating the material is non-endotoxic, non-cytotoxic, non-irritant, non-sensitizing, non-pyrogenic, non-toxic, and non-hemolytic.
	Cleaning Validation	Testing passed all acceptance criteria (for re-usable tools per ISO 15883-1).
	Sterilization Validation	Testing passed all acceptance criteria (for re-usable tools per AAMI TIR12, AAMI TIR30, ANSI AAMI ISO 17665-1, ANSI AAMI ISO TIR17665-2).
	Medical Electrical System Safety	External testing against ANSI AAMI IEC ES60601-1 to verify electrical and mechanical safety was successful.
	Electromagnetic Compatibility	External testing against IEC 60601-1-2 was successful, verifying operation within safe emission and interference limits.
System Validation	User acceptance testing by intended user group	All acceptance criteria met.
	Human Factors Validation	All acceptance criteria met (testing per IEC ANSI AAMI 62366 and FDA Guidance).
Accuracy Characterization	System accuracy with an accuracy measurement phantom	Modus Nav system is accurate to within 2 mm and 2 degrees of the physical tip of the tracked tool, equivalent to the predicate device.
Latency Testing	Comparison of video latency with predicate device	Deemed equivalent to the predicate device.

Additional Information Regarding the Study:

Sample size used for the test set and the data provenance:
- Accuracy Characterization: An "accuracy measurement phantom of similar volume to an adult head" was used. The specific number of measurements or trials conducted on this phantom is not specified.
- Algorithm pipeline verification: "Known data sets" or "truth data sets" were used. The size, type, or provenance (country of origin, retrospective/prospective) of these datasets is not detailed.
- For other tests like software verification, human factors, and user acceptance, the "test set" refers to the specific test cases, scenarios, or participants involved, but detailed numerical sample sizes are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Accuracy Characterization: Ground truth for the accuracy phantom was "obtained using a Coordinate Measurement Machine (CMM)." This implies a metrology standard rather than human experts.
- Algorithm pipeline verification: "Expert review of output generated by the pipeline" was used. However, the number of experts and their qualifications are not specified.
- User acceptance testing and Human Factors Validation: These tests were conducted "by intended user in a simulated use environment" and "by intended users," respectively. While these "users" would be qualified medical professionals, their specific number and detailed qualifications are not provided.
Adjudication method for the test set:
- The document primarily describes verification and validation activities rather than studies requiring adjudicator consensus (like clinical trials for sensitivity/specificity).
- For the "Algorithm pipeline verification," it mentions "expert review of output," but does not detail an adjudication method (e.g., 2+1, 3+1).
- For other tests, the "documentation results" simply state that acceptance criteria were met, implying direct pass/fail assessment rather than a multi-reader adjudication process.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study was done. The document explicitly states: "This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Algorithm pipeline verification: Yes, an "Automated performance verification of the core data processing facility of the software (known as 'algorithm pipeline'). Uses known data sets and expert review of output generated by the pipeline at various stages of processing." This suggests a standalone evaluation of the algorithm's output against known data.
- Accuracy Characterization: This would also be considered a standalone performance test of the system's accuracy, without human interpretation of images directly impacting the accuracy measurement.
The type of ground truth used:
- Accuracy Characterization: Ground truth was established using a "Coordinate Measurement Machine (CMM)" on an accuracy phantom, which is a physical measurement standard.
- Algorithm pipeline verification: "Known data sets or 'truth data sets'" and "expert review" were used to establish ground truth for algorithm outputs. The nature of these "truth data sets" (e.g., expert consensus, pathology, simulated data) is not specified.
- Software verification: Ground truth refers to the defined "software requirements specifications (SRS) items."
The sample size for the training set:
- The document does not mention any training sets for machine learning models. The device's functionality as described primarily involves image-guided navigation based on optical tracking and pre-operative scans, rather than an AI/ML component requiring a separate training set for classification or detection tasks. The reference to "algorithm pipeline" suggests image processing, but no specific machine learning training is detailed.
How the ground truth for the training set was established:
- Not applicable, as no training set for machine learning is explicitly mentioned or described.

Summary

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July 14, 2019

Synaptive Medical Inc. Maham Ansari Director of Regulatory Affairs 555 Richmond Street West, Suite 800 Toronto, ON M5V 3B1

Re: K183325

Trade/Device Name: Modus Nav Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: June 12, 2019 Received: June 14, 2019

Dear Maham Ansari:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Matthew Krueger 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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Indications for Use

510(k) Number (if known) K183325

Device Name Modus Nav 1.7

Indications for Use (Describe)

Modus Nav 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 user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and are familiar with image-guided surgical systems.

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

[As required by 21 CFR 807.92(c)]

Manufacturer:	Synaptive Medical Inc.
Address:	555 Richmond Street West, Suite 800Toronto, ON M5V 3B1Canada
Establishment Registration:	3012075008
Contact Name:	Ms. Maham Ansari, MS, RAC
Title:	Director, Regulatory Affairs
Phone Number:	+1 647 925 3435
Fax Number:	1 888 650 5230
Date Prepared:	15 November 2018
Device Proprietary Name:	Modus Nav
Device Common or Usual Name:	Neurological Stereotaxic Instrument
Classification Panel:	Neurology
Product Code:	HAW
Regulation Number:	21 CFR 882.4560
Regulation Class:	II
Regulation Description:	Stereotaxic Instrument

Predicate Devices:

Substantial equivalence is claimed to the following device:

Trade name	Manufacturer	510(k)Number	Date Cleared
BrightMatter Guide withSurface TraceRegistration	SynaptiveMedical Inc.	K153281	March 30,2016

Device Description

Synaptive

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General use of the system as an image guided surgical tool is composed of the following key steps:

. Equipment setup
. Plan selection and data preparation
Patient registration .
. Tool localization and visualization

Indications for Use

Modus Nav is intended as a planning and intraoperative quidance 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 quidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and are familiar with imagequided surgical systems.

Summary of Technological Comparisons

Modus Nav is an enhanced implementation of BrightMatter Guide with Surface Trace Registration, its previously FDA-cleared version. The primary function of both

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devices is to track surgical instruments using an optical 3D tracking system and to show the location and orientation of these instruments relative to the pre-operative scan images of the patient during cranial procedures. The primary difference between Modus Nav and the predicate device is enhanced functionality through the introduction of new hardware involving tracked instruments, and minor workflow improvements.

Main advantages compared to the predicate device are:

. Minor improvements to usability introduced as a result of user acceptance testing, human factors testing and field feedback.
. Ability to track new instrumentation for enhanced functionality.

There are no known disadvantages.

Modus Nav remains substantially unchanged from the predicate with respect to its intended use and performance claims.

Nonclinical Performance Testing

Verification and validation testing has been conducted on the Modus Nav system to ensure the safety and effectiveness of the device to perform in accordance to its intended use. The following table provides a summary of the testing performed on the Modus Nav system.

Type	Activity	Description ofActivity	DocumentationResults
Softwareverificationtesting(system,sub-system,functionalblock, andcompatibilitytesting)	Functionalverification ofintegratedsoftware system	Test of softwareapplication based onfunctional blocks andtest cases developed toverify softwarerequirementsspecifications (SRS)items.This activity wasrepeated in its entiretyin this submission.	Verified acceptancecriteria for all SRSitems have been met.
	Testing ofresolvedanomalies	Testing of anomaliespresent in previouslyreleased versions of thedevice that have beenresolved in the ModusNav release.	Previous errors weretested and verified tono longer occur.
Type	Activity	Description of Activity	Documentation Results
Algorithm pipeline verification	Performance verification	Automated performance verification of the core data processing facility of the software (known as 'algorithm pipeline'). Uses known data sets and expert review of output generated by the pipeline at various stages of processing.	Performance verified using known data sets or 'truth data sets' to evaluate image processing pipeline and its outputs.
System Requirements Verification	Biocompatibility	See section below.	Testing passed all acceptance criteria.
	Cleaning Validation	External testing to validate cleaning instructions for re-usable tools as per ISO 15883-1.
	Sterilization Validation	External testing to validate sterilization parameters for re-usable tools per AAMI TIR12, AAMI TIR30, ANSI AAMI ISO 17665-1, ANSI AAMI ISO TIR17665-2.
	Medical Electrical System Safety	External testing against the requirements of ANSI AAMI IEC ES60601-1 to verify electrical and mechanical safety of the system.
	Electromagnetic Compatibility	External testing against the requirements of IEC 60601-1-2 to verify that the system operates within safe limits of emission and interference requirements.
Type	Activity	Description ofActivity	DocumentationResults
SystemValidation	User acceptancetesting byintended usergroup	Testing of Modus Navby intended user in asimulated useenvironment to validatecustomer needs andintended use.	All acceptance criteriamet.
	Human FactorsValidation	Testing of criticalfeatures by intendedusers to determine ifdevice is safe andeffective for intendedusers, uses andenvironments. Testingcompleted as per IECANSI AAMI 62366 andFDA Guidance:"Applying HumanFactors and UsabilityEngineering to MedicalDevices."	All acceptance criteriamet.

Svnaptive

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Biocompatibility Testing

The following biocompatibility testing was also conducted on the material used for Modus Nav Tracked Tools, Shunt Stylet and Trackable Suction:

Test	TestDescription	Results	Conclusions
Bacterial Endotoxins	Limulusamebocytelysate (LAL) invitro test	Detected endotoxinis not more than2.15 EU / device.	Non-endotoxic
Cytotoxicity	MEM ElutionCytotoxicity	Cell culture treatedwith samplesexhibited slightreactivity (Grade1).	Non-cytotoxic
Irritation/Intracutaneoustoxicity	IntracutaneousIrritationTest (GLP – 2Extracts)	None of theanimals on studyshowed any clinicalsigns or dermalreactions.	Non-irritant
Sensitization	GuineaPigMaximization	A negativesensitizationincidence was	Non-sensitizing
Test	Test Description	Results	Conclusions
	SensitizationTest (GLP -2 Extracts)	interpreted for alltest animals. Noabnormal clinicalsigns observedduring test period.
Material-mediatedpyrogenicity	MaterialsMediatedRabbitPyrogen (GLP)	None of the rabbitsadministered withthe test articleextract hada temperature rise~ 0.5 °C at therequiredobservation timepoints.	Non-pyrogenic
Acute systemic toxicity	AcuteSystemicInjection Test(GLP - 2Extracts)	None of theanimals on studywere observed withabnormal clinical	Non-toxic
Hemocompatibility	Hemolysis(ExtractMethod)	The differencebetween thehemolytic indexesof the test articleand the negativecontrolwas not higherthan 0.49 percentfor all tools.	Non-hemolytic
Extractables (ShuntStylet only)	Toxicologicalevaluation ofextractablechemicals	GasChromatography-Mass Spectrometry(GC-MS) andInductivelyCoupled PlasmaMass Spectrometry(ICP-MS) metacceptance criteria.	Non-toxic

Synaptive

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The Biocompatibility tests for the material used in both pointers were cleared in K160523.

Synaptive

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The Biocompatibility test results indicate that Modus Nav can be considered safe and suitable for the intended use and is as safe and effective as the predicate device.

The following performance testing was also conducted on Modus Nav:

Accuracy Characterization: .
System accuracy was characterized using an accuracy measurement phantom of similar volume to an adult head. The values of the ground truth data from the accuracy phantom were obtained using a Coordinate Measurement Machine (CMM). Testing was conducted with all tracked tools calculating positional and angular error for both registration methods: Surface Trace Registration and Touch Point Registration. Testing confirmed that the Modus Nav system is accurate to within 2 mm and 2 degrees of the physical tip of the tracked tool. This is equivalent to the predicate device.
. Latency Testing:
The video latency of the subject device and the predicate device were compared and deemed to be equivalent.

All nonclinical testing described in this section successfully passed, demonstrating that the Modus Nav system is safe and effective for its intended use and substantially equivalent to its predicate device.

Clinical Testing

This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing.

Conclusion

Modus Nav has been shown through comparison and performance testing to be substantially equivalent to the identified predicate device. Any technological differences do not raise new questions of safety and effectiveness.

Svnaptive

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).