Modus Nav

K183325 · Synaptive Medical, Inc. · HAW · Jul 14, 2019 · Neurology

Device Facts

• Record ID: K183325
• Device Name: Modus Nav
• Applicant: Synaptive Medical, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jul 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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. 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.

Device Story

Modus Nav is an image-guided surgical system for open and percutaneous cranial procedures. It uses an optical tracking camera to monitor the position and orientation of navigated surgical instruments (e.g., Short Pointer, Shunt Stylet, Trackable Suction) relative to pre-operative patient scan images. The system integrates with BrightMatter Plan for surgical planning. During surgery, the tracking camera, mounted on a cart, maintains a line of sight between a cranial reference and tracked tools equipped with passive reflective markers. The system displays tool location and orientation on an external monitor, assisting surgeons in navigating anatomical structures. It is operated by qualified medical professionals in a clinical setting. The device benefits patients by providing real-time visual guidance during complex neurosurgical procedures, potentially improving surgical accuracy and workflow.

Clinical Evidence

No clinical data. Substantial equivalence supported by nonclinical performance testing, including software verification, algorithm pipeline verification, biocompatibility, cleaning/sterilization validation, electrical safety (ANSI AAMI IEC ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and human factors/usability testing.

Technological Characteristics

Optical 3D tracking system; uses passive reflective markers. Components include navigation cart, auxiliary carts, and tracked surgical instruments. Biocompatibility per ISO 10993; cleaning per ISO 15883-1; sterilization per AAMI TIR12/TIR30 and ISO 17665-1. Software-based image-guided navigation. Accuracy: within 2 mm and 2 degrees.

Indications for Use

Indicated for patients requiring neurosurgical cranial procedures where computer-assisted planning and surgery are appropriate. For use by qualified medical professionals trained in surgery and image-guided systems.

Regulatory Classification

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.

Predicate Devices

• BrightMatter Guide with Surface Trace Registration (K153281)

Reference Devices

• BrightMatter Plan 1.6.0 (K180394)
• Passive reflective markers (K033621)
• K160523

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 800<br>Toronto, ON M5V 3B1<br>Canada |
| Establishment Registration: | 3012075008 |
| Contact Name: | Ms. Maham Ansari, MS, RAC |
| Title: | Director, Regulatory Affairs |
| Phone Number: | [phone] |
| 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)<br>Number | Date Cleared |
|----------------------------------------------------------|---------------------------|------------------|-------------------|
| BrightMatter Guide with<br>Surface Trace<br>Registration | Synaptive<br>Medical Inc. | K153281 | March 30,<br>2016 |

### 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.

# Synaptive

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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.

## 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

Image /page/4/Picture/15 description: The image shows the word "Synaptive" in a bold, sans-serif font. The letters are black against a white background. The word is horizontally oriented and appears to be the primary focus of the image.

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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 of<br>Activity | Documentation<br>Results |
|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Software<br>verification<br>testing<br>(system,<br>sub-system,<br>functional<br>block, and<br>compatibility<br>testing) | Functional<br>verification of<br>integrated<br>software system | Test of software<br>application based on<br>functional blocks and<br>test cases developed to<br>verify software<br>requirements<br>specifications (SRS)<br>items.<br>This activity was<br>repeated in its entirety<br>in this submission. | Verified acceptance<br>criteria for all SRS<br>items have been met. |
| | Testing of<br>resolved<br>anomalies | Testing of anomalies<br>present in previously<br>released versions of the<br>device that have been<br>resolved in the Modus<br>Nav release. | Previous errors were<br>tested and verified to<br>no 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 of<br>Activity | Documentation<br>Results |
| System<br>Validation | User acceptance<br>testing by<br>intended user<br>group | Testing of Modus Nav<br>by intended user in a<br>simulated use<br>environment to validate<br>customer needs and<br>intended use. | All acceptance criteria<br>met. |
| | Human Factors<br>Validation | Testing of critical<br>features by intended<br>users to determine if<br>device is safe and<br>effective for intended<br>users, uses and<br>environments. Testing<br>completed as per IEC<br>ANSI AAMI 62366 and<br>FDA Guidance:<br>"Applying Human<br>Factors and Usability<br>Engineering to Medical<br>Devices." | All acceptance criteria<br>met. |

# 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 | Test<br>Description | Results | Conclusions |
|---------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Bacterial Endotoxins | Limulus<br>amebocyte<br>lysate (LAL) in<br>vitro test | Detected endotoxin<br>is not more than<br>2.15 EU / device. | Non-endotoxic |
| Cytotoxicity | MEM Elution<br>Cytotoxicity | Cell culture treated<br>with samples<br>exhibited slight<br>reactivity (Grade<br>1). | Non-cytotoxic |
| Irritation/Intracutaneous<br>toxicity | Intracutaneous<br>Irritation<br>Test (GLP – 2<br>Extracts) | None of the<br>animals on study<br>showed any clinical<br>signs or dermal<br>reactions. | Non-irritant |
| Sensitization | Guinea<br>Pig<br>Maximization | A negative<br>sensitization<br>incidence was | Non-sensitizing |
| Test | Test Description | Results | Conclusions |
| | Sensitization<br>Test (GLP -<br>2 Extracts) | interpreted for all<br>test animals. No<br>abnormal clinical<br>signs observed<br>during test period. | |
| Material-mediated<br>pyrogenicity | Materials<br>Mediated<br>Rabbit<br>Pyrogen (GLP) | None of the rabbits<br>administered with<br>the test article<br>extract had<br>a temperature rise<br>~ 0.5 °C at the<br>required<br>observation time<br>points. | Non-pyrogenic |
| Acute systemic toxicity | Acute<br>Systemic<br>Injection Test<br>(GLP - 2<br>Extracts) | None of the<br>animals on study<br>were observed with<br>abnormal clinical<br> | Non-toxic |
| Hemocompatibility | Hemolysis<br>(Extract<br>Method) | The difference<br>between the<br>hemolytic indexes<br>of the test article<br>and the negative<br>control<br>was not higher<br>than 0.49 percent<br>for all tools. | Non-hemolytic |
| Extractables (Shunt<br>Stylet only) | Toxicological<br>evaluation of<br>extractable<br>chemicals | Gas<br>Chromatography-<br>Mass Spectrometry<br>(GC-MS) and<br>Inductively<br>Coupled Plasma<br>Mass Spectrometry<br>(ICP-MS) met<br>acceptance 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