StealthConnect Remote Viewing, Planning and Collaboration System

K162655 · Medtronic Navigation, Inc. · HAW · Apr 21, 2017 · Neurology

Device Facts

• Record ID: K162655
• Device Name: StealthConnect Remote Viewing, Planning and Collaboration System
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Apr 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The StealthConnect® System is web-based software to remotely access the StealthStation® Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses. The StealthConnect® system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images. The StealthConnect® Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation® System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformating, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation® System or any DICOM-compliant PACS system. StealthConnect® is not to be used for mammography.

Device Story

StealthConnect is a web-based software accessory to the StealthStation Cranial system. It enables remote, multi-user concurrent access to surgical planning software via standard web browsers on general-purpose computers. Input data consists of DICOM 3.0 compliant images (CT, MRI) accessed via LAN or internet. The system provides tools for plan entry, target selection, 3D model building, anatomical coordinate space creation, stereotactic frame settings, and brain atlas integration. It facilitates secure collaboration using PureWeb technology. Healthcare providers use the system to set or review surgical plans, which are then transferred to a StealthStation or PACS. The device supports clinical decision-making by allowing remote surgical planning and collaboration, potentially improving workflow efficiency and access to surgical expertise. It integrates with hospital LDAP/AD for authentication and uses TLS 1.2/AES-256 for data security.

Clinical Evidence

No clinical data. Bench testing only. Testing included usability testing (IEC 62366), software verification and validation, functional testing of the PureWeb component, accuracy testing for planning components (positional error 1.60mm, trajectory error 0.95 degrees), and display effectiveness testing.

Technological Characteristics

Web-based software; C++/Javascript/HTML5. Connectivity via LAN/Internet. DICOM 3.0 compliant. Security: TLS 1.2 encryption in transit, AES-256 at rest, LDAP/AD integration. Operates on general-purpose computers. Supports X-ray, MR, and Nuclear Medicine modalities.

Indications for Use

Indicated for trained professionals (physicians, technologists, nurses) for remote viewing, stereotactic surgery planning, and collaboration. Not for primary diagnostic reading of DICOM images. Not for mammography.

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

• StealthStation Cranial v 3.0 (K153660)
• StealthSERVER Image Storage and Communication System (K984000)
• ResolutionMD (K161130)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

April 21, 2017

Medtronic Navigation, Inc. Monica Montanez Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K162655

Trade/Device Name: StealthConnect Remote Viewing. Planning and Collaboration System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, LLZ Dated: March 21, 2017 Received: March 22, 2017

Dear Ms. Montanez:

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 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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

# Michael J. Hoffmann -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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K162655

Device Name

StealthConnect Remote Viewing, Planning and Collaboration System

Indications for Use (Describe)

The StealthConnect® System is web-based software to remotely access the StealthStation® Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses.

The StealthConnect® system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images.

The StealthConnect® Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation® System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformating, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation® System or any DICOM-compliant PACS system.

StealthConnect® is not to be used for mammography.

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

| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 2 L14 14 L2 14 Z M4 4 L12 4 L12 12 L4 12 Z" fill="black"></path> <path d="M4 4 L12 12 M12 4 L4 12" stroke="white" stroke-width="2"></path> </svg> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 2 L14 14 L2 14 Z M4 4 L12 4 L12 12 L4 12 Z" fill="white"></path> </svg> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 510(k) Summary

- Submitter: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027
- Contact Person: Monica Montanez (Primary) Principal Regulatory Affairs Specialist Phone: [phone] Fax: [phone] E-mail: [e-mail]

Paul Smolenski (Alternate) Sr Manager Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date Summary Prepared:March 19, 2017

| Device Trade Name: | StealthConnect Remote Viewing, Planning and Collaboration<br>System |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Stereotaxic Instrument (21 CFR 882.4560) |
| Device Classification: | Class II |
| Product Code: | HAW (Stereotaxic Instrument)<br>LLZ (Image Processing System) |
| Classification Name: | 21 CFR 882.4560 – Stereotaxic Instrument (HAW) |
| | 21 CFR 892.2050 – Picture Archiving and<br>Communications System (LLZ) |
| Predicate Device: | K153660 – StealthStation Cranial v 3.0 (Primary)<br>K984000 - StealthSERVER Image Storage and<br>Communication System (Secondary)<br>K161130 - ResolutionMD (Secondary) |
| Device Description: | The StealthConnect™ System enables web clients on users'<br>computers to interact with a version of the existing<br>StealthStation Cranial planning software that is running on a<br>cloud-based server. The StealthConnect System enables |

{4}------------------------------------------------

- Secure remote access for one or more authorized users simultaneously, with each accessing different patients (multi-user concurrent planning sessions) via the server-based cranial software using a web browser on user-supplied, general-purpose client computers. ●
- A safe environment to access, control, and share images on a secure Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) compliance-ready infrastructure.
- Authorization and access control, which is provided ● by integration with the user facility's Lightweight Directory Access Protocol (LDAP) or Windows Active Directory (AD) credentialing system (single sign on).

Indications for Use:

The StealthConnect™ System is web-based software to remotely access the StealthStation™ Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses.

The StealthConnect™ system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images.

The StealthConnect™ Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation™ System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation '10 System or any DICOM-compliant PACS system.

StealthConnect™ is not to be used for mammography.

{5}------------------------------------------------

Substantial Equivalence: The application of Medtronic StealthConnect™ System is substantially equivalent to the predicate(s) StealthStation with StealthStation Cranial v 3.0 (K153660); StealthSERVER Image Storage and Communication System (K984000) and ResolutionMD (K161130) in intended use, technology, design and physician use.

> The Indications for Use for the subject Medtronic StealthConnect™ System are similar as the predicate(s). StealthConnect System is considered an accessory to the StealthStation with Cranial v3.0. Both devices are stereotactic planning devices. Calgary Scientific ResolutionMD is considered a secondary predicate since they share the underlying technology that enables the remote access, collaboration and concurrent use features.

{6}------------------------------------------------

# K162655 Page 4 of 10

## Table 1: StealthConnect Predicate Device Comparison Table

| Predicate<br>Devices for<br>510(k)Feature/<br>Attribute | Subject Device<br>StealthConnect®<br>System (K162655) | (Primary) Predicate:<br>StealthStation® System with<br>StealthStation Cranial v 3.0<br>Software (K153660) | (Secondary)Predicate:<br>StealthSERVER™ Image<br>Storage and<br>Communication System<br>(K984000) | (Secondary) Predicate:<br>Calgary Scientific's<br>ResolutionMD™ (K161130) |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The StealthConnect™<br>System is web- based<br>software to remotely access<br>the StealthStation Cranial<br>software for viewing,<br>stereotactic surgery<br>planning and collaborating<br>by trained professionals<br>such as physicians,<br>technologists and nurses.<br>The StealthConnect™<br>System has not been<br>validated for primary<br>diagnostic reading of<br>DICOM images.<br>The StealthConnect™<br>Remote Viewing, Planning<br>and Collaboration System is<br>an accessory to the<br>StealthStation™ System. It<br>provides a web- based client<br>interface to securely access<br>encrypted storage of<br>DICOM-compliant images<br>via a LAN, and/or the<br>internet using general-<br>purpose computers, and by<br>one or more authorized<br>people. It provides for<br>communication, storage, | The StealthStation™ System with<br>StealthStation™ Cranial software is<br>intended to aid in locating<br>anatomical structures in either open<br>or percutaneous neurosurgical<br>procedures. The system is<br>indicated for any medical condition<br>in which reference to a rigid<br>anatomical structure can be<br>identified relative to images of the<br>anatomy. This can include, but is<br>not limited to, the following cranial<br>procedures (including stereotactic<br>Frame-based and stereotactic frame<br>alternatives-based procedures):<br>-Cranial Biopsies (Including<br>Stereotactic)<br>-Deep Brain Stimulation (DBS) lead<br>placement<br>-Depth Electrode Placement<br>-Tumor Resections<br>Craniotomies/Craniectomies<br>-Skull Base Procedures<br>-Transsphenoidal Procedures<br>Thalamotomies/Pallidotomies<br>-Pituitary Tumor Removal<br>-CSF Leak Repair<br>-Pediatric Ventricular Catheter<br>Placement<br>-General Ventricular Catheter<br>Placement | The StealthServer™ Image<br>Storage and Communication<br>System is used to store and<br>provide remote viewing<br>access to diagnostic images<br>via a LAN, the internet or<br>modem. In addition, the<br>system can be used to<br>remotely set surgical plan for<br>stereotactic surgeries that are<br>compatible with and can be<br>accessed by the<br>StealthStation® Treatment<br>Guidance Platform. | The ResolutionMD™ Web 2.9<br>software-based is intended for<br>use as a diagnostic, review, and<br>analysis tool by trained<br>professionals such as<br>physicians, technologists and<br>nurses. When interpreted by a<br>trained physician, reviewed<br>images may be used as an<br>element for diagnosis. It is the<br>user's responsibility to ensure<br>that the software is installed on<br>appropriate hardware and that<br>the image quality is suitable for<br>the clinical application. Calgary<br>Scientific recommends that the<br>users of the ResolutionMD<br>software consult the appropriate<br>American College of Radiology<br>Practice Guidelines pertaining to<br>the anatomy and pathology<br>being studied. The<br>ResolutionMD™ is a software-<br>based Picture Archiving and<br>Communication System (PACS)<br>used with general purpose<br>computing hardware for the<br>display and 3D visualization of<br>medical image data. It provides<br>for communication, storage,<br>reformatting, rendering, and<br>display of DICOM 3.0 compliant |
| Predicate<br>Devices for<br>510(k)Feature/<br>Attribute | Subject Device<br>StealthConnect®<br>System (K162655) | (Primary) Predicate:<br>StealthStation® System with<br>StealthStation Cranial v 3.0<br>Software (K153660) | (Secondary)Predicate:<br>StealthSERVER™ Image<br>Storage and<br>Communication System<br>(K984000) | (Secondary) Predicate:<br>Calgary Scientific's<br>ResolutionMD™ (K161130) |
| | reformatting, rendering, and<br>display of DICOM 3.0<br>compliant image data<br>derived from various<br>sources including CT and<br>MRI. In addition, the system<br>provides access to the<br>surgical planning aspects of<br>StealthStation™ software,<br>and can be used to set or<br>review surgical plans for<br>stereotactic surgeries that<br>are compatible with and can<br>be transferred to a<br>StealthStation™ System or<br>any DICOM-compliant<br>PACS system.<br>StealthConnect™ is not to<br>be used for mammography. | The user should consult the<br>"Navigational Accuracy" section of<br>the User Manual to assess if the<br>accuracy of the system is suitable<br>for their needs. | | image data derived from various<br>sources including CT and MRI.<br>ResolutionMD is not to be used<br>for mammography. |
| Prescription Use | Yes | Yes | Yes | Yes |
| Intended Users | Trained Professionals | Trained Professionals | Trained Professionals | Trained Professionals |
| Remote Use | Yes: Anywhere the end user<br>can establish a secure<br>connection to the hospital<br>network | No: Hospital only | Yes: Anywhere the end user<br>can establish a secure<br>connection to the<br>StealthSERVER Network<br>Planning system inside and<br>outside hospital. | Yes: By using the web browser<br>over a network connection using<br>a user supplied computer. |
| Predicate<br>Devices for<br>510(k)Feature/<br>Attribute | Subject Device<br>StealthConnect®<br>System (K162655) | (Primary) Predicate:<br>StealthStation® System with<br>StealthStation Cranial v 3.0<br>Software (K153660) | (Secondary)Predicate:<br>StealthSERVER™ Image<br>Storage and<br>Communication System<br>(K984000) | (Secondary) Predicate:<br>Calgary Scientific's<br>ResolutionMD™ (K161130) |
| On Line<br>Collaboration | Yes: Using PureWeb to<br>share medical image data | No: Gather around the<br>StealthStation System in hospital<br>setting only | No: Only simultaneous<br>access | Yes: The feature "Collaboration"<br>is provided in ResolutionMD |
| Concurrent User<br>Sessions | Yes: StealthConnect<br>enables 5 users to<br>simultaneously log on and<br>access multiple patient data<br>for stereotactic planning. | No: Single planning/navigating<br>session | Yes: StealthSERVER allows<br>up to 4 concurrent user<br>sessions. | Yes: ResolutionMD allows<br>multiple concurrent users |
| DICOM<br>Import/Export via<br>Query/Receive<br>and Unattended | Yes: Import/Export DICOM<br>images to/from its Cloud<br>based patient database.<br>Can receive DICOM<br>transfers at any time<br>(Unattended) | Yes: DICOM<br>Import/Export/Query/Retrieve<br>to/from its local patient database,<br>and can receive DICOM transfers at<br>any time if StealthStation is turned<br>on and networked (Unattended). | Yes: DICOM Import/Export to<br>its local patient database at<br>any time | Yes: Import/Export DICOM<br>images to its local database |
| Planning Features | StealthConnect provides:<br>Plan Entry and Target<br>Selection<br>3D Model Building<br>Advanced Visualization<br>Create Patient Based<br>Anatomical Coordinate<br>Space<br>Stereotactic Frame Settings<br>Brain Atlas:Schaltenbrand-<br>Wahren Atlas with Talairach<br>Grid<br>STarFix Designer<br>Annotations | Yes: The device is intended for<br>detailed planning and treatment of<br>patients: Plan Entry and Target<br>Selection<br>3D Model Building<br>Advanced Visualization<br>Create Patient Based Anatomical<br>Coordinate Space<br>Stereotactic Frame Settings<br>Brain Atlas:Schaltenbrand-Wahren<br>Atlas with Talairach Grid<br>STarFix Designer<br>Annotations | Yes: Setting the target point<br>and the entry point for a<br>surgical procedure.<br>3D Model Building<br>For Cranial and Spine<br>procedures | No: The device is used for<br>viewing images rather than<br>stereotactic planning. However,<br>when images are interpreted by<br>a trained physician, the reviewed<br>images may be used as an<br>element for diagnosis and<br>planning of treatment. |
| Predicate<br>Devices for<br>510(k)Feature/<br>Attribute | Subject Device<br>StealthConnect®<br>System (K162655) | (Primary) Predicate:<br>StealthStation® System with<br>StealthStation Cranial v 3.0<br>Software (K153660) | (Secondary)Predicate:<br>StealthSERVER™ Image<br>Storage and<br>Communication System<br>(K984000) | (Secondary) Predicate:<br>Calgary Scientific's<br>ResolutionMD™ (K161130) |
| User<br>Authorization and<br>Authentication | Yes: Device requires user<br>authentication and log on<br>capabilities. StealthConnect<br>ties into the hospital<br>credentialing system. | No: Optional password protection | Yes: Device requires<br>password protection using at<br>the time C2 Security features<br>based upon the requirements<br>outlined in the U.S.<br>Department of Defense<br>Trusted Computer Systems | Yes: Device requires user<br>authentication and provides log<br>on capabilities. |
| 2D Viewing | Yes: StealthConnect<br>provides the same features<br>Cranial v 3.0 offers for 2D<br>standard viewing. | Yes: Utilizes StealthStation Cranial<br>Software viewer for standard<br>viewing to include tools for<br>window/level, pan, zoom. Anatomic<br>Orthogonal; Trajectory 1 and 2;<br>Probes Eye, Look Ahead | Yes: 2 D Standard viewing | Yes: Subject device and<br>predicates all have 2D<br>Viewing features. |
| 3D Viewing | Yes: StealthConnect<br>provides the same features<br>available in Cranial v 3.0 for<br>3 D volume rendering of the<br>data set. | Yes: 3 D Volume rendering of the<br>data set. Interactive controls lasso,<br>wand threshold, annotations and<br>segmentations tools. | Yes: 3D volume rendering of<br>the data set and viewing | Yes: 3 D Volume rendering of<br>the data set. Interactive controls<br>for zoom, pan, rotate and<br>window/level via mouse and<br>keyboard controls. |
| Programming<br>Language | C++/Javascript/HTML5 | C++ | Java | C++/Javascript/HTML |
| Imaging<br>Modalities | X-Ray based,<br>MR based<br>Nuclear Medicine based | X-Ray based,<br>MR based<br>Nuclear Medicine based | X-Ray based,<br>MR based | X-Ray based,<br>MR based<br>Nuclear Medicine based |
| System Accuracy<br>Requirement | Mean Accuracy Values:<br>Positional Error - 1.60mm<br>Trajectory Error - 0.95<br>degrees | Mean Accuracy Values:<br>Positional Error - 1.65mm<br>Trajectory Error - 0.68 degrees | No: Navigational Accuracy<br>was not required at the time | No: Device does not offer<br>Stereotactic Planning |
| Predicate<br>Devices for<br>510(k)Feature/<br>Attribute | Subject Device<br>StealthConnect®<br>System (K162655) | (Primary) Predicate:<br>StealthStation® System with<br>StealthStation Cranial v 3.0<br>Software (K153660)…