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 Description

The StealthConnect™ System enables web clients on users' computers to interact with a version of the existing StealthStation Cranial planning software that is running on a cloud-based server. The StealthConnect System enables 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).

AI/ML Overview

The Medtronic StealthConnect Remote Viewing, Planning and Collaboration System is a web-based software designed to remotely access the StealthStation Cranial software for viewing, stereotactic surgery planning, and collaboration by trained professionals.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining explicit numerical acceptance criteria for a new clinical performance claim. Instead, the "acceptance" is demonstrated through comparative testing against established predicate performance.

Acceptance Criteria (Demonstrated through Equivalence)	Reported Device Performance (StealthConnect System)
Intended Use: Remote viewing, stereotactic surgery planning, and collaboration for trained professionals. Not for primary diagnostic reading or mammography.	Meets this intended use, providing remote access to StealthStation Cranial software functionalities for viewing, planning, and collaboration. Not validated for primary diagnostic reading of DICOM images and not to be used for mammography.
System Accuracy (for planning components): Comparable to StealthStation Cranial v 3.0.	Mean Accuracy Values: Positional Error - 1.60mm, Trajectory Error - 0.95 degrees. (These are compared against the predicate's reported 1.65mm and 0.68 degrees respectively).
Usability: Meets IEC 62366 requirements.	Usability Testing was conducted in accordance with IEC 62366, demonstrating that usability and human factors requirements were adequately met.
Software Functionality: Software and hardware requirements are met, and software performs as intended. Functional equivalence to ResolutionMD's PureWeb component.	Software Verification and Validation testing verified that software and hardware requirements are met and software performs as intended. Functional testing of the PureWeb component demonstrated equivalent functionality to the predicate.
Display Effectiveness: Images sufficient for the same level of stereotactic surgical planning as predicate (StealthStation with Cranial v 3.0 software).	Display Effectiveness testing showed that images provided by StealthConnect System are sufficient for the same level of stereotactic surgical planning as provided by the predicate.
Security/Cybersecurity: Encrypts data in transit and at rest.	Encrypts data in transit using TLS 1.2 and at rest using AES-256 with dedicated hardware key storage.
DICOM Compatibility: Provides communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data.	Handles DICOM 3.0 compliant image data from various sources (CT, MRI), importing/exporting to/from its cloud-based patient database.
Remote Access: Capable of secure remote access.	Enables secure remote access for authorized users via a web browser, compatible with LAN and/or internet.
Collaboration: Supports online collaboration.	Uses PureWeb to share medical image data for online collaboration.
Concurrent User Sessions: Supports multiple concurrent user sessions.	Enables 5 users to simultaneously log on and access multiple patient data for stereotactic planning.
2D/3D Viewing: Provides 2D and 3D viewing capabilities comparable to StealthStation Cranial v 3.0.	Provides the same 2D and 3D viewing features as Cranial v 3.0, including volume rendering and interactive controls.
Programming Language: Uses C++/Javascript/HTML5.	C++/Javascript/HTML5.
Imaging Modalities: Supports X-Ray, MR, and Nuclear Medicine based imaging.	Supports X-Ray, MR, and Nuclear Medicine based imaging.
Scanner Interface Technology: Network Connectivity, CD, DVD, USB, DICOM Import/Export.	Supports Network Connectivity, CD, DVD, USB, DICOM Import/Export.
Registration Features: Supports various registration types (Exam-to-Exam, Stereotactic Localizer, StarFix Bone Anchor).	Provides Exam-to-Exam Registration (Identity Merge, Manual Merge, Automatic Merge), Stereotactic Localizer Registration, and StarFix Bone Anchor Registration.
User Authorization and Authentication: Requires user authentication and log-on capabilities.	Requires user authentication and log-on capabilities, integrating with hospital credentialing systems (LDAP/AD).

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not specify precise sample sizes (e.g., number of cases or patients) for the "test set" in the context of a typical AI/ML study. The performance testing described suggests a verification and validation approach rather than a large-scale clinical test set.

Test Set Sample Size: Not explicitly stated as a number of cases or patients. The tests are described as "laboratory and simulated use settings."
Data Provenance: Not explicitly stated (e.g., country of origin). Given Medtronic's presence and the FDA 510(k) submission, it is highly likely the testing was conducted in the US or under US-equivalent standards. The testing was performed in "laboratory and simulated use settings," implying synthetic or internal data, or potentially clinical data within Medtronic's environment, but not specified. The study is retrospective in nature as it is a verification and validation of a device's performance against pre-established requirements or predicate device performance, not a prospective trial to gather new efficacy data.

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

The document does not mention the use of experts to establish a "ground truth" in the typical sense for a diagnostic device. The device is for planning and collaboration, not primary diagnosis. The accuracy and display effectiveness testing would likely have used quantitative measurements or comparisons against the predicate device's output, rather than expert consensus on a diagnostic outcome. For instance, the "Accuracy testing for planning components" would compare the StealthConnect's output (e.g., calculated positional/trajectory error) to the known/expected values or those of the predicate device, not against expert labels of medical conditions.

4. Adjudication Method for the Test Set:

Not applicable. Since there's no mention of expert readers assessing "ground truth" for diagnostic outcomes, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The document describes verification and validation testing, including "Display Effectiveness testing" to show sufficiency for planning, and accuracy testing comparative to the predicate, but not a study to quantify human reader improvement with AI assistance. The device is an accessory for planning and collaboration, not an AI diagnostic tool intended to assist human readers in image interpretation for primary diagnosis.

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

Yes, in a way. The "performance testing" described (e.g., "Accuracy testing for planning components" and "Functional testing of the PureWeb component") assessed the device's functional performance independently of human interaction, as it aimed to verify that the software and its components perform as intended. However, the device's overall intended use inherently involves human interaction (professionals using it for viewing, planning, and collaboration). There isn't a direct "standalone diagnostic performance" report as typically seen for AI image analysis algorithms.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance assessment appears to be:

Predicate Device Performance: For accuracy (e.g., positional and trajectory error) and display effectiveness, the performance was compared to the predicate StealthStation Cranial v 3.0.
Design Requirements/Specifications: The testing was conducted to ensure the product performs "as intended according to the outlined design requirements."
Established Industry Standards: Usability testing was conducted in accordance with IEC 62366.
Functional Equivalence: For components like PureWeb, the "ground truth" was its known functionality as part of the ResolutionMD predicate.

There is no mention of pathology or outcomes data being used for ground truth.

8. The Sample Size for the Training Set:

Not applicable. The document describes a traditional software verification and validation process for a medical device that established substantial equivalence to predicate devices. It does not describe an AI/Machine Learning model that required a "training set." The "PureWeb component" mentioned is a primary component of a predicate device (ResolutionMD), implying it's a developed software part, not an AI model that undergoes training on data.

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

Not applicable. As stated above, there is no indication that this device developed or utilized an AI/Machine Learning model that required a training set or associated ground truth labeling.

Summary

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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.

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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.

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

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

StealthConnect® is not to be used for mammography.

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

Submitter: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027
Contact Person: Monica Montanez (Primary) Principal Regulatory Affairs Specialist Phone: (720) 890-2149 Fax: (763) 367-2076 E-mail: monica.r.montanez@medtronic.com

Paul Smolenski (Alternate) Sr Manager Regulatory Affairs Phone: (978)698-6065 Fax: (978) 698-6069 E-mail: paul.d.smolenski@medtronic.com

Date Summary Prepared:March 19, 2017

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

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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.

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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.

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Table 1: StealthConnect Predicate Device Comparison Table

PredicateDevices for510(k)Feature/Attribute	Subject DeviceStealthConnect®System (K162655)	(Primary) Predicate:StealthStation® System withStealthStation Cranial v 3.0Software (K153660)	(Secondary)Predicate:StealthSERVER™ ImageStorage andCommunication System(K984000)	(Secondary) Predicate:Calgary Scientific'sResolutionMD™ (K161130)
Indications forUse	The StealthConnect™System is web- basedsoftware to remotely accessthe StealthStation Cranialsoftware for viewing,stereotactic surgeryplanning and collaboratingby trained professionalssuch as physicians,technologists and nurses.The StealthConnect™System has not beenvalidated for primarydiagnostic reading ofDICOM images.The StealthConnect™Remote Viewing, Planningand Collaboration System isan accessory to theStealthStation™ System. Itprovides a web- based clientinterface to securely accessencrypted storage ofDICOM-compliant imagesvia a LAN, and/or theinternet using general-purpose computers, and byone or more authorizedpeople. It provides forcommunication, storage,	The StealthStation™ System withStealthStation™ Cranial software isintended to aid in locatinganatomical structures in either openor percutaneous neurosurgicalprocedures. The system isindicated for any medical conditionin which reference to a rigidanatomical structure can beidentified relative to images of theanatomy. This can include, but isnot limited to, the following cranialprocedures (including stereotacticFrame-based and stereotactic framealternatives-based procedures):-Cranial Biopsies (IncludingStereotactic)-Deep Brain Stimulation (DBS) leadplacement-Depth Electrode Placement-Tumor ResectionsCraniotomies/Craniectomies-Skull Base Procedures-Transsphenoidal ProceduresThalamotomies/Pallidotomies-Pituitary Tumor Removal-CSF Leak Repair-Pediatric Ventricular CatheterPlacement-General Ventricular CatheterPlacement	The StealthServer™ ImageStorage and CommunicationSystem is used to store andprovide remote viewingaccess to diagnostic imagesvia a LAN, the internet ormodem. In addition, thesystem can be used toremotely set surgical plan forstereotactic surgeries that arecompatible with and can beaccessed by theStealthStation® TreatmentGuidance Platform.	The ResolutionMD™ Web 2.9software-based is intended foruse as a diagnostic, review, andanalysis tool by trainedprofessionals such asphysicians, technologists andnurses. When interpreted by atrained physician, reviewedimages may be used as anelement for diagnosis. It is theuser's responsibility to ensurethat the software is installed onappropriate hardware and thatthe image quality is suitable forthe clinical application. CalgaryScientific recommends that theusers of the ResolutionMDsoftware consult the appropriateAmerican College of RadiologyPractice Guidelines pertaining tothe anatomy and pathologybeing studied. TheResolutionMD™ is a software-based Picture Archiving andCommunication System (PACS)used with general purposecomputing hardware for thedisplay and 3D visualization ofmedical image data. It providesfor communication, storage,reformatting, rendering, anddisplay of DICOM 3.0 compliant
PredicateDevices for510(k)Feature/Attribute	Subject DeviceStealthConnect®System (K162655)	(Primary) Predicate:StealthStation® System withStealthStation Cranial v 3.0Software (K153660)	(Secondary)Predicate:StealthSERVER™ ImageStorage andCommunication System(K984000)	(Secondary) Predicate:Calgary Scientific'sResolutionMD™ (K161130)
	reformatting, rendering, anddisplay of DICOM 3.0compliant image dataderived from varioussources including CT andMRI. In addition, the systemprovides access to thesurgical planning aspects ofStealthStation™ software,and can be used to set orreview surgical plans forstereotactic surgeries thatare compatible with and canbe transferred to aStealthStation™ System orany DICOM-compliantPACS system.StealthConnect™ is not tobe used for mammography.	The user should consult the"Navigational Accuracy" section ofthe User Manual to assess if theaccuracy of the system is suitablefor their needs.		image data derived from varioussources including CT and MRI.ResolutionMD is not to be usedfor mammography.
Prescription Use	Yes	Yes	Yes	Yes
Intended Users	Trained Professionals	Trained Professionals	Trained Professionals	Trained Professionals
Remote Use	Yes: Anywhere the end usercan establish a secureconnection to the hospitalnetwork	No: Hospital only	Yes: Anywhere the end usercan establish a secureconnection to theStealthSERVER NetworkPlanning system inside andoutside hospital.	Yes: By using the web browserover a network connection usinga user supplied computer.
PredicateDevices for510(k)Feature/Attribute	Subject DeviceStealthConnect®System (K162655)	(Primary) Predicate:StealthStation® System withStealthStation Cranial v 3.0Software (K153660)	(Secondary)Predicate:StealthSERVER™ ImageStorage andCommunication System(K984000)	(Secondary) Predicate:Calgary Scientific'sResolutionMD™ (K161130)
On LineCollaboration	Yes: Using PureWeb toshare medical image data	No: Gather around theStealthStation System in hospitalsetting only	No: Only simultaneousaccess	Yes: The feature "Collaboration"is provided in ResolutionMD
Concurrent UserSessions	Yes: StealthConnectenables 5 users tosimultaneously log on andaccess multiple patient datafor stereotactic planning.	No: Single planning/navigatingsession	Yes: StealthSERVER allowsup to 4 concurrent usersessions.	Yes: ResolutionMD allowsmultiple concurrent users
DICOMImport/Export viaQuery/Receiveand Unattended	Yes: Import/Export DICOMimages to/from its Cloudbased patient database.Can receive DICOMtransfers at any time(Unattended)	Yes: DICOMImport/Export/Query/Retrieveto/from its local patient database,and can receive DICOM transfers atany time if StealthStation is turnedon and networked (Unattended).	Yes: DICOM Import/Export toits local patient database atany time	Yes: Import/Export DICOMimages to its local database
Planning Features	StealthConnect provides:Plan Entry and TargetSelection3D Model BuildingAdvanced VisualizationCreate Patient BasedAnatomical CoordinateSpaceStereotactic Frame SettingsBrain Atlas:Schaltenbrand-Wahren Atlas with TalairachGridSTarFix DesignerAnnotations	Yes: The device is intended fordetailed planning and treatment ofpatients: Plan Entry and TargetSelection3D Model BuildingAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas:Schaltenbrand-WahrenAtlas with Talairach GridSTarFix DesignerAnnotations	Yes: Setting the target pointand the entry point for asurgical procedure.3D Model BuildingFor Cranial and Spineprocedures	No: The device is used forviewing images rather thanstereotactic planning. However,when images are interpreted bya trained physician, the reviewedimages may be used as anelement for diagnosis andplanning of treatment.
PredicateDevices for510(k)Feature/Attribute	Subject DeviceStealthConnect®System (K162655)	(Primary) Predicate:StealthStation® System withStealthStation Cranial v 3.0Software (K153660)	(Secondary)Predicate:StealthSERVER™ ImageStorage andCommunication System(K984000)	(Secondary) Predicate:Calgary Scientific'sResolutionMD™ (K161130)
UserAuthorization andAuthentication	Yes: Device requires userauthentication and log oncapabilities. StealthConnectties into the hospitalcredentialing system.	No: Optional password protection	Yes: Device requirespassword protection using atthe time C2 Security featuresbased upon the requirementsoutlined in the U.S.Department of DefenseTrusted Computer Systems	Yes: Device requires userauthentication and provides logon capabilities.
2D Viewing	Yes: StealthConnectprovides the same featuresCranial v 3.0 offers for 2Dstandard viewing.	Yes: Utilizes StealthStation CranialSoftware viewer for standardviewing to include tools forwindow/level, pan, zoom. AnatomicOrthogonal; Trajectory 1 and 2;Probes Eye, Look Ahead	Yes: 2 D Standard viewing	Yes: Subject device andpredicates all have 2DViewing features.
3D Viewing	Yes: StealthConnectprovides the same featuresavailable in Cranial v 3.0 for3 D volume rendering of thedata set.	Yes: 3 D Volume rendering of thedata set. Interactive controls lasso,wand threshold, annotations andsegmentations tools.	Yes: 3D volume rendering ofthe data set and viewing	Yes: 3 D Volume rendering ofthe data set. Interactive controlsfor zoom, pan, rotate andwindow/level via mouse andkeyboard controls.
ProgrammingLanguage	C++/Javascript/HTML5	C++	Java	C++/Javascript/HTML
ImagingModalities	X-Ray based,MR basedNuclear Medicine based	X-Ray based,MR basedNuclear Medicine based	X-Ray based,MR based	X-Ray based,MR basedNuclear Medicine based
System AccuracyRequirement	Mean Accuracy Values:Positional Error - 1.60mmTrajectory Error - 0.95degrees	Mean Accuracy Values:Positional Error - 1.65mmTrajectory Error - 0.68 degrees	No: Navigational Accuracywas not required at the time	No: Device does not offerStereotactic Planning
PredicateDevices for510(k)Feature/Attribute	Subject DeviceStealthConnect®System (K162655)	(Primary) Predicate:StealthStation® System withStealthStation Cranial v 3.0Software (K153660)	(Secondary)Predicate:StealthSERVER™ ImageStorage andCommunication System(K984000)	(Secondary) Predicate:Calgary Scientific'sResolutionMD™ (K161130)
Scanner InterfaceTechnology (toimaging devices)	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	DICOM Import/Export (fromPACS, scanners andStealthStation)	Network Connectivity DICOMImportDICOM Export
"Cybersecurity"Encryption ofPatient Data	Yes: StealthConnectencrypts data in transitusing TLS 1.2, and at restusing AES-256 withdedicated hardware keystorage.	No: Data is not encrypted howeverthe StealthStation running thesoftware is located in a controlledaccess hospital environment	No: Data was not encryptedhowever security measureswere addressed in the IFU.	Yes: ResolutionMD is typicallysecured using SSL.
RegistrationFeatures	StealthConnect providesExam-to-Exam Registration:Identity Merge Registration,Manual Merge Registrationand Automatic MergeRegistration, StereotacticLocalizer Registration andStarFix Bone AnchorRegistration. Other patientregistration features inCranial v 3.0 are notprovided since they are fornavigation.	Yes: Exam-to-Exam Registration:Identity Merge Registration, ManualMerge Registration and AutomaticMerge Registration.Stereotactic Localizer Registrationand StarFix Bone AnchorRegistration.Patient Registration: PointMergeregistration, Tracer registration,Touch-N-Go registration, StealthAiRregistration, O-Arm registration	No: None needed to beprovided for the planningpurposes in effect at thattime.	No: ResolutionMD does not offerregistration features.

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Performance Testing: Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthConnect™ System to establish substantial equivalence of the system and verify that the device will perform as intended, meeting all of the design inputs:
- . Usability Testing was conducted in accordance to IEC 62366 demonstrating that the usability and human factors requirements were adequately met.
- Software Verification and Validation testing verifying the . software and hardware requirements are met and software performs as intended. Design verification and validation was performed using the StealthConnect server and software in laboratory and simulated use settings. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions. This includes the following:
  - Functional testing of the PureWeb component, O a primary component of the predicate, ResolutionMD product demonstrated the functionality of the device is equivalent to the predicate.
  - Accuracy testing for planning components was o conducted to ensure that the StealthConnect™ System met the prescribed requirement for accuracy as compared to the predicate, StealthStation Cranial v 3.0.
  - o Display Effectiveness testing was performed to show that the images provided by the StealthConnect™ System, via the client applications, are sufficient to allow for the same level of stereotaxic surgical planning as provided by the predicate. Stealth Station with Cranial v 3.0 software.

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

Description

Software Development Life Cycle

Software Risk Assessment

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Software Configuration Management and Version Control

Clinical testing was not considered necessary since this is not considered new technology.

Conclusion: The non-clinical data support the safety of the device and the software verification and validation demonstrate that the StealthConnect™ Systemv1.0 should perform as intended in the specified use conditions. The non-clinical data demonstrate that the StealthConnect™ System is substantially equivalent to the predicate(s) StealthStation™ Cranial v 3.0; StealthSERVER™ and ResolutionMD.

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).