The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.

This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):

Tumor resections
General ventricular catheter placement
Pediatric ventricular catheter placement
Depth electrode, lead, and probe placement
Cranial biopsies

Device Description

The StealthStation™ Cranial Software v2.0 works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking.

Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The changes to the currently cleared StealthStation™ S8 Cranial Software are as follows:

Addition of white matter tractography (WMT) fiber tract creation for the brain referred to as diffusion Magnetic Resonance Imaging (dMRI) tractography. dMRI tractography will process diffusion-weighted MRI data into 3D fiber tract models that represent whitematter tracts. This will be marketed as a software option called Stealth™ Tractography.
Addition of the Medtronic SenSight™ directional DBS lead to the existing list of view overlays.
Minor changes to the software were made to address user preferences and to fix minor anomalies.

AI/ML Overview

The provided text describes the performance testing and acceptance criteria for the Medtronic Navigation StealthStation S8 Cranial v2.0 software, particularly focusing on the new white matter tractography (WMT) feature.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Performance Measure)	Threshold / Target	Reported Device Performance
System Accuracy (3D positional accuracy)	Mean error ≤ 2.0 mm	Mean error ≤ 2.0 mm
System Accuracy (Trajectory angle accuracy)	Mean error ≤ 2.0 degrees	Mean error ≤ 2.0 degrees
Software Functionality (dMRI tractography)	Correct creation and rendering of dMRI tracts in views and functionality of dMRI tractography feature requirements.	Performance testing demonstrated the design and implementation of the correct creation and rendering of dMRI tracts in views in the application and the functionality of the dMRI tractography feature requirements.
Usability (Summative Validation)	Safe and effective for intended users, uses, and use environments.	Summative evaluations demonstrated StealthStation™ Cranial Software v2.0 with Stealth™ Tractography has been found to be safe and effective for the intended users, uses and use environments.
Clinical Expert Evaluation (White Matter Tracts)	Assessment of rendering of white matter tracts and their relationship to other key structures with respect to treatment planning, intraoperative navigation, and potential to aid clinical decision making.	Clinical experts assessed the rendering of the white matter tracts and their relationship to other key structures with respect to treatment planning, intraoperative navigation and the potential to aid clinical decision making.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify a numerical sample size for the "datasets" used in summative usability validation and clinical expert evaluation. It states "datasets not used for development, composed of normal and abnormal brains in both pediatric and adult populations."
Data Provenance: Not explicitly stated, but the mention of "datasets not used for development" suggests a separate, possibly curated, test set. There is no information on the country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: The document refers to "clinical experts" (plural) but does not specify the exact number.
Qualifications of Experts: Not explicitly stated (e.g., "radiologist with 10 years of experience"). It only identifies them as "representative users" and "clinical experts."

4. Adjudication method for the test set:

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that "Clinical expert evaluations included white matter tract generation and editing," implying direct assessment by these experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study is mentioned. The study focuses on the device's performance and validation through usability and clinical expert evaluation of the tractography feature, not on human reader performance improvement with AI assistance. The device functions as an aid for locating anatomical structures and displays information; it doesn't appear to be an AI that assists human interpretation in a comparative effectiveness sense.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance test was done for the "System Accuracy" related to 3D positional accuracy and trajectory angle accuracy. This was determined "using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components." This implies assessment of the system's ability to achieve these accuracy metrics independently of human interaction during the measurement. The "correct creation and rendering of dMRI tracts" also implies an algorithm-only assessment of the output.

7. The type of ground truth used:

For System Accuracy (Positional and Trajectory): "Anatomically representative phantoms" were used. The ground truth would be the known, precisely measured dimensions and positions within these phantoms.
For Software Functionality (dMRI tractography): The ground truth appears to be based on whether the software correctly creates and renders the dMRI tracts as per established specifications and expectations, as assessed by performance testing. Clinical experts further evaluated the quality and clinical utility of these rendered tracts in relation to other structures.
For Usability and Clinical Expert Evaluation: The ground truth is effectively the consensus or expert judgment of the "representative users" and "clinical experts" regarding the safety, effectiveness, and clinical utility of the software and its new tractography feature. This is a form of expert consensus or clinical judgment. No mention of pathology or outcomes data for establishing ground truth is made in this context.

8. The sample size for the training set:

The document does not provide any information about a training set since this is a regulatory submission for a software device, not an AI model that requires a distinct training phase. The new feature, dMRI tractography, processes diffusion-weighted MRI data into 3D fiber models. While the underlying algorithms would have been developed and "trained" (in a broader development sense), this document does not refer to a dedicated "training set" in the context of the device's clearance.

9. How the ground truth for the training set was established:

Not applicable, as a "training set" distinct for an AI model is not described in this regulatory submission. The development and verification of the tractography algorithms would have involved internal processes and known physics/mathematics of dMRI data processing.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 22, 2021

Medtronic Navigation Carey Brenner Sr. Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K212397

Trade/Device Name: StealthStation S8 Cranial v2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 3, 2021 Received: November 5, 2021

Dear Carey Brenner:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Adam D. Pierce, Ph.D. 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) K212397

Device Name StealthStation S8 Cranial v2.0

Indications for Use (Describe)

This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):

· Tumor resections
General ventricular catheter placement
Pediatric ventricular catheter placement
· Depth electrode, lead, and probe placement
· Cranial biopsies

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

l. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
- Contact: Carey Brenner (Primary) Senior Requlatory Affairs Specialist Telephone Number: 720.352.1146 Fax Number: 720,890,3500 Email: carey.j.brenner@medtronic.com

Rishi Sinha Director Requlatory Affairs Telephone number: 720.890.2485 Fax: 720.890.3500 Email: rishi.k.sinha@medtronic.com

II. Proprietary Trade Name: StealthStation S8 Cranial Software v2.0 Stealth Tractography
1. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
IV. Classification: Class II, Stereotaxic Instrument
V. Product Codes: HAW

VI. Predicate Device

StealthStation™ S8 Cranial Software v1.3.2, K203639 Reference Device: StealthViz™ Advanced Planning Application with StealthDTI™ Package, K081512

VII. Product Description

The changes to the currently cleared StealthStation™ S8 Cranial Software are as follows:

Addition of white matter tractography (WMT) fiber tract creation for the brain referred to as diffusion Magnetic Resonance Imaging (dMRI) tractography. dMRI tractography will process diffusion-weighted MRI data into 3D fiber tract models that represent whitematter tracts. This will be marketed as a software option called Stealth™ Tractography.

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Addition of the Medtronic SenSight™ directional DBS lead to the existing . list of view overlays.
Minor changes to the software were made to address user preferences and to fix ● minor anomalies.

VIII. Indications for Use

The StealthStation™ System, with StealthStation™ Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.

This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):

· Tumor resections
· General ventricular catheter placement
Pediatric ventricular catheter placement
· Depth electrode, lead, and probe placement
· Cranial biopsies

IX. Comparison of the Technological Characteristics

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X. Discussion of the Performance Testing

The following table summarizes the testing conducted on the StealthStation™ Cranial Software v2.0

Description

Under representative worst-case confiquration, the StealthStation™ S8 System with StealthStation™ Cranial Software v2.0 has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error of ≤ 2.0 degrees. This performance was determined using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components.

Software verification and validation testing verified the software requirements are met and the software performs as intended.

Summative usability validation and clinical expert evaluation were performed by representative users on datasets not used for development, composed of normal and abnormal brains in both pediatric and adult populations.

Summative evaluations demonstrated StealthStation™ Cranial Software v2.0 with Stealth™ Tractography has been found to be safe and effective for the intended users, uses and use environments. Performance testing demonstrated the design and implementation of the correct creation and rendering of dMRI tracts in views in the application and the functionality of the dMRI tractography feature requirements.

Clinical expert evaluations included white matter tract generation and editing which are new in the StealthStation™ S8 software. Clinical experts assessed the rendering of the white matter tracts and their relationship to other key structures with respect to treatment planning, intraoperative navigation and the potential to aid clinical decision making.

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

Description
Software Development Life Cycle
Software Risk Assessment
Software Configuration Management and Version Control

XII. Conclusions

The StealthStation™ Cranial Software v2.0 has been found through performance testing and comparison to be substantially equivalent to the identified predicate device. Performance testing in combination with the clinical expert evaluation demonstrates the StealthStation™ Cranial v2.0 software performs as intended and demonstrates substantial equivalence to the predicate device.

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).

Attribute	Subject DeviceCranial Software version 2.0	Predicate DeviceCranial Software (K203639)
Intended use	The StealthStation™ System, withStealthStation™ Cranial software isdesigned as an aid for locating anatomicalstructures in either open or percutaneousneurosurgical procedures.	The StealthStation™ System, withStealthStation™ Cranial software isdesigned as an aid for locating anatomicalstructures in either open or percutaneousneurosurgical procedures.
Indications forUse	The StealthStation™ System, withStealthStation™ Cranial Software, isintended as an aid for locating anatomicalstructures in either open or percutaneousneurosurgical procedures. Their use isindicated for any medical condition inwhich the use of stereotactic surgery maybe appropriate, and where reference to arigid anatomical structure, such as theskull, can be identified relative to images ofthe anatomy.This can include, but is not limited to, thefollowing cranial procedures (includingstereotactic frame-based and stereotacticframe alternatives-based procedures):• Tumor resections• General ventricular catheter placement• Pediatric ventricular catheter placement• Depth electrode, lead, and probeplacement• Cranial biopsies	The StealthStation™ System, withStealthStation™ Cranial Software, isintended as an aid for locating anatomicalstructures in either open or percutaneousneurosurgical procedures. Their use isindicated for any medical condition inwhich the use of stereotactic surgery maybe appropriate, and where reference to arigid anatomical structure, such as theskull, can be identified relative to images ofthe anatomy.This can include, but is not limited to, thefollowing cranial procedures (includingstereotactic frame-based and stereotacticframe alternatives-based procedures):• Tumor resections• General ventricular catheter placement• Pediatric ventricular catheter placement• Depth electrode, lead, and probeplacement• Cranial biopsies
SystemAccuracyRequirement	Under representative worst-caseconfiguration, the StealthStation™ S8System with StealthStation™ Cranial v2.0Software, has demonstrated performancein 3D positional accuracy with a mean error$\le$ 2.0 mm and in trajectory angle accuracywith a mean error $\le$ 2.0 degree.	Under representative worst-caseconfiguration, the StealthStation™ S8System with StealthStation™ CranialSoftware, has demonstrated performancein 3D positional accuracy with a mean error$\le$ 2.0 mm and in trajectory angle accuracywith a mean error $\le$ 2.0°
Attribute	Subject DeviceCranial Software version 2.0	Predicate DeviceCranial Software (K203639)
ImagingModalities	X-Ray based, MR based, Nuclear Medicinebased	X-Ray based, MR based, Nuclear Medicinebased
View (Display)Features	Ultrasound Video In, Ultrasound Overlay,3D, 2D Anatomic Orthogonal, Trajectory 1and 2, Target Guidance, TrajectoryGuidance, Probes Eye, Look Ahead,Microscope Injection, Video Input,Endoscopic	Ultrasound Video In, Ultrasound Overlay,3D, 2D Anatomic Orthogonal, Trajectory 1and 2, Target Guidance, TrajectoryGuidance, Probes Eye, Look Ahead,Microscope Injection, Video Input,Endoscopic
Exam-to-ExamRegistrationFeatures	Identity Merge Registration, Manual MergeRegistration and Automatic MergeRegistration	Identity Merge Registration, Manual MergeRegistration and Automatic MergeRegistration
PatientRegistrationFeatures	PointMerge™ registration (referred to asLandmark registrations),Tracer™ registration,Touch registration (previouslyTouch-N-Go™),StealthAiR™ registration,O-arm™ registration,Mechanical based registrations(Stereotactic Localizer Registration andStarFix™ Bone Anchor Registration)	PointMerge™ registration (referred to asLandmark registrations),Tracer™ registration,Touch registration (previouslyTouch-N-Go™),StealthAiR™ registration,O-arm™ registration,Mechanical based registrations(Stereotactic Localizer Registration andStarFix™ Bone Anchor Registration)
PlanningFeatures	3D Model Building, including fiber tractswith Standard DTI and Enhanced CSDtechniquesPlan Entry and Target SelectionAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand- Wahren Atlaswith Talairach GridSTarFix™ Designer Annotations	3D Model Building (which includes DTIfiber tracts imported from StealthViz)Plan Entry and Target SelectionAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand- Wahren Atlaswith Talairach GridSTarFix™ Designer Annotations
Medical DeviceInterfaces	Microscope Navigation:Zeiss, LeicaUltrasound Navigation:Aloka and SonositeMedtronic O-arm®Stereotactic FrameSystems: Fischer ZD,Fischer RM, Integra CRWand Elekta LeksellNexframe® StereotacticSystemSTarFix™Platform System	Microscope Navigation:Zeiss, LeicaUltrasound Navigation:Aloka and SonositeMedtronic O-arm®Stereotactic FrameSystems: Fischer ZD,Fischer RM, Integra CRWand Elekta LeksellNexframe® StereotacticSystemSTarFix™Platform System
CompatibleMedtronicOpticalInstrumentation	Medtronic instruments tracked via opticalmarkers or LEDs located on instrumentand patient trackers via the opticallocalizing system.	Medtronic instruments tracked via opticalmarkers or LEDs located on instrumentand patient trackers via the opticallocalizing system.
Attribute	Subject DeviceCranial Software with dMRITractography	Predicate DeviceCranial Software (K203639)
CompatibleMedtronic EMInstrumentation	Medtronic instruments tracked viaElectromagnetic localization technologylocated within the instrument and patienttrackers	Medtronic instruments tracked viaElectromagnetic localization technologylocated within the instrument and patienttrackers
SoftwareInterface (GUI)	Black and gray style with procedure taskoverview in left menu option and next/backtask flow at bottom of the screen.Software controls for images, planning andinstrument management and tractographyediting are contained in a right side bar.	Black and gray style with procedure taskoverview in left menu option and next/backtask flow at bottom of the screen.Software controls for images, planning andinstrument management are contained in aright side bar.
ProgrammingLanguage	C++/Java	C++
ScannerInterfaceTechnology (toimagingdevices)	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export
OpticalTechnology	Manufacturer:(Northern Digital Inc.)Localizer: Vega	Manufacturer:(Northern Digital Inc.)Localizer: Vega
ElectromagneticTechnology	Manufacturer:(Medtronic Navigation, Inc.)Localizer: AxiEM IIIEmitter Types: Side, Flat	Manufacturer:(Medtronic Navigation, Inc.)Localizer: AxiEM IIIEmitter Types: Side, Flat