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 v1.3.2 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.

AI/ML Overview

The acceptance criteria for the StealthStation™ Cranial Software v1.3.2 are not explicitly detailed in the provided document beyond the general statement of "System Accuracy Requirements" being "Identical" to the predicate device. The performance characteristics of the predicate device, StealthStation™ Cranial Software v1.3.0, are stated as the benchmark for system accuracy.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria/Feature	Acceptance Criteria (based on Predicate Device K201175)	Reported Device Performance (StealthStation™ Cranial Software v1.3.2)
System Accuracy	Mean 3D positional error ≤ 2.0 mm	Identical; no changes made to the StealthStation™ Cranial Software that would require System Accuracy testing for v1.3.2
	Mean trajectory angle accuracy ≤ 2.0 degrees
All other features	Functions and performs as described for the predicate device.	All other features are identical to the predicate device.

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

The document states that "Software verification testing for each requirement specification" was conducted and "Design verification was performed using the StealthStation™ System with Station™ Cranial Software v1.3.2 in laboratory."
No specific sample size for a test set is mentioned. The testing described is software verification and design verification, not a clinical study on patient data for performance evaluation in the typical sense of AI/ML devices.
Data provenance is not applicable or not disclosed as the document indicates "Clinical testing was not considered necessary prior to release as this is not new technology."

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

Not applicable. The testing described is software and design verification rather than a clinical performance study requiring expert ground truth establishment from patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This information is relevant for clinical studies involving multiple reviewers adjudicating findings, which was not performed.

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. An MRMC comparative effectiveness study was not performed. The device is a navigation system and not an AI-assisted diagnostic tool that would typically involve human readers.

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

No. The device is a surgical navigation system, which is inherently a human-in-the-loop tool. The performance evaluation focuses on its accuracy specifications within that use case during design verification.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. For the system accuracy, the ground truth would be precise measurements taken in a laboratory setting for the navigational accuracy, rather than clinical ground truth from patient data like pathology or outcomes.

8. The sample size for the training set:

Not applicable. The document describes a software update for a stereotaxic instrument, not an AI/ML device that undergoes model training with a dataset.

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

Not applicable. As the device is not described as an AI/ML system requiring a training set, the establishment of ground truth for such a set is not relevant.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

January 13, 2021

Medtronic Navigation, Inc. Taylor West, MBA Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K203639

Trade/Device Name: StealthStation Cranial Software v1.3.2 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 11, 2020 Received: December 14, 2020

Dear Taylor West:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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

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 medical devices and radiation-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

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

Indications for Use

510(k) Number (if known) K203639

Device Name StealthStation Cranial v1.3.2

Indications for Use (Describe)

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 indical 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

Type of Use (Select one or both, as applicable)	Exempt Activities Part 286 Subpart D On-Site Combustion (40 CFR 98 Subpart C)
-------------------------------------------------	----------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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

11 December 2020

I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville. Colorado 80027 USA Telephone Number: 720-890-3200
- Contact: Taylor Gold West, MBA (Primary) Senior Regulatory Affairs Specialist Telephone Number: 720.890.2322 Fax Number: 720.890.3500 Email: taylor.c.goldwest@medtronic.com

K. Elizabeth Waite Regulatory Affairs Manager Telephone number: 720.890.2182 Fax: 720.890.3500 Email: elizabeth.waite@medtronic.com

Proprietary Trade Name: StealthStation™ Cranial Software v1.3.2 II.
III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
IV. Classification: Class II, Stereotaxic Instrument
V. Product Codes: HAW

VI. Primary Predicate Device

510(k): K201175 Device name: StealthStation™ Cranial Software v1.3.0 Manufacturer: Medtronic Navigation, Inc.

VII. Product Description

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

VIII. Indications for Use

The StealthStation™ System, with Station™ 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

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

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

X. Discussion of Performance Testing

The following table summarizes the testing conducted for the StealthStation™ Cranial Software v1.3.2.

Description

Software verification testing for each requirement specification.

{7}------------------------------------------------

Design verification was performed using the StealthStation™ System with Station™ Cranial Software v1.3.2 in laboratory. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions.

Clinical testing was not considered necessary prior to release as this is not new technology.

XI. Conclusions

The StealthStation™ Cranial Software v1.3.2 has been shown through testing and comparison to be substantially equivalent to the identified 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).

Feature	StealthStation™ Cranial Softwarev1.3.2 (Subject Device)	StealthStation™ Cranial Softwarev1.3.0 (Primary Predicate, K201175)
Intended Use	The StealthStation™ System, with StealthStation™ Cranial Software is designed as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.	The StealthStation™ System, with StealthStation™ Cranial Software is designed as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
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	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
Feature	StealthStation™ Cranial Softwarev1.3.2 (Subject Device)	StealthStation™ Cranial Softwarev1.3.0 (Primary Predicate, K201175)
System AccuracyRequirements	Identical; no changes made to theStealthStation™ Cranial Software thatwould require System Accuracy testingfor v1.3.2	Under representative worst-caseconfiguration, the StealthStation™System with StealthStation™ CranialSoftware v1.3.0, has demonstratedperformance in 3D positional accuracywith a mean error $\leq$ 2.0 mm and intrajectory angle accuracy with a meanerror $\leq$ 2.0 degrees.
ImagingModalities	X-Ray based, MR based,Nuclear Medicine based	X-Ray based, MR based,Nuclear Medicine based
View (Display)Features	Ultrasound Video In, UltrasoundOverlay, 3D, 2D Anatomic Orthogonal,Trajectory 1 and 2, Target Guidance,Trajectory Guidance, Probes Eye, LookAhead, Microscope Injection, VideoInput, Endoscopic	Ultrasound Video In, UltrasoundOverlay, 3D, 2D Anatomic Orthogonal,Trajectory 1 and 2, Target Guidance,Trajectory Guidance, Probes Eye, LookAhead, Microscope Injection, VideoInput, Endoscopic
Exam-to-ExamRegistrationFeatures	Identity Merge Registration, ManualMerge Registration and AutomaticMerge Registration	Identity Merge Registration, ManualMerge Registration and AutomaticMerge Registration
PatientRegistrationFeatures	PointMerge™ registration (referred toas Landmark registrations), Tracer™registration, Touch registration(previously Touch-N-Go™),StealthAiR™ registration, O-arm™registration, Mechanical basedregistrations (Stereotactic LocalizerRegistration and StarFix™ BoneAnchor Registration)	PointMerge™ registration (referred toas Landmark registrations), Tracer™registration, Touch registration(previously Touch-N-Go™),StealthAiR™ registration, O-arm™registration, Mechanical basedregistrations (Stereotactic LocalizerRegistration and StarFix™ BoneAnchor Registration)
PlanningFeatures	Plan Entry and Target Selection3D Model BuildingAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand-WahrenAtlas with Talairach GridSTarFix™ DesignerAnnotations	Plan Entry and Target Selection3D Model BuildingAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand-WahrenAtlas with Talairach GridSTarFix™ DesignerAnnotations
Feature	StealthStation™ Cranial Softwarev1.3.2 (Subject Device)	StealthStation™ Cranial Softwarev1.3.0 (Primary Predicate, K201175)
Medical DeviceInterfaces	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-arm™Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta LeksellNexframe™ Stereotactic SystemSTarFix™Platform SystemStealth Midas Rex MR8StealthStation Autoguide	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-arm™Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta LeksellNexframe™ Stereotactic SystemSTarFix™Platform SystemStealth Midas Rex MR8StealthStation Autoguide
CompatibleMedtronicOpticalInstrumentation	Medtronic instruments tracked via optical markers or LEDs located on instrument and patient trackers via the optical localizing system.	Medtronic instruments tracked via optical markers or LEDs located on instrument and patient trackers via the optical localizing system.
CompatibleMedtronic EMInstrumentation	Medtronic instruments tracked via electromagnetic localization technology located within the instrument and patient trackers	Medtronic instruments tracked via electromagnetic localization technology located within the instrument and patient trackers
SoftwareInterface(GUI)	Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management are contained in a right side bar.	Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management are contained in a right side bar.
ProgrammingLanguage	C++	C++
Scanner InterfaceTechnology (toimaging devices)	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 Tunes: Side, Flat	Manufacturer: Medtronic Navigation, Inc.Localizer: AxiEM IIIEmitter Tunes: Side, Flat