The StealthStation System, with StealthStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure 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):

Cranial biopsies (including stereotactic)
Deep brain stimulation (DBS) lead placement
Depth electrode placement
Tumor resections
Craniotomies/Craniectomies
Skull Base Procedures
Transsphenoidal Procedures
Thalamotomies/Pallidotomies
Pituitary Tumor Removal
CSF leak repair
Pediatric Ventricular Catheter Placement
General Ventricular Catheter Placement

Device Description

The StealthStation System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation Cranial Software 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. StealthStation 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 furnished document is a 510(k) premarket notification for the StealthStation Cranial Software, version 3.1.5. It details the device's indications for use, technological characteristics, and substantiates its equivalence to a predicate device through performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (StealthStation Cranial Software Version 3.1.5)	Predicate Device Performance (StealthStation Cranial Software Version 3.1.4)
3D Positional Accuracy (Mean Error) ≤ 2.0 mm	0.824 mm	1.27 mm
Trajectory Angle Accuracy (Mean Error) ≤ 2.0 degrees	0.615 degrees	1.02 degrees

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

The document mentions "System accuracy validation testing" was conducted. However, it does not specify the sample size for this test set (e.g., number of cases, images, or measurements).

Regarding data provenance, the document does not explicitly state the country of origin of the data nor whether the data used for accuracy testing was retrospective or prospective. The study focuses on demonstrating substantial equivalence through testing against predefined accuracy thresholds rather than utilizing patient-specific clinical data.

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

The document does not provide information on the number of experts used to establish ground truth for the system accuracy validation testing, nor their specific qualifications. It mentions "User exploratory testing to explore clinical workflows, including standard and unusual clinically relevant workflows. This testing will include subject matter experts, internal and field support personnel," but this refers to a different type of testing (usability/workflow exploration) rather than objective ground truth establishment for accuracy measurements.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the system accuracy validation testing. The accuracy measurements appear to be objective, derived from controlled testing environments rather than subjective expert interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as part of this submission. The testing described is focused on the standalone performance of the device's accuracy in a controlled environment, not on how human readers perform with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):

Yes, standalone performance testing was done. The "System accuracy validation testing" directly assesses the algorithm's performance in achieving specific positional and angular accuracy. The reported "Positional Error - 0.824 mm" and "Trajectory Error - 0.615 degrees" are metrics of the standalone algorithm's accuracy without direct human intervention in the measurement process itself, although the device is ultimately used by humans in a clinical context.

7. Type of Ground Truth Used:

The ground truth for the system accuracy validation testing appears to be based on objective, controlled measurements within a testing environment, likely involving phantom models or precise physical setups where the true position and orientation are known or can be measured with high precision. This is implied by the nature of "3D positional accuracy" and "trajectory angle accuracy" measurements, which are typically determined against a known, precise reference. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. This is because the StealthStation Cranial Software is a navigation system that uses image processing and registration algorithms, rather than a machine learning model that requires a distinct training dataset in the traditional sense. The software's development likely involves engineering principles and rigorous testing against design specifications, not iterative learning from data.

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

As the device does not appear to be an AI/ML model that undergoes a machine learning "training" phase with a labeled dataset in the conventional understanding for medical imaging analysis, the concept of establishing ground truth for a training set is not applicable in this context. The software's functionality is based on established algorithms for image registration and instrument tracking, which are then validated through performance testing against pre-defined accuracy thresholds.

Summary

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October 19, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Medtronic Navigation, Inc. Rishi Mehta Senior Regulatory Affairs Specialist 200 Medtronic Drive Lafayette, Colorado 80026

Re: K231976

Trade/Device Name: StealthStation Cranial Software, v3.1.5 (9735585) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: September 19, 2023 Received: September 19, 2023

Dear Rishi Mehta:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2023.10.19, and the time is 11:31:58 -04'00'.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices

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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)

K231976

Device Name

StealthStation Cranial Software Version 3.1.5 (9735585)

Indications for Use (Describe)

StealthStation Cranial Software Version 3.1.5

The StealthStation System, with SteathStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure 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):

Cranial biopsies (including stereotactic)
Deep brain stimulation (DBS) lead placement
Depth electrode placement
Tumor resections
Craniotomies/Craniectomies
Skull Base Procedures
Transsphenoidal Procedures
Thalamotomies/Pallidotomies
Pituitary Tumor Removal
CSF leak repair
Pediatric Ventricular Catheter Placement
General Ventricular Catheter Placement

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

October 19, 2023

l. Company: Medtronic Navigation, Inc. 200 Medtronic Drive Lafayette, CO, 80026 Telephone Number: 720-890-2462 Fax Number: 720-890-3500
- Contact: Rishi Mehta Senior Regulatory Affairs Specialist Telephone Number: 720-890-2462

Kyle Hoefling Senior Regulatory Affairs Manager Telephone Number: 720-890-2462

II. Proprietary Trade Name: StealthStation™ Cranial Software v3.1.5
lll. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
IV. Classification: Class II, Stereotaxic Instrument
V. Product Codes: HAW
VI. Predicate: Medtronic Navigation, Inc. manufactured software;
- K221087 StealthStation Cranial Software v3.1.4

VII. Product Description

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VIII. Indications for Use

StealthStation Cranial Software Version 3.1.5

The StealthStation System, with StealthStation Cranial Software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure 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):

Cranial biopsies (including stereotactic) -
-Deep brain stimulation (DBS) lead placement
-Depth electrode placement
-Tumor resections
-Craniotomies/Craniectomies
-Skull Base Procedures
-Transsphenoidal Procedures
Thalamotomies/Pallidotomies -
-Pituitary Tumor Removal
CSF leak repair י
-Pediatric Ventricular Catheter Placement
General Ventricular Catheter Placement -

IX. Summary of the Technological Characteristics

StealthStation Cranial Software Version 3.1.5 as compared to Predicate Device

Item	Subject Device	Predicate Device
	StealthStation System with CranialSoftware Version 3.1.5	StealthStation System withStealthStation Cranial SoftwareVersion 3.1.4 (K221087)
Intended Use	The StealthStation System, withStealthStation Cranial software isdesigned as an aid for locatinganatomical structures in either open orpercutaneous neurosurgicalprocedures.	The StealthStation System, withStealthStation Cranial software isdesigned as an aid for locatinganatomical structures in either open orpercutaneous neurosurgicalprocedures.
Indications for Use	The StealthStation System, withStealthStation Cranial software, isintended to aid in locating anatomicalstructures in either open orpercutaneous neurosurgicalprocedures. The system is indicated forany medical condition in whichreference to a rigid anatomical	The StealthStation System, withStealthStation Cranial software, isintended to aid in locating anatomicalstructures in either open orpercutaneous neurosurgicalprocedures. The system is indicated forany medical condition in whichreference to a rigid anatomical
Item	Subject Device	Predicate Device
	StealthStation System with CranialSoftware Version 3.1.5	StealthStation System withStealthStation Cranial SoftwareVersion 3.1.4 (K221087)
	structure can be identified relative toimages of the anatomy.	structure can be identified relative toimages of the anatomy.

	This can include, but is not limited to,the following cranial procedures(including stereotactic frame-basedand stereotactic frame alternatives-based procedures):- Cranial Biopsies- Deep brain stimulation (DBS)lead placement- Depth electrode placement- Tumor Resections- Craniotomies/Craniectomies- Skull Base Procedures- Transsphenoidal Procedures- Thalamotomies/Pallidotomies- Pituitary Tumor Removal- CSF Leak Repair- Pediatric Ventricular CatheterPlacement- General Ventricular CatheterPlacement	This can include, but is not limited to,the following cranial procedures(including stereotactic frame-basedand stereotactic frame alternatives-based procedures):- Cranial Biopsies- Deep brain stimulation (DBS)lead placement- Depth electrode placement- Tumor Resections- Craniotomies/Craniectomies- Skull Base Procedures- Transsphenoidal Procedures- Thalamotomies/Pallidotomies- Pituitary Tumor Removal- CSF Leak Repair- Pediatric Ventricular CatheterPlacement- General Ventricular CatheterPlacement

	The user should consult the"Navigational Accuracy" section of theUser Manual to assess if the accuracyof the system is suitable to theirneeds.	The user should consult the"Navigational Accuracy" section of theUser Manual to assess if the accuracyof the system is suitable to their needs.

System AccuracyRequirement	Under representative worst-caseconfiguration, the StealthStation®System with StealthStation CranialSoftware, has demonstratedperformance in 3D positional accuracywith a mean error ≤ 2.0 mm and intrajectory angle accuracy with a meanerror ≤ 2.0 degrees.	Under representative worst-caseconfiguration, theStealthStation® System withStealthStation® Cranial Software, hasdemonstrated performance in 3Dpositional accuracy with a mean error≤ 2.0 mm and in trajectory angleaccuracy with a mean error ≤ 2.0degrees.

	Specific Mean Accuracy Values	Specific Mean Accuracy Values

	Positional Error - 0.824 mm	Positional Error - 1.27 mm
	Trajectory Error - 0.615 degrees	Trajectory Error – 1.02 degrees
Item	Subject Device	Predicate Device
	StealthStation System with CranialSoftware Version 3.1.5	StealthStation System withStealthStation Cranial SoftwareVersion 3.1.4 (K221087)
ImagingModalities	X-Ray based,MR basedNuclear Medicine based	X-Ray based,MR basedNuclear Medicine based
RegistrationFeatures	Exam-to-Exam Registration: IdentityMerge Registration, Manual MergeRegistration and Automatic MergeRegistration.	Exam-to-Exam Registration: IdentityMerge Registration, Manual MergeRegistration and Automatic MergeRegistration.
	Patient Registration: PointMergeregistration, Tracer registration,Touch-N-Go registration, StealthAiRregistration, O-arm registration,Stereotactic Localizer Registration andStarFix Bone Anchor Registration	Patient Registration: PointMergeregistration, Tracer registration,Touch-N-Go registration, StealthAiRregistration, O-arm registration,Stereotactic Localizer Registration andStarFix Bone Anchor Registration
Planning Features	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
Medical DeviceInterfaces	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka andSonositeMedtronic O-armStereotactic Frame Systems: FischerZD, Fischer RM, Integra CRW andLeksellNexframe® Stereotactic SystemSTarFix™Platform	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka andSonositeMedtronic O-armStereotactic Frame Systems: FischerZD, Fischer RM, Integra CRW andLeksellNexframe® Stereotactic SystemSTarFix™Platform
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	Ultrasound Video In, UltrasoundOverlay, 3D, 2D Anatomic Orthogonal,Trajectory 1 and 2, Target Guidance,Trajectory Guidance, Probes Eye, LookAhead, Microscope Injection, VideoInput
Software Interface(GUI)	Blue style with chronological next/backtask flow at the top of the screen.Image controls on the left. Planninginformation on the right	Blue style with chronological next/backtask flow at the top of the screen.Image controls on the left. Planninginformation on the right
Item	Subject Device	Predicate Device
ProgrammingLanguage	C++	C++
Scanner InterfaceTechnology (toimaging devices)	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export
LocalizationTechnology	Optical (infra-red)ElectromagneticMechanical based stereotactic	Optical (infra-red)ElectromagneticMechanical based stereotactic
	StealthStation System with CranialSoftware Version 3.1.5	StealthStation System withStealthStation Cranial SoftwareVersion 3.1.4 (K221087)

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X. Identification of Legally Marketing Devices

K190672, StealthStation Cranial Software v3.1.1
K221087, StealthStation Cranial Software v3.1.4

XI. Discussion of the Performance Testing

Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthStation Cranial Software to establish substantial equivalence of the system and verify that the device will perform as intended meeting all of the design inputs:

Verification corrective testing to verify the software changes addressed the Biopsy Depth Gauge Graphic and the Distance to/past Target Text anomalies.
Verification regression testing to confirm that changes introduced to the software do not adversely affect the functionality of the software.
Verify the new software version will install and upgrade properly.
Verify the changes to the instructions for use (IFU).
. User exploratory testing to explore clinical workflows, including standard and unusual clinically relevant workflows. This testing will include subject matter experts, internal and field support personnel.
. System accuracy validation testing to demonstrate that the modified software meets the accuracy acceptance criteria of ≤2.0mm and ≤2.0 degrees, established in previous 510(k) submissions for the predicate device, the StealthStation S7 System.

The following table summarizes the quality assurance 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

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XII. Conclusions

The StealthStation Cranial Software 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).