Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

K221087 · Medtronic Navigation, Inc. · HAW · Jun 10, 2022 · Neurology

Device Facts

• Record ID: K221087
• Device Name: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jun 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The StealthStation System, with Synergy Cranial software, is intended as an aid for 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: - Cranial Biopsies - Tumor Resections - Craniotomies/Craniectomies - Skull Base Procedures - Transsphenoidal Procedures - Thalamotomies/Pallidotomies - Pituitary Tumor Removal - CSF Leak Repair - Pediatric Catheter Shunt Placement - General Catheter Shunt Placement 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 stereotactivesbased 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 Story

Image-guided surgery system (IGS) providing real-time navigation for neurosurgical procedures; inputs include pre-operative/intra-operative diagnostic images (CT, MR, Nuclear Medicine) and tracked surgical instruments; system uses optical (infra-red) or electromagnetic localization to track instrument position relative to patient anatomy; software transforms inputs into 3D visualizations, trajectory guidance, and anatomical overlays; used in OR by neurosurgeons; output displayed on workstation monitor; assists in precise localization of anatomical structures; aids clinical decision-making by providing visual confirmation of instrument position relative to planned targets; benefits include improved surgical accuracy and reduced invasiveness.

Clinical Evidence

Bench testing only. Performance validated using anatomically representative phantoms under worst-case configurations. 3D positional accuracy demonstrated with mean error ≤ 2.0 mm; trajectory angle accuracy demonstrated with mean error ≤ 2.0 degrees. Software verification and validation performed in laboratory and simulated use settings.

Technological Characteristics

Software-based image-guided navigation system. Localization via optical (infra-red) or electromagnetic tracking. Supports X-ray, MR, and Nuclear Medicine imaging modalities. Connectivity via network, CD, DVD, USB; supports DICOM import/export. Programming language: C++. System includes registration (PointMerge, Tracer, Touch-N-Go, StealthAiR, O-arm, stereotactic localizer), planning (3D model building, atlas integration), and interface with surgical microscopes/ultrasound.

Indications for Use

Indicated for patients undergoing open or percutaneous neurosurgical procedures where rigid anatomical structures can be referenced against medical images. Procedures include cranial biopsies, tumor resections, craniotomies/craniectomies, skull base/transsphenoidal procedures, thalamotomies/pallidotomies, pituitary tumor removal, CSF leak repair, and ventricular catheter/DBS lead/depth electrode placement.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• StealthStation Synergy Cranial S7 Software v2.2.8 (K190672)
• StealthStation Cranial Software v3.1.1 (K190672)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA text is in blue, with "FDA" in a solid blue square and the rest of the text in a lighter blue.

June 10, 2022

Medtronic Navigation, Inc. Silver Wirth Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K221087

Trade/Device Name: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: April 11, 2022 Received: April 13, 2022

Dear Silver Wirth:

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

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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 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 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 ([e-mail]) or phone [phone] 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) K221087

### Device Name

Synergy Cranial v2.2.9 (9733763); StealthStation Cranial v3.1.4 (9735585)

# Indications for Use (Describe)

## Synergy Cranial v2.2.9:

The StealthStation System, with Synergy Cranial software, is intended as an aid for 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:

- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement

StealthStation Cranial Software v3.1.4:

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 stereotactivesbased 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

## April 11, 2022

- l. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Contact: Silver Wirth Regulatory Affairs Specialist Telephone Number: 720-890-3200

Olga Lewis (Alternate) Senior Regulatory Affairs Manager Telephone Number: 720-890-3200

- II. Proprietary Trade Name: StealthStation™ Cranial Software
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- IV. Classification: Class II, Stereotaxic Instrument
- V. Product Codes: HAW
- VI. Predicates: Medtronic Navigation, Inc. manufactured software;
- K190672, StealthStation Synergy Cranial S7 Software v2.2.8, StealthStation Cranial Software v3.1.1

#### VII. Product 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.

#### VIII. Indications for Use

## Cranial Software v2.2.9

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The StealthStation System, with Synergy Cranial software, is intended as an aid for 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:

- -Cranial Biopsies
- -Tumor Resections
- Craniotomies/Craniectomies -
- -Skull Base Procedures
- Transsphenoidal Procedures -
- -Thalamotomies/Pallidotomies
- Pituitary Tumor Removal -
- -CSF Leak Repair
- Pediatric Catheter Shunt Placement -
- -General Catheter Shunt Placement

## Cranial Software v3.1.3

The StealthStation System, with Station 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

### IX. Summary of the Technological Characteristics

## StealthStation Cranial Software v2.2.9 as compared to Predicate Device

| Item | Subject Device | Predicate Device |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The StealthStation System, with Synergy Cranial software is designed as an aid for | The StealthStation System, with Synergy Cranial software is designed as an aid for |
| | StealthStation System with Synergy Cranial<br>v2.2.9 Software | K190672 StealthStation System with Synergy Cranial v2.2.8 Software |
| | Subject Device | Predicate Device |
| | StealthStation System with Synergy Cranial | K190672 StealthStation System with |
| Item | v2.2.9 Software | Synergy Cranial v2.2.8 Software |
| | precisely locating anatomical structures in | precisely locating anatomical structures in |
| | either open or percutaneous neurosurgical | either open or percutaneous neurosurgical |
| | procedures. | procedures. |
| Indications for Use | The StealthStation System, with Synergy<br>Cranial software, is intended as an aid for<br>precisely locating anatomical structures in<br>either open or percutaneous neurosurgical<br>procedures. The system is indicated for<br>any medical condition in which reference<br>to a rigid anatomical structure can be<br>identified relative to images of the<br>anatomy.<br><br>This can include, but is not limited to, the<br>following cranial procedures:<br>- Cranial Biopsies<br>- Tumor Resections<br>- Craniotomies/Craniectomies<br>- Skull Base Procedures<br>- Transsphenoidal Procedures<br>- Thalamotomies/Pallidotomies<br>- Pituitary Tumor Removal<br>- CSF Leak Repair<br>- Pediatric Catheter Shunt Placement<br>- General Catheter Shunt Placement | The StealthStation System, with Synergy<br>Cranial software, is intended as an aid for<br>precisely locating anatomical structures in<br>either open or percutaneous neurosurgical<br>procedures. The system is indicated for<br>any medical condition in which reference<br>to a rigid anatomical structure can be<br>identified relative to images of the<br>anatomy.<br><br>This can include, but is not limited to, the<br>following cranial procedures:<br>- Cranial Biopsies<br>- Tumor Resections<br>- Craniotomies/Craniectomies<br>- Skull Base Procedures<br>- Transsphenoidal Procedures<br>- Thalamotomies/Pallidotomies<br>- Pituitary Tumor Removal<br>- CSF Leak Repair<br>- Pediatric Catheter Shunt Placement<br>- General Catheter Shunt Placement |
| System Accuracy | Under representative worst-case<br>configuration, the StealthStation® System<br>with Synergy Cranial Software, has<br>demonstrated performance in 3D<br>positional accuracy with a mean error ≤<br>2.0 mm and in trajectory angle accuracy<br>with a mean error ≤ 2.0 degrees.<br><br>Specific Mean Accuracy Values<br>Position Error - 1.29 mm<br>Trajectory Error - 0.87 degrees | Under representative worst-case<br>configuration, the StealthStation® System<br>with Synergy® Cranial Software, has<br>demonstrated performance in 3D<br>positional accuracy with a mean error ≤<br>2.0 mm and in trajectory angle accuracy<br>with a mean error ≤ 2.0 degrees.<br><br>Specific Mean Accuracy Values<br>Positional Error - 0.70 mm<br>Trajectory Error - 0.46 degrees |
| Requirement | | |
| Imaging Modalities | X-Ray based,<br>MR based<br>Nuclear Medicine based | X-Ray based,<br>MR based<br>Nuclear Medicine based |
| Registration | Exam-to-Exam Registration: Identity<br>Merge Registration, Manual Merge<br>Registration and Automatic Merge<br>Registration. | Exam-to-Exam Registration: Identity<br>Merge Registration, Manual Merge<br>Registration and Automatic Merge<br>Registration. |
| Features | | |
| Page 4 of 7 | | |
| Item | Subject Device | Predicate Device |
| | StealthStation System with Synergy Cranial<br>v2.2.9 Software | K190672 StealthStation System with<br>Synergy Cranial v2.2.8 Software |
| | Patient Registration: PointMerge<br>registration, Tracer registration, Touch-N-<br>Go registration, StealthAiR registration<br>and O-arm registration | Patient Registration: PointMerge<br>registration, Tracer registration, Touch-N-<br>Go registration, StealthAiR registration and<br>O-arm registration |
| Planning Features | Plan Entry and Target Selection<br>3D Model Building<br>Advanced Visualization | Plan Entry and Target Selection<br>3D Model Building<br>Advanced Visualization |
| Medical Device<br>Interfaces | Microscope Navigation: Zeiss, Leica<br>Ultrasound Navigation: Aloka and Sonosite<br>Medtronic O-arm | Microscope Navigation: Zeiss, Leica<br>Ultrasound Navigation: Aloka and Sonosite<br>Medtronic O-arm |
| View (Display)<br>Features | Ultrasound Video In, Ultrasound Overlay,<br>3D, 2D Anatomic Orthogonal, Trajectory 1<br>and 2, Target Guidance, Trajectory<br>Guidance, Probes Eye, Look Ahead,<br>Microscope Injection, Video Input | Ultrasound Video In, Ultrasound Overlay,<br>3D, 2D Anatomic Orthogonal, Trajectory 1<br>and 2, Target Guidance, Trajectory<br>Guidance, Probes Eye, Look Ahead,<br>Microscope Injection, Video Input |
| Software Interface<br>(GUI) | Blue style with chronological next/back<br>task flow at the top of the screen. Image<br>controls on the left. Planning information<br>on the right. | Blue style with chronological next/back<br>task flow at the top of the screen. Image<br>controls on the left. Planning information<br>on the right. |
| Programming<br>Language | C++ | C++ |
| Scanner Interface<br>Technology (to<br>imaging devices) | Network Connectivity<br>CD, DVD, USB<br>DICOM or Stealth format Import<br>Export in Stealth format | Network Connectivity<br>CD, DVD, USB<br>DICOM or Stealth format Import<br>Export in Stealth format |
| Localization<br>Technology | Optical (infra-red)<br>Electromagnetic | Optical (infra-red)<br>Electromagnetic |

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K221087 Page 4 of 7

# StealthStation Cranial Software v3.1.3 as compared to Predicate Device

| Item | Subject Device | Predicate Device |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | StealthStation System with Cranial v3.1.3<br>Software | K190672 StealthStation System with<br>StealthStation Cranial v3.1.1 Software |
| Intended Use | The StealthStation System, with<br>StealthStation Cranial software is designed<br>as an aid for locating anatomical<br>structures in either open or percutaneous<br>neurosurgical procedures. | The StealthStation System, with<br>StealthStation Cranial software is designed<br>as an aid for locating anatomical structures<br>in either open or percutaneous<br>neurosurgical procedures. |
| Indications for Use | The StealthStation System, with<br>StealthStation Cranial software, is<br>intended to aid in locating anatomical<br>structures in either open or percutaneous<br>neurosurgical procedures. The system is<br>indicated for any medical condition in<br>which reference to a rigid anatomical | The StealthStation System, with<br>StealthStation Cranial software, is<br>intended to aid in locating anatomical<br>structures in either open or percutaneous<br>neurosurgical procedures. The system is<br>indicated for any medical condition in<br>which reference to a rigid anatomical |
| | Subject Device | Predicate Device |
| | StealthStation System with Cranial v3.1.3 | K190672 StealthStation System with |
| Item | Software | StealthStation Cranial v3.1.1 Software |
| | structure can be identified relative to | structure can be identified relative to |
| | images of the anatomy. | images of the anatomy. |
| | This can include, but is not limited to, the<br>following cranial procedures (including<br>stereotactic frame-based and stereotactic<br>frame alternatives-based procedures):<br>- Cranial Biopsies<br>- Deep brain stimulation (DBS)<br>lead placement<br>- Depth electrode placement<br>- Tumor Resections<br>- Craniotomies/Craniectomies<br>- Skull Base Procedures<br>- Transsphenoidal Procedures | This can include, but is not limited to, the<br>following cranial procedures (including<br>stereotactic frame-based and stereotactic<br>frame alternatives-based procedures):<br>- Cranial Biopsies<br>- Deep brain stimulation (DBS)<br>lead placement<br>- Depth electrode placement<br>- Tumor Resections<br>- Craniotomies/Craniectomies<br>- Skull Base Procedures<br>- Transsphenoidal Procedures |
| | - Thalamotomies/Pallidotomies<br>- Pituitary Tumor Removal<br>- CSF Leak Repair<br>- Pediatric Ventricular Catheter Placement<br>- General Ventricular Catheter Placement | - Thalamotomies/Pallidotomies<br>- Pituitary Tumor Removal<br>- CSF Leak Repair<br>- Pediatric Ventricular Catheter Placement<br>- General Ventricular Catheter Placement |
| | The user should consult the "Navigational<br>Accuracy" section of the User Manual to<br>assess if the accuracy of the system is<br>suitable to their needs. | The user should consult the "Navigational<br>Accuracy" section of the User Manual to<br>assess if the accuracy of the system is<br>suitable to their needs. |
| System Accuracy | Under representative worst-case | Under representative worst-case |
| Requirement | configuration, the StealthStation® System<br>with StealthStation Cranial v3.0 Software,<br>has demonstrated performance in 3D<br>positional accuracy with a mean error ≤<br>2.0 mm and in trajectory angle accuracy<br>with a mean error ≤ 2.0 degrees. | configuration, the StealthStation® System<br>with StealthStation® Cranial v3.0 Software,<br>has demonstrated performance in 3D<br>positional accuracy with a mean error ≤<br>2.0 mm and in trajectory angle accuracy<br>with a mean error ≤ 2.0 degrees. |
| | Specific Mean Accuracy Values<br>Position Error - 1.27 mm<br>Trajectory Error - 1.02 degrees | Specific Mean Accuracy Values<br>Positional Error – 1.16 mm<br>Trajectory Error – 0.41 degrees |
| Imaging Modalities | X-Ray based,<br>MR based<br>Nuclear Medicine based | X-Ray based,<br>MR based<br>Nuclear Medicine based |
| Registration<br>Features | Exam-to-Exam Registration: Identity<br>Merge Registration, Manual Merge<br>Registration and Automatic Merge<br>Registration. | Exam-to-Exam Registration: Identity<br>Merge Registration, Manual Merge<br>Registration and Automatic Merge<br>Registration. |
| Item | Subject Device | Predicate Device |
| | StealthStation System with Cranial v3.1.3 | K190672 StealthStation System with |
| Item | Software | StealthStation Cranial v3.1.1 Software |
| | Patient Registration: PointMerge | Patient Registration: PointMerge |
| | registration, Tracer registration, Touch-N- | registration, Tracer registration, Touch-N- |
| | Go registration, StealthAiR registration, O- | Go registration, StealthAiR registration, O- |
| | arm registration, Stereotactic Localizer | arm registration, Stereotactic Localizer |
| | Registration and StarFix Bone Anchor | Registration and StarFix Bone Anchor |
| | Registration | Registration |
| Planning Features | Plan Entry and Target Selection | Plan Entry and Target Selection |
| | 3D Model Building | 3D Model Building |
| | Advanced Visualization | Advanced Visualization |
| | Create Patient Based Anatomical | Create Patient Based Anatomical |
| | Coordinate Space | Coordinate Space |
| | Stereotactic Frame Settings…