StealthStation Cranial Software v1.3.2

K203639 · Medtronic Navigation, Inc. · HAW · Jan 13, 2021 · Neurology

Device Facts

• Record ID: K203639
• Device Name: StealthStation Cranial Software v1.3.2
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jan 13, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

StealthStation Cranial Software v1.3.2 is an image-guided surgery (IGS) system component; integrates with platform hardware, surgical instruments, and referencing systems. Inputs: diagnostic/intraoperative images (X-ray, MR, nuclear medicine) and real-time tracking data from optical or electromagnetic sensors. Operation: software registers patient anatomy to images; tracks instrument position relative to surgical site; displays updated positions on screen. Used in OR by neurosurgeons; provides visual guidance for navigation, planning, and instrument placement. Benefits: aids precise localization of anatomical structures during neurosurgery. Output: real-time visual feedback on surgical displays; assists clinical decision-making for trajectory and target selection.

Clinical Evidence

No clinical data. Bench testing only; software verification testing performed for all requirement specifications to support safety and intended performance.

Technological Characteristics

Software-based image guidance system. Features: optical (Northern Digital Vega) and electromagnetic (Medtronic AxiEM III) tracking. Interfaces: DICOM, microscope, ultrasound, stereotactic frames. Programming: C++. Connectivity: Network, CD, DVD, USB. No changes to hardware or core sensing principles from predicate.

Indications for Use

Indicated for patients undergoing open or percutaneous neurosurgical procedures where stereotactic surgery is appropriate and rigid anatomical structures (e.g., skull) can be referenced to images. Includes tumor resections, ventricular catheter placement (general/pediatric), depth electrode/lead/probe placement, and cranial biopsies.

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 Cranial Software v1.3.0 (K201175)

Submission Summary (Full Text)

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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

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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 ([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) 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)

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# 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: [e-mail]

K. Elizabeth Waite Regulatory Affairs Manager Telephone number: 720.890.2182 Fax: [phone] Email: [e-mail]

- 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

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.

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#### 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

| Feature | StealthStation™ Cranial Software<br>v1.3.2 (Subject Device) | StealthStation™ Cranial Software<br>v1.3.0 (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.<br><br>This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):<br>• Tumor resections<br>• General ventricular catheter placement<br>• Pediatric ventricular catheter placement<br>• Depth electrode, lead, and probe placement<br>• 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.<br><br>This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):<br>• Tumor resections<br>• General ventricular catheter placement<br>• Pediatric ventricular catheter placement<br>• Depth electrode, lead, and probe placement<br>• Cranial biopsies |
| Feature | StealthStation™ Cranial Software<br>v1.3.2 (Subject Device) | StealthStation™ Cranial Software<br>v1.3.0 (Primary Predicate, K201175) |
| System Accuracy<br>Requirements | Identical; no changes made to the<br>StealthStation™ Cranial Software that<br>would require System Accuracy testing<br>for v1.3.2 | Under representative worst-case<br>configuration, the StealthStation™<br>System with StealthStation™ Cranial<br>Software v1.3.0, has demonstrated<br>performance in 3D positional accuracy<br>with a mean error $\leq$ 2.0 mm and in<br>trajectory angle accuracy with a mean<br>error $\leq$ 2.0 degrees. |
| Imaging<br>Modalities | X-Ray based, MR based,<br>Nuclear Medicine based | X-Ray based, MR based,<br>Nuclear Medicine based |
| View (Display)<br>Features | Ultrasound Video In, Ultrasound<br>Overlay, 3D, 2D Anatomic Orthogonal,<br>Trajectory 1 and 2, Target Guidance,<br>Trajectory Guidance, Probes Eye, Look<br>Ahead, Microscope Injection, Video<br>Input, Endoscopic | Ultrasound Video In, Ultrasound<br>Overlay, 3D, 2D Anatomic Orthogonal,<br>Trajectory 1 and 2, Target Guidance,<br>Trajectory Guidance, Probes Eye, Look<br>Ahead, Microscope Injection, Video<br>Input, Endoscopic |
| Exam-to-Exam<br>Registration<br>Features | Identity Merge Registration, Manual<br>Merge Registration and Automatic<br>Merge Registration | Identity Merge Registration, Manual<br>Merge Registration and Automatic<br>Merge Registration |
| Patient<br>Registration<br>Features | PointMerge™ registration (referred to<br>as Landmark registrations), Tracer™<br>registration, Touch registration<br>(previously Touch-N-Go™),<br>StealthAiR™ registration, O-arm™<br>registration, Mechanical based<br>registrations (Stereotactic Localizer<br>Registration and StarFix™ Bone<br>Anchor Registration) | PointMerge™ registration (referred to<br>as Landmark registrations), Tracer™<br>registration, Touch registration<br>(previously Touch-N-Go™),<br>StealthAiR™ registration, O-arm™<br>registration, Mechanical based<br>registrations (Stereotactic Localizer<br>Registration and StarFix™ Bone<br>Anchor Registration) |
| Planning<br>Features | Plan Entry and Target Selection<br>3D Model Building<br>Advanced Visualization<br>Create Patient Based Anatomical<br>Coordinate Space<br>Stereotactic Frame Settings<br>Brain Atlas: Schaltenbrand-Wahren<br>Atlas with Talairach Grid<br>STarFix™ Designer<br>Annotations | Plan Entry and Target Selection<br>3D Model Building<br>Advanced Visualization<br>Create Patient Based Anatomical<br>Coordinate Space<br>Stereotactic Frame Settings<br>Brain Atlas: Schaltenbrand-Wahren<br>Atlas with Talairach Grid<br>STarFix™ Designer<br>Annotations |
| Feature | StealthStation™ Cranial Software<br>v1.3.2 (Subject Device) | StealthStation™ Cranial Software<br>v1.3.0 (Primary Predicate, K201175) |
| Medical Device<br>Interfaces | Microscope Navigation: Zeiss, Leica<br>Ultrasound Navigation: Aloka and Sonosite<br>Medtronic O-arm™<br>Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell<br>Nexframe™ Stereotactic System<br>STarFix™Platform System<br>Stealth Midas Rex MR8<br>StealthStation Autoguide | Microscope Navigation: Zeiss, Leica<br>Ultrasound Navigation: Aloka and Sonosite<br>Medtronic O-arm™<br>Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell<br>Nexframe™ Stereotactic System<br>STarFix™Platform System<br>Stealth Midas Rex MR8<br>StealthStation Autoguide |
| Compatible<br>Medtronic<br>Optical<br>Instrumentation | 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. |
| Compatible<br>Medtronic EM<br>Instrumentation | 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 |
| Software<br>Interface<br>(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. |
| Programming<br>Language | C++ | C++ |
| Scanner Interface<br>Technology (to<br>imaging devices) | Network Connectivity<br>CD, DVD, USB<br>DICOM Import<br>DICOM Export | Network Connectivity<br>CD, DVD, USB<br>DICOM Import<br>DICOM Export |
| Optical<br>Technology | Manufacturer: Northern Digital Inc.<br>Localizer: Vega | Manufacturer: Northern Digital Inc.<br>Localizer: Vega |
| Electromagnetic<br>Technology | Manufacturer: Medtronic Navigation, Inc.<br>Localizer: AxiEM III<br>Emitter Tunes: Side, Flat | Manufacturer: Medtronic Navigation, Inc.<br>Localizer: AxiEM III<br>Emitter Tunes: Side, Flat |

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#### 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.

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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.