StealthStation System with Cranial Software

K153660 · Medtronic Navigation, Inc. · HAW · Sep 14, 2016 · Neurology

Device Facts

• Record ID: K153660
• Device Name: StealthStation System with Cranial Software
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Sep 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation System, with StealthStation Cranial Software, is intended to aid in 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.

Device Story

StealthStation System with Cranial v3.0 software; image-guided surgery (IGS) platform. Inputs: diagnostic/intraoperative images (X-ray, MR, nuclear medicine). Operation: tracks surgical instrument position relative to patient anatomy; provides visualization, registration, and planning tools. Used in OR by neurosurgeons. Features: point/tracer/surface registration, 3D model building, brain atlas integration, and interfaces with microscopes, ultrasound, and stereotactic frames. Output: real-time navigation display (2D/3D views, trajectory guidance). Benefits: aids precise anatomical localization during procedures; assists clinical decision-making by correlating instrument position with pre-operative/intra-operative imaging.

Clinical Evidence

No clinical data. Bench testing only. Performance validated using anatomically representative phantoms in simulated clinical workflows. Positional accuracy (mean error ≤ 2.0 mm) and trajectory angle accuracy (mean error ≤ 2.0 degrees) demonstrated across various configurations (stereotactic frame, Nexframe, STarFix, and EM localization).

Technological Characteristics

Optical (infra-red), electromagnetic, and mechanical stereotactic localization. Imaging: X-ray, MR, nuclear medicine. Connectivity: Network, CD, DVD, USB, DICOM. Software: C++ based. Features: 3D model building, brain atlas (Schaltenbrand-Wahren), registration (PointMerge, Tracer, Touch-N-Go, StealthAiR, O-arm).

Indications for Use

Indicated for patients undergoing cranial neurosurgical procedures, including biopsies, DBS lead placement, depth electrode placement, tumor resections, craniotomies/craniectomies, skull base procedures, transsphenoidal procedures, thalamotomies/pallidotomies, pituitary tumor removal, CSF leak repair, and ventricular catheter 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

• Synergy Cranial v2.2.7 Software (K150216)
• Natrex Device for StealthStation System (K992927)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem that resembles an abstract caduceus, with three stylized human profiles forming the staff and a serpent-like shape winding around them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 14, 2016

Medtronic Navigation, Inc. Ms. Augusta Henao Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K153660

Trade/Device Name: StealthStation System with StealthStation Cranial Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 12, 2016 Received: August 15, 2016

Dear Ms. Henao:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -\$=D/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K153660

### Device Name

StealthStation System with StealthStation Cranial Software

Indications for Use (Describe)

The StealthStation System, with StealthStation Cranial Software, is intended to aid in 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
- 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

The user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

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

## September 13, 2016

I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500

## Contact:

Primary Contact: Augusta Henao Senior Regulatory Affairs Specialist Telephone Number: 720-890-3366 Fax Number: 720-890-3500

Secondary Contact: Michael Blasco Senior Regulatory Affairs Manager Telephone Number: 720-890-3391 Fax Number: 720-890-3500

- Proprietary Trade Name: StealthStation® System with StealthStation® Cranial II. Software
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II, Stereotaxic Instrument IV.
- V. Product Codes: HAW

#### VI. Product Description

The StealthStation® System, with Station® Cranial v3.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® Cranial v3.0 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 v3.0 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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#### VII. Indications for Use

The StealthStation® System, with Station® Cranial Software, is intended to aid in 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
- · 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

The user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

#### VIII. Summary of the Technological Characteristics

| Item | Subject Device (StealthStation®<br>System with StealthStation® Cranial<br>v3.0 Software) | Predicate Devices |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The StealthStation® System, with<br>StealthStation® Cranial software is<br>designed as an aid for locating<br>anatomical structures in either open or<br>percutaneous neurosurgical procedures. | Synergy® Cranial v2.2.7 Software -<br>K150216<br>The StealthStation® System, with<br>Synergy® Cranial software is designed as<br>an aid for precisely locating anatomical<br>structures in either open or percutaneous<br>neurosurgical procedures. |
| Indications for<br>Use | The StealthStation® System, with<br>StealthStation® Cranial Software, is<br>intended to aid in locating anatomical<br>structures in either open or<br>percutaneous neurosurgical procedures.<br>The system is indicated for any medical<br>condition in which reference to a rigid<br>anatomical structure can be identified<br>relative to images of the anatomy. | Synergy® Cranial v2.2.7 Software -<br>K150216<br>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.<br>The system is indicated for any<br>medical condition in which reference to a<br>rigid anatomical structure can be identified<br>relative to images of the anatomy. |
| Item | Subject Device (StealthStation®<br>System with StealthStation® Cranial<br>v3.0 Software) | Predicate Devices |
| | This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):<br>- Cranial Biopsies<br>- Deep Brain Stimulation (DBS) Lead Placement<br>- Depth Electrode Placement<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 Ventricular Catheter Placement<br>- General Ventricular Catheter Placement<br><br>The user should consult the “Navigational Accuracy” section of the User Manual to assess if the accuracy of the system is suitable for their needs | This can include, but is not limited to, the 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<br>Accuracy<br>Requirement | The StealthStation® System with StealthStation Cranial v3.0 Software, has demonstrated performance in 3D positional accuracy with a mean error $\le$ 2.0 mm and in trajectory angle accuracy with a mean error $\le$ 2.0 degrees. | Synergy® Cranial v2.2.7 Software - K150216<br>The StealthStation® System with Synergy Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error $\le$ 2.0 mm and in trajectory angle accuracy with a mean error $\le$ 2.0 degrees. |
| Imaging<br>Modalities | X-Ray based, MR based, Nuclear Medicine based | Synergy® Cranial v2.2.7 Software - K150216<br>X-Ray based, MR based, Nuclear Medicine based |
| View (Display)<br>Features | Ultrasound Video In, Ultrasound<br>Overlay,<br>3D, 2D Anatomic Orthogonal,<br>Trajectory 1 and 2, Target Guidance,<br>Trajectory Guidance, Probes Eye,<br>Look Ahead, Microscope Injection,<br>Video Input | Synergy® Cranial v2.2.7 Software - K150216<br>Ultrasound Video In, Ultrasound Overlay,<br>3D, 2D Anatomic Orthogonal, Trajectory<br>1 and 2, Target Guidance, Trajectory<br>Guidance, Probes Eye, Look Ahead,<br>Microscope Injection, Video Input |
| Exam-to-Exam<br>Registration<br>Features | Identity Merge Registration, Manual<br>Merge Registration and Automatic<br>Merge Registration | Synergy® Cranial v2.2.7 Software - K150216<br>Identity Merge Registration, Manual |
| Item | Subject Device (StealthStation® System with StealthStation® Cranial v3.0 Software) | Predicate Devices |
| Patient<br>Registration<br>Features | PointMerge registration, Tracer registration, Touch-N-Go registration, StealthAiR registration, O-arm registration, Stereotactic Localizer Registration and StarFix Bone Anchor Registration | Merge Registration and Automatic Merge Registration.<br>Primary Predicate:<br>Synergy® Cranial v2.2.7 Software - K150216<br>PointMerge registration, Tracer registration, Touch-N-Go registration, StealthAiR registration and O-arm registration<br>Secondary Predicate:<br>Natrex™ Device for StealthStation System K992927<br>Stereotactic Localizer Registration |
| Planning<br>Features | Plan Entry and Target Selection<br>3D Model Building<br>Advanced Visualization<br>Create Patient Based Anatomical Coordinate Space<br>Stereotactic Frame Settings<br>Brain Atlas: Schaltenbrand-Wahren Atlas with Talairach Grid<br>STarFix Designer<br>Annotations | Primary Predicate:<br>Synergy® Cranial v2.2.7 Software - K150216<br>Plan Entry and Target Selection<br>3D Model Building<br>Advanced Visualization<br>Secondary Predicate:<br>Natrex™ Device for StealthStation® System K992927<br>Stereotactic Localizer Registration<br>Plan Entry and Target Selection<br>Create Patient Based Anatomical Coordinate Space<br>Stereotactic Frame Settings<br>Brain Atlas: Schaltenbrand-Wahren Atlas with Talairach Grid<br>Annotations |
| 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 | Primary Predicate:<br>Synergy® Cranial v2.2.7 Software - K150216<br>Microscope Navigation: Zeiss, Leica<br>Ultrasound Navigation: Aloka and Sonosite<br>Medtronic O-arm<br>Secondary Predicate:<br>Natrex™ Device for StealthStation® System K992927<br>Stereotactic Frame Systems: Integra BRW/CRW and Leksell |
| Software<br>Interface (GUI) | Blue style with chronological next/back task flow at the top of the screen.<br>Image controls on the left. Planning | Synergy® Cranial v2.2.7 Software - K150216<br>Blue style with chronological next/back |
| Item | Subject Device (StealthStation®<br>System with StealthStation® Cranial<br>v3.0 Software) | Predicate Devices |
| | information on the right. | task flow at the top of the screen. Image<br>controls on the left. Planning information<br>on the right. |
| Programming<br>Language | C++ | Synergy® Cranial v2.2.7 Software -<br>K150216<br>C++ |
| Scanner<br>Interface<br>Technology (to<br>imaging devices) | Network Connectivity<br>CD, DVD, USB<br>DICOM Import<br>DICOM Export | Synergy® Cranial v2.2.7 Software -<br>K150216<br>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<br>Mechanical based stereotactic | Primary Predicate:<br>Synergy® Cranial v2.2.7 Software -<br>K150216<br>Optical (infra-red)<br>Electromagnetic<br>Secondary Predicate:<br>Natrex™ Device for StealthStation<br>System K992927<br>Optical (infra-red),<br>Mechanical based stereotactic |

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#### IX. Identification of Legally Marketed Devices

StealthStation® System with Synergy Cranial Software (K150216) Natrex Device for StealthStation® System (K992927)

#### X. Discussion of the Performance Testing

The following table summarizes the testing conducted on the StealthStation® System with StealthStation® Cranial v3.0 Software:

## Description

Under representative worst-case configuration, the StealthStation® System with StealthStation® Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error ≤ 2.0 degrees. The positional error is defined as the Euclidean distance from target to instrument tip at final point of insertion. The trajectory angle error is the angle between the planned surgical trajectory and trajectory of the neurosurgical instrument at final point of insertion. Depending on the surgical procedure and the particular neurosurgical instruments used, the resulting navigational accuracy may be negatively impacted.

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This performance was determined using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components in a clinically relevant workflow.

The test configuration for stereotactic frame-based, Nexframe®, and STarFix™ procedures included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm. The following table summarizes the performance of the StealthStation® System using Cranial software with compatible stereotactic hardware platforms.

| Performance Validation | Positional Error (mm) | | | Trajectory Angle Error (degrees) | | |
|--------------------------------------------------------------|-----------------------|--------------------|--------------------|----------------------------------|--------------------|--------------------|
| | Mean | Standard Deviation | 99%CI* Upper Bound | Mean | Standard Deviation | 99%CI* Upper Bound |
| Cranial 3.0 Stereotactic Frame System Performance Validation | 1.57 | 0.63 | 3.04 | 0.52 | 0.34 | 1.31 |
| Cranial 3.0 with Nexframe® System Performance Validation | 1.65 | 0.50 | 2.81 | 0.68 | 0.31 | 1.40 |
| Cranial 3.0 with STarFix™ System Performance Validation | 1.08 | 0.54 | 2.34 | 0.70 | 0.42 | 1.68 |

*CI (Confidence Interval)

The test configuration for procedures using electromagnetic localization included CT images with slice spacing and thickness of 1.0 mm and T1-weighted MR images with slice spacing and thickness of 1.5 mm. The following table summarizes the performance of the Cranial software on the StealthStation System with electromagnetic (EM) localization.

| Performance Validation | Positional Error (mm) | | | Trajectory Angle Error (degrees) | | |
|----------------------------------------------------------------|-----------------------|--------------------|--------------------|----------------------------------|--------------------|--------------------|
| | Mean | Standard Deviation | 99%CI* Upper Bound | Mean | Standard Deviation | 99%CI* Upper Bound |
| Cranial 3.0 with EM Localization System Performance Validation | 1.67 | 0.82 | 3.91 | 1.31 | 0.55 | 2.73 |

*CI (Confidence Interval)

Medtronic developed a test method to simulate clinical configurations and workflows to derive this summary of performance. Due to the uniqueness of this test method, the performance results presented may not be comparable to results derived from other test methods or other medical devices.

Software verification and validation testing for each requirement specification. Design verification and validation was performed using the StealthStation® System with Station® Cranial v3.0 software in laboratory and simulated use settings. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions.

System integration performance testing for cranial surgical procedures using anatomical phantoms.

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

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

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

#### XI. Conclusions

The non-clinical data support the safety of the device and the software verification and validation demonstrate that the StealthStation® System with StealthStation® Cranial v3.0 software should perform as intended in the specified use conditions. The non-clinical data demonstrate that the StealthStation® System with StealthStation® Cranial v3.0 software performs comparably to the predicate devices for the same intended use.