StealthStationTM S8 ENT Software

K170018 · Medtronic Navigation, Inc. · PGW · May 19, 2017 · Neurology

Device Facts

• Record ID: K170018
• Device Name: StealthStationTM S8 ENT Software
• Applicant: Medtronic Navigation, Inc.
• Product Code: PGW · Neurology
• Decision Date: May 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT 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 procedures: - Functional endoscopic sinus surgery (FESS) - Endoscopic skull base procedures - Lateral skull base procedures

Device Story

StealthStation™ S8 ENT software is an image-guided surgery (IGS) system component; operates on StealthStation™ S8 platform. Inputs include preoperative/intraoperative patient images (CT, MR, Nuclear Medicine) and tracked instrument position data via electromagnetic sensors. System registers patient anatomy to images using PointMerge®, Tracer™, or Touch registration. Software transforms inputs to display 3D renderings and 2D orthogonal views (axial, sagittal, coronal, oblique) of anatomy; identifies instrument tip location and trajectory in real-time. Surgeons use software to create/store surgical plans and simulate trajectories. Used in OR by surgeons to guide instruments during ENT procedures (FESS, skull base). Output provides visual feedback on instrument position relative to anatomy and planned trajectory; assists surgeon in validating judgment and navigating anatomy. Benefits include enhanced anatomical localization and surgical guidance.

Clinical Evidence

No clinical data. Bench testing only. Performance verified using anatomically representative phantoms in worst-case configurations. Demonstrated 3D positional accuracy (mean error ≤ 0.88 mm) and trajectory accuracy (mean error ≤ 0.73°), meeting design requirements.

Technological Characteristics

Electromagnetic navigation system. Software runs on StealthStation S8 platform. Supports X-ray, MR, and Nuclear Medicine imaging. Features include 3D/2D visualization, surgical planning, and multiple registration methods (PointMerge, Tracer, Touch). Connectivity via network, CD, DVD, USB (DICOM). C++ programming language.

Indications for Use

Indicated for patients undergoing open or percutaneous ENT procedures where stereotactic surgery is appropriate and rigid anatomical structures (e.g., skull) can be referenced to medical images. Includes FESS, endoscopic skull base, and lateral skull base procedures.

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

• Fusion Compact Navigation System (ENT Software) (K153247)

Reference Devices

• StealthStation S8 with StealthStation S8 Cranial Software (K162309)

Submission Summary (Full Text)

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

May 19, 2017

Medtronic Navigation, Inc. Elizabeth Waite Sr. Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, CO 80027

Re: K170018

Trade/Device Name: StealthStation™ S8 ENT Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: April 21, 2017 Received: April 24, 2017

Dear Elizabeth Waite:

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.

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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 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.

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.

Eric A. Mann -S 2017.05.19 09:23:52 -04'00'

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170018

Device Name StealthStation™ S8 ENT Software

The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT 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 procedures:

- · Functional endoscopic sinus surgery (FESS)
- · Endoscopic skull base procedures
- Lateral skull base procedures

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

### May 8, 2017

- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
- Elizabeth Waite Contact: Senior Regulatory Affairs Specialist Telephone number: [phone] Fax: [phone] Email: [e-mail]

Rishi Sinha Regulatory Affairs Manager Telephone number: [phone] Fax: [phone] Email: [e-mail]

- Proprietary Trade Name: StealthStation™ S8 ENT Software II.
- III. Common Name: Stereotaxic instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II V.
- VI. Product Codes: PGW

#### VII. Product Description

The StealthStation™ ENT software helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The StealthStation™ ENT software runs on the StealthStation™ S8 Platform. The StealthStation system is an Image Guided System (IGS), comprised of a platform, clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.

The ENT software can display patient images from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The

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surgeon may also use the ENT software to create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide.

#### VIII. Indications for Use

The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT 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 procedures:

- · Functional endoscopic sinus surgery (FESS)
- Endoscopic skull base procedures
- · Lateral skull base procedures

#### IX. Identification of Legally Marketed Devices

Predicate: K153247-Fusion Compact Navigation System (ENT Software) Reference: K162309 - StealthStation S8 with StealthStation S8 Cranial Software

#### X. Comparison of the Technological Characteristics

| Item | Subject Device<br>StealthStation™ S8 ENT<br>Software | Predicate Device<br>FUSION Compact™<br>Navigation System<br>(K153247) | Reference Device<br>Stealthstation S8 System<br>Platforms and<br>StealthStation Cranial<br>Software (K162309) |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II |
| Product Code | PGW | PGW | HAW, OLO, PGW |
| Intended/Indications<br>for Use | The StealthStation™<br>System, with<br>StealthStation™ ENT<br>software, is intended as an<br>aid for locating anatomical<br>structures in either open or<br>percutaneous ENT<br>procedures. Their use is<br>indicated for any medical<br>condition in which the use<br>of stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid<br>anatomical structure, such<br>as the skull, can be | The Medtronic FUSION<br>Compact™ computer-<br>assisted surgery system and<br>its associated applications<br>are intended as an aid for<br>precisely locating anatomical<br>structures in either open or<br>percutaneous ENT<br>procedures. Their use is<br>indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure, such as | The StealthStation™<br>System, with<br>StealthStation™ Cranial<br>software, is intended as an<br>aid for locating anatomical<br>structures in either open or<br>percutaneous<br>neurosurgical procedures.<br>Their use is indicated for<br>any medical condition in<br>which the use of<br>stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid<br>anatomical structure, such |
| Item | Subject Device<br>StealthStation™ S8 ENT<br>Software | Predicate Device<br>FUSION Compact™<br>Navigation System<br>(K153247) | Reference Device<br>Stealthstation S8 System<br>Platforms and<br>StealthStation Cranial<br>Software (K162309) |
| | identified relative to<br>images of the anatomy.<br>This can include, but is not<br>limited to, the following<br>procedures:<br>• Functional endoscopic<br>sinus surgery (FESS)<br>• Endoscopic skull base<br>procedures<br>• Lateral skull base<br>procedures | the skull, can be identified<br>relative to a CT or MR based<br>model or digitized landmarks<br>of the anatomy. | as the skull, can be<br>identified relative to<br>images of the anatomy.<br>This can include, but is not<br>limited to, the following<br>cranial procedures<br>(including stereotactic<br>frame-based and<br>stereotactic frame<br>alternatives-based<br>procedures):<br>• Tumor resections<br>• General<br>ventricular catheter<br>placement<br>• Pediatric<br>ventricular catheter<br>placement<br>• Depth electrode,<br>lead, and probe placement<br>• Cranial biopsies<br>The user should consult<br>the "Navigational<br>Accuracy" section of the<br>User Manual to assess if<br>the accuracy of the system<br>is suitable for their needs. |
| Operating<br>Principle | Electromagnetic | Electromagnetic | Optical<br>Electromagnetic |
| Accuracy Testing | Under representative<br>worst-case configuration<br>the StealthStation S8 ENT<br>Software v1.0.0, has<br>demonstrated performance<br>in 3D positional accuracy<br>with a mean error ≤ 2.0<br>mm and in trajectory error<br>≤ 2.0 degrees.<br>Specific Mean Accuracy<br>Values<br>Positional Error- 0.88mm<br>Trajectory Error- 0.73° | Under representative worst-<br>case configuration the<br>Fusion Compact ENT<br>Software, has demonstrated<br>performance in 3D positional<br>accuracy with a mean error ≤<br>3.0 mm.<br>Specific Mean Accuracy<br>Values<br>Positional Error- 2.41mm<br>Trajectory Error- Not<br>applicable | Under representative<br>worst-case configuration,<br>the StealthStation S8<br>System with StealthStation<br>Cranial v1.0.0 Software,<br>has demonstrated<br>performance in 3D<br>positional accuracy with a<br>mean error ≤ 2.0 mm and<br>in trajectory angle<br>accuracy with a mean error<br>≤ 2.0 degrees.<br>Specific Mean Accuracy<br>Values<br>Optical Results:<br>Positional Error - 1.45mm<br>Trajectory Error – 0.60°<br>EM Results:<br>Positional Error - 0.84mm<br>Trajectory Error – 0.47° |
| Item | Subject Device<br>StealthStation™ S8 ENT<br>Software | Predicate Device<br>FUSION Compact™<br>Navigation System<br>(K153247) | Reference Device<br>Stealthstation S8 System<br>Platforms and<br>StealthStation Cranial<br>Software (K162309) |
| | | | Mechanical Results:<br>Positional Error – 1.48mm<br>Trajectory Error – $0.39°$ |
| Imaging Modalities | X-Ray based, MR based,<br>Nuclear Medicine based | X-Ray based, MR based,<br>Nuclear Medicine based | X-Ray based, MR based,<br>Nuclear Medicine based |
| View (Display)<br>Features | 3D, 2D Anatomic<br>Orthogonal (Coronal,<br>Sagittal, Axial), Video<br>Input, Virtual Endoscopic,<br>Trajectory 1 and 2, Target<br>Guidance, Trajectory<br>Guidance, Probe's Eye,<br>Look Ahead | 3D, 2D Anatomic<br>Orthogonal (Coronal,<br>Sagittal, Axial), Video Input | Ultrasound Video In,<br>Ultrasound Overlay,<br>3D, 2D Anatomic<br>Orthogonal,<br>Trajectory 1 and 2, Target<br>Guidance, Trajectory<br>Guidance, Probes Eye,<br>Look Ahead, Microscope<br>Injection, Video Input,<br>Endoscopic |
| Exam-to-Exam<br>Registration Features | Identity Merge<br>Registration, Manual<br>Merge Registration and<br>Automatic Merge<br>Registration | Identity Merge Registration,<br>Manual Merge Registration<br>and Automatic Merge<br>Registration | Identity Merge<br>Registration, Manual<br>Merge Registration and<br>Automatic Merge<br>Registration |
| Patient Registration<br>Features | PointMerge® registration,<br>Tracer™ registration,<br>Touch registration<br>(previously Touch-N-<br>GoTM) | PointMerge® registration,<br>Tracer™ registration | PointMerge® registration<br>(referred to as Landmark<br>registrations), Tracer™<br>registration, Touch<br>registration (previously<br>Touch-N-Go™),<br>StealthAiR® registration,<br>O-arm® registration,<br>Mechanical based<br>registrations (Stereotactic<br>Localizer Registration and<br>StarFix™ Bone Anchor<br>Registration) |
| Planning Features | Plan Entry and Target<br>Selection, 3D Model<br>Building, Advanced<br>Visualization | Not Available | Plan Entry and Target<br>Selection<br>3D Model Building<br>Advanced Visualization<br>Create Patient Based<br>Anatomical Coordinate<br>Space<br>Stereotactic Frame<br>Settings<br>Brain Atlas:<br>Schaltenbrand-Wahren<br>Atlas with Talairach Grid<br>STarFix™ Designer<br>Annotations |
| Scanner Interface<br>Technology (to<br>imaging devices) | Network Connectivity<br>CD, DVD, USB<br>DICOM Import | Network Connectivity<br>CD, DVD, USB<br>DICOM Import | Network Connectivity<br>CD, DVD, USB<br>DICOM Import |
| Item | Subject Device<br>StealthStation™ S8 ENT<br>Software | Predicate Device<br>FUSION Compact™<br>Navigation System<br>(K153247) | Reference Device<br>Stealthstation S8 System<br>Platforms and<br>StealthStation Cranial<br>Software (K162309) |
| Software Interface<br>(GUI) | DICOM Export<br>Black and gray style with<br>procedure task overview in<br>left menu option and<br>next/back task flow at<br>bottom of the screen.<br>Software controls for<br>images, planning and<br>instrument management<br>are contained in a right<br>side bar. | DICOM Export<br>Blue style with<br>chronological next/back task<br>flow at the top of the screen.<br>Image controls on the left.<br>Planning information on the<br>right. | DICOM Export<br>Black and gray style with<br>procedure task overview in<br>left menu option and<br>next/back task flow at<br>bottom of the screen.<br>Software controls for<br>images, planning and<br>instrument management<br>are contained in a right-<br>side bar. |
| Programming<br>Language | C++ | C++ | C++ |
| Compatible Platform | StealthStation S8<br>Platforms including the<br>Planning Station | Fusion Compact Platform | StealthStation S8<br>Platforms including the<br>Planning Station |

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#### XI. Discussion of the Performance Testing

Testing conducted demonstrates the software will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthStation™ S8 ENT Software to establish substantial equivalence of the software and verify that the device will perform as intended meeting all of the design inputs:

- . Software Verification and Validation testing using a production equivalent StealthStation S8 Platform verifying the software requirements are met and software performs as intended.
- Software Verification and Validation testing using a production equivalent StealthStation S8 Platform verifying that the software performs as intended when running on the StealthStation S8 Platform.
- . Usability Testing was conducted in accordance to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" demonstrating that the usability and human factors requirements were adequately met.

The following table summarizes the testing conducted on the StealthStation ™ S8 ENT v1.0.0 Software:

## Description

Under representative worst-case configuration, the StealthStation S8 ENT 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. 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.

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The test configurations 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. In the imaging protocol, we recommend slice spacing and thickness for CT and MR imaging to be 1.0 mm or less.

Software verification and validation testing for each requirement specification. Software verification and validation testing using a production equivalent

StealthStation S8 Platform.

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

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 |

Design verification and validation was performed using the StealthStation S8 ENT software in laboratory and simulated use settings. The results 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.

#### XII. Conclusions

The changes to the subject device. StealthStation S8 ENT Software include: software enhancement modifications to the patient registration feature set, the introduction of additional views displayed by the software, and the introduction of the planning feature set. Bench testing has been conducted to evaluate the overall performance of the software with these modifications and results confirm that the device performs as intended and in a similar manner compared to the predicate and reference devices.

The StealthStation S8 ENT software intended use, technology and performance are equivalent between the subject and predicate and reference devices. Verification and validation testing results confirm there are no new or different questions of safety or effectiveness. The changes do not represent a new intended use, and do not affect the control mechanism, or operating principle. The information presented in this submission supports the subject device to be as safe and effective as the predicate and reference devices, and therefore supports a determination of substantial equivalence.

The StealthStation S8 ENT Software has been shown through comparison and testing to be substantially equivalent to the identified predicate and reference devices.