StealthStation S8 Spine Software v1.0.0

K170011 · Medtronic Navigation · OLO · May 1, 2017 · Neurology

Device Facts

• Record ID: K170011
• Device Name: StealthStation S8 Spine Software v1.0.0
• Applicant: Medtronic Navigation
• Product Code: OLO · Neurology
• Decision Date: May 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation® System, with Station Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as: o Pedicle Screw Placement - o Iliosacral Screw Placement o Interbody Device Placement

Device Story

StealthStation S8 Spine Software is an image-guided surgery (IGS) platform; tracks surgical instruments relative to patient anatomy using optical localization; inputs include diagnostic or intraoperative images (X-ray based); software processes data to provide real-time navigation, registration (PointMerge, SurfaceMerge, FluoroMerge, Auto 2D/3D), and planning (3D model building, deformity planning); output displayed on screen via various views (e.g., Probe's Eye, trajectory guidance, 3D, orthogonal); used in OR by surgeons to guide spinal procedures; assists in precise instrument placement; benefits include improved surgical accuracy and navigation; system integrates with various C-arm imaging devices.

Clinical Evidence

Bench testing only. Performance validated using anatomically representative phantoms in simulated clinical configurations. Mean positional error 1.30mm (99% CI upper bound 2.65mm); mean trajectory angle error 0.64 degrees (99% CI upper bound 1.61 degrees). Software verification and validation performed for all requirements.

Technological Characteristics

Optical localization technology; C++ software; DICOM-compliant network/media connectivity; integrates with O-arm and various C-arm imaging systems. Features include PointMerge, SurfaceMerge, FluoroMerge, and automatic 2D/3D registration. System accuracy requirement: mean positional error 2.0mm.

Indications for Use

Indicated for patients undergoing open or percutaneous neurosurgical and orthopedic procedures, including spinal implant procedures (pedicle screw, iliosacral screw, interbody device placement), where stereotactic surgery is appropriate and rigid anatomical structures (spine/pelvis) can be referenced to imaging.

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 System Update (K050438)
• Synergy Cranial 3.0 Software (K153660)

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 1, 2017

Medtronic Navigation John Connor Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K170011

Trade/Device Name: StealthStation S8 Spine Software V1.0.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 24, 2017 Received: March 27, 2017

Dear John Connor:

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,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170011

Device Name StealthStation S8 Spine Software v1.0.0

### Indications for Use (Describe)

The StealthStation® System, with Station Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:

o Pedicle Screw Placement

- o Iliosacral Screw Placement
o Interbody Device Placement

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

# December 30, 2016

- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80020 USA Telephone Number: [phone] Fax Number: (720-890-3500)
- Contact: John Connor Senior Regulatory Affairs Specialist Telephone number: [phone] Fax: [phone] Email: [e-mail]
- II. Proprietary Trade Name: StealthStation S8 Spine Software v1.0.0
- III. Common Name: Orthopedic Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- V. Classification: Class II
- VI. Product Code: OLO

#### VII. Product Description:

The StealthStation System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments and a referencing system. The IGS tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The StealthStation Spine software helps guide surgeons during spine procedures such as spinal fusion and trauma treatments. StealthStation Spine 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:

The StealthStation System, with Station Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 spine or pelvis, can be identified relative to images of the anatomy.

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This can include the following spinal implant procedures, such as:

- Pedicle Screw Placement •
- . Iliosacral Screw Placement
- Interbody Device Placement

#### IX. Identification of Legally Marketed Devices (Predicate Devices)

- StealthStation System Update (K050438, Main Predicate) .
- Synergy Cranial 3.0 Software (K153660, System Accuracy Predicate) .

#### X. Comparison of the Technological Characteristics:

| Item | Subject Device (StealthStation<br>Spine Software) | Predicate Device (Synergy Spine<br>Software) |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The StealthStation System, with<br>StealthStation Spine Software, is<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>neurosurgical and orthopedic<br>procedures. | The StealthStation System is<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>procedures. |
| Indications<br>for Use | The StealthStation System, with<br>StealthStation Spine Software, is<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>neurosurgical and orthopedic<br>procedures. Their use is indicated<br>for any medical condition in which<br>the use of stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid anatomical<br>structure, such as the spine or<br>pelvis, can be identified relative to<br>images of the anatomy.<br>This can include the following<br>spinal implant procedures, such as:<br>● Pedicle Screw Placement<br>● Iliosacral Screw Placement<br>● Interbody Device Placement | The StealthStation System is<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>procedures. The StealthStation<br>System is indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where reference to<br>a rigid anatomical structure, such as<br>the skull, a long bone, or vertebra,<br>can be identified relative to a CT or<br>MR based model, fluoroscopy<br>images, or digitized landmarks of<br>the anatomy. Example procedures<br>include, but are not limited to:<br>● Spinal Implant Procedures,<br>such as Pedicle Screw<br>Placement<br>● Placement of Iliosacral Screws<br>● Stabilization and Repair of<br>Pelvic Fractures |
| System<br>Accuracy<br>Requirement | System Level Accuracy with a<br>mean positional error of 2.0mm | System Level Accuracy with a<br>mean positional error of 2.0mm and |
| | (Requirement from Cranial 3.0<br>Predicate) | (Requirement from Cranial 3.0<br>Predicate) |
| Imaging<br>Modalities | X-Ray Based Imaging | X-Ray Based Imaging |
| Registration<br>Features | PointMerge Registration<br>SurfaceMerge Registration<br>FluoroMerge Registration<br>Automatic 2D Image Registration<br>Automatic 3D Image Registration | PointMerge Registration<br>SurfaceMerge Registration<br>FluoroMerge Registration<br>Automatic 2D Image Registration<br>Automatic 3D Image Registration |
| Planning<br>Features | Plan Entry and Target Selection<br>3D Model Building<br>Deformity Planning | Plan Entry and Target Selection<br>3D Model Building<br>Deformity Planning |
| Medical<br>Device<br>Interfaces | O-arm Imaging System<br>Ziehm Vision FD Vario 3D C-<br>Arm<br>ISO-C 3D C-Arm<br>Orbic 3D C-Arm | O-arm Imaging System<br>Ziehm Vision FD Vario 3D C-Arm<br>ISO-C 3D C-Arm<br>Orbic 3D C-Arm |
| View<br>(Display)<br>Features | Look Sideways<br>3D<br>Anatomic Orthogonal<br>Trajectory 1 and 2<br>Trajectory Guidance<br>Look Ahead<br>Probe's Eye<br>AP and Lateral<br>Synthetic AP and Lateral<br>Maximum Intensity Projection<br>Video Input | Look Sideways<br>3D<br>Anatomic Orthogonal<br>Trajectory 1 and 2<br>Trajectory Guidance<br>Look Ahead<br>Probe's Eye<br>AP and Lateral<br>Synthetic AP and Lateral<br>Maximum Intensity Projection<br>Video Input |
| Software<br>Interface<br>(GUI) | Black and gray style with<br>procedure task overview in left<br>menu option and next/back task<br>flow at bottom of the screen.<br>Software controls for images,<br>planning and instrument<br>management are contained in a<br>right side bar. | Basic gray and black style with 4<br>main tasks and tab interface to<br>access tools. Controls on the right. |
| Programming<br>Language | C++ | C++ |
| Scanner<br>Interface<br>Technology<br>(to imaging<br>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 |
| Localization<br>Technology | Optical | Optical |

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#### XI. Discussion of the Performance Testing

The following table summarizes the testing conducted on the StealthStation S8 Spine Software v1.0.0

## Description

Under representative worst-case configuration, the StealthStation S8 Spine Software v1.0.0 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 calculated from the difference in the tip position of the instrument and the intended surgical target/entry point. The trajectory error is calculated from the difference in the instrument orientation and the trajectory of the intended surgical plan.

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. The following table summarizes the performance of the StealthStation S8 Spine Software v1.0.0:

| Performance<br>Validation | Positional Error (mm) | | | Trajectory Angle Error<br>(degrees) | | |
|---------------------------|-----------------------|-----------------------|---------------------------|-------------------------------------|-----------------------|---------------------------|
| | Mean | Standard<br>Deviation | 99% CI*<br>Upper<br>Bound | Mean | Standard<br>Deviation | 99% CI*<br>Upper<br>Bound |
| S8 Spine<br>Software | 1.30 | 0.50 | 2.65 | 0.64 | 0.33 | 1.61 |

*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 S8 Spine Software v1.0.0 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 spine 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 |

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#### XII. Conclusions

The StealthStation S8 Spine Software v1.0.0 has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.