Stealthstation S8 Spine Software v1.3.0

K201189 · Medtronic Navigation, Inc. · OLO · May 29, 2020 · Neurology

Device Facts

• Record ID: K201189
• Device Name: Stealthstation S8 Spine Software v1.3.0
• Applicant: Medtronic Navigation, Inc.
• Product Code: OLO · Neurology
• Decision Date: May 29, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation™ System, with StealthStation™ 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

Image-guided surgery system (IGS) tracks surgical instruments relative to patient anatomy using diagnostic or intraoperative images; utilizes optical (infra-red) localization technology. Software provides registration, planning, and visualization features to guide surgeons during spinal procedures (e.g., pedicle/iliosacral screw placement, interbody device placement). System integrates with various imaging modalities (O-arm, C-arms) and displays real-time instrument position on screen. Surgeons use visual feedback to navigate anatomy, aiding precise implant placement. Benefits include improved accuracy in surgical trajectory and positioning. Used in OR by surgeons; software processes inputs to generate 3D models and trajectory guidance.

Clinical Evidence

Bench testing only. Performance validated using anatomically representative phantoms under worst-case configurations. Results demonstrated 3D positional accuracy with mean error ≤ 2.0 mm and trajectory angle accuracy ≤ 2 degrees. Specific mean accuracy values for StealthAiR Spine were 1.01 mm (positional) and 0.37 degrees (trajectory); for Overlapping Slices, 0.51 mm (positional) and 0.41 degrees (trajectory). Software verification and validation testing performed for all requirement specifications.

Technological Characteristics

Optical (infra-red) localization; C++ software; integrates with O-arm and various 3D C-arms. Features include PointMerge, SurfaceMerge, FluoroMerge, and automatic registration (including StealthAiR Spine). Displays include 3D, orthogonal, trajectory guidance, and synthetic AP/lateral views. System accuracy: mean positional error ≤ 2.0 mm, mean trajectory error ≤ 2 degrees.

Indications for Use

Indicated for patients undergoing open or percutaneous neurosurgical and orthopedic procedures, including spinal fusion and trauma treatments, where stereotactic surgery is appropriate and rigid anatomical structures (spine or 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 S8 Spine Software v1.0.0 (K170011)

Submission Summary (Full Text)

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May 29, 2020

Medtronic Navigation, Inc. Jason Woehrle Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K201189

Trade/Device Name: Stealthstation S8 Spine Software v1.3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 30, 2020 Received: May 1, 2020

Dear Jason Woehrle:

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.

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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 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 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.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K201189

Device Name StealthStation™ S8 Spine Software v1.3.0

### Indications for Use (Describe)

The StealthStation™ System, with StealthStation™ 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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K201189

# 510(k) Summary

April 30, 2020

- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville. Colorado 80027 USA Telephone Number: 720-890-3200
- Contact: Jason Woehrle (Primary) Senior Regulatory Affairs Specialist Telephone Number: 949-399-1509 Fax Number: 720-890-3500

K. Elizabeth Waite (Alternate) Regulatory Affairs Manager Telephone Number: 720-890-2182 Fax Number: 720-890-3500

- Proprietary Trade Name: StealthStation™ S8 Spine Software v1.3.0 II.
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- IV. Classification: Class II, Stereotaxic Instrument
- V. Product Codes: OLO

#### VI. 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.

#### VII. Indications for Use

The StealthStation™ System, with StealthStation™ 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:

o Pedicle Screw Placement o Iliosacral Screw Placement o Interbody Device Placement

#### VIII. Summary of the Technological Characteristics

| Feature | StealthStation S8 Spine Software<br>v1.3.0 (Subject Devices) | Predicate Devices (StealthStation<br>S8 Spine Software v1.0.0)<br>K170011 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, 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. |
| Indications for<br>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 reference<br>to a rigid anatomical structure, such<br>as the spine, can be identified<br>relative to images of the anatomy.<br><br>This can include, but is not limited<br>to, the following procedures:<br><br>• Pedicle Screw Placement<br>•Iliosacral Screw Placement<br>•Interbody Device Placement | 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 for<br>any medical condition in which the<br>use of stereotactic surgery may be<br>appropriate, and where reference to a<br>rigid anatomical structure, such as the<br>spine, can be identified relative to<br>images of the anatomy.<br><br>This can include, but is not limited<br>to, the following procedures:<br><br>• Pedicle Screw Placement<br>•Iliosacral Screw Placement<br>•Interbody Device Placement |
| System<br>Accuracy<br>Requirements | Under representative worst-case<br>Configuration, the StealthStation<br>S8 Spine software v1.3.0, has<br>demonstrated performance in 3D<br>positional accuracy with a mean<br>positional error of ≤ 2.0 mm and<br>mean trajectory error of ≤ 2<br>degrees. | Under representative worst-case<br>Configuration, the StealthStation S8<br>Spine software v1.0.0, has<br>demonstrated performance in 3D<br>positional accuracy with a mean<br>positional error of ≤ 2.0 mm<br>and mean trajectory error of ≤ 2<br>degrees. |
| Feature | StealthStation S8 Spine Software<br>v1.3.0 (Subject Devices) | Predicate Devices (StealthStation<br>S8 Spine Software v1.0.0)<br>K170011 |
| | Mean Accuracy Values (StealthAiR<br>Spine):<br>Positional Error – 1.01 mm<br>Trajectory Error – 0.37 degrees | Mean Accuracy Values:<br>Positional Error – 1.30 mm<br>Trajectory Error – 0.64 degrees |
| | Mean Accuracy Values<br>(Overlapping Slices):<br>Positional Error - 0.51 mm<br>Trajectory Error -0.41 degrees | |
| 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<br>StealthAiR Spine Automatic<br>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-Arm<br>ISO-C 3D C-Arm<br>Ziehm Vision RFD 3D C-arm<br>Stealth-Midas MR8<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/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 procedure<br>task overview in left menu option<br>and next/back task flow at bottom<br>of the screen. Software controls for | Black and gray style with procedure<br>task overview in left menu option and<br>next/back task flow at bottom of the<br>screen. Software controls for images, |
| Feature | StealthStation S8 Spine Software<br>v1.3.0 (Subject Devices) | Predicate Devices (StealthStation<br>S8 Spine Software v1.0.0)<br>K170011 |
| | images, planning and instrument<br>management are contained in a<br>right side bar. | planning and instrument management<br>are contained in a right side bar. |
| Programming<br>Language | C++ | C++ |
| Localization<br>Technology | Optical (infra-red) | Optical (infra-red) |

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#### IX. Identification of Legally Marketing Devices

StealthStation S8 Spine Software v1.0.0 (K170011)

#### X. Discussion of the Performance Testing

The following table summarizes the testing conducted on the StealthStation S8 Spine Software v1.3.0

## Description

Under representative worst-case configuration, the StealthStation S8 Spine Software v1.3.0 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. 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.

Software verification and validation testing for each requirement specification. 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 |

#### XI. Conclusions

The StealthStation S8 Spine Software v1.3.0 has been shown through testing and comparison to be substantially equivalent to the identified predicate devices.