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.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.15
Silver Spring, MD 20993
www.fda.gov
K201189 - Jason Woehrle Page 2

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 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-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
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-devices/medical-device-safety/medical-device-reporting-
mdr-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/medical-
devices/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-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S
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 Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.

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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 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

II. Proprietary Trade Name: StealthStation™ S8 Spine Software v1.3.0

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.

Page 1 of 4.
 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 Predicate Devices (StealthStation

v1.3.0 (Subject Devices) S8 Spine Software v1.0.0)
K170011
Intended Use The StealthStation™ System, with The StealthStation® System, with
StealthStation Spine Software, is StealthStation Spine Software, is
intended as an aid for precisely intended as an aid for precisely
locating anatomical structures in locating anatomical structures in
either open or percutaneous either open or percutaneous
neurosurgical and orthopedic neurosurgical and orthopedic
procedures. procedures.
Indications for The StealthStation™ System, with The StealthStation® System, with
Use StealthStation Spine Software, is StealthStation Spine Software, is
intended as an aid for precisely intended as an aid for precisely
locating anatomical structures in locating anatomical structures in
either open or percutaneous either open or percutaneous
neurosurgical and orthopedic neurosurgical and orthopedic
procedures. Their use is indicated procedures. Their use is indicated for
for any medical condition in which any medical condition in which the
the use of stereotactic surgery may use of stereotactic surgery may be
be appropriate, and where reference appropriate, and where reference to a
to a rigid anatomical structure, such rigid anatomical structure, such as the
as the spine, can be identified spine, can be identified relative to
relative to images of the anatomy. images of the anatomy.

This can include, but is not limited This can include, but is not limited
to, the following procedures: to, the following procedures:

• Pedicle Screw Placement • Pedicle Screw Placement

•Iliosacral Screw Placement •Iliosacral Screw Placement
•Interbody Device Placement •Interbody Device Placement
System Under representative worst-case Under representative worst-case
Accuracy Configuration, the StealthStation Configuration, the StealthStation S8
Requirements S8 Spine software v1.3.0, has Spine software v1.0.0, has
demonstrated performance in 3D demonstrated performance in 3D
positional accuracy with a mean positional accuracy with a mean
positional error of ≤ 2.0 mm and positional error of ≤ 2.0 mm
mean trajectory error of ≤ 2 and mean trajectory error of ≤ 2
degrees. degrees.

K201189, Page 2 of 4.
Feature StealthStation S8 Spine Software Predicate Devices (StealthStation
v1.3.0 (Subject Devices) S8 Spine Software v1.0.0)
K170011

Mean Accuracy Values (StealthAiR Mean Accuracy Values:

Spine): Positional Error – 1.30 mm
Positional Error – 1.01 mm Trajectory Error – 0.64 degrees
Trajectory Error – 0.37 degrees

Mean Accuracy Values

(Overlapping Slices):
Positional Error – 0.51 mm
Trajectory Error –0.41 degrees
Imaging X-Ray Based Imaging X-Ray Based Imaging
Modalities
Registration PointMerge Registration PointMerge Registration
Features SurfaceMerge Registration SurfaceMerge Registration
FluoroMerge Registration FluoroMerge Registration
Automatic 2D Image Registration Automatic 2D Image Registration
Automatic 3D Image Registration Automatic 3D Image Registration
StealthAiR Spine Automatic
Registration
Planning Plan Entry and Target Selection Plan Entry and Target Selection
Features 3D Model Building 3D Model Building
Deformity Planning Deformity Planning
Medical O-arm Imaging System O-arm Imaging System
Device Ziehm Vision FD Vario 3D C-Arm Ziehm Vision FD Vario 3D C-Arm
Interfaces ISO-C 3D C-Arm ISO-C 3D C-Arm
Ziehm Vision RFD 3D C-arm Orbic 3D C-Arm
Stealth-Midas MR8
Orbic 3D C-Arm
View/Display Look Sideways Look Sideways
Features 3D 3D
Anatomic Orthogonal Anatomic Orthogonal
Trajectory 1 and 2 Trajectory 1 and 2
Trajectory Guidance Trajectory Guidance
Look Ahead Look Ahead
Probe’s Eye Probe’s Eye
AP and Lateral AP and Lateral
Synthetic AP and Lateral Synthetic AP and Lateral
Maximum Intensity Projection Maximum Intensity Projection
Video Input Video Input
Software Black and gray style with procedure Black and gray style with procedure
Interface task overview in left menu option task overview in left menu option and
(GUI) and next/back task flow at bottom next/back task flow at bottom of the
of the screen. Software controls for screen. Software controls for images,

K201189, Page 3 of 4.
Feature StealthStation S8 Spine Software Predicate Devices (StealthStation
v1.3.0 (Subject Devices) S8 Spine Software v1.0.0)
K170011
images, planning and instrument planning and instrument management
management are contained in a are contained in a right side bar.
right side bar.
Programming C++ C++
Language
Localization Optical (infra-red) Optical (infra-red)
Technology

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.

K201189, Page 4 of 4.