(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image-guided surgery and positional tracking, not AI/ML capabilities.
No.
The device is an Image Guided System (IGS) that aids in precisely locating anatomical structures during neurosurgical and orthopedic procedures, but it does not directly treat or prevent a disease or condition. Its function is to provide guidance for the surgeon, rather than to provide a therapeutic effect itself.
No.
The device is an Image Guided System (IGS) that aids in precisely locating anatomical structures during surgical procedures by tracking the position of instruments relative to the surgical anatomy. It helps to guide surgeons, but it does not make a diagnosis.
No
The device description explicitly states that the StealthStation System is comprised of a platform, clinical software, surgical instruments, and a referencing system, indicating it includes hardware components in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is an "aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures." It is used during surgical procedures to guide instrument placement based on images of the patient's anatomy.
- Device Description: The description reinforces this by explaining that the system "tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis of biological specimens.
The StealthStation System is an image-guided surgical navigation system, which is a type of medical device used to assist surgeons during procedures.
N/A
Intended Use / 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. This can include the following spinal implant procedures, such as: o Pedicle Screw Placement o Iliosacral Screw Placement o Interbody Device Placement
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Based Imaging
Anatomical Site
Spine, Pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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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.
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
v1.3.0 (Subject Devices) | Predicate Devices (StealthStation
S8 Spine Software v1.0.0)
K170011 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| 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, can be identified
relative to images of the anatomy.
This can include, but is not limited
to, the following procedures:
• Pedicle Screw Placement
•Iliosacral Screw Placement
•Interbody Device Placement | 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, can be identified relative to
images of the anatomy.
This can include, but is not limited
to, the following procedures:
• Pedicle Screw Placement
•Iliosacral Screw Placement
•Interbody Device Placement |
| System
Accuracy
Requirements | Under representative worst-case
Configuration, the StealthStation
S8 Spine software v1.3.0, has
demonstrated performance in 3D
positional accuracy with a mean
positional error of ≤ 2.0 mm and
mean trajectory error of ≤ 2
degrees. | Under representative worst-case
Configuration, the StealthStation S8
Spine software v1.0.0, has
demonstrated performance in 3D
positional accuracy with a mean
positional error of ≤ 2.0 mm
and mean trajectory error of ≤ 2
degrees. |
| Feature | StealthStation S8 Spine Software
v1.3.0 (Subject Devices) | Predicate Devices (StealthStation
S8 Spine Software v1.0.0)
K170011 |
| | Mean Accuracy Values (StealthAiR
Spine):
Positional Error – 1.01 mm
Trajectory Error – 0.37 degrees | Mean Accuracy Values:
Positional Error – 1.30 mm
Trajectory Error – 0.64 degrees |
| | Mean Accuracy Values
(Overlapping Slices):
Positional Error - 0.51 mm
Trajectory Error -0.41 degrees | |
| Imaging
Modalities | X-Ray Based Imaging | X-Ray Based Imaging |
| Registration
Features | PointMerge Registration
SurfaceMerge Registration
FluoroMerge Registration
Automatic 2D Image Registration
Automatic 3D Image Registration
StealthAiR Spine Automatic
Registration | PointMerge Registration
SurfaceMerge Registration
FluoroMerge Registration
Automatic 2D Image Registration
Automatic 3D Image Registration |
| Planning
Features | Plan Entry and Target Selection
3D Model Building
Deformity Planning | Plan Entry and Target Selection
3D Model Building
Deformity Planning |
| Medical
Device
Interfaces | O-arm Imaging System
Ziehm Vision FD Vario 3D C-Arm
ISO-C 3D C-Arm
Ziehm Vision RFD 3D C-arm
Stealth-Midas MR8
Orbic 3D C-Arm | O-arm Imaging System
Ziehm Vision FD Vario 3D C-Arm
ISO-C 3D C-Arm
Orbic 3D C-Arm |
| View/Display
Features | Look Sideways
3D
Anatomic Orthogonal
Trajectory 1 and 2
Trajectory Guidance
Look Ahead
Probe's Eye
AP and Lateral
Synthetic AP and Lateral
Maximum Intensity Projection
Video Input | Look Sideways
3D
Anatomic Orthogonal
Trajectory 1 and 2
Trajectory Guidance
Look Ahead
Probe's Eye
AP and Lateral
Synthetic AP and Lateral
Maximum Intensity Projection
Video Input |
| Software
Interface
(GUI) | Black and gray style with procedure
task overview in left menu option
and next/back task flow at bottom
of the screen. Software controls for | Black and gray style with procedure
task overview in left menu option and
next/back task flow at bottom of the
screen. Software controls for images, |
| Feature | StealthStation S8 Spine Software
v1.3.0 (Subject Devices) | Predicate Devices (StealthStation
S8 Spine Software v1.0.0)
K170011 |
| | images, planning and instrument
management are contained in a
right side bar. | planning and instrument management
are contained in a right side bar. |
| Programming
Language | C++ | C++ |
| Localization
Technology | Optical (infra-red) | Optical (infra-red) |
5
6
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