(118 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms. The description focuses on image-guided surgery and tracking technology.
No
The device is image-guided surgery system intended as an aid for precisely locating anatomical structures during surgical procedures. It does not exert any direct therapeutic effect on the patient.
No
This device is an image-guided surgery system intended to aid surgeons in precisely locating anatomical structures during neurosurgical and orthopedic procedures, not to diagnose medical conditions.
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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The StealthStation System is described as an Image Guided System (IGS) used to precisely locate anatomical structures during surgical procedures. It tracks the position of instruments in relation to the surgical anatomy using images. Its intended use is to aid surgeons in procedures like pedicle screw placement and interbody device placement.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples or performing tests on samples taken from the patient. Its function is to provide real-time guidance based on imaging and instrument tracking within the surgical field.
Therefore, the StealthStation System falls under the category of a surgical navigation or image-guided surgery system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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. This can include the following spinal implant procedures, such as:
o Pedicle Screw Placement
- o Iliosacral Screw Placement
o Interbody Device Placement
Product codes
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
rigid anatomical structure, such as the spine or 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
Under representative worst-case configuration, the StealthStation S8 Spine Software v1.0.0 has demonstrated performance in 3D positional 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: (720) 890-3200 Fax Number: (720-890-3500)
- Contact: John Connor Senior Regulatory Affairs Specialist Telephone number: (720) 890-2311 Fax: (720) 890-3500 Email: john.m.connor@medtronic.com
- 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
Spine Software) | Predicate Device (Synergy Spine
Software) |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 is
intended as an aid for precisely
locating anatomical structures in
either open or percutaneous
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 or
pelvis, can be identified relative to
images of the anatomy.
This can include the following
spinal implant procedures, such as:
● Pedicle Screw Placement
● Iliosacral Screw Placement
● Interbody Device Placement | The StealthStation System is
intended as an aid for precisely
locating anatomical structures in
either open or percutaneous
procedures. The StealthStation
System 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, a long bone, or vertebra,
can be identified relative to a CT or
MR based model, fluoroscopy
images, or digitized landmarks of
the anatomy. Example procedures
include, but are not limited to:
● Spinal Implant Procedures,
such as Pedicle Screw
Placement
● Placement of Iliosacral Screws
● Stabilization and Repair of
Pelvic Fractures |
| System
Accuracy
Requirement | System Level Accuracy with a
mean positional error of 2.0mm | System Level Accuracy with a
mean positional error of 2.0mm and |
| | (Requirement from Cranial 3.0
Predicate) | (Requirement from Cranial 3.0
Predicate) |
| 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 | 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
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 images,
planning and instrument
management are contained in a
right side bar. | Basic gray and black style with 4
main tasks and tab interface to
access tools. Controls on the right. |
| Programming
Language | C++ | C++ |
| Scanner
Interface
Technology
(to imaging
devices) | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export |
| Localization
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