(136 days)
K153247-Fusion Compact Navigation System (ENT Software)
No
The summary describes an image-guided surgery system that uses pre-operative or intra-operative images for navigation and tracking, which is a standard function of such systems and does not inherently indicate the use of AI/ML. There are no mentions of AI, ML, or related concepts like deep learning, nor is there a description of training or test sets for an AI/ML model. The performance metrics are related to positional and trajectory accuracy, which are typical for navigation systems and not specific to AI/ML performance.
No
Explanation: The device is an image-guided system intended as an aid for locating anatomical structures during surgery, helping surgeons with guidance and validation of their judgment. It assists in delivering a therapy but does not directly provide a therapeutic effect itself.
No
The device is an image-guided surgery (IGS) system intended to aid surgeons in locating anatomical structures during ENT procedures by tracking instrument positions relative to medical images. It provides real-time positional information to guide the surgeon but does not diagnose medical conditions itself. Its listed function is "as an aid for locating anatomical structures," and it "helps guide surgeons," which are functions of surgical assistance rather than diagnosis.
No
The device description explicitly states that the StealthStation™ system is an Image Guided System (IGS) comprised of a platform, clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the StealthStation™ System with StealthStation™ ENT software is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- StealthStation™ ENT System Function: The StealthStation™ ENT system is an Image Guided System (IGS) that uses pre-operative or intra-operative images of a patient's anatomy to help surgeons navigate during procedures. It tracks the position of surgical instruments in relation to the patient's anatomy.
- Lack of Specimen Analysis: The system does not analyze any biological specimens taken from the patient. Its function is based on image processing and tracking of instruments relative to the patient's physical anatomy as depicted in the images.
Therefore, the StealthStation™ System with StealthStation™ ENT software falls under the category of a surgical navigation system or image-guided surgery system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT 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 skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- · Functional endoscopic sinus surgery (FESS)
- · Endoscopic skull base procedures
- Lateral skull base procedures
Product codes (comma separated list FDA assigned to the subject device)
PGW
Device Description
The StealthStation™ ENT software helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The StealthStation™ ENT software runs on the StealthStation™ S8 Platform. The StealthStation system is an Image Guided System (IGS), comprised of a platform, clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
The ENT software can display patient images from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The surgeon may also use the ENT software to create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based, MR based, Nuclear Medicine based
Anatomical Site
skull
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)
Software Verification and Validation testing using a production equivalent StealthStation S8 Platform verifying the software requirements are met and software performs as intended.
Software Verification and Validation testing using a production equivalent StealthStation S8 Platform verifying that the software performs as intended when running on the StealthStation S8 Platform.
Usability Testing was conducted in accordance to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" demonstrating that the usability and human factors requirements were adequately met.
Under representative worst-case configuration, the StealthStation S8 ENT Software, 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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Medtronic Navigation, Inc. Elizabeth Waite Sr. Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, CO 80027
Re: K170018
Trade/Device Name: StealthStation™ S8 ENT Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: April 21, 2017 Received: April 24, 2017
Dear Elizabeth Waite:
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.
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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 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.
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 yours.
Eric A. Mann -S 2017.05.19 09:23:52 -04'00'
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170018
Device Name StealthStation™ S8 ENT Software
The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT 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 skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- · Functional endoscopic sinus surgery (FESS)
- · Endoscopic skull base procedures
- Lateral skull base procedures
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
May 8, 2017
- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
- Elizabeth Waite Contact: Senior Regulatory Affairs Specialist Telephone number: (720) 890-2182 Fax: (720) 890-3500 Email: elizabeth.waite@medtronic.com
Rishi Sinha Regulatory Affairs Manager Telephone number: (720) 890-2485 Fax: (720) 890-3500 Email: rishi.k.sinha@medtronic.com
- Proprietary Trade Name: StealthStation™ S8 ENT Software II.
- III. Common Name: Stereotaxic instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II V.
- VI. Product Codes: PGW
VII. Product Description
The StealthStation™ ENT software helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The StealthStation™ ENT software runs on the StealthStation™ S8 Platform. The StealthStation system is an Image Guided System (IGS), comprised of a platform, clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
The ENT software can display patient images from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The
4
surgeon may also use the ENT software to create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide.
VIII. Indications for Use
The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT 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 skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- · Functional endoscopic sinus surgery (FESS)
- Endoscopic skull base procedures
- · Lateral skull base procedures
IX. Identification of Legally Marketed Devices
Predicate: K153247-Fusion Compact Navigation System (ENT Software) Reference: K162309 - StealthStation S8 with StealthStation S8 Cranial Software
X. Comparison of the Technological Characteristics
| Item | Subject Device
StealthStation™ S8 ENT
Software | Predicate Device
FUSION Compact™
Navigation System
(K153247) | Reference Device
Stealthstation S8 System
Platforms and
StealthStation Cranial
Software (K162309) |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II |
| Product Code | PGW | PGW | HAW, OLO, PGW |
| Intended/Indications
for Use | The StealthStation™
System, with
StealthStation™ ENT
software, is intended as an
aid for locating anatomical
structures in either open or
percutaneous ENT
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 skull, can be | The Medtronic FUSION
Compact™ computer-
assisted surgery system and
its associated applications
are intended as an aid for
precisely locating anatomical
structures in either open or
percutaneous ENT
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 StealthStation™
System, with
StealthStation™ Cranial
software, is intended as an
aid for locating anatomical
structures in either open or
percutaneous
neurosurgical 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 |
| Item | Subject Device
StealthStation™ S8 ENT
Software | Predicate Device
FUSION Compact™
Navigation System
(K153247) | Reference Device
Stealthstation S8 System
Platforms and
StealthStation Cranial
Software (K162309) |
| | identified relative to
images of the anatomy.
This can include, but is not
limited to, the following
procedures:
• Functional endoscopic
sinus surgery (FESS)
• Endoscopic skull base
procedures
• Lateral skull base
procedures | the skull, can be identified
relative to a CT or MR based
model or digitized landmarks
of the anatomy. | as the skull, can be
identified relative to
images of the anatomy.
This can include, but is not
limited to, the following
cranial procedures
(including stereotactic
frame-based and
stereotactic frame
alternatives-based
procedures):
• Tumor resections
• General
ventricular catheter
placement
• Pediatric
ventricular catheter
placement
• Depth electrode,
lead, and probe placement
• Cranial biopsies
The user should consult
the "Navigational
Accuracy" section of the
User Manual to assess if
the accuracy of the system
is suitable for their needs. |
| Operating
Principle | Electromagnetic | Electromagnetic | Optical
Electromagnetic |
| Accuracy Testing | Under representative
worst-case configuration
the StealthStation S8 ENT
Software v1.0.0, has
demonstrated performance
in 3D positional accuracy
with a mean error ≤ 2.0
mm and in trajectory error
≤ 2.0 degrees.
Specific Mean Accuracy
Values
Positional Error- 0.88mm
Trajectory Error- 0.73° | Under representative worst-
case configuration the
Fusion Compact ENT
Software, has demonstrated
performance in 3D positional
accuracy with a mean error ≤
3.0 mm.
Specific Mean Accuracy
Values
Positional Error- 2.41mm
Trajectory Error- Not
applicable | Under representative
worst-case configuration,
the StealthStation S8
System with StealthStation
Cranial v1.0.0 Software,
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.
Specific Mean Accuracy
Values
Optical Results:
Positional Error - 1.45mm
Trajectory Error – 0.60°
EM Results:
Positional Error - 0.84mm
Trajectory Error – 0.47° |
| Item | Subject Device
StealthStation™ S8 ENT
Software | Predicate Device
FUSION Compact™
Navigation System
(K153247) | Reference Device
Stealthstation S8 System
Platforms and
StealthStation Cranial
Software (K162309) |
| | | | Mechanical Results:
Positional Error – 1.48mm
Trajectory Error – $0.39°$ |
| Imaging Modalities | X-Ray based, MR based,
Nuclear Medicine based | X-Ray based, MR based,
Nuclear Medicine based | X-Ray based, MR based,
Nuclear Medicine based |
| View (Display)
Features | 3D, 2D Anatomic
Orthogonal (Coronal,
Sagittal, Axial), Video
Input, Virtual Endoscopic,
Trajectory 1 and 2, Target
Guidance, Trajectory
Guidance, Probe's Eye,
Look Ahead | 3D, 2D Anatomic
Orthogonal (Coronal,
Sagittal, Axial), Video Input | Ultrasound Video In,
Ultrasound Overlay,
3D, 2D Anatomic
Orthogonal,
Trajectory 1 and 2, Target
Guidance, Trajectory
Guidance, Probes Eye,
Look Ahead, Microscope
Injection, Video Input,
Endoscopic |
| Exam-to-Exam
Registration Features | Identity Merge
Registration, Manual
Merge Registration and
Automatic Merge
Registration | Identity Merge Registration,
Manual Merge Registration
and Automatic Merge
Registration | Identity Merge
Registration, Manual
Merge Registration and
Automatic Merge
Registration |
| Patient Registration
Features | PointMerge® registration,
Tracer™ registration,
Touch registration
(previously Touch-N-
GoTM) | PointMerge® registration,
Tracer™ registration | PointMerge® registration
(referred to as Landmark
registrations), Tracer™
registration, Touch
registration (previously
Touch-N-Go™),
StealthAiR® registration,
O-arm® registration,
Mechanical based
registrations (Stereotactic
Localizer Registration and
StarFix™ Bone Anchor
Registration) |
| Planning Features | Plan Entry and Target
Selection, 3D Model
Building, Advanced
Visualization | Not Available | Plan Entry and Target
Selection
3D Model Building
Advanced Visualization
Create Patient Based
Anatomical Coordinate
Space
Stereotactic Frame
Settings
Brain Atlas:
Schaltenbrand-Wahren
Atlas with Talairach Grid
STarFix™ Designer
Annotations |
| Scanner Interface
Technology (to
imaging devices) | Network Connectivity
CD, DVD, USB
DICOM Import | Network Connectivity
CD, DVD, USB
DICOM Import | Network Connectivity
CD, DVD, USB
DICOM Import |
| Item | Subject Device
StealthStation™ S8 ENT
Software | Predicate Device
FUSION Compact™
Navigation System
(K153247) | Reference Device
Stealthstation S8 System
Platforms and
StealthStation Cranial
Software (K162309) |
| Software Interface
(GUI) | DICOM Export
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. | DICOM Export
Blue style with
chronological next/back task
flow at the top of the screen.
Image controls on the left.
Planning information on the
right. | DICOM Export
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. |
| Programming
Language | C++ | C++ | C++ |
| Compatible Platform | StealthStation S8
Platforms including the
Planning Station | Fusion Compact Platform | StealthStation S8
Platforms including the
Planning Station |
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XI. Discussion of the Performance Testing
Testing conducted demonstrates the software will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthStation™ S8 ENT Software to establish substantial equivalence of the software and verify that the device will perform as intended meeting all of the design inputs:
- . Software Verification and Validation testing using a production equivalent StealthStation S8 Platform verifying the software requirements are met and software performs as intended.
- Software Verification and Validation testing using a production equivalent StealthStation S8 Platform verifying that the software performs as intended when running on the StealthStation S8 Platform.
- . Usability Testing was conducted in accordance to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" demonstrating that the usability and human factors requirements were adequately met.
The following table summarizes the testing conducted on the StealthStation ™ S8 ENT v1.0.0 Software:
Description
Under representative worst-case configuration, the StealthStation S8 ENT Software, has demonstrated performance in 3D positional accuracy with a mean error