(226 days)
Not Found
No
The summary describes a traditional image-guided surgery system that uses optical or electromagnetic tracking to locate instruments relative to pre-operative or intra-operative images. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance testing sections. The focus is on positional and trajectory accuracy based on physical tracking and image registration.
No.
The device is an aid for precisely locating anatomical structures during surgical procedures, not directly treating a disease or condition.
No
The device is described as an aid for locating anatomical structures and guiding surgeons during procedures, not for diagnosing medical conditions. It uses pre-existing diagnostic images but does not perform diagnosis itself.
No
The device description explicitly states that the software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system, and platform/computer hardware. It also mentions hardware verification testing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the StealthStation™ System is an "aid for locating anatomical structures in either open or percutaneous neurosurgical procedures." This describes a device used during a surgical procedure to guide the surgeon, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description explains that the system "helps guide surgeons during cranial surgical procedures" by tracking the position of instruments in relation to the patient's anatomy using imaging. This is consistent with a surgical navigation system, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on laboratory tests
The StealthStation™ System is a surgical navigation system that uses imaging to assist surgeons in locating anatomical structures during procedures. This falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
StealthStation S8 System with StealthStation Cranial software
The StealthStation™ System, with Station™ 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 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.
StealthStation S8 System Platform
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.
Product codes (comma separated list FDA assigned to the subject device)
HAW, OLO, PGW
Device Description
The StealthStation™ S8 System, with StealthStation™ Cranial v1.0.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation™ Cranial v1.0.0 software (cranial software) works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image quidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking. Cranial 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based, MR based, Nuclear Medicine based, CT, Fluoroscopy images
Anatomical Site
Skull, long bone, or vertebra (for the StealthStation™ System platform); Skull (for StealthStation™ Cranial software)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, Clinical Setting
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
The performance of the StealthStation™ S8 System with StealthStation™ Cranial v1.0.0 software was determined using anatomically representative phantoms. The test configurations included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the StealthStation™ S8 Platforms.
- AAMI/ANSI ES 60601-1:2012 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (JEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007 - Medical Electrical Equipment - Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests
- Software Verification and Validation testing verifying the operating system software requirements are met and software performs as intended
- Hardware Verification testing ensuring the hardware requirements identified for the system are met and hardware performs as intended
- 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.
Summary of results:
Under representative worst-case configuration, the StealthStation™ S8 System with StealthStation™ Cranial 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).
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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
Medtronic Navigation, Inc. Tia Fushimi-Bain Sr Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K162309
Trade/Device Name: Stealthstation S8 System Platforms and StealthStation Cranial Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO, PGW Dated: August 16, 2016 Received: August 17, 2016
Dear Ms. Fushimi-Bain:
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
1
the quality systems (OS) 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,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162309
Device Name
StealthStation S8 System with StealthStation Cranial software
Indications for Use (Describe)
The StealthStation™ System, with Station™ 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 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.
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 PRAStaff@fda.hhs.gov
"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."
3
Indications for Use
510(k) Number (if known) K162309
Device Name StealthStation S8 System Platform
Indications for Use (Describe)
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.
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)
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 PRAStaff(@fda.hhs.gov
"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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
510(k) Summary
March 31, 2017
- l. Company: Medtronic Navigation. Inc. 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3200
- Contact: Tia Fushimi-Bain Senior Regulatory Affairs Specialist Telephone number: (720) 890-2178 Fax: (763) 367-2075 Email: tia.k.fushimi-bain@medtronic.com
Elizabeth Waite Senior Regulatory Affairs Specialist Telephone number: (720) 890-2182 Fax: (720) 890-3500 Email: elizabeth.waite@medtronic.com
- ll. Proprietary Trade Name: StealthStation™ S8 Platform with StealthStation™ Cranial Software
- lll. Common Name: Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II V.
- VI. Product Code: HAW
- VII. Product Description: The StealthStation™ S8 System, with StealthStation™ Cranial v1.0.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation™ Cranial v1.0.0 software (cranial software) works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image quidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking.
Cranial 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 is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System is
5
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.
The StealthStation™ System, with Station™ 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 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.
IX. Identification of Leqally Marketed Devices (Predicate Devices):
K153660 - Synergy Cranial 3.0 Software K050438 - StealthStation™ System Update K133444 - StealthStation™ System Update
X. Comparison of the Technological Characteristics:
| Item | Subject Device | Software Predicate | Platform Predicate |
|---|---|---|---|
| Intended Use | Cranial Software | ||
| The StealthStation® | |||
| System, with | |||
| StealthStation® Cranial | |||
| software is designed as an | |||
| aid for locating anatomical | |||
| structures in either open or | |||
| percutaneous | |||
| neurosurgical procedures. | K153660, Synergy | ||
| Cranial 3.0 Software | |||
| The StealthStation® | |||
| System, with | |||
| StealthStation® Cranial | |||
| software is designed as an | |||
| aid for locating anatomical | |||
| structures in either open or | |||
| percutaneous | |||
| neurosurgical procedures. | K050438, | ||
| StealthStation™ | |||
| System Update | |||
| The StealthStation™ | |||
| System is intended as | |||
| an aid for precisely | |||
| locating anatomical | |||
| structures in either | |||
| open or percutaneous | |||
| procedures. | |||
| StealthStation S8 | |||
| Platform | |||
| The StealthStation® | |||
| System is intended as an | |||
| aid for precisely locating | |||
| anatomical structures in | |||
| either open or | |||
| percutaneous surgical | |||
| procedures. | |||
| Item | Subject Device | Software Predicate | Platform Predicate |
| Indications for | |||
| Use | 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 | |||
| 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. | K153660, Synergy
Cranial 3.0 Software
The StealthStation®
System, with
StealthStation® Cranial
software, is intended to aid
in locating anatomical
structures in either open or
percutaneous
neurosurgical procedures.
The system is indicated for
any medical condition in
which reference to a rigid
anatomical structure 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):
- Cranial Biopsies
(including
stereotactic) - Deep brain stimulation
(DBS)
lead placement - Depth electrode
placement - Tumor Resections
Craniotomies/Craniectomi
es
- Skull Base Procedures
- Transsphenoidal
Procedures
Thalamotomies/Pallidotom
ies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Ventricular
Catheter Placement - General Ventricular
Catheter Placement | K050438,
StealthStation™
System Update
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. |
| System
Accuracy
Requirement | Under representative
worst-case configuration,
the StealthStation S8
System with StealthStation
Cranial v1.0.0 Software, | K153660, Synergy
Cranial 3.0 Software
Under representative
worst-case configuration,
the StealthStation® | Not Applicable |
| Item | Subject Device | Software Predicate | Platform Predicate |
| | has demonstrated
performance in 3D
positional accuracy with a
mean error $\leq$ 2.0 mm and
in trajectory angle
accuracy with a mean error
$\leq$ 2.0 degrees. | System with
StealthStation® Cranial
v3.0 Software, has
demonstrated
performance in 3D
positional accuracy with a
mean error $\leq$ 2.0 mm and
in trajectory angle
accuracy with a mean
error $\leq$ 2.0 degrees. | |
| Imaging
Modalities | X-Ray based, MR based,
Nuclear Medicine based | K153660, Synergy
Cranial 3.0 Software
X-Ray based, MR based,
Nuclear Medicine based | Not Applicable |
| View (Display)
Features | 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 | K153660, Synergy
Cranial 3.0 Software
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 | Not Applicable |
| Exam-to-Exam
Registration
Features | Identity Merge
Registration, Manual
Merge Registration and
Automatic Merge
Registration | K153660, Synergy
Cranial 3.0 Software
Identity Merge
Registration, Manual
Merge Registration and
Automatic Merge
Registration. | Not Applicable |
| Patient
Registration
Features | 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) | K153660, Synergy
Cranial 3.0 Software
PointMerge® registration,
Tracer™ registration,
Touch-N-Go™
registration, StealthAiR®
registration, O-arm®
registration, Stereotactic
Localizer Registration and
StarFix™ Bone Anchor
Registration | Not Applicable |
| Planning
Features | Plan Entry and Target
Selection
3D Model Building
Advanced Visualization | K153660, Synergy
Cranial 3.0 Software
Plan Entry and Target
Selection
3D Model Building
Advanced Visualization | Not Applicable |
| Item | Subject Device | Software Predicate | Platform Predicate |
| | Create Patient Based
Anatomical Coordinate
Space
Stereotactic Frame
Settings
Brain Atlas:
Schaltenbrand-Wahren
Atlas with Talairach Grid
STarFix™ Designer
Annotations | Create Patient Based
Anatomical Coordinate
Space
Stereotactic Frame
Settings
Brain Atlas:
Schaltenbrand-Wahren
Atlas with Talairach Grid
STarFix™ Designer
Annotations | |
| Medical Device
Interfaces | Microscope Navigation:
Zeiss, Leica
Ultrasound Navigation:
Aloka and Sonosite
Medtronic O-arm®
Stereotactic Frame
Systems: Fischer ZD,
Fischer RM, Integra CRW
and Elekta Leksell
Nexframe® Stereotactic
System
STarFix™Platform System | K153660, Synergy
Cranial 3.0 Software
Microscope Navigation:
Zeiss, Leica
Ultrasound Navigation:
Aloka and Sonosite
Medtronic O-arm®
Stereotactic Frame
Systems: Fischer ZD,
Fischer RM, Integra CRW
and Elekta Leksell
Nexframe® Stereotactic
System
STarFix™Platform System | Not Applicable |
| Compatible
Medtronic
Optical
Instrumentation | Medtronic instruments
tracked via optical markers
or LEDs located on
instrument and patient
trackers via the optical
localizing system. | K153660, Synergy
Cranial 3.0 Software
Medtronic instruments
tracked via optical markers
or LEDs located on
instrument and patient
trackers via the optical
localizing system | K050438
StealthStation™
System Update
StealthStation S7
supports optical
instrumentation
compatible with
StealthStation software
via optical localization. |
| Compatible
Medtronic EM
Instrumentation | Medtronic instruments
tracked via
electromagnetic
localization technology
located within the
instrument and patient
trackers | K153660, Synergy
Cranial 3.0 Software
Medtronic instruments
tracked via
electromagnetic
localization technology
located within the
instrument and patient
trackers | K050438
StealthStation™
System Update
StealthStation S7
supports EM
instrumentation
compatible with
StealthStation software
via EM localization. |
| 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. | K153660, Synergy
Cranial 3.0 Software
Blue style with
chronological next/back
task flow at the top of the
screen. Image controls on
the left. Planning
information on the right. | Not Applicable |
| Item | Subject Device | Software Predicate | Platform Predicate |
| Programming
Language | C++ | K153660, Synergy
Cranial 3.0 Software
C++ | Not Applicable |
| Scanner
Interface
Technology (to
imaging
devices) | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | K153660, Synergy
Cranial 3.0 Software
Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | Not Applicable |
| Optical
Technology | Manufacturer: Identical
(Northern Digital Inc.)
Localizer: Vega | K153660, Synergy
Cranial 3.0 Software
Optical (infra-red) | K050438,
StealthStation™
System Update
Manufacturer: Northern
Digital Inc.
Localizer: Polaris |
| Electromagnetic
Technology | Manufacturer: Identical
(Medtronic Navigation,
Inc.)
Localizer: AxiEM III
Emitter Types: Side, Flat | K153660, Synergy
Cranial 3.0 Software
Electromagnetic
Mechanical based
stereotactic | K050438,
StealthStation™
System Update
Manufacturer:
Medtronic Navigation,
Inc.
Localizer: AxiEM
Emitter Types: Side |
| Computer | Intel-based PC | Not Applicable | K050438,
StealthStation™
System Update
Intel-based PC |
| RFID Reader | Capability added to
system. Functionality not
yet available with this
release | Not Applicable | Not Available |
| Network
Connectivity | Connection Type:
Standard Ethernet
2.4gHz and 5.0 gHz
Wireless connection | Not Applicable | K050438,
StealthStation™
System Update
Connection Type:
Standard Ethernet
Connection and modem
connection |
| Remote Service
Connectivity | Remote service access
providing capability for
secure remote desktop
service over high speed
connection (Branded
Remote Presence) | Not Applicable | Not Available |
| Operating
System | Linux-based: Ubuntu | Not Applicable | K133444,
StealthStation™ S7,
i7, Fusion
Debian Linux |
6
7
8
9
XI. Discussion of the Performance Testing
10
Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthStation™ S8 Platforms to establish substantial equivalence of the system and verify that the device will perform as intended meeting all of the design inputs:
- . AAMI/ANSI ES 60601-1:2012 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (JEC 60601-1:2005, MOD)
- . IEC 60601-1-2:2007 - Medical Electrical Equipment - Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests
- . Software Verification and Validation testing verifying the operating system software requirements are met and software performs as intended
- . Hardware Verification testing ensuring the hardware requirements identified for the system are met and hardware performs as intended
- . 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 System with StealthStation™ Cranial v1.0.0 Software:
Description
Under representative worst-case configuration, the StealthStation™ S8 System with StealthStation™ Cranial 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. 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 in a clinically relevant workflow.
There were three distinct end-to-end worst-case configuration pathways identified for the localization types (optical, electromagnetic and mechanical) in StealthStation™ Cranial software. The test configurations included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm. In the imaging protocol, we recommend slice spacing and thickness for CT and MR imaging to be 1.0 mm or less. The following table summarizes the performance of the StealthStation™ S8 System using StealthStation™ Cranial software with optical, electromagnetic (EM) and mechanical localization.
| Performance Validation | Positional Error (mm) | Trajectory Angle Error (degrees) | ||||
|---|---|---|---|---|---|---|
| Mean | Standard Deviation | 99% CI* Upper | Mean | Standard Deviation | 99% CI* Upper | |
| Cranial S8 System with Optical Localization Performance Validation | 1.45 | 0.67 | 3.02 | 0.60 | 0.32 | 1.68 |
11
| | Cranial S8
System with | 0.84 | 0.37 | 1.69 | 0.47 | 0.25 | 1.24 | | |
|----------------------|----------------------------------------------------------------------------------|------|------|------|------|------|------|--|--|
| | EM | | | | | | | | |
| | Localization
Performance | | | | | | | | |
| | Validation | | | | | | | | |
| | Cranial S8 | 1.48 | 0.47 | 2.58 | 0.39 | 0.31 | 1.12 | | |
| | System with | | | | | | | | |
| | Mechanical | | | | | | | | |
| | Localization | | | | | | | | |
| | Performance | | | | | | | | |
| | Validation | | | | | | | | |
| | *CI (confidence interval) | | | | | | | | |
| | | | | | | | | | |
| | Software verification and validation testing for each requirement specification. | | | | | | | | |
| | Design verification and validation was performed using the StealthStation™ S8 | | | | | | | | |
| | System with the StealthStation™ Cranial software in laboratory and simulated | | | | | | | | |
| | use settings. The results support the safety of the device and demonstrate that | | | | | | | | |
| | the software should perform as intended in the specified use conditions. | | | | | | | | |
| | System integration performance testing for cranial 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 |
Design verification and validation was performed using the StealthStation™ S8 System with StealthStation™ Cranial software in laboratory and simulated use settings. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions.
Clinical testing was not considered necessary prior to release as this is not new technology.
XII.Conclusions
The StealthStation™ S8 Platforms with Station™ Cranial software have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.