(138 days)
Not Found
No
The summary describes a surgical navigation system that uses image guidance to track instrument position relative to anatomy. It focuses on positional and trajectory accuracy metrics and does not mention any AI/ML specific terms, training data, or algorithms.
No.
This device is a surgical navigation system intended to aid in precisely locating anatomical structures during neurosurgical procedures. It provides guidance and planning features but does not directly treat or prevent a disease or condition itself.
No
The device is surgical navigation software intended to aid in precisely locating anatomical structures during neurosurgical procedures, not to diagnose medical conditions.
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. This indicates it is not a software-only device.
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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Synergy® Cranial software, used with the StealthStation® System, is a surgical navigation system. Its purpose is to aid surgeons in precisely locating anatomical structures during surgical procedures by tracking instruments in relation to patient anatomy and images.
- Lack of Sample Testing: The description focuses on image guidance and surgical navigation, not on analyzing biological samples.
The device is clearly intended for use in vivo (within the living body) during surgery, not in vitro (in a test tube or lab setting) for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Synergy® Cranial software is surgical navigation software that, when used with the StealthStation® System as a planning and intraoperative guidance system, is intended to aid in precisely 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:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
The StealthStation® System, with StealthStation® Cranial software, is intended to aid in precisely 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/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF leak repair
- Pediatric Ventricular Catheter Placement
- General Ventricular Catheter Placement
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The StealthStation® System, with StealthStation Cranial software helps quide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® 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 surqical anatomy and identifies this position on diagnostic or intraoperative images of the patient. StealthStation® 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based, MR based, Nuclear Medicine based
Anatomical Site
Cranial
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
Under representative worst-case configuration, the StealthStation® System with StealthStation® Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in traiectory 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.
The test configurations included CT images with slice spacing and thickness ranging between 0.6 mm to 1.25 mm and T1-weighted MR images with slice spacing and thickness ranging between 1.0 mm to 3.0 mm. In the imaging protocol, we recommend slice spacing and thickness for CT and MR imaging to be 1.0 mm or less.
Software verification and validation testing for each requirement specification. Design verification and validation was performed using 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error ≤ 2.0 degrees. This performance was determined using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components. Software verification and validation testing was performed. System integration performance testing for cranial surgical procedures using anatomical phantoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positional Error - 0.70 mm (Synergy Cranial Software v2.2.8)
Trajectory Error - 0.46 degrees (Synergy Cranial Software v2.2.8)
Positional Error – 1.16 mm (StealthStation Cranial Software v3.1.1)
Trajectory Error – 0.41 degrees (StealthStation Cranial Software v3.1.1)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
July 31, 2019
Medtronic Navigation Inc. Elizabeth Waite Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville. Colorado 80027
Re: K190672
Trade/Device Name: StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: March 14, 2019 Received: March 15, 2019
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. 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.
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
1
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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,
for Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190672
Device Name Synergy® Cranial Software
Indications for Use (Describe)
The Synergy® Cranial software is surgical navigation software that, when used with the StealthStation® System as a planning and intraoperative guidance system, is intended to aid in precisely 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:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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) K190672
Device Name StealthStation Cranial Software
Indications for Use (Describe)
The StealthStation® System, with StealthStation® Cranial software, is intended to aid in precisely 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/Craniectomies
- Skull Base Procedures
- · Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- · Pituitary Tumor Removal
- · CSF leak repair
- · Pediatric Ventricular Catheter Placement
- · General Ventricular Catheter 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)
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."
4
510(k) Summary
April 18, 2019
- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Contact: K. Elizabeth Waite (Primary) Principal Regulatory Affairs Specialist Telephone Number: 720-890-2182 Fax Number: 720-890-3500
Rishi Sinha (Alternate) Regulatory Affairs Manager Telephone Number: 720-890-2485 Fax Number: 720-890-3500
- II. Proprietary Trade Name: StealthStation® Cranial Software
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- IV. Classification: Class II, Stereotaxic Instrument
- V. Product Codes: HAW
- VI. Predicates: Medtronic Navigation, Inc. manufactured software;
VII. Product Description
The StealthStation® System, with StealthStation Cranial software helps quide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® 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 surqical anatomy and identifies this position on diagnostic or intraoperative images of the patient. StealthStation® Cranial
5
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
Cranial Software v2.2.8
The StealthStation System, with Synerqy Cranial software, is intended as an aid for precisely 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:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
Cranial Software v3.1.1
The StealthStation® System, with StealthStation® Cranial software, is intended to aid in precisely 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/Craniectomies
- · Skull Base Procedures
6
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF leak repair
- Pediatric Ventricular Catheter Placement
- General Ventricular Catheter Placement
IX. Summary of the Technological Characteristics
StealthStation Cranial Software v2.2.8 as compared to Predicate Device
| Subject Device | Predicate Device | |
|---|---|---|
| StealthStation System with Synergy Cranial | K150216 StealthStation System with | |
| Item | v2.2.8 Software | Synergy Cranial v2.2.7 Software |
| Intended Use | The StealthStation® System, with | |
| Synergy® Cranial software is designed as | ||
| an aid for precisely locating anatomical | ||
| structures in either open or percutaneous | ||
| neurosurgical procedures. | The StealthStation® System, with | |
| Synergy® Cranial software is designed as | ||
| an aid for precisely locating anatomical | ||
| structures in either open or percutaneous | ||
| neurosurgical procedures. | ||
| Indications for Use | The StealthStation System, with Synergy | |
| Cranial software, is intended as an aid for | ||
| precisely 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: |
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement | The StealthStation System, with Synergy
Cranial software, is intended as an aid for
precisely 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: - Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement |
| System Accuracy
Requirement | Under representative worst-case
configuration, the StealthStation® System
with Synergy 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.
Specific Mean Accuracy Values | Under representative worst-case
configuration, the StealthStation® System
with Synergy® 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.
Specific Mean Accuracy Values |
| | Positional Error - 0.70 mm | Position Error - ≤ 2.00 mm |
| Item | Subject Device
StealthStation System with Synergy Cranial
v2.2.8 Software | Predicate Device
K150216 StealthStation System with
Synergy Cranial v2.2.7 Software |
| | Trajectory Error - 0.46 degrees | Trajectory Error - ≤ 2.0° |
| Imaging Modalities | X-Ray based,
MR based
Nuclear Medicine based | X-Ray based,
MR based
Nuclear Medicine based |
| Registration
Features | Exam-to-Exam Registration: Identity Merge
Registration, Manual Merge Registration
and Automatic Merge Registration.
Patient Registration: PointMerge
registration, Tracer registration, Touch-N-
Go registration, StealthAiR registration and
O-arm registration | Exam-to-Exam Registration: Identity Merge
Registration, Manual Merge Registration
and Automatic Merge Registration.
Patient Registration: PointMerge
registration, Tracer registration, Touch-N-
Go registration, StealthAiR registration and
O-arm registration |
| Planning Features | Plan Entry and Target Selection
3D Model Building
Advanced Visualization | Plan Entry and Target Selection
3D Model Building
Advanced Visualization |
| Medical Device
Interfaces | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and Sonosite
Medtronic O-arm | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and Sonosite
Medtronic O-arm |
| 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 | 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 |
| Software Interface
(GUI) | Blue style with chronological next/back
task flow at the top of the screen. Image
controls on the left. Planning information
on the right. | Blue style with chronological next/back
task flow at the top of the screen. Image
controls on the left. Planning information
on the right. |
| Programming
Language | C++ | C++ |
| Scanner Interface
Technology (to
imaging devices) | Network Connectivity
CD, DVD, USB
DICOM or Stealth format Import
Export in Stealth format | Network Connectivity
CD, DVD, USB
DICOM or Stealth format Import
Export in Stealth format |
| Localization
Technology | Optical (infra-red)
Electromagnetic | Optical (infra-red)
Electromagnetic |
7
StealthStation Cranial Software v3.1.1 as compared to Predicate Device
| Item | Subject Device | Predicate Device |
|---|---|---|
| Intended Use | StealthStation System with Cranial v3.1.1 | |
| 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 StealthStation System with | |
| StealthStation Cranial v3.0 Software | ||
| The StealthStation® System, with | ||
| StealthStation® Cranial software is | ||
| designed as an aid for locating anatomical | ||
| structures in either open or percutaneous | ||
| neurosurgical procedures. | ||
| Item | Subject Device | Predicate Device |
| StealthStation System with Cranial v3.1.1 | K153660 StealthStation System with | |
| Software | StealthStation Cranial v3.0 Software | |
| Indications for Use | 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. | 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
- Deep brain stimulation (DBS)
lead placement - Depth electrode placement
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Ventricular Catheter Placement
- General Ventricular Catheter Placement
The user should consult the "Navigational
Accuracy" section of the User Manual to | This can include, but is not limited to, the
following cranial procedures (including
stereotactic frame-based and stereotactic
frame alternatives-based procedures): - Cranial Biopsies
- Deep brain stimulation (DBS)
lead placement - Depth electrode placement
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Ventricular Catheter Placement
- General Ventricular Catheter Placement
The user should consult the "Navigational
Accuracy" section of the User Manual to |
| | assess if the accuracy of the system is
suitable to their needs. | assess if the accuracy of the system is
suitable to their needs. |
| System Accuracy
Requirement | Under representative worst-case
configuration, the StealthStation® System
with StealthStation Cranial v3.0 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 | Under representative worst-case
configuration, the StealthStation® System
with StealthStation® Cranial v3.0 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 |
| | Positional Error – 1.16 mm
Trajectory Error – 0.41 degrees | Position Error - ≤ 2.00 mm
Trajectory Error - ≤ 2.0° |
| Imaging Modalities | X-Ray based,
MR based
Nuclear Medicine based | X-Ray based,
MR based
Nuclear Medicine based |
| | Subject Device | Predicate Device |
| | StealthStation System with Cranial v3.1.1
Software | K153660 StealthStation System with
StealthStation Cranial v3.0 Software |
| Item | | |
| Registration
Features | Exam-to-Exam Registration: Identity Merge
Registration, Manual Merge Registration
and Automatic Merge Registration.
Patient Registration: PointMerge
registration, Tracer registration, Touch-N-
Go registration, StealthAiR registration, O-
arm registration, Stereotactic Localizer
Registration and StarFix Bone Anchor
Registration | Exam-to-Exam Registration: Identity Merge
Registration, Manual Merge Registration
and Automatic Merge Registration.
Patient Registration: PointMerge
registration, Tracer registration, Touch-N-
Go registration, StealthAiR registration, O-
arm registration, Stereotactic Localizer
Registration and StarFix Bone Anchor
Registration |
| Planning Features | 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 | 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 |
| 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 Leksell
Nexframe® Stereotactic System
STarFix™Platform | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and Sonosite
Medtronic O-arm
Stereotactic Frame Systems: Fischer ZD,
Fischer RM, Integra CRW and Leksell
Nexframe® Stereotactic System
STarFix™Platform |
| 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 | 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 |
| Software Interface
(GUI) | Blue style with chronological next/back
task flow at the top of the screen. Image
controls on the left. Planning information
on the right. | Blue style with chronological next/back
task flow at the top of the screen. Image
controls on the left. Planning information
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 (infra-red)
Electromagnetic | Optical (infra-red)
Electromagnetic |
8
9
X. Identification of Legally Marketing Devices
StealthStation® System with Synergy Cranial Software (K150216) StealthStation® System with Cranial Software (K150663)
10
XI. Discussion of the Performance Testing
The following table summarizes the testing conducted on the StealthStation® System with StealthStation® Cranial Software:
Description
Under representative worst-case configuration, the StealthStation® System with StealthStation® Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in traiectory 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.
The test configurations included CT images with slice spacing and thickness ranging between 0.6 mm to 1.25 mm and T1-weighted MR images with slice spacing and thickness ranging between 1.0 mm to 3.0 mm. In the imaging protocol, we recommend slice spacing and thickness for CT and MR imaging to be 1.0 mm or less.
Software verification and validation testing for each requirement specification. Design verification and validation was performed using 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
XII. Conclusions
The StealthStation Cranial software has been shown through testing and comparison to be substantially equivalent to the identified predicate devices.