(58 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image-guided navigation and tracking, not AI/ML-driven analysis or decision support.
No.
The device is an image-guided system intended to aid surgeons in precisely locating anatomical structures during neurosurgical procedures, rather than directly treating a medical condition.
No
This device is described as an aid for precisely locating anatomical structures during neurosurgical procedures and for guiding surgeons, not for diagnosing medical conditions. It assists in surgical navigation rather than providing a diagnosis.
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 that the device is a system that includes hardware components, not just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the StealthStation System is used to aid surgeons in precisely locating anatomical structures within the patient's body during surgical procedures. It works with images of the patient's anatomy and tracks instruments in relation to that anatomy.
- The device description focuses on image-guided surgery (navigation). This involves using imaging data to guide surgical instruments in real-time within the patient. This is fundamentally different from the laboratory testing of biological samples that characterizes IVDs.
- The performance studies and key metrics relate to positional and trajectory accuracy. These metrics are relevant to surgical navigation systems, not to the analytical performance of tests on biological specimens.
Therefore, the StealthStation System with StealthStation Cranial software is a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synergy Cranial v2.2.9:
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
StealthStation Cranial Software v3.1.4:
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 stereotactivesbased 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
HAW
Device Description
The StealthStation System, with StealthStation Cranial software helps guide 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 guidance, 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. 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
surgeons / 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
Performance testing was conducted using anatomically representative phantoms and a subset of system components that represent worst-case combinations. 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. Software verification and validation testing for each requirement specification was performed using the StealthStation Cranial software in laboratory and simulated use settings. System integration performance testing for cranial surgical procedures using anatomical phantoms was also performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The StealthStation 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
StealthStation Cranial Software v2.2.9:
System Accuracy:
Position Error - 1.29 mm
Trajectory Error - 0.87 degrees
StealthStation Cranial Software v3.1.3:
System Accuracy:
Position Error - 1.27 mm
Trajectory Error - 1.02 degrees
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). The logo consists of two parts: a symbol representing the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA text is in blue, with "FDA" in a solid blue square and the rest of the text in a lighter blue.
June 10, 2022
Medtronic Navigation, Inc. Silver Wirth Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K221087
Trade/Device Name: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: April 11, 2022 Received: April 13, 2022
Dear Silver Wirth:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Adam D. Pierce, Ph.D. 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) K221087
Device Name
Synergy Cranial v2.2.9 (9733763); StealthStation Cranial v3.1.4 (9735585)
Indications for Use (Describe)
Synergy Cranial v2.2.9:
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
StealthStation Cranial Software v3.1.4:
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 stereotactivesbased 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
April 11, 2022
- l. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Contact: Silver Wirth Regulatory Affairs Specialist Telephone Number: 720-890-3200
Olga Lewis (Alternate) Senior Regulatory Affairs Manager Telephone Number: 720-890-3200
- 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;
- K190672, StealthStation Synergy Cranial S7 Software v2.2.8, StealthStation Cranial Software v3.1.1
VII. Product Description
The StealthStation System, with StealthStation Cranial software helps guide 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 guidance, 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. 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.
VIII. Indications for Use
Cranial Software v2.2.9
5
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
Cranial Software v3.1.3
The StealthStation System, with Station 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
IX. Summary of the Technological Characteristics
StealthStation Cranial Software v2.2.9 as compared to Predicate Device
| Item | Subject Device | Predicate Device |
|---|---|---|
| Intended Use | The StealthStation System, with Synergy Cranial software is designed as an aid for | The StealthStation System, with Synergy Cranial software is designed as an aid for |
| StealthStation System with Synergy Cranial | ||
| v2.2.9 Software | K190672 StealthStation System with Synergy Cranial v2.2.8 Software | |
| Subject Device | Predicate Device | |
| StealthStation System with Synergy Cranial | K190672 StealthStation System with | |
| Item | v2.2.9 Software | Synergy Cranial v2.2.8 Software |
| precisely locating anatomical structures in | precisely locating anatomical structures in | |
| either open or percutaneous neurosurgical | either open or percutaneous neurosurgical | |
| procedures. | 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 | 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
Position Error - 1.29 mm
Trajectory Error - 0.87 degrees | 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
Trajectory Error - 0.46 degrees |
| Requirement | | |
| Imaging Modalities | X-Ray based,
MR based
Nuclear Medicine based | X-Ray based,
MR based
Nuclear Medicine based |
| Registration | Exam-to-Exam Registration: Identity
Merge Registration, Manual Merge
Registration and Automatic Merge
Registration. | Exam-to-Exam Registration: Identity
Merge Registration, Manual Merge
Registration and Automatic Merge
Registration. |
| Features | | |
| Page 4 of 7 | | |
| Item | Subject Device | Predicate Device |
| | StealthStation System with Synergy Cranial
v2.2.9 Software | K190672 StealthStation System with
Synergy Cranial v2.2.8 Software |
| | Patient Registration: PointMerge
registration, Tracer registration, Touch-N-
Go registration, StealthAiR registration
and O-arm 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 |
6
7
K221087 Page 4 of 7
StealthStation Cranial Software v3.1.3 as compared to Predicate Device
| Item | Subject Device | Predicate Device |
|---|---|---|
| StealthStation System with Cranial v3.1.3 | ||
| Software | K190672 StealthStation System with | |
| StealthStation Cranial v3.1.1 Software | ||
| Intended Use | The StealthStation System, with | |
| StealthStation Cranial software is designed | ||
| as an aid for locating anatomical | ||
| structures in either open or percutaneous | ||
| neurosurgical procedures. | The StealthStation System, with | |
| StealthStation Cranial software is designed | ||
| as an aid for locating anatomical structures | ||
| in either open or percutaneous | ||
| neurosurgical procedures. | ||
| 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 | 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 | ||
| Subject Device | Predicate Device | |
| StealthStation System with Cranial v3.1.3 | K190672 StealthStation System with | |
| Item | Software | StealthStation Cranial v3.1.1 Software |
| structure can be identified relative to | structure can be identified relative to | |
| images of the anatomy. | 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 | 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 | - 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. | 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. |
| System Accuracy | Under representative worst-case | Under representative worst-case |
| Requirement | 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. | 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
Position Error - 1.27 mm
Trajectory Error - 1.02 degrees | Specific Mean Accuracy Values
Positional Error – 1.16 mm
Trajectory Error – 0.41 degrees |
| 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. | Exam-to-Exam Registration: Identity
Merge Registration, Manual Merge
Registration and Automatic Merge
Registration. |
| Item | Subject Device | Predicate Device |
| | StealthStation System with Cranial v3.1.3 | K190672 StealthStation System with |
| Item | Software | StealthStation Cranial v3.1.1 Software |
| | Patient Registration: PointMerge | Patient Registration: PointMerge |
| | registration, Tracer registration, Touch-N- | registration, Tracer registration, Touch-N- |
| | Go registration, StealthAiR registration, O- | Go registration, StealthAiR registration, O- |
| | arm registration, Stereotactic Localizer | arm registration, Stereotactic Localizer |
| | Registration and StarFix Bone Anchor | Registration and StarFix Bone Anchor |
| | Registration | Registration |
| Planning Features | Plan Entry and Target Selection | Plan Entry and Target Selection |
| | 3D Model Building | 3D Model Building |
| | Advanced Visualization | Advanced Visualization |
| | Create Patient Based Anatomical | Create Patient Based Anatomical |
| | Coordinate Space | Coordinate Space |
| | Stereotactic Frame Settings | Stereotactic Frame Settings |
| | Brain Atlas: Schaltenbrand-Wahren Atlas | Brain Atlas: Schaltenbrand-Wahren Atlas |
| | with Talairach Grid | with Talairach Grid |
| | STarFix Designer | STarFix Designer |
| | Annotations | Annotations |
| Medical Device | Microscope Navigation: Zeiss, Leica | Microscope Navigation: Zeiss, Leica |
| Interfaces | Ultrasound Navigation: Aloka and Sonosite | Ultrasound Navigation: Aloka and Sonosite |
| | Medtronic O-arm | Medtronic O-arm |
| | Stereotactic Frame Systems: Fischer ZD, | Stereotactic Frame Systems: Fischer ZD, |
| | Fischer RM, Integra CRW and Leksell | Fischer RM, Integra CRW and Leksell |
| | Nexframe® Stereotactic System | Nexframe® Stereotactic System |
| | STarFix™Platform | STarFix™Platform |
| View (Display) | Ultrasound Video In, Ultrasound Overlay, | Ultrasound Video In, Ultrasound Overlay, |
| Features | 3D, 2D Anatomic Orthogonal, Trajectory 1 | 3D, 2D Anatomic Orthogonal, Trajectory 1 |
| | and 2, Target Guidance, Trajectory | and 2, Target Guidance, Trajectory |
| | Guidance, Probes Eye, Look Ahead, | Guidance, Probes Eye, Look Ahead, |
| | Microscope Injection, Video Input | Microscope Injection, Video Input |
| Software Interface | Blue style with chronological next/back | Blue style with chronological next/back |
| (GUI) | task flow at the top of the screen. Image | task flow at the top of the screen. Image |
| | controls on the left. Planning information | controls on the left. Planning information |
| | on the right. | on the right. |
| Programming | C++ | C++ |
| Language | | |
| Scanner Interface | Network Connectivity | Network Connectivity |
| Technology (to | CD, DVD, USB | CD, DVD, USB |
| imaging devices) | DICOM Import | DICOM Import |
| | DICOM Export | DICOM Export |
| Localization | Optical (infra-red) | Optical (infra-red) |
| Technology | Electromagnetic | Electromagnetic |
| | Mechanical based stereotactic | Mechanical based stereotactic |
8
K221087 Page 5 of 7
9
X. Identification of Legally Marketing Devices
10
K190672, StealthStation Synergy Cranial S7 Software v2.2.8, StealthStation Cranial Software v3.1.1
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 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.
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.