(268 days)
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 assess if the accuracy of the system is suitable for their needs.
The StealthStation® System, with Station® Cranial v3.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® Cranial v3.0 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 v3.0 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|---|
| 3D Positional Accuracy | Mean error ≤ 2.0 mm | Stereotactic Frame Systems: |
| - Cranial 3.0 Stereotactic Frame System: 1.57 mm (Mean) | ||
| - Cranial 3.0 with Nexframe® System: 1.65 mm (Mean) | ||
| - Cranial 3.0 with STarFix™ System: 1.08 mm (Mean) | ||
| Electromagnetic (EM) Localization: | ||
| - Cranial 3.0 with EM Localization System: 1.67 mm (Mean) | ||
| Trajectory Angle Accuracy | Mean error ≤ 2.0 degrees | Stereotactic Frame Systems: |
| - Cranial 3.0 Stereotactic Frame System: 0.52 degrees (Mean) | ||
| - Cranial 3.0 with Nexframe® System: 0.68 degrees (Mean) | ||
| - Cranial 3.0 with STarFix™ System: 0.70 degrees (Mean) | ||
| Electromagnetic (EM) Localization: | ||
| - Cranial 3.0 with EM Localization System: 1.31 degrees (Mean) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size (e.g., number of phantoms, number of trials) used for the performance testing. It mentions using "anatomically representative phantoms" and "a subset of system components and features that represent the worst-case combinations."
The data provenance is from laboratory and simulated use settings, implying prospective testing conducted by Medtronic Navigation, Inc. The country of origin is not explicitly stated, but the company is located in Louisville, Colorado, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the performance validation tests. The "ground truth" for positional and trajectory accuracy in this context would likely be established by precise measurements within the engineered phantoms themselves, not by human experts.
4. Adjudication Method for the Test Set
Not applicable. The performance validation used objective measurements against engineered phantoms, not human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance?
No, an MRMC comparative effectiveness study involving human readers or AI assistance in that context was not performed. This device is an image-guided surgery system, not an AI diagnostic tool that assists human readers in interpreting images. Its function is to provide real-time navigation during surgical procedures based on pre-operative imaging.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done?
Yes, the performance validation described is a standalone evaluation of the algorithm and system's accuracy. The tests measured the system's ability to accurately determine 3D positional and trajectory angle, independent of direct human-in-the-loop performance during the measurement process. It's evaluating the mechanical and software accuracy of the navigation system itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used was based on engineered phantoms with known anatomical representations and precise target locations. The "ground truth" for accuracy measurements would be the known, precisely defined coordinates and trajectories within these phantoms.
8. The Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. This implies that the device's accuracy is being verified against its design specifications, likely through a deterministic system or one with pre-calibrated components, rather than a machine learning model that requires a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" and associated ground truth establishment for a machine learning model are not described in the context of this device's validation. The device's performance is driven by its inherent design and calibration, not by learning from a training dataset.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem that resembles an abstract caduceus, with three stylized human profiles forming the staff and a serpent-like shape winding around them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2016
Medtronic Navigation, Inc. Ms. Augusta Henao Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K153660
Trade/Device Name: StealthStation System with StealthStation Cranial Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 12, 2016 Received: August 15, 2016
Dear Ms. Henao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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,
Carlos L. Pena -$=D/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153660
Device Name
StealthStation System with StealthStation Cranial Software
Indications for Use (Describe)
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 assess if the accuracy of the system is suitable for their needs.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
September 13, 2016
I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
Contact:
Primary Contact: Augusta Henao Senior Regulatory Affairs Specialist Telephone Number: 720-890-3366 Fax Number: 720-890-3500
Secondary Contact: Michael Blasco Senior Regulatory Affairs Manager Telephone Number: 720-890-3391 Fax Number: 720-890-3500
- Proprietary Trade Name: StealthStation® System with StealthStation® Cranial II. Software
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II, Stereotaxic Instrument IV.
- V. Product Codes: HAW
VI. Product Description
The StealthStation® System, with Station® Cranial v3.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® Cranial v3.0 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 v3.0 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.
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VII. Indications for Use
The StealthStation® System, with Station® 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 assess if the accuracy of the system is suitable for their needs.
VIII. Summary of the Technological Characteristics
| Item | Subject Device (StealthStation®System with StealthStation® Cranialv3.0 Software) | Predicate Devices |
|---|---|---|
| Intended Use | The StealthStation® System, withStealthStation® Cranial software isdesigned as an aid for locatinganatomical structures in either open orpercutaneous neurosurgical procedures. | Synergy® Cranial v2.2.7 Software -K150216The StealthStation® System, withSynergy® Cranial software is designed asan aid for precisely locating anatomicalstructures in either open or percutaneousneurosurgical procedures. |
| Indications forUse | The StealthStation® System, withStealthStation® Cranial Software, isintended to aid in locating anatomicalstructures in either open orpercutaneous neurosurgical procedures.The system is indicated for any medicalcondition in which reference to a rigidanatomical structure can be identifiedrelative to images of the anatomy. | Synergy® Cranial v2.2.7 Software -K150216The StealthStation System, with SynergyCranial software, is intended as an aid forprecisely locating anatomical structures ineither open or percutaneous neurosurgicalprocedures.The system is indicated for anymedical condition in which reference to arigid anatomical structure can be identifiedrelative to images of the anatomy. |
| Item | Subject Device (StealthStation®System with StealthStation® Cranialv3.0 Software) | Predicate Devices |
| 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 PlacementThe user should consult the “Navigational Accuracy” section of the User Manual to assess if the accuracy of the system is suitable for their needs | 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 | |
| SystemAccuracyRequirement | The StealthStation® System with StealthStation Cranial v3.0 Software, has demonstrated performance in 3D positional accuracy with a mean error $\le$ 2.0 mm and in trajectory angle accuracy with a mean error $\le$ 2.0 degrees. | Synergy® Cranial v2.2.7 Software - K150216The StealthStation® System with Synergy Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error $\le$ 2.0 mm and in trajectory angle accuracy with a mean error $\le$ 2.0 degrees. |
| ImagingModalities | X-Ray based, MR based, Nuclear Medicine based | Synergy® Cranial v2.2.7 Software - K150216X-Ray based, MR based, Nuclear Medicine based |
| View (Display)Features | Ultrasound Video In, UltrasoundOverlay,3D, 2D Anatomic Orthogonal,Trajectory 1 and 2, Target Guidance,Trajectory Guidance, Probes Eye,Look Ahead, Microscope Injection,Video Input | Synergy® Cranial v2.2.7 Software - K150216Ultrasound Video In, Ultrasound Overlay,3D, 2D Anatomic Orthogonal, Trajectory1 and 2, Target Guidance, TrajectoryGuidance, Probes Eye, Look Ahead,Microscope Injection, Video Input |
| Exam-to-ExamRegistrationFeatures | Identity Merge Registration, ManualMerge Registration and AutomaticMerge Registration | Synergy® Cranial v2.2.7 Software - K150216Identity Merge Registration, Manual |
| Item | Subject Device (StealthStation® System with StealthStation® Cranial v3.0 Software) | Predicate Devices |
| PatientRegistrationFeatures | PointMerge registration, Tracer registration, Touch-N-Go registration, StealthAiR registration, O-arm registration, Stereotactic Localizer Registration and StarFix Bone Anchor Registration | Merge Registration and Automatic Merge Registration.Primary Predicate:Synergy® Cranial v2.2.7 Software - K150216PointMerge registration, Tracer registration, Touch-N-Go registration, StealthAiR registration and O-arm registrationSecondary Predicate:Natrex™ Device for StealthStation System K992927Stereotactic Localizer Registration |
| PlanningFeatures | Plan Entry and Target Selection3D Model BuildingAdvanced VisualizationCreate Patient Based Anatomical Coordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand-Wahren Atlas with Talairach GridSTarFix DesignerAnnotations | Primary Predicate:Synergy® Cranial v2.2.7 Software - K150216Plan Entry and Target Selection3D Model BuildingAdvanced VisualizationSecondary Predicate:Natrex™ Device for StealthStation® System K992927Stereotactic Localizer RegistrationPlan Entry and Target SelectionCreate Patient Based Anatomical Coordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand-Wahren Atlas with Talairach GridAnnotations |
| Medical DeviceInterfaces | Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-armStereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta LeksellNexframe® Stereotactic SystemSTarFix™Platform System | Primary Predicate:Synergy® Cranial v2.2.7 Software - K150216Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-armSecondary Predicate:Natrex™ Device for StealthStation® System K992927Stereotactic Frame Systems: Integra BRW/CRW and Leksell |
| SoftwareInterface (GUI) | Blue style with chronological next/back task flow at the top of the screen.Image controls on the left. Planning | Synergy® Cranial v2.2.7 Software - K150216Blue style with chronological next/back |
| Item | Subject Device (StealthStation®System with StealthStation® Cranialv3.0 Software) | Predicate Devices |
| information on the right. | task flow at the top of the screen. Imagecontrols on the left. Planning informationon the right. | |
| ProgrammingLanguage | C++ | Synergy® Cranial v2.2.7 Software -K150216C++ |
| ScannerInterfaceTechnology (toimaging devices) | Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export | Synergy® Cranial v2.2.7 Software -K150216Network ConnectivityCD, DVD, USBDICOM or Stealth format ImportExport in Stealth format |
| LocalizationTechnology | Optical (infra-red)ElectromagneticMechanical based stereotactic | Primary Predicate:Synergy® Cranial v2.2.7 Software -K150216Optical (infra-red)ElectromagneticSecondary Predicate:Natrex™ Device for StealthStationSystem K992927Optical (infra-red),Mechanical based stereotactic |
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IX. Identification of Legally Marketed Devices
StealthStation® System with Synergy Cranial Software (K150216) Natrex Device for StealthStation® System (K992927)
X. Discussion of the Performance Testing
The following table summarizes the testing conducted on the StealthStation® System with StealthStation® Cranial v3.0 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. The positional error is defined as the Euclidean distance from target to instrument tip at final point of insertion. The trajectory angle error is the angle between the planned surgical trajectory and trajectory of the neurosurgical instrument at final point of insertion. Depending on the surgical procedure and the particular neurosurgical instruments used, the resulting navigational accuracy may be negatively impacted.
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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.
The test configuration for stereotactic frame-based, Nexframe®, and STarFix™ procedures 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. The following table summarizes the performance of the StealthStation® System using Cranial software with compatible stereotactic hardware platforms.
| Performance Validation | Positional Error (mm) | Trajectory Angle Error (degrees) | ||||
|---|---|---|---|---|---|---|
| Mean | Standard Deviation | 99%CI* Upper Bound | Mean | Standard Deviation | 99%CI* Upper Bound | |
| Cranial 3.0 Stereotactic Frame System Performance Validation | 1.57 | 0.63 | 3.04 | 0.52 | 0.34 | 1.31 |
| Cranial 3.0 with Nexframe® System Performance Validation | 1.65 | 0.50 | 2.81 | 0.68 | 0.31 | 1.40 |
| Cranial 3.0 with STarFix™ System Performance Validation | 1.08 | 0.54 | 2.34 | 0.70 | 0.42 | 1.68 |
*CI (Confidence Interval)
The test configuration for procedures using electromagnetic localization included CT images with slice spacing and thickness of 1.0 mm and T1-weighted MR images with slice spacing and thickness of 1.5 mm. The following table summarizes the performance of the Cranial software on the StealthStation System with electromagnetic (EM) localization.
| Performance Validation | Positional Error (mm) | Trajectory Angle Error (degrees) | ||||
|---|---|---|---|---|---|---|
| Mean | Standard Deviation | 99%CI* Upper Bound | Mean | Standard Deviation | 99%CI* Upper Bound | |
| Cranial 3.0 with EM Localization System Performance Validation | 1.67 | 0.82 | 3.91 | 1.31 | 0.55 | 2.73 |
*CI (Confidence Interval)
Medtronic developed a test method to simulate clinical configurations and workflows to derive this summary of performance. Due to the uniqueness of this test method, the performance results presented may not be comparable to results derived from other test methods or other medical devices.
Software verification and validation testing for each requirement specification. Design verification and validation was performed using the StealthStation® System with Station® Cranial v3.0 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.
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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 |
Clinical testing was not considered necessary prior to release as this is not new technology.
XI. Conclusions
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the StealthStation® System with StealthStation® Cranial v3.0 software should perform as intended in the specified use conditions. The non-clinical data demonstrate that the StealthStation® System with StealthStation® Cranial v3.0 software performs comparably to the predicate devices for the same intended use.
§ 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).