(136 days)
The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- · Functional endoscopic sinus surgery (FESS)
- · Endoscopic skull base procedures
- Lateral skull base procedures
The StealthStation™ ENT software helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The StealthStation™ ENT software runs on the StealthStation™ S8 Platform. The StealthStation system is an Image Guided System (IGS), comprised of a platform, clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
The ENT software can display patient images from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The surgeon may also use the ENT software to create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the StealthStation™ S8 ENT Software:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 3D positional accuracy: mean error ≤ 2.0 mm | Positional Error: 0.88 mm |
| Trajectory angle accuracy: mean error ≤ 2.0 degrees | Trajectory Error: 0.73° |
Note: The reported performance metrics meet the acceptance criteria (0.88mm ≤ 2.0mm and 0.73° ≤ 2.0°).
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." The testing involved "anatomically representative phantoms" and "a subset of system components and features that represent the worst-case combinations of all potential system components." The text does not provide a specific numerical sample size for the test set.
- Data Provenance: The data provenance is from "anatomically representative phantoms" and "laboratory and simulated use settings." It's not human patient data. As such, country of origin is not applicable in the typical sense; the data is generated from simulated environments. This is not retrospective or prospective clinical data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The provided text does not mention the use of human experts to establish ground truth for the test set. The ground truth for positional and trajectory accuracy is inherent in the design and measurement capabilities of the "anatomically representative phantoms" and the testing methodology itself, which would involve precise physical measurements.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth was established through physical measurements on phantoms, not through expert consensus requiring adjudication.
-
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 was not done. The device is a navigation system that aids surgeons, and the performance testing focuses on its accuracy rather than its impact on human reader (or surgeon) diagnostic/interpretative performance in a comparative study. Clinical testing "was not considered necessary prior to release as this is not new technology."
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the accuracy testing described (positional error and trajectory error) represents the standalone performance of the algorithm and system, as measured on phantoms. This is the performance of the StealthStation™ S8 ENT Software itself in tracking and displaying anatomical information accurately, independent of direct human judgment during the measurement process.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance testing (accuracy) was established through physical measurements and known parameters of "anatomically representative phantoms." The expected or "true" position and trajectory within the phantom were precisely known, allowing for the calculation of measurement errors.
-
The sample size for the training set:
- Not applicable. The StealthStation™ S8 ENT Software is an Image Guided System (IGS) that relies on tracking and displaying pre-acquired patient images and instrument positions. It is not an AI/ML algorithm that requires a separate "training set" in the traditional sense of machine learning for classification or prediction tasks. Its functionality is based on established engineering principles and algorithms, not a trained model from a specific data set. The document refers to "Software Verification and Validation testing" which implies testing against requirements, not training data.
-
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm that predicts or classifies. The software's functionality is deterministic based on its programming and inputs (like imaging data and tracker signals).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Medtronic Navigation, Inc. Elizabeth Waite Sr. Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, CO 80027
Re: K170018
Trade/Device Name: StealthStation™ S8 ENT Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: April 21, 2017 Received: April 24, 2017
Dear Elizabeth Waite:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S 2017.05.19 09:23:52 -04'00'
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170018
Device Name StealthStation™ S8 ENT Software
The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- · Functional endoscopic sinus surgery (FESS)
- · Endoscopic skull base procedures
- Lateral skull base procedures
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
May 8, 2017
- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
- Elizabeth Waite Contact: Senior Regulatory Affairs Specialist Telephone number: (720) 890-2182 Fax: (720) 890-3500 Email: elizabeth.waite@medtronic.com
Rishi Sinha Regulatory Affairs Manager Telephone number: (720) 890-2485 Fax: (720) 890-3500 Email: rishi.k.sinha@medtronic.com
- Proprietary Trade Name: StealthStation™ S8 ENT Software II.
- III. Common Name: Stereotaxic instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II V.
- VI. Product Codes: PGW
VII. Product Description
The StealthStation™ ENT software helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The StealthStation™ ENT software runs on the StealthStation™ S8 Platform. The StealthStation system is an Image Guided System (IGS), comprised of a platform, clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
The ENT software can display patient images from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The
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surgeon may also use the ENT software to create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide.
VIII. Indications for Use
The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- · Functional endoscopic sinus surgery (FESS)
- Endoscopic skull base procedures
- · Lateral skull base procedures
IX. Identification of Legally Marketed Devices
Predicate: K153247-Fusion Compact Navigation System (ENT Software) Reference: K162309 - StealthStation S8 with StealthStation S8 Cranial Software
X. Comparison of the Technological Characteristics
| Item | Subject DeviceStealthStation™ S8 ENTSoftware | Predicate DeviceFUSION Compact™Navigation System(K153247) | Reference DeviceStealthstation S8 SystemPlatforms andStealthStation CranialSoftware (K162309) |
|---|---|---|---|
| Classification | Class II | Class II | Class II |
| Product Code | PGW | PGW | HAW, OLO, PGW |
| Intended/Indicationsfor Use | The StealthStation™System, withStealthStation™ ENTsoftware, is intended as anaid for locating anatomicalstructures in either open orpercutaneous ENTprocedures. Their use isindicated for any medicalcondition in which the useof stereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure, suchas the skull, can be | The Medtronic FUSIONCompact™ computer-assisted surgery system andits associated applicationsare intended as an aid forprecisely locating anatomicalstructures in either open orpercutaneous ENTprocedures. Their use isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and wherereference to a rigidanatomical structure, such as | The StealthStation™System, withStealthStation™ Cranialsoftware, is intended as anaid for locating anatomicalstructures in either open orpercutaneousneurosurgical procedures.Their use is indicated forany medical condition inwhich the use ofstereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure, such |
| Item | Subject DeviceStealthStation™ S8 ENTSoftware | Predicate DeviceFUSION Compact™Navigation System(K153247) | Reference DeviceStealthstation S8 SystemPlatforms andStealthStation CranialSoftware (K162309) |
| identified relative toimages of the anatomy.This can include, but is notlimited to, the followingprocedures:• Functional endoscopicsinus surgery (FESS)• Endoscopic skull baseprocedures• Lateral skull baseprocedures | the skull, can be identifiedrelative to a CT or MR basedmodel or digitized landmarksof the anatomy. | as the skull, can beidentified relative toimages of the anatomy.This can include, but is notlimited to, the followingcranial procedures(including stereotacticframe-based andstereotactic framealternatives-basedprocedures):• Tumor resections• Generalventricular catheterplacement• Pediatricventricular catheterplacement• Depth electrode,lead, and probe placement• Cranial biopsiesThe user should consultthe "NavigationalAccuracy" section of theUser Manual to assess ifthe accuracy of the systemis suitable for their needs. | |
| OperatingPrinciple | Electromagnetic | Electromagnetic | OpticalElectromagnetic |
| Accuracy Testing | Under representativeworst-case configurationthe StealthStation S8 ENTSoftware v1.0.0, hasdemonstrated performancein 3D positional accuracywith a mean error ≤ 2.0mm and in trajectory error≤ 2.0 degrees.Specific Mean AccuracyValuesPositional Error- 0.88mmTrajectory Error- 0.73° | Under representative worst-case configuration theFusion Compact ENTSoftware, has demonstratedperformance in 3D positionalaccuracy with a mean error ≤3.0 mm.Specific Mean AccuracyValuesPositional Error- 2.41mmTrajectory Error- Notapplicable | Under representativeworst-case configuration,the StealthStation S8System with StealthStationCranial v1.0.0 Software,has demonstratedperformance in 3Dpositional accuracy with amean error ≤ 2.0 mm andin trajectory angleaccuracy with a mean error≤ 2.0 degrees.Specific Mean AccuracyValuesOptical Results:Positional Error - 1.45mmTrajectory Error – 0.60°EM Results:Positional Error - 0.84mmTrajectory Error – 0.47° |
| Item | Subject DeviceStealthStation™ S8 ENTSoftware | Predicate DeviceFUSION Compact™Navigation System(K153247) | Reference DeviceStealthstation S8 SystemPlatforms andStealthStation CranialSoftware (K162309) |
| Mechanical Results:Positional Error – 1.48mmTrajectory Error – $0.39°$ | |||
| Imaging Modalities | X-Ray based, MR based,Nuclear Medicine based | X-Ray based, MR based,Nuclear Medicine based | X-Ray based, MR based,Nuclear Medicine based |
| View (Display)Features | 3D, 2D AnatomicOrthogonal (Coronal,Sagittal, Axial), VideoInput, Virtual Endoscopic,Trajectory 1 and 2, TargetGuidance, TrajectoryGuidance, Probe's Eye,Look Ahead | 3D, 2D AnatomicOrthogonal (Coronal,Sagittal, Axial), Video Input | Ultrasound Video In,Ultrasound Overlay,3D, 2D AnatomicOrthogonal,Trajectory 1 and 2, TargetGuidance, TrajectoryGuidance, Probes Eye,Look Ahead, MicroscopeInjection, Video Input,Endoscopic |
| Exam-to-ExamRegistration Features | Identity MergeRegistration, ManualMerge Registration andAutomatic MergeRegistration | Identity Merge Registration,Manual Merge Registrationand Automatic MergeRegistration | Identity MergeRegistration, ManualMerge Registration andAutomatic MergeRegistration |
| Patient RegistrationFeatures | PointMerge® registration,Tracer™ registration,Touch registration(previously Touch-N-GoTM) | PointMerge® registration,Tracer™ registration | PointMerge® registration(referred to as Landmarkregistrations), Tracer™registration, Touchregistration (previouslyTouch-N-Go™),StealthAiR® registration,O-arm® registration,Mechanical basedregistrations (StereotacticLocalizer Registration andStarFix™ Bone AnchorRegistration) |
| Planning Features | Plan Entry and TargetSelection, 3D ModelBuilding, AdvancedVisualization | Not Available | Plan Entry and TargetSelection3D Model BuildingAdvanced VisualizationCreate Patient BasedAnatomical CoordinateSpaceStereotactic FrameSettingsBrain Atlas:Schaltenbrand-WahrenAtlas with Talairach GridSTarFix™ DesignerAnnotations |
| Scanner InterfaceTechnology (toimaging devices) | Network ConnectivityCD, DVD, USBDICOM Import | Network ConnectivityCD, DVD, USBDICOM Import | Network ConnectivityCD, DVD, USBDICOM Import |
| Item | Subject DeviceStealthStation™ S8 ENTSoftware | Predicate DeviceFUSION Compact™Navigation System(K153247) | Reference DeviceStealthstation S8 SystemPlatforms andStealthStation CranialSoftware (K162309) |
| Software Interface(GUI) | DICOM ExportBlack and gray style withprocedure task overview inleft menu option andnext/back task flow atbottom of the screen.Software controls forimages, planning andinstrument managementare contained in a rightside bar. | DICOM ExportBlue style withchronological next/back taskflow at the top of the screen.Image controls on the left.Planning information on theright. | DICOM ExportBlack and gray style withprocedure task overview inleft menu option andnext/back task flow atbottom of the screen.Software controls forimages, planning andinstrument managementare contained in a right-side bar. |
| ProgrammingLanguage | C++ | C++ | C++ |
| Compatible Platform | StealthStation S8Platforms including thePlanning Station | Fusion Compact Platform | StealthStation S8Platforms including thePlanning Station |
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XI. Discussion of the Performance Testing
Testing conducted demonstrates the software will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthStation™ S8 ENT Software to establish substantial equivalence of the software and verify that the device will perform as intended meeting all of the design inputs:
- . Software Verification and Validation testing using a production equivalent StealthStation S8 Platform verifying the software requirements are met and software performs as intended.
- Software Verification and Validation testing using a production equivalent StealthStation S8 Platform verifying that the software performs as intended when running on the StealthStation S8 Platform.
- . Usability Testing was conducted in accordance to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" demonstrating that the usability and human factors requirements were adequately met.
The following table summarizes the testing conducted on the StealthStation ™ S8 ENT v1.0.0 Software:
Description
Under representative worst-case configuration, the StealthStation S8 ENT Software, has demonstrated performance in 3D positional accuracy with a mean error < 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.
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The test configurations included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm. In the imaging protocol, we recommend slice spacing and thickness for CT and MR imaging to be 1.0 mm or less.
Software verification and validation testing for each requirement specification. Software verification and validation testing using a production equivalent
StealthStation S8 Platform.
System integration performance testing for ENT surgical procedures using anatomical phantoms.
The following table summarizes the quality assurance measures that were applied during development of the software component of the system:
| Description |
|---|
| Software Development Life Cycle |
| Software Risk Assessment |
| Software Configuration Management and Version Control |
Design verification and validation was performed using the StealthStation S8 ENT software in laboratory and simulated use settings. The results demonstrate that the software should perform as intended in the specified use conditions.
Clinical testing was not considered necessary prior to release as this is not new technology.
XII. Conclusions
The changes to the subject device. StealthStation S8 ENT Software include: software enhancement modifications to the patient registration feature set, the introduction of additional views displayed by the software, and the introduction of the planning feature set. Bench testing has been conducted to evaluate the overall performance of the software with these modifications and results confirm that the device performs as intended and in a similar manner compared to the predicate and reference devices.
The StealthStation S8 ENT software intended use, technology and performance are equivalent between the subject and predicate and reference devices. Verification and validation testing results confirm there are no new or different questions of safety or effectiveness. The changes do not represent a new intended use, and do not affect the control mechanism, or operating principle. The information presented in this submission supports the subject device to be as safe and effective as the predicate and reference devices, and therefore supports a determination of substantial equivalence.
The StealthStation S8 ENT Software has been shown through comparison and testing to be substantially equivalent to the identified predicate and reference devices.
§ 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).