Who can help prepare an FDA 510(k) submission like StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

Q: Who is the manufacturer of StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

Medtronic Navigation, Inc. filed the 510(k) submission for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 (K190672).

Q: What is the FDA product code for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

HAW. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

510(k) clearance (submission type: Traditional).

K190672 · Medtronic Navigation, Inc. · HAW · Jul 31, 2019 · Neurology

Device Facts

Record ID	K190672
Device Name	StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
Applicant	Medtronic Navigation, Inc.
Product Code	HAW · Neurology
Decision Date	Jul 31, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

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 StealthStation® Cranial software is designed as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Device Story

StealthStation System is an image-guided surgical navigation platform. It integrates diagnostic images (CT, MR, Nuclear Medicine) to track surgical instruments relative to patient anatomy. The system uses optical (infrared) or electromagnetic localization to provide real-time guidance. Surgeons use the software for preoperative planning, target selection, and intraoperative visualization. The system displays 2D/3D anatomical views, trajectory guidance, and instrument position. It is used in neurosurgical settings (OR) by surgeons to improve precision in procedures like biopsies, resections, and lead placements. The output aids clinical decision-making by providing visual confirmation of instrument location relative to planned targets, potentially reducing surgical invasiveness and improving accuracy.

Clinical Evidence

Bench testing only. Performance validated using anatomically representative phantoms under worst-case configurations. Primary endpoints were 3D positional accuracy and trajectory angle accuracy. Results demonstrated mean positional error ≤ 2.0 mm and mean trajectory angle error ≤ 2.0 degrees. Software verification and validation performed in laboratory and simulated use settings.

Technological Characteristics

Software-based surgical navigation system. Localization via optical (infrared) or electromagnetic tracking. Interfaces with imaging modalities (CT, MR, Nuclear Medicine) via DICOM. Supports various registration methods (PointMerge, Tracer, Touch-N-Go, StealthAiR, O-arm, Stereotactic Localizer, StarFix). Programming language: C++. Connectivity: Network, CD, DVD, USB.

Indications for Use

Indicated for patients undergoing open or percutaneous neurosurgical procedures where reference to rigid anatomical structures can be identified relative to images. Includes cranial biopsies, tumor resections, craniotomies/craniectomies, skull base procedures, transsphenoidal procedures, thalamotomies/pallidotomies, pituitary tumor removal, CSF leak repair, and ventricular catheter/lead/electrode placement.

Regulatory Classification

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.

Predicate Devices

StealthStation System with Synergy Cranial v2.2.7 software (K150216)
StealthStation System with StealthStation Cranial v3.0 Software (K153660)

Related Devices

K150216 — Synergy Cranial · Medtronic Navigation, Inc. · Jun 11, 2015
K133444 — STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM · Medtronic Navigation, Inc. · Jul 25, 2014
K153660 — StealthStation System with Cranial Software · Medtronic Navigation, Inc. · Sep 14, 2016
K201175 — StealthStation Cranial Software v1.3.0 · Medtronic Navigation, Inc. · Jun 3, 2020
K203639 — StealthStation Cranial Software v1.3.2 · Medtronic Navigation, Inc. · Jan 13, 2021

Submission Summary (Full Text)

{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) | <div style="display:inline-block;"><input checked="true" type="checkbox"/></div> | | |----------------------------------------------------------------------------------|--| | <div style="display:inline-block;"><input type="checkbox"/></div> | | 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; - K150216, StealthStation System with Synergy Cranial v2.2.7 software ● - K153660, StealthStation System with StealthStation Cranial v3.0 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.