Who is the manufacturer of StealthStation S8 Cranial v2.0?

Medtronic Navigation filed the 510(k) submission for StealthStation S8 Cranial v2.0 (K212397).

What is the FDA product code for StealthStation S8 Cranial v2.0?

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

What is the regulatory pathway for StealthStation S8 Cranial v2.0?

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

Who can help prepare an FDA 510(k) submission like StealthStation S8 Cranial v2.0?

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 S8 Cranial v2.0

Q: What are the predicate devices for StealthStation S8 Cranial v2.0?

StealthStation S8 Cranial Software v1.3.2 (K203639).

K212397 · Medtronic Navigation · HAW · Dec 22, 2021 · Neurology

Device Facts

Record ID	K212397
Device Name	StealthStation S8 Cranial v2.0
Applicant	Medtronic Navigation
Product Code	HAW · Neurology
Decision Date	Dec 22, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2
Attributes	Pediatric

Intended Use

The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical 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 cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): - Tumor resections - General ventricular catheter placement - Pediatric ventricular catheter placement - Depth electrode, lead, and probe placement - Cranial biopsies

Device Story

Image-guided surgery system (IGS) tracking surgical instruments relative to patient anatomy; utilizes optical or electromagnetic tracking. Inputs: diagnostic/intraoperative images (X-ray, MR, nuclear medicine), dMRI data. Processing: registers patient anatomy to images; creates 3D fiber tract models from dMRI data (Stealth Tractography); provides navigation overlays. Output: real-time instrument position on images; 3D white matter tract visualizations. Used in OR by neurosurgeons. Benefits: aids anatomical localization, surgical planning, and intraoperative guidance; supports clinical decision-making via visualization of critical structures.

Clinical Evidence

Bench testing only. Performance validated using anatomically representative phantoms; 3D positional accuracy mean error ≤ 2.0 mm; trajectory angle accuracy mean error ≤ 2.0 degrees. Software V&V confirmed requirements met. Summative usability validation and clinical expert evaluations performed on pediatric and adult datasets (normal/abnormal brains) confirmed safety, effectiveness, and utility of dMRI tractography for treatment planning and navigation.

Technological Characteristics

Stereotaxic instrument (21 CFR 882.4560). Components: clinical software, surgical instruments, referencing system, platform hardware. Tracking: optical (NDI Vega) or electromagnetic (Medtronic AxiEM III). Connectivity: DICOM import/export, network, CD/DVD/USB. Software: C++/Java. Imaging: X-ray, MR, nuclear medicine. Features: dMRI tractography (Standard DTI/Enhanced CSD), 3D model building, stereotactic frame support, microscope/ultrasound integration.

Indications for Use

Indicated for patients undergoing open or percutaneous neurosurgical procedures where stereotactic surgery is appropriate and rigid anatomical structures (e.g., skull) can be referenced to images. Includes tumor resections, ventricular catheter placement (general/pediatric), depth electrode/lead/probe placement, and cranial biopsies.

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 S8 Cranial Software v1.3.2 (K203639)

Reference Devices

StealthViz Advanced Planning Application with StealthDTI Package (K081512)

Related Devices

K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 · Medtronic Navigation, Inc. · Jun 10, 2022
K162309 — StealthStation S8 System Platforms and StealthStation Cranial Software · Medtronic Navigation, Inc. · Mar 31, 2017
K150216 — Synergy Cranial · Medtronic Navigation, Inc. · Jun 11, 2015
K153660 — StealthStation System with Cranial Software · Medtronic Navigation, Inc. · Sep 14, 2016
K230087 — POINT Kinguide Agile Hybrid Navigation System · Point Robotics MedTech, Inc. · Jul 17, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 22, 2021 Medtronic Navigation Carey Brenner Sr. Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027 Re: K212397 Trade/Device Name: StealthStation S8 Cranial v2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 3, 2021 Received: November 5, 2021 Dear Carey Brenner: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 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) K212397 Device Name StealthStation S8 Cranial v2.0 ### Indications for Use (Describe) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical 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 cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): - · Tumor resections - General ventricular catheter placement - Pediatric ventricular catheter placement - · Depth electrode, lead, and probe placement - · Cranial biopsies | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |-------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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}------------------------------------------------ ## 510(k) Summary - l. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 - Contact: Carey Brenner (Primary) Senior Requlatory Affairs Specialist Telephone Number: 720.352.1146 Fax Number: 720,890,3500 Email: carey.j.brenner@medtronic.com Rishi Sinha Director Requlatory Affairs Telephone number: 720.890.2485 Fax: 720.890.3500 Email: rishi.k.sinha@medtronic.com - II. Proprietary Trade Name: StealthStation S8 Cranial Software v2.0 Stealth Tractography - 111. Classification Name: Stereotaxic Instrument (21 CFR 882.4560) - IV. Classification: Class II, Stereotaxic Instrument - V. Product Codes: HAW #### VI. Predicate Device StealthStation™ S8 Cranial Software v1.3.2, K203639 Reference Device: StealthViz™ Advanced Planning Application with StealthDTI™ Package, K081512 #### VII. Product Description The StealthStation™ Cranial Software v2.0 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. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking. 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. The changes to the currently cleared StealthStation™ S8 Cranial Software are as follows: - Addition of white matter tractography (WMT) fiber tract creation for the brain referred to as diffusion Magnetic Resonance Imaging (dMRI) tractography. dMRI tractography will process diffusion-weighted MRI data into 3D fiber tract models that represent whitematter tracts. This will be marketed as a software option called Stealth™ Tractography. {4}------------------------------------------------ - Addition of the Medtronic SenSight™ directional DBS lead to the existing . list of view overlays. - Minor changes to the software were made to address user preferences and to fix ● minor anomalies. #### VIII. Indications for Use The StealthStation™ System, with StealthStation™ Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical 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 cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): - · Tumor resections - · General ventricular catheter placement - Pediatric ventricular catheter placement - · Depth electrode, lead, and probe placement - · Cranial biopsies #### IX. Comparison of the Technological Characteristics | Attribute | Subject Device Cranial Software version 2.0 | Predicate Device Cranial Software (K203639) | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 as an aid for locating anatomical structures in either open or percutaneous neurosurgical 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 cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): • Tumor resections • General ventricular catheter placement • Pediatric ventricular catheter placement • Depth electrode, lead, and probe placement • Cranial biopsies | The StealthStation™ System, with StealthStation™ Cranial Software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical 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 cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): • Tumor resections • General ventricular catheter placement • Pediatric ventricular catheter placement • Depth electrode, lead, and probe placement • Cranial biopsies | | System Accuracy Requirement | Under representative worst-case configuration, the StealthStation™ S8 System with StealthStation™ Cranial v2.0 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 degree. | Under representative worst-case configuration, the StealthStation™ S8 System with StealthStation™ 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° | | Attribute | Subject Device Cranial Software version 2.0 | Predicate Device Cranial Software (K203639) | | Imaging Modalities | X-Ray based, MR based, Nuclear Medicine based | X-Ray based, MR based, Nuclear Medicine based | | 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, Endoscopic | 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, Endoscopic | | Exam-to-Exam Registration Features | Identity Merge Registration, Manual Merge Registration and Automatic Merge Registration | Identity Merge Registration, Manual Merge Registration and Automatic Merge Registration | | Patient Registration Features | PointMerge™ registration (referred to as Landmark registrations), Tracer™ registration, Touch registration (previously Touch-N-Go™), StealthAiR™ registration, O-arm™ registration, Mechanical based registrations (Stereotactic Localizer Registration and StarFix™ Bone Anchor Registration) | PointMerge™ registration (referred to as Landmark registrations), Tracer™ registration, Touch registration (previously Touch-N-Go™), StealthAiR™ registration, O-arm™ registration, Mechanical based registrations (Stereotactic Localizer Registration and StarFix™ Bone Anchor Registration) | | Planning Features | 3D Model Building, including fiber tracts with Standard DTI and Enhanced CSD techniques Plan Entry and Target Selection Advanced Visualization Create Patient Based Anatomical Coordinate Space Stereotactic Frame Settings Brain Atlas: Schaltenbrand- Wahren Atlas with Talairach Grid STarFix™ Designer Annotations | 3D Model Building (which includes DTI fiber tracts imported from StealthViz) Plan Entry and Target Selection 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 Elekta Leksell Nexframe® Stereotactic System STarFix™Platform System | Microscope Navigation: Zeiss, Leica Ultrasound Navigation: Aloka and Sonosite Medtronic O-arm® Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell Nexframe® Stereotactic System STarFix™Platform System | | Compatible Medtronic Optical Instrumentation | Medtronic instruments tracked via optical markers or LEDs located on instrument and patient trackers via the optical localizing system. | Medtronic instruments tracked via optical markers or LEDs located on instrument and patient trackers via the optical localizing system. | | Attribute | Subject Device Cranial Software with dMRI Tractography | Predicate Device Cranial Software (K203639) | | Compatible Medtronic EM Instrumentation | Medtronic instruments tracked via Electromagnetic localization technology located within the instrument and patient trackers | Medtronic instruments tracked via Electromagnetic localization technology located within the instrument and patient trackers | | Software Interface (GUI) | Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management and tractography editing are contained in a right side bar. | Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management are contained in a right side bar. | | Programming Language | C++/Java | 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 | | Optical Technology | Manufacturer: (Northern Digital Inc.) Localizer: Vega | Manufacturer: (Northern Digital Inc.) Localizer: Vega | | Electromagnetic Technology | Manufacturer: (Medtronic Navigation, Inc.) Localizer: AxiEM III Emitter Types: Side, Flat | Manufacturer: (Medtronic Navigation, Inc.) Localizer: AxiEM III Emitter Types: Side, Flat | {5}------------------------------------------------ {6}------------------------------------------------ #### X. Discussion of the Performance Testing The following table summarizes the testing conducted on the StealthStation™ Cranial Software v2.0 ### Description Under representative worst-case confiquration, the StealthStation™ S8 System with StealthStation™ Cranial Software v2.0 has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error of ≤ 2.0 degrees. This performance was determined using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components. Software verification and validation testing verified the software requirements are met and the software performs as intended. Summative usability validation and clinical expert evaluation were performed by representative users on datasets not used for development, composed of normal and abnormal brains in both pediatric and adult populations. Summative evaluations demonstrated StealthStation™ Cranial Software v2.0 with Stealth™ Tractography has been found to be safe and effective for the intended users, uses and use environments. Performance testing demonstrated the design and implementation of the correct creation and rendering of dMRI tracts in views in the application and the functionality of the dMRI tractography feature requirements. Clinical expert evaluations included white matter tract generation and editing which are new in the StealthStation™ S8 software. Clinical experts assessed the rendering of the white matter tracts and their relationship to other key structures with respect to treatment planning, intraoperative navigation and the potential to aid clinical decision making. {7}------------------------------------------------ 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 v2.0 has been found through performance testing and comparison to be substantially equivalent to the identified predicate device. Performance testing in combination with the clinical expert evaluation demonstrates the StealthStation™ Cranial v2.0 software performs as intended and demonstrates substantial equivalence to the predicate device.