Who is the manufacturer of StealthStation Cranial Software v1.3.0?

Medtronic Navigation, Inc. filed the 510(k) submission for StealthStation Cranial Software v1.3.0 (K201175).

What is the FDA product code for StealthStation Cranial Software v1.3.0?

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 Cranial Software v1.3.0?

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

Who can help prepare an FDA 510(k) submission like StealthStation Cranial Software v1.3.0?

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 Cranial Software v1.3.0

Q: What are the predicate devices for StealthStation Cranial Software v1.3.0?

StealthStation S8 Cranial Software v1.0.0 (K162309).

K201175 · Medtronic Navigation, Inc. · HAW · Jun 3, 2020 · Neurology

Device Facts

Record ID	K201175
Device Name	StealthStation Cranial Software v1.3.0
Applicant	Medtronic Navigation, Inc.
Product Code	HAW · Neurology
Decision Date	Jun 3, 2020
Decision	SESE
Submission Type	Special
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.

Device Story

StealthStation Cranial Software v1.3.0 is an image-guided surgery (IGS) system component. It processes diagnostic or intraoperative images (X-ray, MR, Nuclear Medicine) to track surgical instruments in real-time relative to patient anatomy. The system uses optical or electromagnetic tracking to update instrument positions on a display. Used in ORs by neurosurgeons, the software provides registration, planning, and navigation visualization. It aids surgeons in locating anatomical structures, guiding instrument trajectories, and performing biopsies or resections. By providing continuous visual feedback of instrument position relative to pre-operative or intra-operative imaging, the device assists in precise surgical navigation, potentially improving accuracy and patient outcomes in cranial procedures.

Clinical Evidence

Bench testing only. No clinical data. Performance validated using anatomically representative phantoms under worst-case configurations. Software verification and validation testing performed for all requirement specifications. System integration performance testing confirmed accuracy metrics (3D positional error ≤ 2.0 mm; trajectory angle error ≤ 2.0 degrees).

Technological Characteristics

Software-based IGS system. C++ programming language. Supports X-ray, MR, and Nuclear Medicine imaging. Connectivity via network, CD, DVD, USB; DICOM compliant. Optical tracking (Northern Digital Vega) and electromagnetic tracking (Medtronic AxiEM III). Integrates with various stereotactic frames and surgical instruments. Software features include registration (PointMerge, Tracer, Touch, StealthAiR, O-arm, mechanical), 3D model building, and brain atlas integration.

Indications for Use

Indicated for patients undergoing neurosurgical procedures where stereotactic surgery is appropriate, including tumor resections, ventricular catheter placement (general and 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 v1.0.0 (K162309)

Related Devices

K203639 — StealthStation Cranial Software v1.3.2 · Medtronic Navigation, Inc. · Jan 13, 2021
K150216 — Synergy Cranial · Medtronic Navigation, Inc. · Jun 11, 2015
K231976 — StealthStation Cranial Software, v3.1.5 (9735585) · Medtronic Navigation, Inc. · Oct 19, 2023
K153660 — StealthStation System with Cranial Software · Medtronic Navigation, Inc. · Sep 14, 2016
K190672 — StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 · Medtronic Navigation, Inc. · Jul 31, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 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. June 3, 2020 Medtronic Navigation Inc. Amelia Striegel Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027 Re: K201175 Trade/Device Name: StealthStation Cranial Software v1.3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: April 30, 2020 Received: May 1, 2020 Dear Amelia Striegel: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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, Adam D. Pierce Acting 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) ### K201175 Device Name StealthStation™ Cranial Software v1.3.0 ### 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) | <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> <path d="M2,2 L10,10 M2,10 L10,2" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| cription 65c (Part 21 CFR 601 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}------------------------------------------------ # 510(k) Summary 30 April 2020 - l. Company: Medtronic Navigation. Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 - Amelia Striegel (Primary) Contact: Senior Regulatory Affairs Specialist Telephone Number: 720.890.2528 Fax Number: 720.890.3500 K. Elizabeth Waite Regulatory Affairs Manager Telephone number: 720.890.2182 Fax: 720.890.3500 Email: elizabeth.waite@medtronic.com - Proprietary Trade Name: StealthStation™ Cranial Software v1.3.0 II. - lll. Classification Name: Stereotaxic Instrument (21 CFR 882.4560) - IV. Classification: Class II, Stereotaxic Instrument - V. Product Codes: HAW - VI. Predicate Device 510(k): K162309 Device name: StealthStation S8 Cranial Software v1.0.0 Manufacturer: Medtronic Navigation, Inc. #### VII. Product Description The StealthStation™ Cranial Software v1.3.0 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 an optional image display that allows the user to see through outer layers to increase the visibility of other models. {4}------------------------------------------------ - . Update the imaging protocol to support overlapping slices. - . 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 | Feature | StealthStation Cranial Software v1.3.0 (Subject Device) | StealthStation S8 Cranial software v1.0.0 (Predicate Device; K162309) | |---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The StealthStationTM System, with StealthStationTM 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. | | Feature | StealthStation Cranial Software v1.3.0 (Subject Device) | StealthStation S8 Cranial software v1.0.0 (Predicate Device; K162309) | | 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. | 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 | 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 Requirements | Under representative worst-case configuration, the StealthStation S8 System with StealthStation Cranial Software v1.3.0, 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. | Under representative worst-case configuration, the StealthStation S8 System with StealthStation Cranial v1.0.0 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. | | 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 | | Feature | StealthStation Cranial Software v1.3.0 (Subject Device) | StealthStation S8 Cranial software v1.0.0 (Predicate Device; K162309) | | 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 | PointMergeTM registration (referred to as Landmark registrations), TracerTM registration, Touch registration (previously Touch-N- GoTM), StealthAiRTM registration, O- armTM registration, Mechanical based registrations (Stereotactic Localizer Registration and StarFixTM Bone Anchor Registration) | PointMerge® registration (referred to as Landmark registrations), TracerTM registration, Touch registration (previously Touch-N- GoTM), StealthAiR® registration, O- arm® registration, Mechanical based registrations (Stereotactic Localizer Registration and StarFixTM 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 STarFixTM 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 STarFixTM Designer Annotations | | Medical Device Interfaces | Microscope Navigation: Zeiss, Leica Ultrasound Navigation: Aloka and Sonosite Medtronic O-armTM Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell NexframeTM Stereotactic System STarFixTMPlatform System Stealth Midas Rex MR8 StealthStation Autoguide | 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 STarFixTMPlatform 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. | | 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 | | Feature | StealthStation Cranial Software v1.3.0 (Subject Device) | StealthStation S8 Cranial software v1.0.0 (Predicate Device; K162309) | | 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 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++ | 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}------------------------------------------------ {7}------------------------------------------------ #### Identification of Legally Marketed Devices X. StealthStation S8 Cranial Software v1.0.0 (K162309) #### XI. Discussion of the Performance Testing The following table summarizes the testing conducted on the StealthStation Cranial Software v1.3.0 ### Description Under representative worst-case configuration, the StealthStation S8 System with StealthStation Cranial Software v1.3.0 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 for each requirement specification. 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 | {8}------------------------------------------------ Design verification and validation was performed using the StealthStation S8 System with StealthStation Cranial Software v1.3.0 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. Clinical testing was not considered necessary prior to release as this is not new technology. #### XII. Conclusions The StealthStation Cranial Software v1.3.0 has been shown through testing and comparison to be substantially equivalent to the identified predicate device.