What is the FDA product code for StealthStation S8 System Platforms and StealthStation Cranial Software?

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 System Platforms and StealthStation Cranial Software?

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

What are the predicate devices for StealthStation S8 System Platforms and StealthStation Cranial Software?

Synergy Cranial 3.0 Software (K153660); StealthStation System Update (K050438); StealthStation System Update (K133444).

Who can help prepare an FDA 510(k) submission like StealthStation S8 System Platforms and StealthStation Cranial Software?

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 System Platforms and StealthStation Cranial Software

Q: Who is the manufacturer of StealthStation S8 System Platforms and StealthStation Cranial Software?

Medtronic Navigation, Inc. filed the 510(k) submission for StealthStation S8 System Platforms and StealthStation Cranial Software (K162309).

K162309 · Medtronic Navigation, Inc. · HAW · Mar 31, 2017 · Neurology

Device Facts

Record ID	K162309
Device Name	StealthStation S8 System Platforms and StealthStation Cranial Software
Applicant	Medtronic Navigation, Inc.
Product Code	HAW · Neurology
Decision Date	Mar 31, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2
Attributes	Pediatric

Indications for Use

The StealthStation™ System, with Station™ 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 user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

Device Story

Image-guided surgery system (IGS) for neurosurgery; tracks surgical instruments relative to patient anatomy using optical or electromagnetic (EM) localization. Inputs: diagnostic/intraoperative images (CT, MR, X-ray, nuclear medicine). Operation: surgeon uses system to register patient anatomy to images; software displays instrument position in real-time on 2D/3D views. Features: planning, registration (PointMerge, Tracer, Touch, StealthAiR, O-arm, mechanical), and interfaces with microscopes/ultrasound. Output: visual navigation guidance on display. Used in OR by neurosurgeons to assist in precise instrument placement for biopsies, resections, and catheter/lead placement. Benefits: improved anatomical localization accuracy; facilitates minimally invasive approaches.

Clinical Evidence

No clinical data. Bench testing only. Performance validated using anatomically representative phantoms in simulated use settings. 3D positional accuracy mean error ≤ 1.48 mm and trajectory angle error ≤ 0.60 degrees across optical, EM, and mechanical localization modes. Testing confirmed compliance with AAMI/ANSI ES 60601-1 and IEC 60601-1-2.

Technological Characteristics

Intel-based PC running Ubuntu Linux. Optical (Vega localizer) and EM (AxiEM III) tracking. Connectivity: Ethernet, 2.4/5.0 GHz wireless, DICOM import/export. Software: C++ based. Interfaces: Microscope (Zeiss, Leica), Ultrasound (Aloka, Sonosite), O-arm, stereotactic frames (Fischer, Integra, Elekta, Nexframe, STarFix).

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 imaging. 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

Synergy Cranial 3.0 Software (K153660)
StealthStation System Update (K050438)
StealthStation System Update (K133444)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 31, 2017 Medtronic Navigation, Inc. Tia Fushimi-Bain Sr Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027 Re: K162309 Trade/Device Name: Stealthstation S8 System Platforms and StealthStation Cranial Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO, PGW Dated: August 16, 2016 Received: August 17, 2016 Dear Ms. Fushimi-Bain: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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, Michael J. Hoffmann -S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K162309 Device Name StealthStation S8 System with StealthStation Cranial software Indications for Use (Describe) The StealthStation™ System, with Station™ 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 user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs. Type of Use (Select one or both, as applicable) > 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) K162309 Device Name StealthStation S8 System Platform ### Indications for Use (Describe) The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. 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) ### 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ # 510(k) Summary # March 31, 2017 - l. Company: Medtronic Navigation. Inc. 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3200 - Contact: Tia Fushimi-Bain Senior Regulatory Affairs Specialist Telephone number: (720) 890-2178 Fax: (763) 367-2075 Email: tia.k.fushimi-bain@medtronic.com Elizabeth Waite Senior Regulatory Affairs Specialist Telephone number: (720) 890-2182 Fax: (720) 890-3500 Email: elizabeth.waite@medtronic.com - ll. Proprietary Trade Name: StealthStation™ S8 Platform with StealthStation™ Cranial Software - lll. Common Name: Stereotaxic Instrument - IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560) - Classification: Class II V. - VI. Product Code: HAW - VII. Product Description: The StealthStation™ S8 System, with StealthStation™ Cranial v1.0.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation™ Cranial v1.0.0 software (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 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. #### VIII. Indications for Use: The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System is {5}------------------------------------------------ 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The StealthStation™ System, with Station™ 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 user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs. #### IX. Identification of Leqally Marketed Devices (Predicate Devices): K153660 - Synergy Cranial 3.0 Software K050438 - StealthStation™ System Update K133444 - StealthStation™ System Update #### X. Comparison of the Technological Characteristics: | Item | Subject Device | Software Predicate | Platform Predicate | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Cranial 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, Synergy Cranial 3.0 Software The StealthStation® System, with StealthStation® Cranial software is designed as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. | K050438, StealthStation™ System Update The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. | | | StealthStation S8 Platform The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous surgical procedures. | | | | Item | Subject Device | Software Predicate | Platform Predicate | | 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 user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs. | K153660, Synergy Cranial 3.0 Software 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 (including stereotactic) - Deep brain stimulation (DBS) lead placement - Depth electrode placement - Tumor Resections Craniotomies/Craniectomi es - Skull Base Procedures - Transsphenoidal Procedures Thalamotomies/Pallidotom ies - Pituitary Tumor Removal - CSF Leak Repair - Pediatric Ventricular Catheter Placement - General Ventricular Catheter Placement | K050438, StealthStation™ System Update The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | | System Accuracy Requirement | Under representative worst-case configuration, the StealthStation S8 System with StealthStation Cranial v1.0.0 Software, | K153660, Synergy Cranial 3.0 Software Under representative worst-case configuration, the StealthStation® | Not Applicable | | Item | Subject Device | Software Predicate | Platform Predicate | | | has demonstrated performance in 3D positional accuracy with a mean error $\leq$ 2.0 mm and in trajectory angle accuracy with a mean error $\leq$ 2.0 degrees. | System with StealthStation® Cranial v3.0 Software, has demonstrated performance in 3D positional accuracy with a mean error $\leq$ 2.0 mm and in trajectory angle accuracy with a mean error $\leq$ 2.0 degrees. | | | Imaging Modalities | X-Ray based, MR based, Nuclear Medicine based | K153660, Synergy Cranial 3.0 Software X-Ray based, MR based, Nuclear Medicine based | Not Applicable | | 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 | K153660, Synergy Cranial 3.0 Software 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 | Not Applicable | | Exam-to-Exam Registration Features | Identity Merge Registration, Manual Merge Registration and Automatic Merge Registration | K153660, Synergy Cranial 3.0 Software Identity Merge Registration, Manual Merge Registration and Automatic Merge Registration. | Not Applicable | | 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) | K153660, Synergy Cranial 3.0 Software PointMerge® registration, Tracer™ registration, Touch-N-Go™ registration, StealthAiR® registration, O-arm® registration, Stereotactic Localizer Registration and StarFix™ Bone Anchor Registration | Not Applicable | | Planning Features | Plan Entry and Target Selection 3D Model Building Advanced Visualization | K153660, Synergy Cranial 3.0 Software Plan Entry and Target Selection 3D Model Building Advanced Visualization | Not Applicable | | Item | Subject Device | Software Predicate | Platform Predicate | | | Create Patient Based Anatomical Coordinate Space Stereotactic Frame Settings Brain Atlas: Schaltenbrand-Wahren Atlas with Talairach Grid STarFix™ Designer Annotations | 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 | K153660, Synergy Cranial 3.0 Software 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 | Not Applicable | | Compatible Medtronic Optical Instrumentation | Medtronic instruments tracked via optical markers or LEDs located on instrument and patient trackers via the optical localizing system. | K153660, Synergy Cranial 3.0 Software Medtronic instruments tracked via optical markers or LEDs located on instrument and patient trackers via the optical localizing system | K050438 StealthStation™ System Update StealthStation S7 supports optical instrumentation compatible with StealthStation software via optical localization. | | Compatible Medtronic EM Instrumentation | Medtronic instruments tracked via electromagnetic localization technology located within the instrument and patient trackers | K153660, Synergy Cranial 3.0 Software Medtronic instruments tracked via electromagnetic localization technology located within the instrument and patient trackers | K050438 StealthStation™ System Update StealthStation S7 supports EM instrumentation compatible with StealthStation software via EM localization. | | 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. | K153660, Synergy Cranial 3.0 Software Blue style with chronological next/back task flow at the top of the screen. Image controls on the left. Planning information on the right. | Not Applicable | | Item | Subject Device | Software Predicate | Platform Predicate | | Programming Language | C++ | K153660, Synergy Cranial 3.0 Software C++ | Not Applicable | | Scanner Interface Technology (to imaging devices) | Network Connectivity CD, DVD, USB DICOM Import DICOM Export | K153660, Synergy Cranial 3.0 Software Network Connectivity CD, DVD, USB DICOM Import DICOM Export | Not Applicable | | Optical Technology | Manufacturer: Identical (Northern Digital Inc.) Localizer: Vega | K153660, Synergy Cranial 3.0 Software Optical (infra-red) | K050438, StealthStation™ System Update Manufacturer: Northern Digital Inc. Localizer: Polaris | | Electromagnetic Technology | Manufacturer: Identical (Medtronic Navigation, Inc.) Localizer: AxiEM III Emitter Types: Side, Flat | K153660, Synergy Cranial 3.0 Software Electromagnetic Mechanical based stereotactic | K050438, StealthStation™ System Update Manufacturer: Medtronic Navigation, Inc. Localizer: AxiEM Emitter Types: Side…

StealthStation S8 System Platforms and StealthStation Cranial Software

Device Facts

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Device Story

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StealthStation S8 System Platforms and StealthStation Cranial Software

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

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Identification

Predicate Devices

Submission Summary (Full Text)

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