Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

{0}------------------------------------------------ February 16, 2023 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Stryker Corporation Bryan Hann Senior Staff Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, Baden-Wuerttemberg D-79111 Germany Re: K212194 Trade/Device Name: Cranial Guidance Software, Q Guidance System, CranialMask Tracker, EM Stylet, and Navigated Biopsy Needle Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 13, 2023 Received: January 17, 2023 Dear Bryan Hann: 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 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, Image /page/1/Picture/5 description: The image shows the name "Adam D. Pierce -S" in a large, sans-serif font. The text is arranged in two lines, with "Adam D." on the first line and "Pierce -S" on the second line. The letters are black against a white background, and there is a faint, light blue watermark in the background. Digitally signed by Adam D. Pierce -S Date: 2023.02.16 16:53:33 -05'00' 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}------------------------------------------------ 510(k) Number (if known) K212194 Device Name Cranial Guidance Software #### Indications for Use (Describe) The Stryker Q Guidance System, with the Cranial Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery. The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified. The system assists in the positioning of instruments for cranial procedures, including: - Cranial biopsies - Craniotomies - Craniectomies - Resection of tumors and other lesions - Skull base procedures - Transnasal neurosurgical procedures - Transphenoidal pituitary surgery - Craniofacial procedures - Skull reconstruction procedures - Orbital cavity reconstruction procedures - General ventricular catheter and shunt placement - Pediatric ventricular catheter and shunt placement 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 {3}------------------------------------------------ 510(k) Number (if known) K212194 Device Name Q Guidance System #### Indications for Use (Describe) The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> 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 {4}------------------------------------------------ 510(k) Number (if known) K212194 Device Name CranialMask Tracker Indications for Use (Describe) The Stryker CranialMask Tracker is intended to be used as an accessory to the Cranial Guidance software applications. It is intended to be placed on the patient's facial skin and used in combination with preoperative and intraoperative imaging devices to enable automatic patient registration for open or percutaneous computer-assisted surgery. The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial neurosurgical procedures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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 {5}------------------------------------------------ 510(k) Number (if known) K212194 Device Name EM Stylet #### Indications for Use (Describe) The Stryker EM Stylet is indicated for use as an accessory to the Q Guidance System when used with the Cranial Guidance Software and electromagnetic navigation. It is indicated for use in locating anatomical structures during navigated cranial procedures. The system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The 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, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy. The EM Stylet is indicated for use in the following procedures: - · General ventricular catheter and shunt placement - Pediatric ventricular catheter and shunt placement | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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 {6}------------------------------------------------ 510(k) Number (if known) K212194 Device Name Navigated Biopsy Needle #### Indications for Use (Describe) The Stryker Navigated Biopsy Needle is intended to be used as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software. It is a side cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula for use in the stereotaxic biopsy of cranial tissue. The Stryker Navigated Biopsy Needle may be used as part of the Stryker Cranial Guidance System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. | 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 {7}------------------------------------------------ # 510(k) SUMMARY ## A. Device Information | Category | Comments | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Stryker Leibinger GmbH & Co. KG<br>Bötzinger Straße 41<br>79111 Freiburg, Germany | | Correspondent Contact<br>Information: | Bryan K. Hann<br>1941 Stryker Way<br>Portage, MI 49002<br>(269) 366-9863 | | Device Common Name: | Stereotaxic Instruments | | Device Regulation & Name: | Regulation: 21 CFR 882.4560<br>Name: Neurologic Stereotaxic Instrument | | Classification & Product Code: | Classification: Class II<br>Product Code: HAW | | 510(k) Number: | K212194 | | Device Proprietary Name: | Q Guidance System with Cranial Guidance Software<br>including:<br>Calibration Body Passive Optical Pointers Passive Instrument Trackers Endoscope Tracker Instrument Clamps Patient Tracker Advanced Precision Targeting System Universal Base Skull Elbow 45° Mayfield Base with Articulating Arm Electromagnetic Patient Trackers and Tabs Electromagnetic Pointers Zeiss Microscope Tracker Q Guidance System<br>CranialMask Tracker<br>EM Stylet<br>Navigated Biopsy Needle | {8}------------------------------------------------ K212194 Page 2 of 17 | Predicate Device: | StealthStation S8 Cranial Software v2.0 Stealth Tractography | | | |---------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------| | | Medtronic StealthStation™ S8 System Platform | | | | | CranialMask Tracker | | | | | Stylet, 23 cm | | | | | MDT Navigable Brain Biopsy Cannula | | | | Predicate Device<br>Manufacturer: | Medtronic<br>Navigation, Inc. | StealthStation S8 Cranial Software v2.0<br>Stealth Tractography | | | | | Medtronic StealthStation™ S8 System<br>Platform | | | | | Stylet, 23 cm | | | | Stryker Leibinger<br>GmbH & Co. KG | CranialMask Tracker | | | | IZI Medical<br>Products | MDT Navigable Brain Biopsy Cannula | | | Predicate Device Common<br>Name | Stereotaxic Instruments | | | | Predicate Device Premarket<br>Notification # | StealthStation S8 Cranial Software v2.0 Stealth<br>Tractography | | K212397 | | | Medtronic StealthStation™ S8 System Platform | | K162309 | | | CranialMask Tracker | | K162929 | | | Stylet, 23 cm | | K141833 | | | MDT Navigable Brain Biopsy Cannula | | K143241 | | Predicate Device Classification<br>& Name | Regulation: 21 CFR 882.4560 | | | | | Name: Neurologic Stereotaxic Instrument | | | | Predicate Device Classification<br>& Product Code | Classification: Class II | | | | | Product Code: HAW | | | ## Predicate Device Information ## B. Date Summary Prepared February 15, 2023 {9}------------------------------------------------ #### C. Description of Device #### Q Guidance System with Cranial Guidance Software System Overview The O Guidance System with Cranial Guidance Software is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning instruments and locating patient anatomy during cranial surgery. The Q Guidance System with Cranial Guidance Software system is comprised of a computer platform. Cranial Guidance Software, navigated instruments (e.g., patient/ instrument trackers, pointers), and various system components. The system provides intraoperative guidance to the surgeon using electromagnetic, passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, electromagnetic field generator and box to plug in electromagnetic instruments, big touchscreen monitor, and a small touchscreen monitor. The Cranial Guidance Software is dedicated to cranial surgical procedures as defined in the indications for use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, pointers, suction tubes, seekers, etc. An instrument battery is required when a battery powered instrument or calibration device is used. The Cranial Guidance Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via electromagnetic or wireless optical tracking technology. The software provides the functions to perform the indicated navigated cranial surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated cranial surgical procedures. The Q Guidance System was initially cleared in premarket notification K220593. The only change to this device from its initial clearance is the addition of the electromagnetic tracking technology and the integration of the Zeiss Microscope using the Zeiss Microscope Tracker. The Cranial Guidance Software includes the following system components described below. #### . System Components - Passive Optical Navigation Instruments O - A The Calibration Body is used to validate and calibrate active and passive optically navigated instruments when used with the Cranial Guidance System. - A The Pointer, Straight and the Registration Pointer are optional system components to the Cranial Guidance Software. They include pins for the connection of reflective spheres that allow them to be tracked by the cranial guidance system. - A The Instrument Trackers connect to the Instrument Clamps and are optional system components of the Cranial Guidance System. {10}------------------------------------------------ They enable non-navigated surgical instruments to be tracked by the system. The Elbow, 45° can be used as an interface between the Instrument Trackers and Clamps to allow better visibility with the camera if needed due to patient or procedure setup. - A The Patient Tracker Advanced connects to the Universal Base Skull, which is a patient tracker fixating device, to allow the system to track the patient's head. - A The Endoscope Tracker can be connected to rigid endoscopes to enable tracking by the cranial guidance system. - A The Mayfield Base with Articulating Arm has a mechanical interface to the starburst connection on skull clamps. A Universal Tracker or an nGenius Universal Tracker can be attached to the Mayfield Base with Articulating Arm to enable tracking by the cranial guidance system. - > The Precision Targeting System is comprised of the Precision Targeting Guide, Tracker Sleeve, Needle Sleeve, Twist Drill Sleeve, and the Elite Drill Sleeve. When assembled as intended, the Precision Targeting System provides guidance of the Navigated Biopsy Needle, 3.2 mm Twist Drills, and Stryker's Signature Series of High-Speed Drills with Elite Attachments during drilling and biopsy of cranial tissue. - O Electromagnetic (EM) Navigation Instruments - A The Electromagnetic Pointers are electromagnetically navigated instruments for use in patient registration and locating patient anatomy during navigated cranial neurosurgical procedures when using electromagnetic navigation. - A The Patient Tracker EM - 10 Uses serves as a patient tracker when using electromagnetic navigation. It is fixed to the patient's skin using a double-sided adhesive pad called Patient Tracker Tab. - Zeiss Microscope Tracker O - A The Zeiss Microscope Tracker can be permanently attached to either a Zeiss Pentero or Kinevo microscope and is used to track the microscope during navigated cranial neurosurgical procedures. #### CranialMask Tracker The CranialMask Tracker is a sterile, single-use, non-invasive, flexible patient tracker. It is indicated as an optional accessory to the Cranial Guidance Software. The CranialMask {11}------------------------------------------------ #### K212194 Page 5 of 17 Tracker directly attaches to the patient's skin to provide non-invasive tracking of the patient's skull via an integrated tape. #### EM Stylet The EM Stylet is a single use instrument that is only compatible with the Q Guidance System with Cranial Guidance Software. It is used for ventricular catheter and shunt placement in adult and pediatric patients. #### Navigated Biopsy Needle The Navigated Biopsy Needle is currently cleared and marketed by IZI Medical Products for use with the Medtronic StealthStation per 510(k) number K143241. It includes a calibrated biopsy cannula that is used with the Precision Targeting System and the Cranial Guidance Software. It is used in stereotaxic biopsy of cranial tissue. The Navigated Biopsy Needle has the same design as its predicate device. It is a sterile, single-use, device that uses a side-cutting cannula within another cannula to biopsy cranial tissue. #### D. Indications for Use The indications for use for the subject devices are included in the table below. | Subject Device | Indications for Use | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cranial Guidance Software | The Stryker Q Guidance System, with the Cranial<br>Guidance Software, is intended as a planning and<br>intraoperative guidance system to enable open or<br>percutaneous computer-assisted surgery.<br>The system is indicated for any medical condition in<br>which the use of computer-assisted planning and surgery<br>may be appropriate. The system can be used for<br>intraoperative guidance where a reference to a rigid<br>anatomical structure can be identified.<br>The system assists in the positioning of instruments for<br>cranial procedures, including:<br>Cranial biopsies Craniotomies Craniectomies Resection of tumors and other lesions Skull base procedures Transnasal neurosurgical procedures Transsphenoidal pituitary surgery Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures General ventricular catheter and shunt placement | | Subject Device | Indications for Use | | | Pediatric ventricular catheter and shunt placement | | Q Guidance System | The Q Guidance System is intended as an aid for precisely<br>locating anatomical structures in open or percutaneous<br>computer assisted surgery. The system is indicated for<br>any medical condition in which the use of computer<br>assisted planning and surgery may be appropriate and<br>where reference to a rigid anatomical structure such as the<br>skull, vertebra, or long bone can be identified. | | CranialMask Tracker | The Stryker CranialMask Tracker is intended to be used<br>as an accessory to the CranialMap and the Cranial<br>Guidance software applications. It is intended to be placed<br>on the patient's facial skin and used in combination with<br>preoperative and intraoperative imaging devices to enable<br>automatic patient registration for open or percutaneous<br>computer-assisted surgery. The Stryker CranialMask<br>Tracker can be used as a noninvasive patient tracker to<br>support open or percutaneous cranial neurosurgical<br>procedures. | | EM Stylet | The Stryker EM Stylet is indicated for use as an accessory<br>to the Stryker Q Guidance System when used with the<br>Cranial Guidance Software and electromagnetic<br>navigation. It is indicated for use in locating anatomical<br>structures during navigated cranial procedures.<br>The system is intended as an aid for precisely locating<br>anatomical structures in either open or percutaneous<br>procedures. The system is indicated for any medical<br>condition in which the use of stereotactic surgery may be<br>appropriate and where reference to a rigid anatomical<br>structure, such as the skull, can be identified relative to a<br>CT-based or MR-based model, fluoroscopy images, or<br>digitized landmarks of the anatomy.<br>The EM Stylet is indicated for use in the following<br>procedures: General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement | | Navigated Biopsy Needle | The Stryker Navigated Biopsy Needle is intended to be<br>used as an accessory to the Stryker Q Guidance System<br>when used with the Cranial Guidance Software. It is a<br>side cutting cannula where the cutting action is achieved<br>by rotation of an inner cannula within an outer cannula for<br>use in the stereotaxic biopsy of cranial tissue.<br>The Stryker Navigated Biopsy Needle may be used as part<br>of the Stryker Cranial Guidance System, which is | | Subject Device | Indications for Use | | | indicated for any medical condition in which the use of<br>computer assisted planning and surgery may be<br>appropriate. The system can be used for intraoperative<br>guidance where a reference to a rigid anatomical structure<br>can be identified. | {12}------------------------------------------------ K212194 Page 6 of 17 {13}------------------------------------------------ K212194 Page 7 of 17 *Note: The Q Guidance System was cleared under premarket notification K220593. No changes have been made to the indications for use. {14}------------------------------------------------ #### E. Comparison of the Technological Characteristics A comparison of the technological characteristics of the subject devices included in the scope of this Traditional 510(k) is included below. #### Stryker Q Guidance with Cranial Guidance Software . The technological comparison between the subject device, Stryker Q Guidance System with Cranial Guidance Software, and the predicate device (StealthStation S8 Cranial Software v2.0 Stealth Tractography) is included in the StealthStation S8 Cranial Software v2.0 Stealth Tractography received 510(k) clearance per 510(k) number K212397. | Characteristic | Application Device:<br>Stryker Q Guidance System with<br>Cranial Guidance Software (K212194) | Predicate Device:<br>StealthStation S8 Cranial Software<br>v2.0 Stealth Tractography (K212397) | Impact on Substantial<br>Equivalence | |---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Stryker Leibinger GmbH & Co. KG. | Medtronic Navigation, Inc. | N/A - No substantial<br>equivalence impact. | | Regulation<br>Number | 21 CFR 882.4560 | 21 CFR 882.4560 | Identical | | Product Code | HAW | HAW | Identical | | Intended Use | The Q Guidance System with Cranial<br>Guidance Software is a computer-assisted<br>stereotactic, image-guided, planning, and<br>intraoperative guidance system intended to<br>enable open or percutaneous computer-<br>assisted surgery. It assists the surgeon in<br>precisely positioning instruments and<br>locating patient anatomy during cranial<br>surgery. | The StealthStationTM System, with<br>StealthStationTM Cranial software is designed<br>as an aid for locating anatomical structures in<br>either open or percutaneous neurosurgical<br>procedures. | Identical - The intended uses<br>of the subject and predicate<br>devices are the same. Both<br>are used as aids for locating<br>anatomical structures and<br>precisely positioning<br>instruments in either open or<br>percutaneous neurosurgical<br>navigated procedures. | | Indications for<br>Use | The Stryker Q Guidance System, with the<br>Cranial Guidance Software, is intended as a<br>planning and intraoperative guidance system | The StealthStationTM System, with<br>StealthStationTM Cranial Software, is<br>intended as an aid for locating anatomical<br>structures in either open or percutaneous | Equivalent - The differences<br>between the subject and<br>predicate devices do not raise | | Characteristic | Application Device:<br>Stryker Q Guidance System with<br>Cranial Guidance Software (K212194) | Predicate Device:<br>StealthStation S8 Cranial Software<br>v2.0 Stealth Tractography (K212397) | Impact on Substantial<br>Equivalence | | | to enable open or percutaneous computer-<br>assisted surgery.<br>The system is indicated for any medical<br>condition in which the use of computer-<br>assisted planning and surgery may be<br>appropriate. The system can be used for<br>intraoperative guidance where a reference to<br>a rigid anatomical structure can be identified.<br>The system assists in the positioning of<br>instruments for cranial procedures, including:<br>Cranial biopsies Craniotomies Craniectomies Resection of tumors and other lesions Skull base procedures Transnasal neurosurgical procedures Transsphenoidal pituitary surgery Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction<br>procedures General ventricular catheter and shunt<br>placement Pediatric ventricular catheter and shunt<br>placement | neurosurgical procedures. Their use is<br>indicated for any medical condition in which<br>the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid<br>anatomical structure, such as the skull, can<br>be identified relative to images of the<br>anatomy. This can include, but is not limited<br>to, the following cranial procedures<br>(including stereotactic frame-based and<br>stereotactic frame alternatives-based<br>procedures):<br>Tumor resections General ventricular catheter placement Pediatric ventricular catheter<br>placement Depth electrode, lead, and probe<br>placement Cranial biopsies | any concerns of safety and<br>effectiveness. | | Technology | | | | | System Accuracy<br>Requirement | The System is designed to work in the<br>working space with a mean accuracy of 2<br>mm point and 2° angular axis displacement<br>within the registration zone. | Under representative worst-case<br>configuration, the StealthStationTM S8<br>System with StealthStationTM Cranial v2.0<br>Software, has demonstrated performance in<br>3D positional accuracy with a mean error ≤ | Equivalent - The subject and<br>predicate devices both have a<br>mean accuracy of 2mm for<br>positional accuracy and<br>angular axis displacement | | Characteristic | Application Device:<br>Stryker Q Guidance System with<br>Cranial Guidance Software (K212194) | Predicate Device:<br>StealthStation S8 Cranial Software<br>v2.0 Stealth Tractography (K212397) | Impact on Substantial<br>Equivalence | | | | 2.0 mm and in trajectory angle accuracy with<br>a mean error ≤ 2.0 degree. | (trajectory angle) mean<br>accuracy of 2°. | | Compatible<br>Optical<br>Instrumentation | Stryker instruments tracked via optical<br>markers or LEDs located on instrument and<br>patient trackers via the optical localizing<br>system. | Medtronic instruments tracked via optical<br>markers or LEDs located on instrument and<br>patient trackers via the optical localizing<br>system. | Equivalent - The subject and<br>predicate devices both utilize<br>optical tracking technology.<br>The compatible instruments<br>used both require the use of<br>optical markers or LEDs<br>located on the navigable<br>instruments and patient<br>trackers. | | Compatible EM<br>Instrumentation | Stryker instruments tracked via<br>Electromagnetic (EM) localization<br>technology located within the EM navigated<br>instruments and patient trackers. | Medtronic instruments tracked via<br>Electromagnetic localization technology<br>located within the instrument and patient<br>trackers. | Equivalent - The subject and<br>predicate devices both utilize<br>electromagnetic tracking<br>technology. The compatible<br>instruments require the use of<br>Electromagnetic localization<br>technology located withing the<br>navigable EM instruments and<br>patient trackers. | | Software<br>Interface (GUI) | Black-style graphical user interface with a<br>16:9 screen ratio that includes a Case<br>Dashboard to access all operation modes, an<br>Image box with image tools, a current task<br>panel on the right, and an image settings task<br>panel on the left. | Black and gray style with procedure task<br>overview in left menu option and next/back<br>task flow at bottom of the screen. Software<br>controls for images, planning and instrument<br>management and tractography editing are<br>contained in a right-side bar. | Equivalent - The differences<br>between the subject and<br>predicate devices do not raise<br>any concerns of safety and<br>effectiveness. | | Programming<br>Language | C++, QML | C++ / Java | Equivalent - The differences<br>between the subject and<br>predicate devices do not raise<br>any concerns of safety and<br>effectiveness. | | Characteristic | Application Device:<br>Stryker Q Guidance System with<br>Cranial Guidance Software (K212194) | Predicate Device:<br>StealthStation S8 Cranial Software<br>v2.0 Stealth Tractography (K212397) | Impact on Substantial<br>Equivalence | | | | | any concerns of safety and<br>effectiveness. | | Scanner Interface<br>Technology (to<br>imaging devices) | Network Connectivity CD DVD USB DICOM Import | Network Connectivity CD DVD USB DICOM Import DICOM Export | Equivalent - The differences<br>between the subject and<br>predicate devices do not raise<br>any concerns of safety and<br>effectiveness. | | Optical<br>Technology | Manufacturer: Stryker Leibinger Localizer: FP8000 Camera Note: The FP8000 Camera is component of<br>the Q Guidance System. | Manufacturer: (Northern Digital Inc.) Localizer: Vega | Equivalent - The differences<br>between the subject and<br>predicate devices do not raise<br>any concerns of safety and<br>effectiveness. | | Electromagnetic<br>Technology | Manufacturer: Northern Digital, Inc. Localizer: Aurora System Emitter Types: Planar | Manufacturer: (Medtronic Na…