Stryker Q Guidance System with Cranial Guidance Software - 510(k) Summary

Date: February 16, 2023

Device Information

Category	Stryker Leibinger GmbH & Co. KG
Sponsor	Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 79111 Freiburg, Germany
Correspondent Contact Information	Bryan K. Hann 1941 Stryker Way Portage, MI 49002 (269) 366-9863
Device Common Name	Stereotaxic Instruments
Device Regulation & Name	Regulation: 21 CFR 882.4560 Name: Neurologic Stereotaxic Instrument
Classification & Product Code	Classification: Class II Product Code: HAW
510(k) Number	K212194
Device Proprietary Name	Q Guidance System with Cranial Guidance Software including: 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 CranialMask Tracker EM Stylet Navigated Biopsy Needle

Predicate Device Information

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 Manufacturer	Medtronic Navigation, Inc. Stryker Leibinger GmbH & Co. KG IZI Medical Products
Predicate Device Common Name	Stereotaxic Instruments
Predicate Device Premarket Notification #	K212397 K162309 K162929 K141833 K143241
Predicate Device Classification & Name	Regulation: 21 CFR 882.4560 Name: Neurologic Stereotaxic Instrument
Predicate Device Classification & Product Code	Classification: Class II Product Code: HAW
Date Summary Prepared	February 15, 2023

Description of Device

Q Guidance System with Cranial Guidance Software System Overview

The Stryker Q 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 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 includes a computer, camera, electromagnetic field generator and box, a large touchscreen monitor, and a small touchscreen monitor.

The Cranial Guidance Software is dedicated to cranial surgical procedures. Required navigated instruments include a patient tracker, an instrument tracker, pointers, suction tubes, and seekers. An instrument battery is required for battery-powered instruments or calibration devices. The software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via electromagnetic or wireless optical tracking technology. It guides the user through preoperative and intraoperative steps for navigated cranial surgical procedures.

The Q Guidance System was initially cleared under premarket notification K220593. The current modification adds electromagnetic tracking technology and integrates the Zeiss Microscope using the Zeiss Microscope Tracker.

System Components

Passive Optical Navigation Instruments

Calibration Body: Used to validate and calibrate active and passive optically navigated instruments.
Pointer, Straight and Registration Pointer: Optional system components that include pins for connecting reflective spheres for tracking.
Instrument Trackers: Connect to Instrument Clamps and are optional system components. They enable non-navigated surgical instruments to be tracked. The Elbow, 45° can be used as an interface between Instrument Trackers and Clamps for better camera visibility.
Patient Tracker Advanced: Connects to the Universal Base Skull (a patient tracker fixating device) to track the patient's head.
Endoscope Tracker: Connects to rigid endoscopes for tracking by the cranial guidance system.
Mayfield Base with Articulating Arm: Has a mechanical interface for skull clamps. A Universal Tracker or nGenius Universal Tracker can be attached to enable tracking.
Precision Targeting System: Comprised of the Precision Targeting Guide, Tracker Sleeve, Needle Sleeve, Twist Drill Sleeve, and Elite Drill Sleeve. It guides the Navigated Biopsy Needle, 3.2 mm Twist Drills, and Stryker's Signature Series of High-Speed Drills during cranial tissue biopsy.

Electromagnetic (EM) Navigation Instruments

Electromagnetic Pointers: Used for patient registration and locating patient anatomy during navigated cranial neurosurgical procedures using electromagnetic navigation.
Patient Tracker EM – 10 Uses: Serves as a patient tracker for electromagnetic navigation, fixed to the patient's skin with a double-sided adhesive pad called Patient Tracker Tab.

Zeiss Microscope Tracker

Permanently attached to a Zeiss Pentero or Kinevo microscope to track the microscope during navigated cranial neurosurgical procedures.

CranialMask Tracker

A sterile, single-use, non-invasive, flexible patient tracker that attaches directly to the patient's skin via integrated tape to provide non-invasive tracking of the patient's skull.

EM Stylet

A single-use instrument compatible with the Q Guidance System with Cranial Guidance Software, used for ventricular catheter and shunt placement in adult and pediatric patients.

Navigated Biopsy Needle

A sterile, single-use, side-cutting cannula accessory for the Stryker Q Guidance System, used in stereotaxic biopsy of cranial tissue. It is used with the Precision Targeting System and Cranial Guidance Software.

Indications for Use

Subject Device	Indications for Use
Cranial Guidance Software	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 reference to 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 Transsphenoidal pituitary surgery Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement
Q Guidance System	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.
CranialMask Tracker	The Stryker CranialMask Tracker is intended to be used as an accessory to the CranialMap and 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.
EM Stylet	The Stryker EM Stylet is indicated for use as an accessory to the Stryker 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 or MR-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
Navigated Biopsy Needle	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.

*Note: The Q Guidance System was cleared under premarket notification K220593. No changes have been made to the indications for use.

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 table below. The StealthStation S8 Cranial Software v2.0 Stealth Tractography received 510(k) clearance per 510(k) number K212397.

Characteristic	Application Device: Stryker Q Guidance System with Cranial Guidance Software (K212194)	Predicate Device: StealthStation S8 Cranial Software v2.0 Stealth Tractography (K212397)	Impact on Substantial Equivalence
Company	Stryker Leibinger GmbH & Co. KG.	Medtronic Navigation, Inc.	N/A - No substantial equivalence impact.
Regulation Number	21 CFR 882.4560	21 CFR 882.4560	Identical
Product Code	HAW	HAW	Identical
Intended Use	The Q Guidance System with Cranial Guidance Software is a computer-assisted stereotactic, 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 StealthStation™ System, with StealthStation™ Cranial software is designed as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.	Identical – The intended uses of the subject and predicate devices are the same. Both are used as aids for locating anatomical structures and precisely positioning instruments in either open or percutaneous neurosurgical navigated procedures.
Indications for Use	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 reference to a rigid anatomical structure can be identified.	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	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Technology
System Accuracy Requirement	The System is designed to work in the working space with a mean accuracy of 2 mm point and 2º angular axis displacement within the registration zone.	Under representative worst-case configuration, the StealthStation™ S8 System with StealthStation™ Cranial v2.0 Software, has demonstrated performance in 3D positional accuracy with a mean error < 2.0 mm and in trajectory angle accuracy with a mean error ≤ 2.0 degree.	Equivalent - The subject and predicate devices both have a mean accuracy of 2mm for positional accuracy and angular axis displacement (trajectory angle) mean accuracy of 2°.
Compatible Optical Instrumentation	Stryker 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.	Equivalent – The subject and predicate devices both utilize optical tracking technology. The compatible instruments used both require the use of optical markers or LEDs located on the navigable instruments and patient trackers.
Compatible EM Instrumentation	Stryker instruments tracked via Electromagnetic (EM) localization technology located within the EM navigated instruments and patient trackers.	Medtronic instruments tracked via Electromagnetic localization technology located within the instrument and patient trackers.	Equivalent - The subject and predicate devices both utilize electromagnetic tracking technology. The compatible instruments require the use of Electromagnetic localization technology located withing the navigable EM instruments and patient trackers.
Software Interface (GUI)	Black-style graphical user interface with a 16:9 screen ratio that includes a Case Dashboard to access all operation modes, an Image box with image tools, a current task panel on the right, and an image settings task panel on the left.	Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management and tractography editing are contained in a right-side bar.	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Programming Language	C++, QML	C++/Java	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Scanner Interface Technology (to imaging devices)	Network Connectivity CD DVD USB DICOM Import	Network Connectivity CD DVD USB DICOM Import DICOM Export	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Optical Technology	Manufacturer: Stryker Leibinger Localizer: FP8000 Camera Note: The FP8000 Camera is component of the Q Guidance System.	Manufacturer: (Northern Digital Inc.) Localizer: Vega	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Electromagnetic Technology	Manufacturer: Northern Digital, Inc. Localizer: Aurora System Emitter Types: Planar	Manufacturer: (Medtronic Navigation, Inc.) Localizer: AxiEM III Emitter Types: Side, Flat	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Computer	Intel-based PC	Intel-based PC	Identical
RFID Reader	Standard RFID receiver running on 13.56 MHz	Capability added to system. Functionality not yet available with this release.	Equivalent – Both the subject and predicate devices feature RFID capability.
Network Connectivity	Connection Type: Standard Ethernet; 2.4 gHz and 5.0 gHz Wireless connection	Connection Type: Standard Ethernet 2.4gHz and 5.0 gHz Wireless connection	Equivalent - Both the subject and predicate devices utilize Standard Ethernet and have 2.4gHz and 5.0gHz Wireless connection connectivity.
Remote Service Connectivity	Remote secure shell access over high-speed connection with strong public private key authentication and encryption.	Remote service access providing capability for secure remote desktop service over high-speed connection (Branded Remote Presence)	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Operating System	Linux-based: Yocto Distro Version 3.1	Linux-based: Ubuntu	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Features
Imaging Modalities	X-Ray based MR based Nuclear medicine based	X-Ray based MR based Nuclear Medicine based	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
View (Display) Features	3D 3D Targeting 2D Anatomical (Coronal, Sagittal, Axial) 2D Anatomical Targeting (Coronal, Sagittal, Axial) 2D Oriented Targeting (Along 0, Along 90, Perpendicular) Instrument's Eye (Along 0, Along 90, Perpendicular)	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	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Exam-to-Exam Registration Features	Same Coordinate System Alignment (Identity Merge Registration) Manual Alignment (Manual Merge Registration) Auto Alignment (Automatic Merge Registration)	Identity Merge Registration Manual Merge Registration Automatic Merge Registration	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Patient Registration Features	Point-to-point registration Surface registration Automatic intraoperative mask (AIM) registration	PointMerge™ registration (referred to as Landmark registrations) Tracerī™ registration Touch registration (previously Touch-N-GO™) StealthAiR™ registration, O-arm™ registration Mechanical based registrations (Stereotactic Localizer Registration and StarFix™™ Bone Anchor Registration)	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Planning Features	Creation of segments Planning of approaches Setting of annotation points Planning of imported 3D models Distance and angle measurement Anatomical alignment of multiplanar images (image merge) Planning of fiber bundles Advanced visualization Automatic segmentation Semi-automatic head holder removal	3D Model Building, including fiber tracts with Standard DTI and Enhanced CSD techniques (fiber bundles) Plan Entry and Target Selection (planning of approaches) Advanced Visualization (image settings) Create Patient Based Anatomical Coordinate Space (none) Stereotactic Frame Settings (none) Brain Atlas: Schaltenbrand- Wahren Atlas with Talairach Grid (none) StarFix™™ Designer Annotations (none)	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.
Medical Device Interfaces	Microscope Navigation: Zeiss Ultrasound Navigation: Aloka and Sonosite Medtronic O-arm® Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell Nexframe® Stereotactic System STarFixTM Platform System	Microscope Navigation: Zeiss, Leica Ultrasound Navigation: Aloka and Sonosite Medtronic O-arm® Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell Nexframe® Stereotactic System STarFixTM Platform System	Equivalent - The differences between the subject and predicate devices do not raise any concerns of safety and effectiveness.

Technological Comparison of the Navigated Instruments with their Predicate Devices and System Components

The navigated instruments in scope of this Traditional 510(k) have similar designs, materials, intended use, sterilization, and fundamental scientific technology to their predicate devices and system components. The modifications to the instruments do not adversely impact the technological characteristics of the predicate devices. A detailed comparison to the predicate devices and system components can be found in Section 13 (Substantial Equivalence) of this Traditional 510(k).

Summary of Supporting Data

The function and performance of the subject devices and system components have been evaluated through non-clinical design verification and validation testing. The results of the evaluation tests demonstrate that the subject devices and system components successfully meet the requirements of their intended use.

Discussion of Performance Testing

Performance testing was conducted on the subject devices and system components to ensure they met their design requirements. A summary of the testing and the results are included in the table below.

Item

Summary of Testing

Intended Use/ User Needs

The subject devices and system components were validated with intended users in cadaver labs or simulated use tests to ensure the user needs and intended use requirements were met. All requirements were met and no new issues of safety or effectiveness were raised.

Accuracy

The System is designed to work in the working space with a mean accuracy of 2 mm point and 2º angular axis displacement within the registration zone.
Optical Navigation Accuracy

	Positional Displacement (mm)	Trajectory Angle Displacement (degrees)
99% Confidence Interval (Upper)	2.65	2.93
Mean	1.45	1.38
Standard Deviation	0.49	0.62

General Requirements and Performance

Electromagnetic Navigation Accuracy

	Positional Displacement (mm)	Trajectory Angle Displacement (degrees)
99% Confidence Interval (Upper)	2.57	2.82
Mean	1.19	1.21
Standard Deviation	0.54	0.62

Non-clinical accuracy testing for pediatric patients was performed using pediatric models made based on a neonate image set. Accuracy testing for adult patients was performed via a Simulated Use study with cadavers.

Verified the effectiveness of all risk controls determined in the device risk analysis. No new issues of safety or effectiveness were raised.

Verified all subject devices and system components against their design specifications. All requirements were met, no new issues of safety or effectiveness were raised.

Software

Software verification and validation testing was conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002. All requirements were met, no new issues of safety or effectiveness were raised.

Biocompatibility

The biocompatibility of all patient contact materials was verified according to ISO 10993-1:2018 and FDA guidance on the use of ISO 10993-1, September 2020. No new issues of safety or effectiveness were raised.

Electrical Safety

Verified conformance to IEC 60601-1: 2005, COR. 1:2006, COR. 2:2007, AMD 1:2012 (equivalent to IEC 60601-1:2012 Reprint).

Electromagnetic Compatibility

Verified conformance to IEC 60601-1-2: 2014, CISPR 11 Group 1, Class A requirements as well as additional testing to verify compatibility with RFID devices operating in the 125 - 134 kHz and 13.56 MHz frequency band.

Shipping

The functionality of the devices after simulated shipping conditions was verified. No new issues of safety or effectiveness were raised.

Sterilization

The reusable subject devices and system components underwent a steam sterilization validation to demonstrate that they can be expected to be sterile and have a sterility assurance level (SAL) of 10⁻⁶ or greater after processing. All requirements were met and no new issues of safety or effectiveness were raised.
The single-use subject device underwent a sterilization validation with Ethylene Oxide to demonstrate that they can be expected to be sterile and have an SAL of 10⁻⁶ or greater after processing. All requirements were met, and no new issues of safety or effectiveness were raised.

Summary of Clinical Testing

No clinical testing was performed.

Conclusion

The subject devices and system components perform as intended and are substantially equivalent to their respective predicate device intended use, design, principles of operation, technology, materials, and performance.

File Info : application/pdf, 24 Pages, 1.30MB

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