(582 days)
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 Transsphenoidal pituitary surgery Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement
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.
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.
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
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.
The 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 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.
Here's a breakdown of the acceptance criteria and study information for the Stryker Q Guidance System with Cranial Guidance Software, EM Stylet, and Navigated Biopsy Needle, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Design Goal) | Reported Device Performance (Mean and 99% CI Upper) |
|---|---|
| Optical Navigation Accuracy: | |
| Positional Displacement ≤ 2 mm | 1.45 mm (Mean), 2.65 mm (99% CI Upper) |
| Trajectory Angle Displacement ≤ 2° | 1.38° (Mean), 2.93° (99% CI Upper) |
| Electromagnetic Navigation Accuracy: | |
| Positional Displacement ≤ 2 mm | 1.19 mm (Mean), 2.57 mm (99% CI Upper) |
| Trajectory Angle Displacement ≤ 2° | 1.21° (Mean), 2.82 mm (99% CI Upper) |
| User Needs / Intended Use Met | All requirements met through cadaver labs or simulated use tests. |
| Safety Standards Met | All risk controls effective. No new issues of safety or effectiveness raised. |
| General Requirements & Performance Met | All design specifications met. No new issues of safety or effectiveness raised. |
| Software Verification & Validation Met | All requirements met. No new issues of safety or effectiveness raised. |
| Biocompatibility Met | Conformance to ISO 10993-1:2018 and FDA guidance. No new issues of safety or effectiveness raised. |
| Electrical Safety Met | Conformance to IEC 60601-1:2012 Reprint. |
| Electromagnetic Compatibility Met | Conformance to IEC 60601-1-2:2014, CISPR 11 Group 1, Class A, and RFID compatibility. |
| Shipping Functionality Maintained | Functionality maintained after simulated shipping. No new issues of safety or effectiveness raised. |
| Sterility Assurance Level (SAL) | 10⁻⁶ or greater for reusable devices (steam) and single-use devices (Ethylene Oxide). All requirements met. |
Important Note: The document explicitly states the system's design goal for accuracy is a mean of 2mm positional and 2° angular displacement. The reported performance includes a 99% Confidence Interval (Upper) which exceeds the 2mm/2° stated design goal in some instances (e.g., Optical Nav Positional Displacement 2.65mm, Optical Nav Trajectory Angle Displacement 2.93°, EM Nav Positional Displacement 2.57mm, EM Nav Trajectory Angle Displacement 2.82°). However, the document concludes that "All requirements were met and no new issues of safety or effectiveness were raised," implying these results were considered acceptable within the overall context of the safety and performance evaluation.
2. Sample Size Used for the Test Set and the Data Provenance
- Accuracy Testing:
- Pediatric patients: Non-clinical accuracy testing was performed using pediatric models made based on a neonate image set. The exact number of models is not specified.
- Adult patients: Accuracy testing was performed via a Simulated Use study with cadavers. The exact number of cadavers is not specified.
- Intended Use/User Needs Validation: Conducted in "cadaver labs or simulated use tests." The exact number of participants or cases is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the datasets used in testing (pediatric models, cadavers). The testing seems to be prospective (i.e., designed as part of the validation process) rather than retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth specifically for the accuracy testing of the device (i.e., for the positional and angular displacement measurements). The "Intended Use/User Needs" validation involved "intended users," but their specific number or qualifications (e.g., years of experience as surgeons) are not detailed.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the performance metrics. The accuracy measurements appear to be objective, engineering-style measurements against a known reference. For the "Intended Use/User Needs" validation, it simply states that all requirements were met, implying a qualitative assessment by the "intended users."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The 510(k) summary explicitly states: "No clinical testing was performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size on human reader improvement with AI assistance is reported.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The primary performance data reported (positional and angular displacement accuracy) are standalone algorithm/device accuracy metrics, as they quantify the device's ability to precisely locate structures and guide instruments in a controlled testing environment (using pediatric models and cadavers), independent of a human surgeon's subjective interpretation or decision-making beyond the act of using the device. This testing is focused on the device's intrinsic measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the accuracy measurements (positional and angular displacement), the ground truth would be based on precisely measured, known physical locations or trajectories within the test setup (pediatric models or cadavers). This is an engineering- or physics-based ground truth, where the "true" position or angle is established by highly accurate measurement systems or a known fiducial reference.
8. The sample size for the training set
The document does not provide any information about a training set size. This 510(k) summary describes a navigation system and its accessories, not a machine learning or AI algorithm that typically requires a separate training set. While the "Cranial Guidance Software" is mentioned, the performance evaluation focuses on the accuracy of the navigation system components rather than a pattern recognition or diagnostic AI.
9. How the ground truth for the training set was established
Since no information on a training set or its size is provided, the method for establishing its ground truth is also not described. As noted above, the device's evaluation is primarily based on the accuracy of its navigation capabilities, which rely on precise physical measurements rather than annotated data for training.
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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
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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
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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.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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) | |
|---|---|
| ☒ 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
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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) | |
|---|---|
| ☑ 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
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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) | |
|---|---|
| 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
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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
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510(k) SUMMARY
A. Device Information
| Category | Comments |
|---|---|
| Sponsor: | Stryker Leibinger GmbH & Co. KGBötzinger Straße 4179111 Freiburg, Germany |
| Correspondent ContactInformation: | Bryan K. Hann1941 Stryker WayPortage, MI 49002(269) 366-9863 |
| Device Common Name: | Stereotaxic Instruments |
| Device Regulation & Name: | Regulation: 21 CFR 882.4560Name: Neurologic Stereotaxic Instrument |
| Classification & Product Code: | Classification: Class IIProduct Code: HAW |
| 510(k) Number: | K212194 |
| Device Proprietary Name: | Q Guidance System with Cranial Guidance Softwareincluding: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 SystemCranialMask TrackerEM StyletNavigated Biopsy Needle |
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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 DeviceManufacturer: | MedtronicNavigation, Inc. | StealthStation S8 Cranial Software v2.0Stealth Tractography | |
| Medtronic StealthStation™ S8 SystemPlatform | |||
| Stylet, 23 cm | |||
| Stryker LeibingerGmbH & Co. KG | CranialMask Tracker | ||
| IZI MedicalProducts | MDT Navigable Brain Biopsy Cannula | ||
| Predicate Device CommonName | Stereotaxic Instruments | ||
| Predicate Device PremarketNotification # | StealthStation S8 Cranial Software v2.0 StealthTractography | K212397 | |
| Medtronic StealthStation™ S8 System Platform | K162309 | ||
| CranialMask Tracker | K162929 | ||
| Stylet, 23 cm | K141833 | ||
| MDT Navigable Brain Biopsy Cannula | 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 |
Predicate Device Information
B. Date Summary Prepared
February 15, 2023
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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.
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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
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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 CranialGuidance Software, is intended as a planning andintraoperative guidance system to enable open orpercutaneous computer-assisted surgery.The system is indicated for any medical condition inwhich the use of computer-assisted planning and surgerymay be appropriate. The system can be used forintraoperative guidance where a reference to a rigidanatomical structure can be identified.The system assists in the positioning of instruments forcranial 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 |
| Subject Device | Indications for Use |
| Pediatric ventricular catheter and shunt placement | |
| Q Guidance System | The Q Guidance System is intended as an aid for preciselylocating anatomical structures in open or percutaneouscomputer assisted surgery. The system is indicated forany medical condition in which the use of computerassisted planning and surgery may be appropriate andwhere reference to a rigid anatomical structure such as theskull, vertebra, or long bone can be identified. |
| CranialMask Tracker | The Stryker CranialMask Tracker is intended to be usedas an accessory to the CranialMap and the CranialGuidance software applications. It is intended to be placedon the patient's facial skin and used in combination withpreoperative and intraoperative imaging devices to enableautomatic patient registration for open or percutaneouscomputer-assisted surgery. The Stryker CranialMaskTracker can be used as a noninvasive patient tracker tosupport open or percutaneous cranial neurosurgicalprocedures. |
| EM Stylet | The Stryker EM Stylet is indicated for use as an accessoryto the Stryker Q Guidance System when used with theCranial Guidance Software and electromagneticnavigation. It is indicated for use in locating anatomicalstructures during navigated cranial procedures.The system is intended as an aid for precisely locatinganatomical structures in either open or percutaneousprocedures. The system is indicated for any medicalcondition in which the use of stereotactic surgery may beappropriate and where reference to a rigid anatomicalstructure, such as the skull, can be identified relative to aCT-based or MR-based model, fluoroscopy images, ordigitized landmarks of the anatomy.The EM Stylet is indicated for use in the followingprocedures: General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement |
| Navigated Biopsy Needle | The Stryker Navigated Biopsy Needle is intended to beused as an accessory to the Stryker Q Guidance Systemwhen used with the Cranial Guidance Software. It is aside cutting cannula where the cutting action is achievedby rotation of an inner cannula within an outer cannula foruse in the stereotaxic biopsy of cranial tissue.The Stryker Navigated Biopsy Needle may be used as partof the Stryker Cranial Guidance System, which is |
| Subject Device | Indications for Use |
| indicated for any medical condition in which the use ofcomputer assisted planning and surgery may beappropriate. The system can be used for intraoperativeguidance where a reference to a rigid anatomical structurecan be identified. |
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*Note: The Q Guidance System was cleared under premarket notification K220593. No changes have been made to the indications for use.
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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:Stryker Q Guidance System withCranial Guidance Software (K212194) | Predicate Device:StealthStation S8 Cranial Softwarev2.0 Stealth Tractography (K212397) | Impact on SubstantialEquivalence |
|---|---|---|---|
| Company | Stryker Leibinger GmbH & Co. KG. | Medtronic Navigation, Inc. | N/A - No substantialequivalence impact. |
| RegulationNumber | 21 CFR 882.4560 | 21 CFR 882.4560 | Identical |
| Product Code | HAW | HAW | Identical |
| Intended Use | The Q Guidance System with CranialGuidance Software is a computer-assistedstereotactic, image-guided, planning, andintraoperative guidance system intended toenable open or percutaneous computer-assisted surgery. It assists the surgeon inprecisely positioning instruments andlocating patient anatomy during cranialsurgery. | The StealthStationTM System, withStealthStationTM Cranial software is designedas an aid for locating anatomical structures ineither open or percutaneous neurosurgicalprocedures. | Identical - The intended usesof the subject and predicatedevices are the same. Bothare used as aids for locatinganatomical structures andprecisely positioninginstruments in either open orpercutaneous neurosurgicalnavigated procedures. |
| Indications forUse | The Stryker Q Guidance System, with theCranial Guidance Software, is intended as aplanning and intraoperative guidance system | The StealthStationTM System, withStealthStationTM Cranial Software, isintended as an aid for locating anatomicalstructures in either open or percutaneous | Equivalent - The differencesbetween the subject andpredicate devices do not raise |
| Characteristic | Application Device:Stryker Q Guidance System withCranial Guidance Software (K212194) | Predicate Device:StealthStation S8 Cranial Softwarev2.0 Stealth Tractography (K212397) | Impact on SubstantialEquivalence |
| to enable open or percutaneous computer-assisted surgery.The system is indicated for any medicalcondition in which the use of computer-assisted planning and surgery may beappropriate. The system can be used forintraoperative guidance where a reference toa rigid anatomical structure can be identified.The system assists in the positioning ofinstruments 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 reconstructionprocedures General ventricular catheter and shuntplacement Pediatric ventricular catheter and shuntplacement | neurosurgical procedures. Their use isindicated for any medical condition in whichthe use of stereotactic surgery may beappropriate, and where reference to a rigidanatomical structure, such as the skull, canbe identified relative to images of theanatomy. This can include, but is not limitedto, the following cranial procedures(including stereotactic frame-based andstereotactic frame alternatives-basedprocedures):Tumor resections General ventricular catheter placement Pediatric ventricular catheterplacement Depth electrode, lead, and probeplacement Cranial biopsies | any concerns of safety andeffectiveness. | |
| Technology | |||
| System AccuracyRequirement | The System is designed to work in theworking space with a mean accuracy of 2mm point and 2° angular axis displacementwithin the registration zone. | Under representative worst-caseconfiguration, the StealthStationTM S8System with StealthStationTM Cranial v2.0Software, has demonstrated performance in3D positional accuracy with a mean error ≤ | Equivalent - The subject andpredicate devices both have amean accuracy of 2mm forpositional accuracy andangular axis displacement |
| Characteristic | Application Device:Stryker Q Guidance System withCranial Guidance Software (K212194) | Predicate Device:StealthStation S8 Cranial Softwarev2.0 Stealth Tractography (K212397) | Impact on SubstantialEquivalence |
| 2.0 mm and in trajectory angle accuracy witha mean error ≤ 2.0 degree. | (trajectory angle) meanaccuracy of 2°. | ||
| CompatibleOpticalInstrumentation | Stryker instruments tracked via opticalmarkers or LEDs located on instrument andpatient trackers via the optical localizingsystem. | Medtronic instruments tracked via opticalmarkers or LEDs located on instrument andpatient trackers via the optical localizingsystem. | Equivalent - The subject andpredicate devices both utilizeoptical tracking technology.The compatible instrumentsused both require the use ofoptical markers or LEDslocated on the navigableinstruments and patienttrackers. |
| Compatible EMInstrumentation | Stryker instruments tracked viaElectromagnetic (EM) localizationtechnology located within the EM navigatedinstruments and patient trackers. | Medtronic instruments tracked viaElectromagnetic localization technologylocated within the instrument and patienttrackers. | Equivalent - The subject andpredicate devices both utilizeelectromagnetic trackingtechnology. The compatibleinstruments require the use ofElectromagnetic localizationtechnology located withing thenavigable EM instruments andpatient trackers. |
| SoftwareInterface (GUI) | Black-style graphical user interface with a16:9 screen ratio that includes a CaseDashboard to access all operation modes, anImage box with image tools, a current taskpanel on the right, and an image settings taskpanel on the left. | Black and gray style with procedure taskoverview in left menu option and next/backtask flow at bottom of the screen. Softwarecontrols for images, planning and instrumentmanagement and tractography editing arecontained in a right-side bar. | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| ProgrammingLanguage | C++, QML | C++ / Java | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| Characteristic | Application Device:Stryker Q Guidance System withCranial Guidance Software (K212194) | Predicate Device:StealthStation S8 Cranial Softwarev2.0 Stealth Tractography (K212397) | Impact on SubstantialEquivalence |
| any concerns of safety andeffectiveness. | |||
| Scanner InterfaceTechnology (toimaging devices) | Network Connectivity CD DVD USB DICOM Import | Network Connectivity CD DVD USB DICOM Import DICOM Export | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| OpticalTechnology | Manufacturer: Stryker Leibinger Localizer: FP8000 Camera Note: The FP8000 Camera is component ofthe Q Guidance System. | Manufacturer: (Northern Digital Inc.) Localizer: Vega | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| ElectromagneticTechnology | Manufacturer: Northern Digital, Inc. Localizer: Aurora System Emitter Types: Planar | Manufacturer: (Medtronic Navigation,Inc.) Localizer: AxiEM III Emitter Types: Side, Flat | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| Computer | Intel-based PC | Intel-based PC | Identical |
| RFID Reader | Standard RFID receiver running on 13.56MHz | Capability added to system. Functionality notyet available with this release. | Equivalent - Both the subjectand predicate devices featureRFID capability. |
| NetworkConnectivity | Connection Type:Standard Ethernet; 2.4 gHz and 5.0 gHzWireless connection | Connection Type:Standard Ethernet 2.4gHz and 5.0 gHzWireless connection | Equivalent - Both the subjectand predicate devices utilizeStandard Ethernet and have2.4gHz and 5.0gHz Wirelessconnection connectivity |
| Characteristic | Application Device:Stryker Q Guidance System withCranial Guidance Software (K212194) | Predicate Device:StealthStation S8 Cranial Softwarev2.0 Stealth Tractography (K212397) | Impact on SubstantialEquivalence |
| Remote ServiceConnectivity | Remote secure shell access over high-speedconnection with strong public private keyauthentication and encryption. | Remote service access providing capabilityfor secure remote desktop service over high-speed connection (Branded RemotePresence) | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| Operating System | Linux-based: Yocto Distro Version 3.1 | Linux-based: Ubuntu | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| Features | |||
| ImaginingModalities | • X-Ray based• MR based• Nuclear medicine based | • X-Ray based• MR based• Nuclear Medicine based | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| 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 OrthogonalTrajectory 1 and 2• Target Guidance• Trajectory Guidance• Probes Eye• Look Ahead• Microscope Injection• Video Input• Endoscopic | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| Characteristic | Application Device:Stryker Q Guidance System withCranial Guidance Software (K212194) | Predicate Device:StealthStation S8 Cranial Softwarev2.0 Stealth Tractography (K212397) | Impact on SubstantialEquivalence |
| Exam-to-ExamRegistrationFeatures | Same Coordinate System Alignment(Identity Merge Registration) Manual Alignment (Manual MergeRegistration) Auto Alignment (Automatic MergeRegistration) | Identity Merge Registration Manual Merge Registration Automatic Merge Registration | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| PatientRegistrationFeatures | Point-to-point registration Surface registration Mask registration Automatic intraoperative mask (AIM)registration | PointMergeTM registration (referred toas Landmark registrations) TracerTM registration Touch registration (previously Touch-N-GoTM) StealthAiRTM registration, O-armTMregistration Mechanical based registrations(Stereotactic Localizer Registrationand StarFixTM Bone AnchorRegistration) | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| Planning Features | Creation of segments Planning of approaches Setting of annotation points Planning of imported 3D models Distance and angle measurement Anatomical alignment of multiplanarimages (image merge) Planning of fiber bundles Advanced visualization Automatic segmentation Semi-automatic head holder removal | 3D Model Building, including fibertracts with Standard DTI andEnhanced CSD techniques (fiberbundles) Plan Entry and Target Selection(planning of approaches) Advanced Visualization (imagesettings) Create Patient Based AnatomicalCoordinate Space (none) Stereotactic Frame Settings (none) Brain Atlas: Schaltenbrand- WahrenAtlas with Talairach Grid (none) StarFixTM Designer Annotations(none) | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
| Characteristic | Application Device:Stryker Q Guidance System withCranial Guidance Software (K212194) | Predicate Device:StealthStation S8 Cranial Softwarev2.0 Stealth Tractography (K212397) | Impact on SubstantialEquivalence |
| Medical DeviceInterfaces | Microscope Navigation:• Zeiss | Microscope Navigation:• Zeiss, LeicaUltrasound Navigation:• Aloka and Sonosite Medtronic O-arm®Stereotactic Frame Systems:• Fischer ZD, Fischer RM, Integra CRWand Elekta Leksell• Nexframe® Stereotactic System• STarFix™Platform System | Equivalent - The differencesbetween the subject andpredicate devices do not raiseany concerns of safety andeffectiveness. |
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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).
F. 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.
G. 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/ UserNeeds | The subject devices and system components were validated withintended users in cadaver labs or simulated use tests to ensure theuser needs and intended use requirements were met. Allrequirements were met and no new issues of safety or effectivenesswere raised. | ||||||||||||
| Accuracy | The System is designed to work in the working space with a meanaccuracy of 2 mm point and 2° angular axis displacement within theregistration zone.Optical Navigation Accuracy | ||||||||||||
| PositionalDisplacement (mm) Trajectory AngleDisplacement(degrees) 99% ConfidenceInterval (Upper) 2.65 2.93 Mean 1.45 1.38 Standard Deviation 0.49 0.62 |
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| Item | Summary of Testing | ||
|---|---|---|---|
| Electromagnetic Navigation Accuracy | |||
| PositionalDisplacement (mm) | Trajectory AngleDisplacement(degrees) | ||
| 99% ConfidenceInterval (Upper) | 2.57 | 2.82 | |
| Mean | 1.19 | 1.21 | |
| Standard Deviation | 0.54 | 0.62 | |
| Non-clinical accuracy testing for pediatric patients was performedusing pediatric models made based on a neonate image set.Accuracy testing for adult patients was performed via a SimulatedUse study with cadavers. | |||
| Safety | Verified the effectiveness of all risk controls determined in thedevice risk analysis. No new issues of safety or effectiveness wereraised. | ||
| General Requirementsand Performance | Verified all subject devices and system components against theirdesign specifications. All requirements were met, no new issues ofsafety or effectiveness were raised. | ||
| Software | Software verification and validation testing was conducted asrequired by IEC 62304 and FDA guidance on general principles ofsoftware 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 verifiedaccording to ISO 10993-1:2018 and FDA guidance on the use ofISO 10993-1, September 2020. No new issues of safety oreffectiveness 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). | ||
| ElectromagneticCompatibility | Verified conformance to IEC 60601-1-2: 2014, CISPR 11 Group 1,Class A requirements as well as additional testing to verifycompatibility with RFID devices operating in the 125 - 134 kHz and13.56 MHz frequency band. | ||
| Shipping | The functionality of the devices after simulated shipping conditionswas verified. No new issues of safety or effectiveness were raised. | ||
| Sterilization | The reusable subject devices and system components underwent asteam sterilization validation to demonstrate that they can beexpected to be sterile and have a sterility assurance level (SAL) of10-6 or greater after processing. All requirements were met and nonew issues of safety or effectiveness were raised.The single-use subject device underwent a sterilization validationwith Ethylene Oxide to demonstrate that they can be expected to besterile and have an SAL of 10-6 or greater after processing. All |
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| Item | Summary of Testing |
|---|---|
| requirements were met, and no new issues of safety or effectivenesswere raised. |
H. Summary of Clinical Testing
No clinical testing was performed.
I. 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.
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).