(582 days)
No
The summary describes a computer-assisted surgical navigation system using optical and electromagnetic tracking, but does not mention AI or ML.
No.
This device is an intraoperative guidance system used to assist surgeons in precisely positioning instruments and locating patient anatomy during cranial surgery, rather than directly treating a medical condition.
No
The device is an intraoperative guidance system used for planning and assisting in computer-assisted surgery. It helps in precisely locating anatomical structures and positioning instruments during surgical procedures, rather than diagnosing medical conditions.
No
The device description explicitly states that the system is comprised of a computer platform, navigated instruments (e.g., patient/instrument trackers, pointers), and various system components, including a camera, electromagnetic field generator, monitors, and instruments. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the Stryker Q Guidance System, with the Cranial Guidance Software and its accessories, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a "planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery." It assists in "precisely locating anatomical structures" and "positioning of instruments" during surgical procedures. This is a surgical navigation and guidance system, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a system comprised of hardware (computer platform, camera, electromagnetic field generator, monitors) and software that uses tracking technologies to display the location of surgical instruments relative to patient images. This aligns with a surgical guidance system, not an IVD.
- Input Imaging Modality: The system uses various imaging modalities (CT, MR, fluoroscopy, X-Ray, Nuclear Medicine) as input, which are used for surgical planning and guidance, not for analyzing biological samples.
- Performance Studies: The performance studies focus on accuracy of navigation, safety, general performance, software validation, biocompatibility, electrical safety, electromagnetic compatibility, shipping, and sterilization. These are typical performance metrics for a surgical device, not an IVD.
- Key Metrics: The key metrics provided are related to positional and angular displacement accuracy, which are relevant to surgical navigation, not IVD performance metrics like sensitivity, specificity, AUC, etc.
In summary, the Stryker Q Guidance System is a surgical navigation and guidance system used during procedures to assist the surgeon in locating anatomy and positioning instruments. It does not perform in vitro testing on biological specimens for diagnostic purposes.
N/A
Intended Use / 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 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
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.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
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.
System Components:
- Passive Optical Navigation Instruments:
- The Calibration Body is used to validate and calibrate active and passive optically navigated instruments when used with the Cranial Guidance System.
- 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.
- The Instrument Trackers connect to the Instrument Clamps and are optional system components of the Cranial Guidance System. 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.
- 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.
- The Endoscope Tracker can be connected to rigid endoscopes to enable tracking by the cranial guidance system.
- 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.
- Electromagnetic (EM) Navigation Instruments:
- 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.
- 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:
- 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based, MR based, Nuclear medicine based, fluoroscopy images, digitized landmarks of the anatomy
Anatomical Site
Cranial, skull, vertebra, long bone
Indicated Patient Age Range
Adult and pediatric patients (for EM Stylet and ventricular catheter/shunt placement)
Intended User / Care Setting
Surgeon, medical professionals in an intraoperative setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical design verification and validation testing, cadaver labs or simulated use tests.
Sample Size: Not specified for pediatric models or cadaver studies.
Key Results:
- 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 (Optical Navigation):
- Positional Displacement (mm): Mean 1.45, Standard Deviation 0.49, 99% Confidence Interval (Upper) 2.65
- Trajectory Angle Displacement (degrees): Mean 1.38, Standard Deviation 0.62, 99% Confidence Interval (Upper) 2.93
- Accuracy (Electromagnetic Navigation):
- Positional Displacement (mm): Mean 1.19, Standard Deviation 0.54, 99% Confidence Interval (Upper) 2.57
- Trajectory Angle Displacement (degrees): Mean 1.21, Standard Deviation 0.62, 99% Confidence Interval (Upper) 2.82
- Safety: Verified the effectiveness of all risk controls determined in the device risk analysis. No new issues of safety or effectiveness were raised.
- General Requirements and Performance: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Accuracy (Optical Navigation): Positional Displacement (mm) 1.45, Trajectory Angle Displacement (degrees) 1.38
Mean Accuracy (Electromagnetic Navigation): Positional Displacement (mm) 1.19, Trajectory Angle Displacement (degrees) 1.21
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
StealthStation S8 Cranial Software v2.0 Stealth Tractography K212397, Medtronic StealthStation™ S8 System Platform K162309, CranialMask Tracker K162929, Stylet, 23 cm K141833, MDT Navigable Brain Biopsy Cannula K143241
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) | |
|---|---|
| ☒ 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
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) | |
|---|---|
| ☑ 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
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) | |
|---|---|
| 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
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 |
| 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 |
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 | |||
| Manufacturer: | Medtronic | ||
| Navigation, Inc. | StealthStation S8 Cranial Software v2.0 | ||
| Stealth Tractography | |||
| Medtronic StealthStation™ S8 System | |||
| Platform | |||
| Stylet, 23 cm | |||
| Stryker Leibinger | |||
| GmbH & Co. KG | CranialMask Tracker | ||
| IZI Medical | |||
| Products | MDT Navigable Brain Biopsy Cannula | ||
| Predicate Device Common | |||
| Name | Stereotaxic Instruments | ||
| Predicate Device Premarket | |||
| Notification # | StealthStation S8 Cranial Software v2.0 Stealth | ||
| Tractography | 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
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
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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 |
| 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 | |
| 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 |
| 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 | |
| Subject Device | Indications for Use |
| 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. |
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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 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 StealthStationTM System, with
StealthStationTM 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 | The StealthStationTM System, with
StealthStationTM Cranial Software, is
intended as an aid for locating anatomical
structures in either open or percutaneous | Equivalent - The differences
between the subject and
predicate devices do not raise |
| 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 |
| | 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 | 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 | 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 2° angular axis displacement
within the registration zone. | Under representative worst-case
configuration, the StealthStationTM S8
System with StealthStationTM Cranial v2.0
Software, has demonstrated performance in
3D positional accuracy with a mean error ≤ | Equivalent - The subject and
predicate devices both have a
mean accuracy of 2mm for
positional accuracy and
angular axis displacement |
| 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 |
| | | 2.0 mm and in trajectory angle accuracy with
a mean error ≤ 2.0 degree. | (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. |
| 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 |
| | | | 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 |
| 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 |
| 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 | | | |
| Imagining
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. |
| 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 |
| 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 Mask registration Automatic intraoperative mask (AIM)
registration | PointMergeTM registration (referred to
as Landmark registrations) TracerTM registration Touch registration (previously Touch-
N-GoTM) StealthAiRTM registration, O-armTM
registration Mechanical based registrations
(Stereotactic Localizer Registration
and StarFixTM Bone Anchor
Registration) | 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) StarFixTM Designer Annotations
(none) | Equivalent - The differences
between the subject and
predicate devices do not raise
any concerns of safety and
effectiveness. |
| 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 |
| Medical Device
Interfaces | Microscope Navigation:
• Zeiss | Microscope Navigation:
• Zeiss, Leica
Ultrasound Navigation:
• Aloka and Sonosite Medtronic O-arm®
Stereotactic Frame Systems:
• Fischer ZD, Fischer RM, Integra CRW
and Elekta Leksell
• Nexframe® Stereotactic System
• STarFix™Platform System | Equivalent - The differences
between the subject and
predicate devices do not raise
any concerns of safety and
effectiveness. |
15
16
17
18
19
20
21
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/ 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 2° 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 |
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K212194 Page 16 of 17
| Item | Summary of Testing | ||
|---|---|---|---|
| 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. | |||
| Safety | Verified the effectiveness of all risk controls determined in the | ||
| device risk analysis. No new issues of safety or effectiveness were | |||
| raised. | |||
| General Requirements | |||
| and Performance | 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 |
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K212194 Page 17 of 17
| Item | Summary of Testing |
|---|---|
| requirements were met, and no new issues of safety or effectiveness | |
| were 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.