X-Guide Surgical Navigation System

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February 3, 2020 X-Nav Technologies, LLC Fred Cowdery VP - Regulatory and Quality Compliance 1555 Bustard Road, Suite 75 Lansdale, Pennsylvania 19446 Re: K192579 Trade/Device Name: X-Guide® Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: November 4, 2019 Received: November 5, 2019 Dear Fred Cowdery: 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192579 Device Name X-Guide® Surgical Navigation System ### Indications for Use (Describe) The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan. | 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. 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Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, gray letters. # 510(k) Summary K192579 (As required by Section 807.92) | Date Prepared: | January 30, 2020 | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | X-NAV Technologies, LLC<br>1555 Bustard Road, Suite 75<br>Lansdale, PA. 19446 | | Contact Person: | Fred Cowdery<br>Vice President – Regulatory Affairs and Quality Compliance<br>Ph 267-436.0414<br>Email: fred.cowdery@x-navtech.com | | Device Trade/Proprietary Name: | X-Guide® Surgical Navigation System,<br>Model P007839 | | Device Name: Common / Usual: | Surgical Navigation System | | Classification Name: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories) | Regulatory Class: II - Product Code: PLV (Dental Stereotaxic Instrument) {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" with green and gray bars, followed by the text "-NAV" in dark blue. Below the main logo, the word "TECHNOLOGIES" is written in a smaller, lighter font. ### Predicate Device Information | Category | Comments | |-------------------------------------------|-----------------------------------------------------------| | Predicate Device: | X-Guide® Surgical Navigation System | | Predicate Device Manufacturer: | X-Nav Technologies, LLC. | | Predicate Device Common Name: | Surgical Navigation System | | Predicate Device Premarket Notification#: | K150222 | | Predicate Device Classification: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories) | | Predicate Device Class & Product Code: | Class 2, PLV | ### Reference Device Information | Category | Comments | |-------------------------------------------|--------------------------------------------------------------| | Reference Device: | StealthStation™ System with StealthStation™ Cranial Software | | Reference Device Manufacturer: | Medtronic Navigation, Inc. | | Reference Device Common Name: | Stereotaxic Instrument | | Reference Device Premarket Notification#: | K153660 | | Reference Device Classification: | 21 CFR 882.4560 (Stereotaxic Instrument) | | Reference Device Class & Product Code: | Class II, HAW | ### Reference Device Information | Category | Comments | |-------------------------------------------|-----------------------------------------------------------------------| | Reference Device: | Cranial Image Guided Surgery System | | Reference Device Manufacturer: | BrainLab | | Reference Device Common Name: | BrainLAB Cranial Image Guided Surgery System/ Instrument, Stereotaxic | | Reference Device Premarket Notification#: | K092467 | | Reference Device Classification: | 21 CFR 882.4560 (Stereotaxic Instrument) | | Reference Device Class & Product Code: | Class II ,HAW | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of green and gray horizontal bars, followed by the word "-NAV" in large, bold, blue letters. Below the main logo, the word "TECHNOLOGIES" is written in smaller, gray letters. ### Indications for Use: The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous adult and geriatric patients who need dental implants as part of their treatment plan. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of horizontal lines in shades of blue, green, and gray. To the right of the "X" is the word "-NAV" in large, bold, dark blue letters. Below the "X" and "-NAV" is the word "TECHNOLOGIES" in smaller, gray letters. ### Device Description: The X-Guide® Surgical Navigation Systemis an electro-optical device designed to aid dental surgical providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data. The system provides the surgeon with a three-dimensional real time video visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y,Z, Pitch, Yaw,andRoll) and anaccuracy (RMS) of < 1 mm. Thishelps to improve the Oral Surgeon drilling precision within a patient oral cavity. Since the system is video based, the surgeon is still working in the freehand mode, meaning he/she is always in control of the surgery. The implant process occurs in two stages. Stage 1 is the surgical implantation procedure. The dental surgeon plans the surgical procedure in the Implant Planning Software, XOS®. A virtual implant is aligned to the desired location in the CT scan. allowing the dental surgeon to avoid interfering with critical anatomical structures during implant has been optimally positioned, the plan is transferred to the X-Guide® Surgical Navigation System in preparation for implant surgery. In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the pre-operative plan. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processing hardware to precisely and continuously track the motion of the dental handpiece and the surgically-relevant portion of the patient. The relative motion of the dental handpiece and the patient an the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpiece to be animated and drientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of horizontal lines in green, blue, and gray. To the right of the "X" is the word "NAV" in large, bold, blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, gray letters. Several patient-specific calibrations underpin the guidance system. Hand Piece callbration is performed to geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument. Likewise. Patient Tracker calibration is performed to determine the geometric relationship between the Patient Tracker and the scan coordinates of the patient anatomy. There are separate procedures for Patient Tracker calibration, depending on whether the X-Clip or the Edentulous Clip is used. For toothed patients (partially edentulous), an X-Clip®, which contains embedded radiodense spheres, is attached to CT image acquisition. The location of these spheres on the X-Clip establishes a link between the CT coordinate system and the patient's surgical anatomy. Immediately prior to surgery, the Pattached, and a separate calibration determines the relationship between the spheres and the Patient Tracker. This device remains on the patient teeth for the duration of surgery. For edentulous (toothless) patients, the surgeon drills several narrow holes in the bone to serve as fiducials for the CT scan. Nothing is implanted. After the CT scan and surgical plan are completed, including the step of locating and marking the holes in the CT image, an Edentulous Clip is attached to the patient just prior to surgery. This device is necessary to attach tracking patterns to faciliate the navigation and tracking process, and is calibrated to the patient and CT by probing each of the fiducial holes and correlating these locations to the locations marked in the plan. During execution of the surgical procedure, the X-Guide® System correlates between the surgical plan and the surgeon's actual performance. If significant deviation between the plan and the system performance occur, the system will alert the user. The X-Guide® Surgical Navigation System is a supporting additional information to the decision-making process during the surgical procedure. It is by no means intensed to replace in judgment. The final decisions as to the exact location and depth of the surgery are the sole responsibility of the surgeon can at any time during the surgical procedure modify the plant positions. Under no circumstances does the device the surgeon of his or her ultimate clinical responsibility. Modifications made to the subject device are as follows: - 1. An alternate method (X-Mark) is being proposed for registration of dentate and edentulous patients. - 2. A new process is being proposed for correcting inaccurate patient registrations. - 3. Two system hardware components, Probe Tool and Probe Tracker, are required to support these processes. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of green and gray horizontal bars, followed by the word "NAV" in large, bold, dark blue letters. Below the logo, the word "TECHNOLOGIES" is written in smaller, gray letters. #### X- Mark Process (Proposed Patient Registration Change) The X-Mark process is an alternate method of patient registration to the aforementioned cleared methods. Instead of placing and marking organic fiducials / Bone Screws (edentulous) or using an X-Clip (dentate), the doctor has the option to use existing anatomical landmarks as fiducials instead. These landmarks are manually marked in the X-Guide Software. Once at least 3 anatomical landmarks are marked, the anatomical landmarks by touching them with the tip of a Probe Tool while the tracking system tracks the relationship between the Pracker to complete the patient registration. This registration algorithm is identical to the existing cleared patient registration algorithm. The doctor can choose teeth or anatomical landmarks as the fiducials. ### Refinement Process The Refinement process is a method for correcting inaccurate patient registrations. This method involves "painting" an anatomical surface by moving the surface of a patients oral anatomy in order to generate a surface comprised of hundreds of surface points in the patient tracking coordinates. The process then aligns the generated surface with the CBCT derived anatomical surface using the same cleared algorithms that are currently employed. #### X-Mark Probe Tool / Probe Tracker The X-Mark Probe Tool is used to register the locations of organic fiducials, bone screws, or anatomic landmarks within the patient's oral cavity as part of the Patient Registration process. The Probe Tool is designed as a rigid structure for identifying locations within the patient oral cavity anatomy. The Probe Tracker is geometrically similar to the X-Corner Handpiece Tracker. Patterns on the Probe Tracked by the stereo cameras to indicate the X-Mark Probe Tool Tool Tool Tool Tip location, relative to pationt anatomy. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of green, blue, and gray horizontal bars. To the right of the "X" is the word "NAV" in large, bold, blue letters. Below the "X" and "NAV" is the word "TECHNOLOGIES" in a smaller, gray font. ### Comparison to Predicate and Reference Devices: As described in the tables below, the application device X-Guide® Surgical Navigation System (K192579) is substantially equivalent in intended use, design and physician use to the predicate device X-Guide® Surgical Navigation device is substantially equivalent in scientific technology to the reference device SteathStation™ Cranial Software (K.53660), specifically the cranial software. The application device is also substantially equivalent in scientific technology to the reference device (KN2447), supporting the method of patient registration using anatomical landmarks. | | Application Device | Primary Predicate Device | Reference Device | | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Use<br>Specifications | X-Guide® Surgical Navigation<br>System (K192579) | X-Guide® Surgical Navigation<br>System (K150222) | StealthStation™ System with<br>StealthStation™ Cranial<br>Software (K153660) | Justification of<br>Differences | | Indications for<br>Use | The X-Guide® Surgical Navigation System<br>is a computerized navigational system<br>intended to provide assistance in both the<br>preoperative planning phase and the intra-<br>operative surgical phase of dental<br>implantation procedures.<br>The system provides software to<br>preoperatively plan dental surgical<br>procedures and provides navigational<br>guidance of the surgical instruments.<br>The device is intended for use for<br>partially edentulous and edentulous adult<br>and geriatric<br>patients who need dental implants as<br>part of their treatment plan. | The X-Guide® Surgical Navigation<br>System is a computerized navigational<br>system intended to provide assistance<br>in both the preoperative planning<br>phase and the intra-operative surgical<br>phase of dental implantation<br>procedures.<br>The system provides software to<br>preoperatively plan dental surgical<br>procedures and provides navigational<br>guidance of the surgical instruments.<br>The device is intended for use for<br>partially edentulous and edentulous<br>adult and geriatric<br>patients who need dental implants<br>as part of their treatment plan. | The StealthStation® System, with<br>StealthStation® Cranial Software<br>is intended as an aid for locating<br>anatomical structures in either open or<br>percutaneous procedures. The system is<br>indicated for any medical condition in<br>which reference to a rigid anatomical<br>structure can be identified relative to<br>images of the anatomy.<br>This can include, but is not limited to,<br>the following cranial procedures<br>(including stereotactic frame-based and<br>stereotactic frame alternatives-based<br>procedures): • Cranial Biopsies • Deep<br>Brain Stimulation (DBS) Lead<br>Placement • Depth Electrode Placement<br>• Tumor Resections •<br>Craniotomies/Craniectomies • Skull<br>Base Procedures • Transsphenoidal<br>Procedures • Thalamotomies<br>• Pallidotomies • Pituitary Tumor<br>Removal • CSF Leak Repair • Pediatric<br>Ventricular Catheter Placement •<br>General Ventricular Catheter Placement<br>The user should consult the<br>"Navigational Accuracy" section of the<br>User Manual to assess if the accuracy of<br>the system is suitable for their needs. | The Indications for Use of the<br>application and Predicate Devices<br>are identical.<br>All of these devices are surgical<br>navigation systems. The<br>Application and Reference<br>devices both have the ability to<br>register patient anatomy using a<br>combination of anatomical<br>landmarks and software. As<br>evidenced by the Reference<br>Device, this capability has long<br>been applied to such devices and<br>raises no new questions for these<br>types of devices. | | Product Code | PLV | PLV | HAW | All three devices are stereotaxic<br>instruments intended to be used<br>for surgical navigation | | | Application Device | Primary Predicate Device | Reference Device | | | Technology /<br>Performance<br>Characteristics | X-Guide® Surgical<br>Navigation System<br>(K192579) | X-Guide® Surgical<br>Navigation System<br>(K150222) | StealthStation™ System with<br>StealthStation™ Cranial<br>Software (K153660) | Justification of Differences | | Operating Temperature | 10 - 35 deg C | 10 - 35 deg C | Not Applicable | No difference. | | Operating Relative<br>Humidity | 30% - 90% non-condensing | 30% - 90% non-condensing | Not Applicable | No difference. | | Altitude | 500 hPa-1060hPa | 500 hPa – 1060 hPa | Not Applicable | No difference. | | Transport Temperature | -20 - +60 deg C | -20 - +60 deg C | Not Applicable | No difference. | | Transport Humidity | 10% - 95% non-condensing | 10% - 95% non-condensing | Not Applicable | No difference. | | Optical Radiation | LED, Risk Group 1<br>(minimal risk) per<br>IEC 62471-1 | LED, Risk Group 1 (minimal<br>risk) per IEC 62471-1 | Not Applicable | No difference. | | Tracking Technology | Stereo Cameras / LEDs /<br>Patterns | Stereo Cameras /<br>LEDs / Patterns | Stereo Cameras / LED Optical Markers /<br>Sterile Sphere<br>Or<br>Electromagnetics (EM) AXIEM™ | Tracking technology is equivalent for all<br>three devices. The Reference Device offers<br>an additional tracking technology option<br>EM. The Application and Predicate devices<br>do not require this additional tracking<br>technology. | | Calibration Frequency | Prior to each surgery | Prior to each surgery | Prior to each surgery | No difference. | | Overall System Accuracy<br>(RMS) | <1mm | <1 mm | <2 mm | No difference. | | Alarms | Audible, Visual | Audible, Visual | Not Applicable | No difference. | | Monitor | LCD-TFT | LCD-TFT | Not Applicable | No difference. | | Communications Interface | Ethernet | Ethernet | Ethernet | No difference. | | Software | Navigational Guidance<br>and Implant<br>Planning | Navigational Guidance and<br>Implant Planning | Navigational Guidance and Surgical<br>Planning | No Difference | | Fiducial Identification | X-Clip Organic Fiducials<br> Rigid Anatomical<br>Landmarks | X-Clip Organic Fiducials | Rigid Anatomical Landmarks and<br>StarFix™ Bone Anchor | Organic Fiducials are equivalent to Bone Screws.<br>The Application and Reference Devices both<br>provide similar means of Fiducial Identification.<br>Similarly, the Application and Predicate Device<br>each share common means (X-Clip or Organic<br>Fiducials) of Fiducial Identification. | | Edentulous Fiducial<br>Registration Tool | X-Mark Probe Tool | Dental Handpiece with Burr | Registration Probes…