X-Guide® Surgical Navigation System

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February 1, 2022 X-Nav Technologies, LLC Kimberly Chan Regulatory Affairs Manager 1555 Bustard Road, Suite 75 Lansdale, Pennsylvania 19446 Re: K211701 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: QRY, PLV Dated: January 5, 2022 Received: January 6, 2022 Dear Kimberly Chan: 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. 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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 mediation-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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K211701 Device Name X-Guide® Surgical Navigation System #### Indications for Use (Describe) 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 and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures access 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 a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate 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 main text, "TECHNOLOGIES" is written in a smaller, lighter gray font. # 510(k) Summary - K211701 (As required by Section 807.92(c)) | Date Prepared: | February 1, 2022 | |----------------------------------|---------------------------------------------------------------------------------------------------| | Applicant: | X-Nav Technologies, LLC<br>1555 Bustard Road, Suite 75<br>Lansdale, PA. 19446 | | Contact Person: | Kimberly Chan<br>Regulatory Affairs Manager<br>Phone: 267-436-0414<br>kimberly.chan@x-navtech.com | | Device Trade / Proprietary Name: | X-Guide® Surgical Navigation System<br>Model P007839<br>Model P011000 | | Device Name, Common/Usual: | Surgical Navigation System | | Classification Name: | 21 CFR 872.4120 (Bone Cutting Instrument and<br>Accessories) | | Regulatory Class: | II | | Product Code: | QRY, PLV | | Predicate Device: | X-Guide® Surgical Navigation System (K192579) | | Reference Devices: | X-Guide® Surgical Navigation System (K150222, K200662) | {4}------------------------------------------------ Image /page/4/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 bars, followed by the text "-NAV" in a bold, dark blue font. Below the main logo is the word "TECHNOLOGIES" in a smaller, gray font. ### Proposed Change to Indications The indication statements are different from those of the predicate device. ### Proposed 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 and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access 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 a part of their treatment plan. The device is also intended for endodontic access procedures and or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan. #### Proposed Intended 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 and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The subject device is the same as the X-Guide® Surgical Navigation System cleared under K192579 (the predicate device) except for the changes to the indications for use. There is no change to the technological characteristics or components. There are no changes to the calibration process or navigation process. During dental implantation surgery for which the X-Guide System is already cleared, the dental surgeon performs several pilot drills to create a space for the implant in the implant itself. This is no different than drilling a trajectory for endodonic access. The trajectory is established based on pre-planning in the software with a CBCT scan. {5}------------------------------------------------ Image /page/5/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, dark blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, light gray letters. The differences in indication statements do not affect the substantial equivalence of the device is still for use with dental surgical procedures under the control of a trained surgeon. The X-Guide® Surgical Navigation is a supporting device, providing additional information to the decision-making process during the surgical procedure. It is by no means intended to replace the surgeon's 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 planned trajectories. Under no circumstances does the device the surgeon of his or her ultimate clinical responsibility. {6}------------------------------------------------ Image /page/6/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 text "-NAV" in dark blue. Below the main logo, the word "TECHNOLOGIES" is written in gray, smaller font. ### Device Overview The X-Guide® Surgical Navigation System is a cart mounted mobile system utilizing video technology to track position and movement of a surgical instrument (Dental Hand-Piece) during surgical procedures. The X-Guide® Surgical Navigation System consists of a Mobile Cart, equipped with an LCD Monitor, Boom Arm, Navigation Assembly, Keyboard, Mouse and an Electronics Enclosure. Reference Figure 1 for an illustration. The Electronics Enclosure contains the system power supplies, data processing hardware, and electronics control circuity for coordinating operation of the X-Guide® Surgical Navigation System. A LCD Monitor, Keyboard, and Mouse serve as the main user interface for the surgeon. The Go-Button serves as an additional form of input by providing virtual buttons that a user can activate by touching them with the surgical instrument tip. The Boom Arm allows the operator to manipulate the Navigation for optimal distance and alignment to patterns located with the surgical region (Navi-Zone) for tracking purposes. The Boom Arm can be extended up to ~79" in the X-Axis and retracts to ~35". It can be positioned 180 degrees in the left to right to left motion range. The Navigation Assembly contains two cameras oriented in a stereo configuration, along with blue lighting the patterns and mitigating ambient lighting noise. This electro-optical device is designed to improve dental surgical procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data. The implant process occurs in two stage 1 is the pre-planning of the surgical implantation procedure. The dental surgeon plans the surgical procedure in the X-Guide System Planning Software. A virtual implant is aligned location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Once an 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. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of green, blue, and gray bars, followed by the text "-NAV" in large, bold, dark blue letters. Below the main logo, the word "TECHNOLOGIES" is written in smaller, gray letters. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracking patterns on the Handpiece 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 anatomy, captured by the tracking hardware, is combined with patientspecific calibration data. This enables a 3D graphical representation of the handpiece to be animated and depicted in precise location and orientation 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 manewer the dental handpiece into precise alignment. During execution of the surgical procedure, the X-Guide® Surgical Navigation 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. Safety glasses are provided for patient use on an optional as needed basis. Device accuracy has been evaluated for compliance with FDA recognized performance standard ASTM F2554- 18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. {8}------------------------------------------------ Image /page/8/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 lines. 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. Figure 1: X-Guide® Surgical Navigation System Image /page/8/Figure/2 description: The image shows a medical device with several labeled components. The device includes a boom arm extending from the top, a navigation assembly with LEDs and cameras, and a monitor mounted on a stand. At the base, there is an electronics enclosure, indicating the device's power and control systems are housed there. 1555 Bustard Road, Suite #75, Landsdale, PA 19446 267-436-0420 www.X-NavTech.com / 1 {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, dark blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, gray letters. ## Device Description The benefit is to improve surgical procedures and reduce risk of potential damage to adjacent anatomical structures and fissues, resulting in a reduction of risk to the patient. 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, Yav, and Roll) and an accuracy (RMS) of < 1 mm. This helps to improve the 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. Several patient-specific callbrations underpin the guidance system. Hand Piece callbration is performed to determine the geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument. #### Patient Tracker Calibration Patient Tracker calibration is performed to determine the geometric relationship between the scan coordinates of the patient anatomy. There are separate procedures for Patient Tracker callbration, depending on whether the patient is edentulous, partially edentulous, or if the surgeon wishes to use the X-Mark process. - X-Clip Calibration: For toothed patially edentulous), an X-Clip®, which contains embedded radiodense . spheres, is attached to patient teeth prior 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 Patient Tracker is attached, 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. - Edentulous Fiducial Registration: For edentulous (toothless) patients, the surgeon drills several bone screws in the ● bone to serve as fiducials for the CT scan. The location of these bone screws establishes a link between the CT coordinate system and the patient's surgical anatomy. The surgeon then locates and marks the screws in the CT image in the X-Guide software. Just prior to surgery, an Edentulous Clip, CLX Tracker arm, or EDX Tracker arm is attached to the patient. This device is necessary to attach Tracker to the patient, and facilitates the navigation and tracking process. The system is calibrated to the patient anatomy and CT by probing each of the fiducial screws and correlating these locations to the locations marked in the plan. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of blue, green, and gray horizontal bars. To the right of the "X" is the text "-NAV" in a bold, dark blue font. Below the "X-NAV" text is the word "TECHNOLOGIES" in a smaller, gray font. - X-Mark Registration: The CT scan of the patient is taken without any fiducials in the image. The doctor ● manually marks anatomical landmarks as fiducials instead, and because of this, this process is well suited for both dentate and edentulous patients. Once at least 3 anatomical landmarks are marked, the doctor registers the anatomical landmarks by touching them with the tip of a Probe Tool on the registration page. The tracking system tracks the relationship between the Patient Tracker to complete the patient registration. {11}------------------------------------------------ Image /page/11/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 text "-NAV" in large, bold, dark blue letters. Below the main text, the word "TECHNOLOGIES" is written in smaller, light gray letters. ## Specifications A comparison of the following specifications is itemized in the tables on the ensuing pages. - · Use Specifications - Technology / Performance Characteristics . - Safety Features . - Components . - Energy . {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made up of green, blue, and gray sections, followed by the text "-NAV" in blue. Below the main logo, the word "TECHNOLOGIES" is written in a smaller, gray font. ### Use Specifications | Use<br>Specifications | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ;<br>K192579 | Justification of Differences | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The X-Guide® Surgical Navigation System is a<br>computerized navigational system intended to<br>provide assistance in both the preoperative<br>planning phase and the intra-operative surgical<br>phase of dental implantation procedures and/or<br>endodontic access procedures.<br><br>The system provides software to preoperatively<br>plan dental implantation procedures and/or<br>endodontics access procedures and provides<br>navigational guidance of the surgical instruments.<br><br>The device is intended for use for partially<br>edentulous and edentulous adult and geriatric<br>patients who need dental implants as a part of<br>their treatment plan. The device is also intended<br>for endodontic access procedures (i.e.,<br>apicoectomies and/or access of calcified canals)<br>where a CBCT is deemed appropriate as part of<br>their treatment plan. | The X-Guide® Surgical<br>Navigation System is a<br>computerized navigational system<br>intended to provide assistance in<br>both the preoperative planning<br>phase and the intra-operative<br>surgical phase of dental<br>implantation procedures.<br><br>The system provides software to<br>preoperatively plan dental surgical<br>procedures and provides<br>navigational guidance of the<br>surgical instruments.<br><br>The device is intended for use for<br>partially edentulous and edentulous<br>adult and geriatric patients who<br>need dental implants as part of<br>their treatment plan. | The inclusion of endodontic access procedures does not change the<br>efficacy or safety of the X-Guide System.<br><br>The X-Guide System is currently cleared to guide the dental<br>surgeon to place implants. During dental implantation surgery, the<br>dental surgeon drills pilot holes in the patient bone to make a space<br>for the implant. The process for drilling a trajectory for endodontic<br>access is no different.<br><br>The independent studies listed in this 510(k) show that the X-Guide<br>System is more accurate than freehand when used for this purpose.<br><br>This 510(k) submission solely claims that the X-Guide System is<br>safe and efficacious when used to create an endodontic access<br>point. This 510(k) does not make claims regarding endodontic<br>procedures beyond the creation of the access point. | | Intended Use | The X-Guide® Surgical Navigation System is a<br>computerized navigational system intended to<br>provide assistance in both the preoperative<br>planning phase and the intra-operative surgical<br>phase of dental implantation procedures and/or<br>endodontic access procedures.<br><br>The system provides software to preoperatively<br>plan dental implantation procedures and/or<br>endodontics access procedures and provides<br>navigational guidance of the surgical instruments. | The X-Guide® Surgical<br>Navigation System is a<br>computerized navigational system<br>intended to provide assistance in<br>both the preoperative planning<br>phase and the intra-operative<br>surgical phase of dental<br>implantation procedures.<br><br>The system provides software to<br>preoperatively plan dental surgical<br>procedures and provides<br>navigational guidance of the<br>surgical instruments. | The inclusion of endodontic access procedures does not change the<br>efficacy or safety of the X-Guide System.<br><br>The X-Guide System is currently cleared to guide the dental<br>surgeon to place implants. During dental implantation surgery, the<br>dental surgeon drills pilot holes in the patient bone to make a space<br>for the implant. The process for drilling a trajectory for endodontic<br>access is no different.<br><br>The independent studies listed in this 510(k) show that the X-Guide<br>System is more accurate than freehand when used for this purpose.<br><br>This 510(k) submission solely claims that the X-Guide System is<br>safe and efficacious when used to create an endodontic access<br>point. This 510(k) does not make claims regarding endodontic<br>procedures beyond the creation of the access point. | | Technology / Performance<br>Characteristics | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K192579 | Justification of<br>Differences | | Operating Temperature | 10 - 35 deg C | 10 - 35 deg C | No difference. | | Operating Relative Humidity Altitude | 30% - 90% non-condensing | 30% - 90% non-condensing | No difference. | | Transport Temperature Transport<br>Humidity | 500 hPa-1060hPa | 500 hPa-1060hPa | No difference. | | Optical Radiation | -20 - +60 deg C | -20 - +60 deg C | No difference. | | Tracking Technology | 10% - 95% non-condensing | 10% - 95% non-condensing | No difference. | | Calibration Frequency | LED, Risk Group 1 (minimal risk) per IEC<br>62471-1 | LED, Risk Group 1 (minimal risk) per IEC<br>62471-1 | No difference. | | Overall System Accuracy (RMS)<br>Alarms | Stereo Cameras / LEDs / Pattern | Stereo Cameras / LEDs / Pattern | No difference. | | Alarms | Prior to each surgery | Prior to each surgery | No difference. | | Monitor | <1mm | <1mm | No difference. | | Communications | Audible, Visual | Audible, Visual | No difference. | | Interface | LCD-TFT | LCD-TFT | No difference. | | Software | Ethernet | Ethernet | No difference. | | Fiducial Identification | Navigational Guidance and Implant Planning X-<br>Clip \ Organic Fiducials \ Anatomical Landmarks | Navigational Guidance and Implant Planning X-<br>Clip \ Organic Fiducials \ Anatomical<br>Landmarks | No difference. | | Edentulous Fiducial Registration | X-Mark Probe Tool | X-Mark Probe Tool | No difference. | | Dimensions | Height: 64.653 in (1642.19 mm)<br>Width: 21.011 in (533.67mm) | Height: 64.653 in (1642.19 mm)<br>Width: 21.011 in (533.67mm) | No difference. | | Mounting | Mobile Cart | Mobile Cart | No difference. | | Configuration Weight | 130lbs. (58.97 kg) | 130lbs. (58.97 kg) | No difference. | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" in green, blue, and gray, followed by the text "-NAV" in dark blue. Below the main logo is the word "TECHNOLOGIES" in light gray. | Use Environment | Clinical Setting, Doctors Office | |-----------------|----------------------------------| | | Clinical Setting, Doctors Office | | | No difference | #### Technology/Performance Characteristics {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the 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 text "-NAV" in a bold, dark blue font. Below the main logo is the word "TECHNOLOGIES" in a smaller, gray font. #### Safety Features | Safety Features | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K192579 | Justification of Differences | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Electrical Safety | IEC 60601-1:2005 Edition 3.1<br>AAMI ES60601-1:2005 +A1:2009 +A2:2010<br>EN 60601-1:2006 ISO15223-1:2012<br>BS EN ISO 14971:2012<br>IEC 62304: 2006, A1:2015 | IEC 60601-1:2005 Edition 3.1<br>AAMI ES60601-1:2005 +A1:2009 +A2:2010<br>EN 60601-1:2006 ISO15223-1:2012<br>BS EN ISO 14971:2012<br>IEC 62304: 2006, A1:2015 | No difference | | Electromagnetic<br>Compatibility | IEC 60601-1-2:2014 4th Edition | IEC 60601-1-2:2007 3rd Edition | No difference | | Biocompatibility | Yes (ISO 10993-1, -5, -10, -11, -12) | Yes (ISO 10993-1, -5, -10, -11, -12) | No difference | | Sterilization | Steam | Steam | No difference | | Disinfectant (High Level) | 3% Glutaraldehyde solution | 3% Glutaraldehyde solution | No difference | | Ingress Protection | IP2X | IP2X | No difference | {15}------------------------------------------------ Image /page/15/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of green, blue, and gray horizontal bars. To the right of the "X" is the text "-NAV" in a dark blue sans-serif font, and below the "X" is the word "TECHNOLOGIES" in a light gray sans-serif font. #### Components | Components | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K192579 ;<br>K200662 | Justification of<br>Differences | |--------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|---------------------------------| | Bone Screw | Bone Screw(s) | Bone Screw(s) | No difference | | CT / Patient Registration | X-Clip, Organic Fiducials, Anatomical Landmarks | X-Clip, Organic Fiducials, Anatomical Landmarks | No difference | | Patient Tracking Device | X-Corner Patient Tracker | X-Corner Patient Tracker | No difference | | Surgical Tool Tracking Device | X-Corner Handpiece Tracker | X-Corner Handpiece Tracker | No difference | | Screwdriver | Yes | Yes | No difference | | Edentulous Patient Tracking<br>Attachment System | Edentulous Clip, EDX Tracker Arms, CLX Tracker<br>Arms | Edentulous Clip, EDX Tracker Arms, CLX Tracker<br>Arms | No difference | | Registration Tool | Probe Tool | Probe Tool | No difference | | Drill Bit Length Determination | Go Plate | Go Plate | No difference | | Patient Tracker Attachment Arms | Posterior Tracker Arm; Anterior Tracker Arm | Posterior Tracker Arm; Anterior Tracker Arm | No difference | {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of green, blue, and…