← Product Code [PLV](/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV) · K150222 # X-Guide Surgical Navigation System (K150222) _X-Nav Technologies, LLC · PLV · Oct 8, 2015 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K150222 ## Device Facts - **Applicant:** X-Nav Technologies, LLC - **Product Code:** [PLV](/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV.md) - **Decision Date:** Oct 8, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4120 - **Device Class:** Class 2 - **Review Panel:** Dental ## Intended Use The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and 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. ## Device Story X-Guide Surgical Navigation System is an electro-optical device for dental implant surgery. It uses CT scan data for preoperative planning and intra-operative guidance. The system tracks the patient and dental handpiece using stereo cameras that detect 2D barcode patterns on trackers. It provides 3D visual feedback on an LCD monitor, showing the drill position relative to the surgical plan with 6 degrees of freedom and <1 mm accuracy. Used in clinical settings by oral surgeons, it assists in precise tool placement to avoid critical anatomical structures. The surgeon remains in control of the procedure; the system provides alerts if significant deviations from the plan occur. It benefits patients by improving drilling precision and reducing risks to adjacent structures. ## Clinical Evidence Clinical study involving >150 adult and geriatric patients over 7 months. Conducted by board-certified oral surgeons in clinical settings. Primary endpoint was navigation accuracy, usability, and performance. Results confirmed accuracy <1 mm, consistent with the predicate device. No adverse events or complications reported. ## Technological Characteristics Mobile cart-based system with stereo cameras and LED array for tracking. Components include X-Clip/E-Clip for patient registration and handpiece trackers. Materials are biocompatible per ISO 10993. Connectivity via Ethernet. Sterilization of instruments via steam; high-level disinfection of system components via 3% glutaraldehyde. Electrical safety per IEC 60601-1 (3rd ed). ## Regulatory Identification A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw. ## Predicate Devices - IGI-System™ by DENX Advanced Dental Systems Ltd. ([K023424](/device/K023424.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 8, 2015 X-Nav Technologies, LLC. Mr. Fred Cowdery Director- Regulatory Affairs 1555 Bustard Road, Suite 75 Lansdale, PA 19446 Re: K150222 Trade/Device Name: X-Guide® Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: PLV Dated: September 14, 2015 Received: September 15, 2015 Dear Mr. 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. 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. {1}------------------------------------------------ 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang-S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K150222 #### Device Name X-Guide(R) 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 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) | ✔ 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for X-NAV Technologies. The X is stylized with green, blue, and gray horizontal lines. The NAV is in large, bold, blue letters. The word "TECHNOLOGIES" is in smaller, gray letters below the X-NAV. # 510(k) Summary (As required by Section 807.92) | Date Prepared: | October 8, 2015 | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Applicant: | X-NAV Technologies, LLC
1555 Bustard Road, Suite 75
Lansdale, PA. 19446 | | Contact Person: | Fred Cowdery
Director – Regulatory Affairs and Quality Assurance
Ph 267-436.0414
Email: fred.cowdery@x-navtech.com | | Device Trade/Proprietary Name: | X-Guide® Surgical Navigation System,
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) | | Predicate Device(s): | IGI-System™ by DENX Advanced Dental Systems Ltd. (K023424) | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of overlapping bars in blue, green, 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. ## Device Description: The X-Guide® Surgical Navigation System is an electro-ontical device designed to aid dental 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 system provides the surgeon with a three visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y, Z, Pitch, Yaw, and Roll) and an accuracy (RMS) of < 1 mm. This helps to improve the Oral Surgeon drilling precision within a patient oral cavity. Since the system is still working in the freehand mode, meaning he/she is always in control of the surgery. The implant process occurs in two stages is the preplanning of 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 surgery. Once an implant has been optimally positioned, the X-Guide® Surgical Navigation System in preparation for implant surgery. In Stage 2 the system provides accurate quidance 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 tracking patterns on the Hand Piece Tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processed by data processing hardware to precisely and continuously track the motion of 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 patient-specific calibration data. This enables a 3D graphical representation of the handpieced 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 maneuver the dental handpiece into precise alignment. Several patient-specific calibrations underpin the quidance system. Hand Piece calibration is performed to determine the geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument. {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 horizontal lines in shades of blue, green, and gray. To the right of the "X" is the word "-NAV" in a bold, dark blue font. Below the "X-NAV" is the word "TECHNOLOGIES" in a light gray, sans-serif font. Likewise. 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 calibration, depending on whether the X-Clip or the E-Clip is used. For toothed patients (partially edentulous), an X-Clip®, which contains embedded radiodense spheres, is attached to patient teeth prior to CT image acquisition. The location of 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 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 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 E-Clip" is attached to the patient just prior to surgery. This device is necessary to attach tracking patterns to facilitate the navigation and tracking process, and is calibrated to the patient anatomy 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® 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. 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 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 implant positions. Under no circumstances does the device relieve the 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 horizontal bars in shades of blue, green, and gray. To the right of the "X" is the word "NAV" in large, bold, dark blue letters, and below the "X-NAV" is the word "TECHNOLOGIES" in smaller, light 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. ## Comparison of Technological Characteristics: The X-Guide® Surgical Navigation System shares clinical, technological, and performance features with a similar FDA cleared tracking device - The Denx Ltd. IGI-System™ (K023424). Both systems provide accurate guidal tools and implantable devices through the use of computer aided navigation. This guidance is achieved through the use of optical tracking of the surgical tools. Neither device is intended to replace human assessment, but to provide objective information relating and alignment of the surgical tools or implantable devices in reference to the patient anatomy. Additionally, the X-Guide' Surgical Navigation System and the predicate device share several other significant features: - Both devices have the same Intended Use. ● - Both devices provides animated indicators to show the real time location of the surgical tool relative to the patient . anatomy, showing the tool in the patient CT in real time. - Both devices employ stereo computer vision tracking techniques. . - Both devices reduce risk of damage to adjacent anatomical structures. - Both devices share identical specified environments of use. ● - Both devices provide Planning Software allowing for placement of implant, target surgical site, and guidance to the ● implant site. - Both devices provide sub-millimeter navigation accuracy. ● - Both devices use CT Scans for registration of the patient tracking attachment, for use in planning the desired ● implant location, and as a reference to determine the exact positioning of the surgical tools during the surgical procedure. There are many similarities between the X-Guide® Surgical Navigation System™, however there are also some differences, mostly relating to technology and performance. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of horizontal bars in shades of blue, green, and gray. To the right of the "X" is the word "NAV" in large, bold, dark blue letters, and below that is the word "TECHNOLOGIES" in smaller, light gray letters. While the X-Guide® Surgical Navigation System™ both use stereo cameras to gather tracking information, the two systems have a fundamental difference in the tracking mediums and methods used. The IGI-System™ utilizes Infrared LEDs, operating at approximately 1050 nm, configured in an Emitter Collector configuration for tracking whereas the X-Guide® System utilizes a pattern illuminated by an LED array for tracking purposes. Furthermore, the X-Guide® Surgical Navigation System's feature points are based on contrast saddle-points, whose detected locations are more stable under pertations in lighting, partial obscuration) than the roughly circular intensity pattern produced by an Infrared LED, resulting in higher theoretical accuracy in surgical environments. The X-Guide® Surgical Navigation System™ both have provisions for patient and stereo camera alignment within the tracking volume. Since the lG-System™ cameras can only detect in the infrared spectrum, not allowing for video feedback to aide in the positioning process, lasers are necessary. In the X-Guide® system stereo cameras are positioned visually utilizing video feedback from the stereo cameras. The X-Guide® Surgical Navigation System™ both attach the Applied Part to the patient. The X-Guide® System Applied part is a Type B whereas the IGI System Applied Part is Type BF. The difference in applied part rating extends from the IGI-System™ applied part being both conductive and utilizing electrical energy on the component. The applied part utilized by the X-Guide® Surgical Navigation System is nonconductive and does not utilize electrical energy, providing a lower risk of electrical shock to the patient in the event of a single fault. Several times during a surqical procedure it is common for the surgical instrument. (Dental Hand Piece) to exit and enter a "havigation zone", which is essentially the surgical region. Typically, the reason to ext is to change drill bit types and lengths. When the surgical instrument is entering the "havigation zone", the X-Guide" Surgical Navigation System requires the doctor to touch the "Go Button". This action will automatically trigger the calculation of the drill bit length prior to resuming surgery. {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, blue, and gray angled bars. The words "-NAV" are in large, bold, dark blue letters, and the word "TECHNOLOGIES" is in smaller, light gray letters below. # Comparison of Technological Characteristics: | | N/A | K023424 | | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Use Specifications | X-Guide® | IGI-System™ | Justification of
Differences | | 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 surgical
procedures and provides navigational
guidance of the surgical instruments.
The device is intended for use for partially
edentulous and edentulous adult and
geriatric patients who need dental implants
as part of their treatment plan. | The Image-Guided Implantation (IGI)
System is a computerized navigational
system intended to provide assistance in
both the planning (pre-operative) and the
surgical (intra-operative) phases of dental
implantation procedure. The system
provides accurate navigational guidance of
surgical instruments, with regard to the pre-
operative planning in dental implantation
procedure.
The device is intended for use for partially
or fully endentulous patients who need
dental implants as part of their treatment
plan. | There is no
difference between
the products in
Intended Use.
The X-Guide®
Surgical Navigation
System specifies a
target population,
whereas the
IGI-System™ does
not. | | Use Environment | Clinical Setting, Doctors Office | Clinical Setting, Doctors Office | No Difference | | | N/A | K023424 | | | Technology / Performance
Characteristics | X-Guide® | IGI-System™ | Justification of Differences | | Operating Temperature | 10 - 35 deg C | Not specified | Both systems are intended for use in similar
clinical environments. | | Operating Relative Humidity | 30% - 90% non-condensing | Not Specified | Both systems are intended for use in similar
clinical environments. | | Altitude | 500 hPa-1060hPa | 500 hPa - 1060 hPA | No Difference | | Transport Temperature | -20 - +60 deg C | 0 - 40 deg C | The X-Guide® can withstand a wider range of
storage / transport temperature without
compromising system integrity | | Transport Humidity | 10% - 95% non-condensing | 10% - 80% non-condensing | The X-Guide® can withstand a higher level of
humidity during transport without compromising
system integrity. | | Optical Radiation | LED, Risk Group 1 (minimal
risk) per IEC 62471-1 | Laser, Class II (<1mW) per
IEC 60825-1, 620-690nm | No Difference in Risk Level | | Tracking Technology | Stereo Cameras / LEDs /
Pattern | Stereo Cameras /
Infrared LEDs | X-Guide® Surgical Navigation System uses passive
elements on the patient for tracking purposes
whereas the IGI-System™ uses active elements
(containing electrical energy) attached to the
patient for tracking purposes. | | Calibration Frequency | Prior to each surgery | Factory Calibrated and
authorized service
personnel. | No Difference | | Overall System Accuracy (RMS) | <1mm | <1 mm | No Difference | | Alarms | Audible, Visual | Audible, Visual | No Difference | | Monitor | LCD-TFT | LCD-TFT | No Difference | | Communications Interface | Ethernet | Ethernet | No Difference | | Software | Navigational Guidance and
Implant Planning | Navigational Guidance and
Implant Planning | No Difference | | | N/A | K023424 | | | Technology / Performance
Characteristics | X-Guide® | IGI-System™ | Justification of Differences | | Dimensions | Height: 64.653 in (1642.19 mm)
Width: 21.011 in (533.67mm) | Unavailable | Both systems are intended for use in similar
clinical environments and are classified as mobile
per IEC / EN 60601-1definition. | | Mounting Configuration | Mobile Cart | Mobile Cart | No Difference | | Weight | 130lbs. (58.97 kg) | Unavailable | Both systems are classified as Mobile, per IEC / EN
60601-1definition. Differences in weight that may
exist do not affect either devices efficacy or
intended use. | | Safety Features | X-Guide® | IGI-System™ | Justification of Differences | | Electrical Safety | IEC 60601-1:2005 3rd Edition
AAMI ES60601-1:2005
+A1:2009 +A2:2010
EN 60601-1:2006 | EN60601-1:1990 +A1:1992
+A2: 1995; +A13
IEC 601-1:1998 +A1:1991
+A2:1995 +Corrigendum
EN60601-1-1:1993
+A1:1995
IEC60601-1-4:1996 | The X-Guide® system has been certified to more
recent editions of the Electrical Safety Standards,
which have a heavier influence of ISO 14971 Risk
Management. EN60601-1-1 and IEC 60601-1-4
have been merged into the 3rd edition of EN60601-
1:2006 and IEC60601-1:2005. Therefore both
system were evaluated to the same standards.
While both standards provide guidance for
symbolic labeling of medical devices, ISO 15223-
1:2012 is an FDA recognized standard.
While both standards provide guidance for
evaluating risk in medical devices, ISO 14971:2012
is an FDA recognized standard. | | | ISO15223-1:2012 | EN980:1996 +A1:1999 | | | | BS EN ISO 14971:2012 | EN1441:1997 | | | | Electromagnetic Compatibility | IEC 60601-1-2:2007 3rd Edition | EN 60601-1-2:1993
IEC 601-2:1993 | | Biocompatibility | Yes (ISO 10993-1, -5, -10, -11, -
12) | not specified | Do not anticipate any significant difference in this
characteristic since both systems are intended for
use in similar clinical environments. | | Sterilization | Steam | Steam | No Difference | | Disinfectant (High-Level) | 3% Glutaraldehyde solution | 3% Glutaraldehyde solution | No Difference | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of horizontal bars in green, dark blue, and gray. The words "-NAV" are in dark blue, and the word "TECHNOLOGIES" is in gray below the main logo. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image is a logo for X-NAV Technologies. The X is made up of green, gray, and blue horizontal lines. The NAV and Technologies are in a sans-serif font, with NAV being in a dark blue and Technologies being in a light gray. {11}------------------------------------------------ | Safety Features | X-GuideR | IGI-System™ | Justification of Differences | |--------------------|----------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Ingress Protection | IP2X | Not Specified in IFU or
Product Labeling | Do not anticipate any significant difference in this
characteristic since both systems are intended for
use in similar clinical environments. | | | N/A | K023424 | | |------------------------------… --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K150222](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K150222) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com