(243 days)
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 (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.
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.
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 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Context: The FDA 510(k) submission (K211701) for the X-Guide® Surgical Navigation System is seeking to expand its indications for use to include endodontic access procedures, in addition to its existing clearance for dental implantation procedures. The core argument is that endodontic access procedures are technologically similar to drilling pilot holes for implants, and existing system performance (accuracy) is sufficient.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or target performance format for this specific submission's expanded indication. Instead, it relies on the existing performance characteristics of the predicate device (X-Guide® Surgical Navigation System, K192579) and demonstrates through comparative studies that this performance is better than freehand for the new indication.
The key performance characteristic cited is Overall System Accuracy (RMS) < 1mm. This is implicitly the acceptance criterion carried over from the predicate device and is expected to hold for the new indication.
| Acceptance Criterion (Implicitly Carried Over from Predicate Device) | Reported Device Performance (for new indication based on comparative studies) |
|---|---|
| Overall System Accuracy (RMS) < 1mm | X-Guide Dynamic Navigation resulted in better linear and angular deviation compared to freehand for endodontic access procedures (Root Canal Access and Apico Access). |
Note: The document explicitly states "No performance standards have been established for Dental Stereotaxic Instruments under Section 514 of the Food, Drug and Cosmetic Act." This usually means the FDA relies on comparative performance and substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and the Data Provenance:
-
Study 1: Root Canal Access
- Sample Size: 40 total human roots
- Data Provenance: Cadaver study using 2 cadaver heads. (Implies retrospective use of cadaveric material, but the study itself is prospective in its execution.)
-
Study 2: Apico Access
- Sample Size: 60 total human single-rooted teeth
- Data Provenance: Cadaver study using teeth mounted in 2 dry cadaver jaws. (Implies retrospective use of cadaveric material, but the study itself is prospective in its execution.)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not specify the number of experts or their qualifications for establishing ground truth. The studies relied on a "presurgical CBCT plan" that was compared to "navigated or freehanded trajectories in the post-operative CBCT." This implies that the ground truth for planning was based on the CBCT image and the surgical plan created by a user of the X-Guide system, without explicit mention of external experts for adjudication or ground truth establishment beyond the system's inherent planning capabilities. The studies were likely performed by endodontists, as the description states "endodontists can effectively perform endodontic access procedures with the X-Guide."
4. Adjudication Method for the Test Set:
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparison was made between the "presurgical CBCT plan" and the "post-operative CBCT" (drilled trajectory). This suggests a direct comparison of imaging data, likely involving measurement software, rather than a consensus-based expert review.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not an MRMC comparative effectiveness study in the traditional sense of evaluating AI assistance on human reader performance. This device is a surgical navigation system, not an AI diagnostic tool that assists human readers.
The studies compared two surgical methods:
- Dynamically navigated surgery (with X-Guide System assistance)
- Freehand surgery (without X-Guide System assistance)
The effect size is described qualitatively:
- "The linear deviation and angular deviation in dynamically navigated roots were found to be better than freehand."
No specific quantitative effect size (e.g., percentage improvement in accuracy, reduction in deviations) is provided in the summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device requires human-in-the-loop performance. It is a "computerized navigational system intended to provide assistance" to a surgeon. The studies directly evaluate the performance with a surgeon using the system versus without. Therefore, a standalone (algorithm only) performance assessment would not be relevant or conducted for this type of device.
7. The type of ground truth used:
The ground truth used for comparison was the presurgical CBCT plan for the intended trajectory. This plan was compared against the post-operative CBCT showing the actual drilled trajectory.
8. The sample size for the training set:
The document does not mention a training set for the device itself in the context of these studies. The X-Guide System is a navigation system that was already developed and "currently cleared." This submission is about expanding its indications for use based on its existing, proven technology. The studies assess the application of the already-trained system, not the training of a new AI model for this indication.
9. How the ground truth for the training set was established:
As no training set is mentioned for this specific submission, the method for establishing its ground truth is not provided. The X-Guide System's initial development and clearance (K192579, K150222, K200662) would have involved its own validation, but that information is beyond the scope of this particular 510(k) summary.
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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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
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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)
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510(k) Summary - K211701
(As required by Section 807.92(c))
| Date Prepared: | February 1, 2022 |
|---|---|
| Applicant: | X-Nav Technologies, LLC1555 Bustard Road, Suite 75Lansdale, PA. 19446 |
| Contact Person: | Kimberly ChanRegulatory Affairs ManagerPhone: 267-436-0414kimberly.chan@x-navtech.com |
| Device Trade / Proprietary Name: | X-Guide® Surgical Navigation SystemModel P007839Model P011000 |
| Device Name, Common/Usual: | Surgical Navigation System |
| Classification Name: | 21 CFR 872.4120 (Bone Cutting Instrument andAccessories) |
| Regulatory Class: | II |
| Product Code: | QRY, PLV |
| Predicate Device: | X-Guide® Surgical Navigation System (K192579) |
| Reference Devices: | X-Guide® Surgical Navigation System (K150222, K200662) |
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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.
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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.
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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.
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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.
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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
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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.
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- 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.
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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 .
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Use Specifications
| UseSpecifications | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ;K192579 | Justification of Differences |
|---|---|---|---|
| Indications forUse | The X-Guide® Surgical Navigation System is acomputerized navigational system intended toprovide assistance in both the preoperativeplanning phase and the intra-operative surgicalphase of dental implantation procedures and/orendodontic access procedures.The system provides software to preoperativelyplan dental implantation procedures and/orendodontics access procedures and providesnavigational guidance of the surgical instruments.The device is intended for use for partiallyedentulous and edentulous adult and geriatricpatients who need dental implants as a part oftheir treatment plan. The device is also intendedfor endodontic access procedures (i.e.,apicoectomies and/or access of calcified canals)where a CBCT is deemed appropriate as part oftheir treatment plan. | The X-Guide® SurgicalNavigation System is acomputerized navigational systemintended to provide assistance inboth the preoperative planningphase and the intra-operativesurgical phase of dentalimplantation procedures.The system provides software topreoperatively plan dental surgicalprocedures and providesnavigational guidance of thesurgical instruments.The device is intended for use forpartially edentulous and edentulousadult and geriatric patients whoneed dental implants as part oftheir treatment plan. | The inclusion of endodontic access procedures does not change theefficacy or safety of the X-Guide System.The X-Guide System is currently cleared to guide the dentalsurgeon to place implants. During dental implantation surgery, thedental surgeon drills pilot holes in the patient bone to make a spacefor the implant. The process for drilling a trajectory for endodonticaccess is no different.The independent studies listed in this 510(k) show that the X-GuideSystem is more accurate than freehand when used for this purpose.This 510(k) submission solely claims that the X-Guide System issafe and efficacious when used to create an endodontic accesspoint. This 510(k) does not make claims regarding endodonticprocedures beyond the creation of the access point. |
| Intended Use | The X-Guide® Surgical Navigation System is acomputerized navigational system intended toprovide assistance in both the preoperativeplanning phase and the intra-operative surgicalphase of dental implantation procedures and/orendodontic access procedures.The system provides software to preoperativelyplan dental implantation procedures and/orendodontics access procedures and providesnavigational guidance of the surgical instruments. | The X-Guide® SurgicalNavigation System is acomputerized navigational systemintended to provide assistance inboth the preoperative planningphase and the intra-operativesurgical phase of dentalimplantation procedures.The system provides software topreoperatively plan dental surgicalprocedures and providesnavigational guidance of thesurgical instruments. | The inclusion of endodontic access procedures does not change theefficacy or safety of the X-Guide System.The X-Guide System is currently cleared to guide the dentalsurgeon to place implants. During dental implantation surgery, thedental surgeon drills pilot holes in the patient bone to make a spacefor the implant. The process for drilling a trajectory for endodonticaccess is no different.The independent studies listed in this 510(k) show that the X-GuideSystem is more accurate than freehand when used for this purpose.This 510(k) submission solely claims that the X-Guide System issafe and efficacious when used to create an endodontic accesspoint. This 510(k) does not make claims regarding endodonticprocedures beyond the creation of the access point. |
| Technology / PerformanceCharacteristics | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K192579 | Justification ofDifferences |
| 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 TransportHumidity | 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 IEC62471-1 | LED, Risk Group 1 (minimal risk) per IEC62471-1 | No difference. |
| Overall System Accuracy (RMS)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-Clip \ Organic Fiducials \ Anatomical Landmarks | Navigational Guidance and Implant Planning X-Clip \ Organic Fiducials \ AnatomicalLandmarks | No difference. |
| Edentulous Fiducial Registration | X-Mark Probe Tool | X-Mark Probe Tool | No difference. |
| Dimensions | Height: 64.653 in (1642.19 mm)Width: 21.011 in (533.67mm) | Height: 64.653 in (1642.19 mm)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. |
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| Use Environment | Clinical Setting, Doctors Office |
|---|---|
| Clinical Setting, Doctors Office | |
| No difference |
Technology/Performance Characteristics
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Safety Features
| Safety Features | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K192579 | Justification of Differences |
|---|---|---|---|
| Electrical Safety | IEC 60601-1:2005 Edition 3.1AAMI ES60601-1:2005 +A1:2009 +A2:2010EN 60601-1:2006 ISO15223-1:2012BS EN ISO 14971:2012IEC 62304: 2006, A1:2015 | IEC 60601-1:2005 Edition 3.1AAMI ES60601-1:2005 +A1:2009 +A2:2010EN 60601-1:2006 ISO15223-1:2012BS EN ISO 14971:2012IEC 62304: 2006, A1:2015 | No difference |
| ElectromagneticCompatibility | 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 |
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Components
| Components | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K192579 ;K200662 | Justification ofDifferences |
|---|---|---|---|
| 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 TrackingAttachment System | Edentulous Clip, EDX Tracker Arms, CLX TrackerArms | Edentulous Clip, EDX Tracker Arms, CLX TrackerArms | 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 |
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Energy
| Energy | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K192579 | Justification of Differences |
|---|---|---|---|
| Mains Voltage, Frequency | 100 - 127VAC / 200 - 240VAC ; 50 / 60 Hz | 100 - 127VAC / 200 - 240VAC ; 50 / 60 Hz | No difference |
| Input Power (VA) | 1500VA | 1500VA | No difference |
| Fusing Type / Rating | Circuit Breaker: 100-127VAC, 10A | Circuit Breaker: 100-127VAC, 10A | No difference |
| Degree of Protection AgainstElectrical Shock | Applied Part Type B | Applied Part Type B | No difference |
| Type of Protection AgainstElectrical Shock | Class I | Class I | No difference |
| Mode of Operation | Continuous | Continuous | No difference |
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Performance Testing
No performance standards have been established for Dental Stereotaxic Instruments under Section 514 of the Food, Drug and Cosmetic Act.
There are no changes to Biocompatibility, cleaning and sterilization, electromagnetic compatibility, and software, as there are no changes to the physical X-Guide System itself or any of its components.
Because there were no design changes to the X-Guide System, no verification was performed. The rationale for this decision is rooted in the existence of independent studies that show the X-Guide System for endodontic access procedures when the system is used in its currently cleared configuration.
The inclusion of endodontic access procedures does not change the substantial equivalence of the X-Guide System.
The X-Guide System is currently cleared to guide the dental surgeon to place implants. During dental implantation surgery, the dental surgeon drills pilot holes in the patient bone to make a space for the implant. The process for the ondontic access is no different. The trajectory is established based on pre-planning in the software with a CBCT scan.
This 510(k) submission solely claims that the X-Guide System performance when used to create an endodontic access point. This 510(k) does not make claims regarding endodontic procedures beyond the creation of the access point.
Risk Analysis
A Product Risk Analysis was conducted in accordance with ISO 14971, considering the modifications for use.
Risk Management includes FMEA analysis to review the following:
- risks associated with the use, usability and performance of the device (HFFMEA and Risk Analysis)
It was determined that there is no significant differences that required an update to the Risk Analysis. There are no new differences that raises any new issues of safety and effectiveness.
Clinical Studies
No clinical studies were performed for the submission of this 510k.
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Assessment of Non-clinical Data
The use of the X-Guide Surgical Navigation System for endodontic access procedures did not create any new requirements, specifications, or design changes that required verification or validation. This conclusion is supported by an assessment of independent, non-clinical studies.
The studies were performed at the system level. They confirm the performance of the X-Guide® System. The studies are described in the table below.
| Study Type | Description |
|---|---|
| Comparative cadaver study of40 total human roots in 2cadaver heads comparingX-Guide Dynamic Navigationversus FreehandAccuracy - Root Canal Access | This study demonstrates that endodontists can effectively perform endodontic access procedures with the X-Guide.The test method compared dynamically navigated endodontic surgeries and freehanded endodontic surgeries. Thepresurgical CBCT plan was compared to the navigated or freehanded trajectories in the post-operative CBCT. Bothlinear deviation and angular deviation were compared between the two experimental groups. The linear deviationand angular deviation in dynamically navigated roots were found to be better than freehand. |
| The method used in this study is well-established. It is the same as the method used in the predicate devices' 510(k)submissions, and involves a superimposition of the plan to the post-operative CT scan. This study's method deviatedslightly from the predicate devices' 510(k). Instead of superimposing the pre-operative plan on the post-operativeplaced implant, the method in this study superimposed the plan to the post-operative drilled trajectory. | |
| Comparative cadaver study of60 total human single-rootedteeth mounted in 2 dry cadaverjaws comparing X-GuideDynamic Navigation versusFreehandAccuracy - Apico Access | This study demonstrates that endodontists can effectively perform endodontic access procedures with the X-Guideusing apico access. The test method compared dynamically navigated endodontic surgeries and freehandedendodontic surgeries. The presurgical CBCT plan was compared to the navigated or freehanded trajectories in thepost-operative CBCT. Both linear deviation and angular deviation were compared between the two experimentalgroups. The linear deviation and angular deviation in dynamically navigated roots were found to be better thanfreehand. |
| The method used in this study is well-established. It is the same as the method used in the predicate devices' 510(k)submissions, and involves a superimposition of the plan to the post-operative CT scan. This study's method deviatedslightly from the predicate devices' 510(k). Instead of superimposing the pre-operative plan on the post-operativeplaced implant, the method in this study superimposed the plan to the post-operative drilled trajectory. |
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Conclusions
In summary, using the X-Guide System for endodontic access procedures does not change the substantial equivalence of the device. The endodontic access procedures are no different than the existing X-Guide® Surgical Navigation System process for implants.
Based upon the information provided within this 510(k) Premarket Notification, we conclude that the X-Guide® Surgical Navigation System is substantially equivalent to the identified predicate devices when used as intended.
§ 872.4120 Bone cutting instrument and accessories.
(a)
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.(b)
Classification. Class II.