(243 days)
No
The description focuses on video tracking and image processing for navigation, with no mention of AI or ML algorithms for planning, analysis, or guidance.
No.
The device assists in surgical procedures by providing guidance for instruments but does not directly apply therapy or offer treatment itself.
No.
The device is described as a surgical navigation system intended to assist in planning and providing guidance for dental implantation and endodontic access procedures, not to diagnose conditions.
No
The device description explicitly states it is a "cart mounted mobile system utilizing video technology" and lists multiple hardware components including a Mobile Cart, LCD Monitor, Boom Arm, Navigation Assembly (containing cameras), Keyboard, Mouse, and an Electronics Enclosure with power supplies and data processing hardware. While software is a key component for planning and navigation, the system relies heavily on dedicated hardware for its function.
Based on the provided information, the X-Guide® Surgical Navigation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- X-Guide's Function: The X-Guide system is a surgical navigation system. Its primary function is to assist the surgeon during dental implantation and endodontic access procedures by providing guidance based on pre-operative imaging data (CT/CBCT scans). It does not analyze biological specimens from the patient.
- Intended Use: The intended use clearly states assistance in surgical procedures, not in vitro analysis of patient samples.
- Device Description: The description details hardware for tracking surgical instruments and processing imaging data for navigation, not for analyzing biological samples.
- Input Data: The input data is imaging data (CT/CBCT scans), not biological specimens.
Therefore, the X-Guide® Surgical Navigation System falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.
Product codes (comma separated list FDA assigned to the subject device)
QRY, PLV
Device Description
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.
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 patient-specific 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.
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
§ 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.
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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
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)
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Image /page/3/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" in green and gray, followed by "-NAV" in dark blue. 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 |
| 1555 Bustard Road, Suite 75 | |
| Lansdale, PA. 19446 | |
| Contact Person: | Kimberly Chan |
| Regulatory Affairs Manager | |
| Phone: 267-436-0414 | |
| kimberly.chan@x-navtech.com | |
| Device Trade / Proprietary Name: | X-Guide® Surgical Navigation System |
| Model P007839 | |
| Model P011000 | |
| Device Name, Common/Usual: | Surgical Navigation System |
| Classification Name: | 21 CFR 872.4120 (Bone Cutting Instrument and |
| 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) |
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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.
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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.
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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.
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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.
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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
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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