(137 days)
The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan.
The X-Guide® Surgical Navigation Systemis an electro-optical device designed to aid dental surgical providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data.
The system provides the surgeon with a three-dimensional real time video visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y,Z, Pitch, Yaw,andRoll) and anaccuracy (RMS) of < 1 mm. Thishelps to improve the Oral Surgeon drilling precision within a patient oral cavity. Since the system is video based, the surgeon is still working in the freehand mode, meaning he/she is always in control of the surgery.
The implant process occurs in two stages. Stage 1 is the surgical implantation procedure. The dental surgeon plans the surgical procedure in the Implant Planning Software, XOS®. A virtual implant is aligned to the desired location in the CT scan. allowing the dental surgeon to avoid interfering with critical anatomical structures during implant has been optimally positioned, the plan is transferred to the X-Guide® Surgical Navigation System in preparation for implant surgery.
In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the pre-operative plan. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processing hardware to precisely and continuously track the motion of the dental handpiece and the surgically-relevant portion of the patient.
The relative motion of the dental handpiece and the patient an the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpiece to be animated and drientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment.
This document primarily describes the substantial equivalence of the X-Guide Surgical Navigation System to a predicate device, focusing on changes made to patient registration methods. While it outlines various non-clinical performance tests, it does not provide a detailed study proving the device meets specific acceptance criteria in the format requested for an AI/ML device.
Specifically, the document lacks the following critical information for describing an AI/ML device's acceptance criteria and a study proving it:
- No mention of an AI/ML component: The device is described as an "electro-optical device" providing "accurate surgical tool placement and guidance" and "three-dimensional real time video visual aid." There's no indication of machine learning, AI-driven decision-making, or any algorithms that learn from data. The "software" mentioned is for planning and navigation, characteristic of traditional surgical navigation systems.
- No explicitly stated acceptance criteria for algorithmic performance: The performance tests focus on system accuracy (RMS < 1mm), calibrated device accuracy, and successful sterilization/biocompatibility, which are typical for non-AI medical devices.
- No "study" in the sense of an AI/ML performance study with a test set: The "performance testing" section describes basic engineering verification like accuracy, calibration, and simulated use, not a study evaluating an algorithm's performance on a dataset against ground truth.
- No data provenance, sample sizes, expert involvement, or ground truth details for an AI/ML test set.
- No MRMC study information.
- No standalone (algorithm only) performance information.
- No training set details.
Therefore, I cannot fulfill the request as the provided text does not describe an AI/ML device or a study proving its performance against acceptance criteria in the requested format for such devices. The performance data provided is for a traditional surgical navigation system.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 3, 2020
X-Nav Technologies, LLC Fred Cowdery VP - Regulatory and Quality Compliance 1555 Bustard Road, Suite 75 Lansdale, Pennsylvania 19446
Re: K192579
Trade/Device Name: X-Guide® Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: November 4, 2019 Received: November 5, 2019
Dear Fred Cowdery:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192579
Device Name X-Guide® Surgical Navigation System
Indications for Use (Describe)
The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of green, blue, and gray horizontal bars. To the right of the "X" is the word "NAV" in large, bold, blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, gray letters.
510(k) Summary K192579 (As required by Section 807.92)
| Date Prepared: | January 30, 2020 |
|---|---|
| Applicant: | X-NAV Technologies, LLC1555 Bustard Road, Suite 75Lansdale, PA. 19446 |
| Contact Person: | Fred CowderyVice President – Regulatory Affairs and Quality CompliancePh 267-436.0414Email: 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)
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Image /page/4/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" with green and gray bars, followed by the text "-NAV" in dark blue. Below the main logo, the word "TECHNOLOGIES" is written in a smaller, lighter font.
Predicate Device Information
| Category | Comments |
|---|---|
| Predicate Device: | X-Guide® Surgical Navigation System |
| Predicate Device Manufacturer: | X-Nav Technologies, LLC. |
| Predicate Device Common Name: | Surgical Navigation System |
| Predicate Device Premarket Notification#: | K150222 |
| Predicate Device Classification: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories) |
| Predicate Device Class & Product Code: | Class 2, PLV |
Reference Device Information
| Category | Comments |
|---|---|
| Reference Device: | StealthStation™ System with StealthStation™ Cranial Software |
| Reference Device Manufacturer: | Medtronic Navigation, Inc. |
| Reference Device Common Name: | Stereotaxic Instrument |
| Reference Device Premarket Notification#: | K153660 |
| Reference Device Classification: | 21 CFR 882.4560 (Stereotaxic Instrument) |
| Reference Device Class & Product Code: | Class II, HAW |
Reference Device Information
| Category | Comments |
|---|---|
| Reference Device: | Cranial Image Guided Surgery System |
| Reference Device Manufacturer: | BrainLab |
| Reference Device Common Name: | BrainLAB Cranial Image Guided Surgery System/ Instrument, Stereotaxic |
| Reference Device Premarket Notification#: | K092467 |
| Reference Device Classification: | 21 CFR 882.4560 (Stereotaxic Instrument) |
| Reference Device Class & Product Code: | Class II ,HAW |
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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 of green and gray horizontal bars, followed by the word "-NAV" in large, bold, blue letters. Below the main logo, the word "TECHNOLOGIES" is written in smaller, gray letters.
Indications for Use:
The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous adult and geriatric patients who need dental implants as part of their treatment plan.
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Image /page/6/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of horizontal lines in shades of blue, green, and gray. To the right of the "X" is the word "-NAV" in large, bold, dark blue letters. Below the "X" and "-NAV" is the word "TECHNOLOGIES" in smaller, gray letters.
Device Description:
The X-Guide® Surgical Navigation Systemis an electro-optical device designed to aid dental surgical providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data.
The system provides the surgeon with a three-dimensional real time video visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y,Z, Pitch, Yaw,andRoll) and anaccuracy (RMS) of < 1 mm. Thishelps to improve the Oral Surgeon drilling precision within a patient oral cavity. Since the system is video based, the surgeon is still working in the freehand mode, meaning he/she is always in control of the surgery.
The implant process occurs in two stages. Stage 1 is the surgical implantation procedure. The dental surgeon plans the surgical procedure in the Implant Planning Software, XOS®. A virtual implant is aligned to the desired location in the CT scan. allowing the dental surgeon to avoid interfering with critical anatomical structures during implant has been optimally positioned, the plan is transferred to the X-Guide® Surgical Navigation System in preparation for implant surgery.
In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the pre-operative plan. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processing hardware to precisely and continuously track the motion of the dental handpiece and the surgically-relevant portion of the patient.
The relative motion of the dental handpiece and the patient an the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpiece to be animated and drientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment.
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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 horizontal lines in green, blue, and gray. To the right of the "X" is the word "NAV" in large, bold, blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, gray letters.
Several patient-specific calibrations underpin the guidance system. Hand Piece callbration is performed to geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument.
Likewise. Patient Tracker calibration is performed to determine the geometric relationship between the Patient Tracker and the scan coordinates of the patient anatomy. There are separate procedures for Patient Tracker calibration, depending on whether the X-Clip or the Edentulous Clip is used.
For toothed patients (partially edentulous), an X-Clip®, which contains embedded radiodense spheres, is attached to CT image acquisition. The location of these spheres on the X-Clip establishes a link between the CT coordinate system and the patient's surgical anatomy. Immediately prior to surgery, the Pattached, and a separate calibration determines the relationship between the spheres and the Patient Tracker. This device remains on the patient teeth for the duration of surgery.
For edentulous (toothless) patients, the surgeon drills several narrow holes in the bone to serve as fiducials for the CT scan. Nothing is implanted. After the CT scan and surgical plan are completed, including the step of locating and marking the holes in the CT image, an Edentulous Clip is attached to the patient just prior to surgery. This device is necessary to attach tracking patterns to faciliate the navigation and tracking process, and is calibrated to the patient and CT by probing each of the fiducial holes and correlating these locations to the locations marked in the plan.
During execution of the surgical procedure, the X-Guide® System correlates between the surgical plan and the surgeon's actual performance. If significant deviation between the plan and the system performance occur, the system will alert the user.
The X-Guide® Surgical Navigation System is a supporting additional information to the decision-making process during the surgical procedure. It is by no means intensed to replace in judgment. The final decisions as to the exact location and depth of the surgery are the sole responsibility of the surgeon can at any time during the surgical procedure modify the plant positions. Under no circumstances does the device the surgeon of his or her ultimate clinical responsibility.
Modifications made to the subject device are as follows:
-
- An alternate method (X-Mark) is being proposed for registration of dentate and edentulous patients.
-
- A new process is being proposed for correcting inaccurate patient registrations.
-
- Two system hardware components, Probe Tool and Probe Tracker, are required to support these processes.
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Image /page/8/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of green and gray horizontal bars, followed by the word "NAV" in large, bold, dark blue letters. Below the logo, the word "TECHNOLOGIES" is written in smaller, gray letters.
X- Mark Process (Proposed Patient Registration Change)
The X-Mark process is an alternate method of patient registration to the aforementioned cleared methods. Instead of placing and marking organic fiducials / Bone Screws (edentulous) or using an X-Clip (dentate), the doctor has the option to use existing anatomical landmarks as fiducials instead. These landmarks are manually marked in the X-Guide Software.
Once at least 3 anatomical landmarks are marked, the anatomical landmarks by touching them with the tip of a Probe Tool while the tracking system tracks the relationship between the Pracker to complete the patient registration. This registration algorithm is identical to the existing cleared patient registration algorithm.
The doctor can choose teeth or anatomical landmarks as the fiducials.
Refinement Process
The Refinement process is a method for correcting inaccurate patient registrations.
This method involves "painting" an anatomical surface by moving the surface of a patients oral anatomy in order to generate a surface comprised of hundreds of surface points in the patient tracking coordinates.
The process then aligns the generated surface with the CBCT derived anatomical surface using the same cleared algorithms that are currently employed.
X-Mark Probe Tool / Probe Tracker
The X-Mark Probe Tool is used to register the locations of organic fiducials, bone screws, or anatomic landmarks within the patient's oral cavity as part of the Patient Registration process.
The Probe Tool is designed as a rigid structure for identifying locations within the patient oral cavity anatomy.
The Probe Tracker is geometrically similar to the X-Corner Handpiece Tracker. Patterns on the Probe Tracked by the stereo cameras to indicate the X-Mark Probe Tool Tool Tool Tool Tip location, relative to pationt anatomy.
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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, blue letters. Below the "X" and "NAV" is the word "TECHNOLOGIES" in a smaller, gray font.
Comparison to Predicate and Reference Devices:
As described in the tables below, the application device X-Guide® Surgical Navigation System (K192579) is substantially equivalent in intended use, design and physician use to the predicate device X-Guide® Surgical Navigation device is substantially equivalent in scientific technology to the reference device SteathStation™ Cranial Software (K.53660), specifically the cranial software. The application device is also substantially equivalent in scientific technology to the reference device (KN2447), supporting the method of patient registration using anatomical landmarks.
| Application Device | Primary Predicate Device | Reference Device | ||
|---|---|---|---|---|
| UseSpecifications | X-Guide® Surgical NavigationSystem (K192579) | X-Guide® Surgical NavigationSystem (K150222) | StealthStation™ System withStealthStation™ CranialSoftware (K153660) | Justification ofDifferences |
| Indications forUse | The X-Guide® Surgical Navigation Systemis a computerized navigational systemintended to provide assistance in both thepreoperative planning phase and the intra-operative surgical phase of dentalimplantation procedures.The system provides software topreoperatively plan dental surgicalprocedures and provides navigationalguidance of the surgical instruments.The device is intended for use forpartially edentulous and edentulous adultand geriatricpatients who need dental implants aspart of their treatment plan. | The X-Guide® Surgical NavigationSystem is a computerized navigationalsystem intended to provide assistancein both the preoperative planningphase and the intra-operative surgicalphase of dental implantationprocedures.The system provides software topreoperatively plan dental surgicalprocedures and provides navigationalguidance of the surgical instruments.The device is intended for use forpartially edentulous and edentulousadult and geriatricpatients who need dental implantsas part of their treatment plan. | The StealthStation® System, withStealthStation® Cranial Softwareis intended as an aid for locatinganatomical structures in either open orpercutaneous procedures. The system isindicated for any medical condition inwhich reference to a rigid anatomicalstructure can be identified relative toimages of the anatomy.This can include, but is not limited to,the following cranial procedures(including stereotactic frame-based andstereotactic frame alternatives-basedprocedures): • Cranial Biopsies • DeepBrain Stimulation (DBS) LeadPlacement • Depth Electrode Placement• Tumor Resections •Craniotomies/Craniectomies • SkullBase Procedures • TranssphenoidalProcedures • Thalamotomies• Pallidotomies • Pituitary TumorRemoval • CSF Leak Repair • PediatricVentricular Catheter Placement •General Ventricular Catheter PlacementThe user should consult the"Navigational Accuracy" section of theUser Manual to assess if the accuracy ofthe system is suitable for their needs. | The Indications for Use of theapplication and Predicate Devicesare identical.All of these devices are surgicalnavigation systems. TheApplication and Referencedevices both have the ability toregister patient anatomy using acombination of anatomicallandmarks and software. Asevidenced by the ReferenceDevice, this capability has longbeen applied to such devices andraises no new questions for thesetypes of devices. |
| Product Code | PLV | PLV | HAW | All three devices are stereotaxicinstruments intended to be usedfor surgical navigation |
| Application Device | Primary Predicate Device | Reference Device | ||
| Technology /PerformanceCharacteristics | X-Guide® SurgicalNavigation System(K192579) | X-Guide® SurgicalNavigation System(K150222) | StealthStation™ System withStealthStation™ CranialSoftware (K153660) | Justification of Differences |
| Operating Temperature | 10 - 35 deg C | 10 - 35 deg C | Not Applicable | No difference. |
| Operating RelativeHumidity | 30% - 90% non-condensing | 30% - 90% non-condensing | Not Applicable | No difference. |
| Altitude | 500 hPa-1060hPa | 500 hPa – 1060 hPa | Not Applicable | No difference. |
| Transport Temperature | -20 - +60 deg C | -20 - +60 deg C | Not Applicable | No difference. |
| Transport Humidity | 10% - 95% non-condensing | 10% - 95% non-condensing | Not Applicable | No difference. |
| Optical Radiation | LED, Risk Group 1(minimal risk) perIEC 62471-1 | LED, Risk Group 1 (minimalrisk) per IEC 62471-1 | Not Applicable | No difference. |
| Tracking Technology | Stereo Cameras / LEDs /Patterns | Stereo Cameras /LEDs / Patterns | Stereo Cameras / LED Optical Markers /Sterile SphereOrElectromagnetics (EM) AXIEM™ | Tracking technology is equivalent for allthree devices. The Reference Device offersan additional tracking technology optionEM. The Application and Predicate devicesdo not require this additional trackingtechnology. |
| Calibration Frequency | Prior to each surgery | Prior to each surgery | Prior to each surgery | No difference. |
| Overall System Accuracy(RMS) | <1mm | <1 mm | <2 mm | No difference. |
| Alarms | Audible, Visual | Audible, Visual | Not Applicable | No difference. |
| Monitor | LCD-TFT | LCD-TFT | Not Applicable | No difference. |
| Communications Interface | Ethernet | Ethernet | Ethernet | No difference. |
| Software | Navigational Guidanceand ImplantPlanning | Navigational Guidance andImplant Planning | Navigational Guidance and SurgicalPlanning | No Difference |
| Fiducial Identification | X-Clip Organic Fiducials Rigid AnatomicalLandmarks | X-Clip Organic Fiducials | Rigid Anatomical Landmarks andStarFix™ Bone Anchor | Organic Fiducials are equivalent to Bone Screws.The Application and Reference Devices bothprovide similar means of Fiducial Identification.Similarly, the Application and Predicate Deviceeach share common means (X-Clip or OrganicFiducials) of Fiducial Identification. |
| Edentulous FiducialRegistration Tool | X-Mark Probe Tool | Dental Handpiece with Burr | Registration Probes | No Difference - Equivalent to predicate andreference devices. X-Mark Probe Tool Tipprovides increased rigidity and stability for moreprecise registration, minimizing accuracy errorsduring registration. |
| Technology / PerformanceCharacteristics | Application DeviceX-Guide® Surgical NavigationSystem (K192579) | Primary Predicate DeviceX-Guide® SurgicalNavigation System(K150222) | Reference DeviceStealthStation™ Systemwith StealthStation™Cranial Software(K153660) | Justification ofDifferences |
| Dimensions | Height: 64.653 in (1642.19 mm)Width: 21.011 in (533.67mm) | Height: 64.653 in (1642.19mm) Width: 21.011 in(533.67mm) | Not Applicable | No difference. |
| Mounting Configuration | Mobile Cart | Mobile Cart | Not Applicable | No difference. |
| Weight | 130lbs. (58.97 kg) | 130lbs. (58.97 kg) | Not Applicable | No difference. |
| Application Device | Primary Predicate Device | Reference Device | ||
| Safety Features | X-Guide® Surgical NavigationSystem (K192579) | X-Guide® SurgicalNavigation System(K150222) | StealthStation™ Systemwith StealthStation™Cranial Software(K153660) | Justification ofDifferences |
| Electrical Safety | IEC 60601-1:2005 Edition 3.1 AAMIES60601-1:2005 +A1:2009+A2:2010EN 60601-1:2006ISO15223-1:2012BS EN ISO 14971:2012 IEC62304: 2006, A1:2015 | IEC 60601-1:2005 Edition3.0 AAMI ES60601-1:2005+A1:2009+A2:2010EN60601-1:2006ISO15223-1:2012BS EN ISO14971:2012 IEC62304:2006 | Not Applicable | No difference - Productevaluated to latest revision ofstandards for compliance withEU Regulations |
| Electromagnetic Compatibility | IEC 60601-1-2:2014 4th Edition | IEC 60601-1-2:2007 3rdEdition | Not Applicable | No difference - Productevaluated to latest revision ofstandards for compliance withEU Regulations |
| Biocompatibility | Yes (ISO 10993-1, -5, -10, -11, -12) | Yes (ISO 10993-1, -5, -10, -11, -12) | Not Applicable | No difference. |
| Sterilization | Steam | Steam | Not Applicable | No difference. |
| Disinfectant (High-Level) | 3% Glutaraldehyde solution | 3% Glutaraldehyde solution | Not Applicable | No difference. |
| Ingress Protection | IP2X | IP2X | Not Applicable | No difference. |
Table 1: Summary of Technological Characteristics Comparison
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Image /page/10/Picture/0 description: The image shows the logo for X-NAV Technologies. The X is made up of green, blue, and gray horizontal bars. The NAV is in large blue font, and the word TECHNOLOGIES is in a smaller gray font below the X-NAV.
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Image /page/11/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of green and blue horizontal bars, followed by the text "-NAV" in large, bold, blue letters. Below the main logo, the word "TECHNOLOGIES" is written in smaller, gray letters.
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Image /page/12/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of green, blue, and gray horizontal bars. To the right of the "X" is the text "-NAV" in a bold, dark blue font. Below the "X-NAV" is the word "TECHNOLOGIES" in a smaller, light gray font.
| Application Device | Primary Predicate Device | Reference Device | ||
|---|---|---|---|---|
| Components | X-Guide® SurgicalNavigation System(K192579) | X-Guide® SurgicalNavigation System(K150222) | StealthStation™ Systemwith StealthStation™Cranial Software (K153660) | Justification of Differences |
| Bone Screw | Bone Screw | Bone Screw | StarFix™ Bone Anchor | No difference - Bone Screw and BoneAnchors both used to create fiducialsto facilitate patient registrationprocess. |
| CT / Patient Registration | X-Clip, Organic Fiducials,Anatomical Landmarks | X-Clip, Organic Fiducials | PointMerge registration, Tracerregistration, Touch-N-Goregistration.StealthAiR registration, O-armregistration, StereotacticLocalizerRegistration and StarFix BoneAnchorRegistration | The Application and ReferenceDevices both utilize the applicationsoftware to create a "translationmap" between all points in thepatient CT images and thecorresponding points (AnatomicalLandmarks) on the patient anatomy.After establishing this map,whenever the operator touches apoint on the patient using a probingtool, the computer uses the map toidentify the corresponding point onthe images. |
| Patient Tracking Device | X-Corner Patient Tracker | X-Corner Patient Tracker | Localizer - Optical Markers orElectromagnetics | No difference. |
| Surgical Tool Tracking Device | X-Corner HandpieceTracker | X-Corner Handpiece Tracker | Optical Markers | No difference. |
| Screwdriver | Yes | Yes | Not Applicable | No difference. |
| Edentulous Patient Tracking AttachmentSystem | Edentulous Clip | Edentulous Clip | Not Applicable | No difference. |
| Drill Bit Length Determination | Go Plate | Go Button | Not Applicable | No change to part - Name changeonly |
| Patient Tracker Attachment Arms | Posterior Tracker ArmAnterior Tracker Arm | Posterior Tracker ArmAnterior Tracker Arm | Not Applicable | No difference. |
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Image /page/13/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, blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, gray letters.
| Application Device | Primary Predicate Device | Reference Device | ||
|---|---|---|---|---|
| Energy | X-Guide® SurgicalNavigation System(K192579) | X-Guide® Surgical NavigationSystem (K150222) | StealthStation™ Systemwith StealthStation™Cranial Software(K153660) | Justification ofDifferences |
| Mains Voltage, Frequency | 100 - 127VAC / 200– 240VAC ;50 / 60 Hz | 100 - 127VAC / 200 - 240VAC ;50 / 60 Hz | Not Applicable | No difference. |
| Input Power (VA) | 1500VA | 1500VA | Not Applicable | No difference. |
| Fusing Type / Rating | Circuit Breaker:100-127VAC, 10A | Circuit Breaker: 100-127VAC,10A | Not Applicable | No difference. |
| Degree of Protection AgainstElectrical Shock | Applied Part Type B | Applied Part Type B | Not Applicable | No difference. |
| Type of Protection AgainstElectrical Shock | Class I | Class I | Not Applicable | No difference. |
| Mode of Operation | Continuous | Continuous | Not Applicable | No difference. |
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Image /page/14/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of green, gray, and blue horizontal bars. To the right of the "X" is the word "NAV" in large, bold, blue letters. Below the "X" and "NAV" is the word "TECHNOLOGIES" in smaller, gray letters.
Performance Testing:
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Dental Stereotaxic Instruments.
Biocompatibility Testing:
The biocompatibility evaluation for X-Guide® components was conducted in accordance with the FDA Blue Book Memorandum #395-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, ""May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Nanagement Process," as recognized by FDA. The battery of testing included Cytotoxicity, Sensitization, and System Toxicity. The components of the X-Guide® are considered tissue contacting for a duration of less than 24 hours. This testing demonstrates that the device materials will not cause a biocompatibility reaction when used as intended.
This testing demonstrates that the device materials will not cause a biocompatibility reaction when used as.
Cleaning and Sterilization Validation:
A representative sample of the re-usable components were that the X-Guide® components can withstand the sterilization process and that acceptable sterility is achieved when were recommended sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the reusable X-Guide® Surgical Navigation System components can be sterilized to reach an acceptable sterility assurance level.
Electrical Safety and Electromagnetic Compatibility (EMC):
Comprehensive performance testing has been conducted on the X-Guide® Surgical Navigation System in accordance with the latest recognized industry standards, by an accredited NRTL. Product Safety was evaluated for compliance with IEC 60601- 1:2005 Edition 3.1 ANSI/AAMI ES60601-1:2005 / 2012 and C1:2009/ 2012 and A2:2010/ 2012 (Consolidated Text) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performanetic Compatibility was assessed for compliance with IEC 60601-1-2:2014 Edition 4.0. A risk-based approach was used to assess product compliance for Safety and EMC.
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Image /page/15/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 geometric shapes. To the right of the "X" is the word "NAV" in large, bold, blue letters. Below the "X" and "NAV" is the word "TECHNOLOGIES" in smaller, gray letters.
Software and System Verification and Validation Testing:
Software verification and validation testing were conmented by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices." The software for this device was considered as a "moderat" level of concern, since a failure or latent flaw in the software could in result in minor injury to the patient or operator.
The combined testing and analysis of results provides assurance that the device performs as intended.
Software Development and Testing was performed per IEC 62304:2006 Medical Device Software Lifecycle Processes, FDA Guidance for the Content of Premarket. Submissions for Software Contained in Medical Devices and FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
Risk Management was performed in compliance with ISO 14971:2012 and includes FMEA analysis to review the following:
- risks associated with the use, usability and performance of the device (HFFMEA and Risk Analysis) •
- the risks associated with and specific to the design aspects of the device (Risk Analysis) •
- the risks associated with software functionality and software interaction with the user (Risk Analysis) •
- Risks associated with biocompatibility, cleaning and sterilization .
Non-Clinical Testing:
X-Mark and Refinement process verification and validation testing has been performed at the testing is described in the table below.
| Verification / Validation Type | Description |
|---|---|
| Simulated Use (End User Validation) | This usability validation test demonstrates that the intended end users of X-Guide canperform critical tasks with the X-Mark and Refinement processes for the intended uses inthe expected use environments. |
| Total System Accuracy | Quantify Position Accuracy of X-Mark and Refinement processes using ASTM 2554-18with additional testing to the PAF process in comparison to predicate system accuracy. |
| Probe Tool / Probe Tracker Calibration | Confirm accuracy and repeatability of calibrations for both devices. |
| Accuracy (Dentate Patients) | Comparison in accuracy of Patient Registration between X-Clip and X-Mark processes |
| Accuracy (Edentulous Patients) | Comparison in accuracy of Patient Registration between X-Mark and Organic Fiducialregistration. |
| Reusable components Sterilization LifeExpectancy | Intended to confirm number of sterilization cycles the Probe Tracker can withstand withoutcompromising pattern integrity. |
| End User Validation of User Requirementsfor Probe Tool and Probe Tracker | Confirm Probe tool and Probe Tracker function as intended and meet user needs. |
| Probe Tool Tip Mechanical Properties | Confirms the X-Mark Probe Tool tip radius within the pivot hole of the Go Plate meets thefunctional requirement for tip radius. |
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Image /page/16/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of green, gray, and blue horizontal bars. The word "NAV" is in large, bold, blue letters, and the word "TECHNOLOGIES" is in smaller, gray letters below the "X-NAV".
Nonclinical Comparisons to Predicate Device in this Submission
The following tests performed to establish substantial equivalence for the Probe Tracker to the Dental Handpiece with a burr
- Probe Tip Accuracy and Deflection
- The interaction between the X-Mark probe tip and Go-Plate (P008641) during calibration is crucial in . controlling accuracy. By controlling the tip design, the lateral movement of the tip in the Go Plate can be limited. Dental handpiece burrs can wear over time making this lateral movement hard to control/ quantify.
- The length of the X-Mark Probe Tool has been kept small to minimize bending of the probe tip, as well as allow easier access to the posterior region of the mouth. The tip is also welded to the handle, so no motion can occur at the attachment point. In a dental handpiece, however, there will be slop in the chuck due to tolerances inherent in handpiece designs.
- Comparison of materials' material safety data sheets (MSDS)
- o Probe Tool Tip vs. Dental Burr
- Dental burrs are made from tungsten carbide. Tungsten carbide is extremely hard which allows the bur to . maintain a sharp cutting edge. Due to the hardness, the drills are stiffer than stainless steel but more prone to fracturing.
- The Probe Tool Tip is made of 316L Stainless Steel allowing the user to push on the probe laterally without the risk of fracturing the probe tip. 316L Stainless Steel is a commonly used material for surgical instruments.
- o Probe Tool Tip vs. Dental Burr
- Simulated clinical use validation (simulated processes using cadavers)
- Surgeons separately performed patient registrations using both the X-Mark and Refinement processes on Dentate and Edentulous patients. Qualitative and Quantitative validation data and usability endpoints were captured and recorded for each of the tests.
Clinical Testing:
No clinical studies were perforned as appropriate verification of the application device was achieved from the results of bench performance testing, biocompatibility evaluation, sterilization, and cleaning evaluation
Conclusions:
The X-Guide® Surgical Navigation System has been shown through companison and testing to be substantially equivalent to the identified predicate and referenced 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.