(137 days)
No
The description focuses on electro-optical tracking and 3D visualization based on pre-operative planning and real-time tracking of instruments and the patient. There is no mention of AI or ML in the device description, intended use, or testing sections. The system appears to be based on traditional computer vision and navigation techniques.
No.
The device assists in surgical navigation, which is a tool for a medical procedure, not a therapeutic intervention itself.
No
Explanation: The "Intended Use / Indications for Use" section states that the system is "intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures" and "provides navigational guidance of the surgical instruments." This describes a surgical navigation system, which guides a surgeon during a procedure, rather than diagnosing a condition.
No
The device description explicitly states it is an "electro-optical device" and mentions "visible light cameras in a stereo configuration and processing hardware" for tracking, indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide assistance in the preoperative planning and intra-operative surgical phases of dental implantation procedures. This involves guiding surgical instruments based on imaging data.
- Device Description: The device is an electro-optical system that tracks surgical instruments and the patient's anatomy to provide real-time visual guidance during surgery.
- Lack of In Vitro Activity: The device does not perform any tests on biological samples (blood, tissue, etc.) outside of the body to diagnose a condition or provide information about a patient's health status. Its function is entirely focused on surgical navigation and guidance within the patient's oral cavity.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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. 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.
Product codes (comma separated list FDA assigned to the subject device)
PLV
Device Description
The X-Guide® Surgical Navigation System is 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 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 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, LLC |
| 1555 Bustard Road, Suite 75 | |
| Lansdale, PA. 19446 | |
| Contact Person: | Fred Cowdery |
| Vice President – Regulatory Affairs and Quality Compliance | |
| Ph 267-436.0414 | |
| Email: fred.cowdery@x-navtech.com | |
| Device Trade/Proprietary Name: | X-Guide® Surgical Navigation System, |
| Model P007839 | |
| Device Name: Common / Usual: | Surgical Navigation System |
| Classification Name: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories) |
Regulatory Class: II
- Product Code: PLV (Dental Stereotaxic Instrument)
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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