(251 days)
Not Found
No
The description focuses on optical tracking, data processing, and 3D visualization for surgical guidance, without mentioning AI or ML algorithms.
No
Explanation: The device is a surgical navigation system that provides guidance for surgical instruments during dental implantation procedures. It assists the surgeon in accurate tool placement and guidance, but it does not directly treat or diagnose a disease, nor does it restore a bodily function. Its purpose is to assist the surgeon, not to provide therapy itself.
No
This device is described as a surgical navigation system, providing assistance and guidance for dental implantation procedures in both planning and intra-operative phases. Its purpose is to guide surgical instruments and improve drilling precision based on pre-operative CT scan data, not to diagnose medical conditions or diseases.
No
The device description explicitly mentions "electro-optical device," "visible light cameras," "stereo configuration," "data processing hardware," "Hand Piece Tracker," and "Patient Tracker," indicating the presence of significant hardware components beyond just software.
Based on the provided information, the X-Guide(R) Surgical Navigation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- X-Guide Function: The X-Guide system is a surgical navigation system that uses imaging data (CT scans) and optical tracking to guide surgical instruments during a procedure on the patient's body. It assists the surgeon in placing dental implants.
- No Specimen Analysis: The system does not analyze any biological specimens taken from the patient. Its function is entirely focused on guiding the surgical procedure based on pre-operative planning and real-time tracking of instruments relative to the patient's anatomy.
Therefore, the X-Guide(R) Surgical Navigation System falls under the category of a surgical navigation or guidance 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 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
PLV
Device Description
The X-Guide® Surgical Navigation System is an electro-ontical device designed to aid dental procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data.
The system provides the surgeon with a three visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y, Z, Pitch, Yaw, and Roll) and an accuracy (RMS) of
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2015
X-Nav Technologies, LLC. Mr. Fred Cowdery Director- Regulatory Affairs 1555 Bustard Road, Suite 75 Lansdale, PA 19446
Re: K150222
Trade/Device Name: X-Guide® Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: PLV Dated: September 14, 2015 Received: September 15, 2015
Dear Mr. Cowdery:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150222
Device Name
X-Guide(R) Surgical Navigation System
Indications for Use (Describe)
The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra-operative surgical phase of dental implantation procedures.
The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan.
Type of Use (Select one or both, as applicable)
| ✔ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for X-NAV Technologies. The X is stylized with green, blue, and gray horizontal lines. The NAV is in large, bold, blue letters. The word "TECHNOLOGIES" is in smaller, gray letters below the X-NAV.
510(k) Summary (As required by Section 807.92)
| Date Prepared: | October 8, 2015 |
|---|---|
| Applicant: | X-NAV Technologies, LLC |
| 1555 Bustard Road, Suite 75 | |
| Lansdale, PA. 19446 | |
| Contact Person: | Fred Cowdery |
| Director – Regulatory Affairs and Quality Assurance | |
| Ph 267-436.0414 | |
| Email: fred.cowdery@x-navtech.com | |
| Device Trade/Proprietary Name: | X-Guide® Surgical Navigation System, |
| Model P007839 | |
| Device Name: Common / Usual: | Surgical Navigation System |
| Classification Name: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories) |
| Regulatory Class: | II |
| Product Code: | PLV (Dental Stereotaxic Instrument) |
| Predicate Device(s): | IGI-System™ by DENX Advanced Dental Systems Ltd. (K023424) |
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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" made of overlapping bars in blue, green, and gray. To the right of the "X" is the word "NAV" in large, bold, blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, gray letters.
Device Description:
The X-Guide® Surgical Navigation System is an electro-ontical device designed to aid dental procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data.
The system provides the surgeon with a three visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y, Z, Pitch, Yaw, and Roll) and an accuracy (RMS) of