Lumos 3DX

{0}------------------------------------------------ July 6, 2023 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 3Dio % Mr. Douglas Hansen President 1119 South 1680 West OREM UT 84058 Re: K223780 Trade/Device Name: Lumos 3DXTM Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: June 1, 2023 Received: June 5, 2023 Dear Mr. Hansen: 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 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 {1}------------------------------------------------ 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, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223780 Device Name Lumos 3DX тм Indications for Use (Describe) The Lumos 3DX ™ System is an extraoral X-ray source (intraoral X-ray detection) dental X-ray system for producing diagnostic dental radiographs of the teeth, jav, and other oral structures. The system provides 3D imaging for diagnostic purposes via tomosynthesis. For use on adult patients only. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | <div style="display:inline-block;"><span>\[X]</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;"><span>\[ ]</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for 3Dio, a Turner Company. The logo consists of a stylized tooth inside of a circle on the left, followed by the text "3Dio" in a sans-serif font. Below the text "3Dio" is the text "a Turner Company" in a smaller font. The tooth and the text "3Dio" are in a light teal color, while the circle and the text "a Turner Company" are in a light gray color. 510k #: K223780 ### Lumos 3DX X-ray Imaging System 12 June 2023 ### Submitter: | Name: | 3Dio, LLC. | |-------------------------|---------------------------------| | Address: | 1119 S 1680 W<br>Orem, UT 84058 | | Official Correspondent: | Doug Hansen, CEO and President | | Telephone No: | 801-796-2951 | | Email: | dhansen@3dteeth.com | | Proposed Device: | | |-----------------------|-------------------------------| | Trade Name: | Lumos 3DX™ | | Class: | II | | Common/Usual Name: | Dental X-ray System, Mobile | | Classification Name: | Extraoral source x-ray system | | Primary Product Code: | EHD | | Regulatory Standard: | 21CFR 872.1800 | | Predicate Device: | | |-----------------------|-------------------------------| | Manufacturer: | Surround Medical Systems | | Trade Name: | Portray System | | 510(k): | K211014 | | Class: | II | | Common/Usual Name: | Extraoral source x-ray system | | Primary Product Code: | EHD | | Regulatory Standard: | 21CFR 872.1800 | Description: The Lumos 3DX system is a 3D dental chairside X-ray system on a mobile stand that uses tomosynthesis (limited-angle tomography) to generate 3D images of the teeth and surrounding structures. A custom digital sensor is placed in the patient's mouth and multiple images are acquired around an arc of rotation and then fed into a 3D reconstruction algorithm. The digital sensor provided with the system is specifically for use with the Lumos 3DX device. The sensor has a higher frame rate that enables the Lumos 3DX system to capture 30 images in a short period of time. A server is provided as part of the Lumos 3DX system and wirelessly connects to one or more Lumos 3DX systems. After capturing images, the Lumos 3DX wirelessly transfers them to the server for reconstruction. This server can then be connected to the local network for access of the reconstructed data. - Indications for Use: The Lumos 3DX™ System is an extraoral X-ray source (intraoral X-ray detection) dental X-ray system for producing diagnostic dental radiographs of the teeth, jaw, and other oral structures. The system provides 3D imaging for diagnostic purposes via tomosynthesis. For use on adult patients only. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for 3Dio, a Turner Company. The logo consists of a circular icon with a tooth inside, colored in shades of gray and teal. To the right of the icon, the text "3Dio" is written in a teal sans-serif font, with the words "a Turner Company" appearing in a smaller font size below. # Document Title: Lumos 3DX 510(k) Summary 510k #: K223780 Page 2 of 5 ## Table 1. Comparison with predicate device: | Characteristic<br>or Property | Surround Medical, Portray System,<br>K211014 | 3Dio Lumos 3DX™ | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | Regulation number: 21 CFR 872.1800<br>Regulation name: Extraoral source x-<br>ray system<br>Regulatory Class: II<br>Product Code: EHD | Regulation number: 21 CFR 872.1800<br>Regulation name: Extraoral source x-ray<br>system<br>Regulatory Class: II<br>Product Code: EHD | | Intended Use | The Portray System is an extraoral X-<br>ray source (intraoral X-ray detection)<br>dental X-ray system for producing<br>diagnostic dental radiographs of the<br>teeth, jaw and other oral structures. The<br>system provides 2D imaging for<br>diagnostic purposes and 3D imaging as<br>an adjunctive tool. | The Lumos 3DX™ System is an extraoral<br>X-ray source (intraoral X-ray detection)<br>dental X-ray system for producing<br>diagnostic dental radiographs of the teeth,<br>jaw, and other oral structures. The system<br>provides 3D imaging for diagnostic<br>purposes via tomosynthesis. For use on<br>adult patients only. | | Target<br>Anatomical Site | Oral Cavity | Oral Cavity | | Principle of Use | X-ray tube | X-ray tube | | Electrical: | | | | Power | Must be plugged in to AC Mains | Must be plugged in to AC Mains | | X-ray Source | Anode: Tungsten<br>Cathode: Carbon Nanotube<br>Focal spot: 0.7mm<br>Tube Voltage: 60 or 70 kV<br>Current: 7 mA<br>Exposure time: 0.6 Sec (2D & 3D)<br>Tube Anode Angle: 12° | Anode: Tungsten<br>Cathode: Tungsten Filament<br>Focal spot: 0.4mm<br>Tube Voltage range: 60 to 70 kV<br>Current range: 3 mA to 7mA<br>Exposure Time: 0.063 – 1.0 sec (3D)<br>Tube Anode Angle: 12° | | Leakage<br>Radiation | < 0.25 mGy/h (@ 1 m) | < 0.25 mGy/h (@ 1 m) | | Exposure Type | Multi-beam stationary | Single beam pulsed | | Exposure Times | Microprocessor controlled exposure<br>times | Microprocessor controlled exposure times | | Exposure Modes | Preset loading factors or manual mode | Preset loading factors or manual mode | | Selectable<br>parameter | Patient type (adult/child), anatomical<br>positions, 2D or 3D mode, x-ray tube<br>voltage, exposure time | Anatomical positions, 3D mode, x-ray tube<br>voltage & current | | Image type | 2D diagnostic and/or 3D adjunct | 3D Diagnostic with 2D slices | | Image data<br>acquired | 7 images | 30 images | | Detector | Digital Sensor<br>Frame Rate: < 2 images per second<br>Xray Sensitivity: Standard dental<br>detector X-ray sensitivity | Custom #2 intra-oral digital sensor (19.5<br>μm x 19.5 μm pixel size) Frame Rate: ≥ 9.0<br>images per second<br>Xray Sensitivity: High-sensitivity for low-<br>dose rapid 3D data acquisition | | Characteristic<br>or Property | Surround Medical, Portray System,<br>K211014 | 3Dio Lumos 3DX | | Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-65<br>IEC 61233-3-4<br>IEC 62304 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-65<br>IEC 61223-3-4<br>IEC 62304<br>IEC 62366-1 | | Mechanical/Physical: | | | | Physical<br>Dimensions | Head:<br>Length: ~49 cm (~19 in)<br>Width: ~20 cm (~8 in)<br>Height: ~18 cm (~7 in)<br>Arm:<br>Vertical Reach: ±19.5" from neutral<br>Horizontal Reach: 41.1" extension<br>arm reach with 177° rotation.<br>The articulating arm has 42.7”<br>of additional extension with<br>205° of rotation. | X-Ray Head:<br>Length: 34.5 cm (13.6 in)<br>Width: 38.4 cm (15.1 in)<br>Height: 31.8 cm (12.5 in)<br>Arm:<br>Vertical Reach: ±18" from neutral<br>Horizontal Reach: The articulating arm<br>has 40" of extension with 90° of<br>rotation.<br>Stand:<br>Height with folded arm: 200 cm (78.7 in)<br>Width of base: 54.0 cm (21.2 in)<br>Length of base: 50.8 cm (20.0 in) | | Source to<br>Detector<br>distance (SDD) | 400 mm | 313 mm | | Minimum<br>Source to Skin<br>Distance (SSD) | 308 mm | 200 mm | | Weight | 112.5 lbs | 117.0 lbs | | Imaging, Display, and Software: | | | | Sensor Physical<br>Dimensions | Exterior Size: 41.76 mm x 30.42 mm<br>Imaging Size: 35.92 mm x 25.82 mm<br>Pixel Size: 19.5 µm x 19.5 µm<br>Image Resolution: 1324 x 1842 | Exterior Size: 41.82 mm x 30.50 mm<br>Imaging Size: 35.98 mm x 26.25 mm<br>Pixel Size: 19.5 µm x 19.5 µm<br>Image Resolution: 1346 x 1845 | | Sensor<br>Technology | CMOS with Cesium Iodide Scintillator | CMOS with Cesium Iodide Scintillator | | Dimensions of<br>X-ray beam at<br>Imaging Plate | 36.6 mm x 33.6 mm Rectangle | 63.6 mm x 59.7 mm Ellipse | | Data Transfer<br>Rate | <0.5 Frames/sec | < 10.2 Frames/sec | | Characteristic<br>or Property | Surround Medical, Portray System,<br>K211014 | 3Dio Lumos 3DX | | X-ray signal<br>Gain (WRT<br>standard) | 1X | About 9X | | X-ray emission<br>control | Wired Control | Wired control | | 3D data<br>acquisition time | 6 sec (approximately) | 3 sec (approximately) | | 3D slice<br>thickness | 0.5 mm fixed | Variable down to <0.1 mm | | 3D volume<br>rendering | No | Yes | | 2D Image | Synthetic | 2D Slices | | Acquisition<br>Geometry | Arc segment | 360° Conical | | Installation<br>Configuration | Wall Mount | Mobile Stand | | Software | Windows operating system and<br>Windows-like user interface. | Windows operating system with<br>touchscreen user interface. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for 3Dio, a Turner Company. The logo consists of a circular icon on the left, featuring a stylized tooth shape in white against a background of gray and light blue. To the right of the icon is the text "3Dio" in a light blue sans-serif font, with the words "a Turner Company" appearing in a smaller font size below. # Document Title: Lumos 3DX 510(k) Summary 510k #: K223780 Page 3 of 5 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the 3Dio logo. The logo consists of a tooth inside of a circle on the left and the text "3Dio a Turner Company" on the right. The tooth is white and the circle is gray and teal. The text is teal. ### Document Title: Lumos 3DX 510(k) Summary 510k #: K223780 Page 4 of 5 The Lumos 3DX system and the Portray System are both intra-oral x-ray systems that Discussion: take multiple images and render a finished image for viewing. The systems view these images in slices that allow the dental professionals to see the teeth at various depths. The Portray system uses carbon nanotubes in its X-ray source that are positioned along an arc to get their seven shots from different angles. The Lumos 3DX uses a conventional X-ray Tube that pulses 30 times while rotating along a 360° circular path. > The Lumos 3DX and predicate device both allow for viewing slices, but the thickness is much smaller in the Lumos 3DX system which allows for a more detailed viewing process for the dental professional. In addition, because the Lumos 3DX takes images around a circle rather than along a single plane it provides more spatial information for reconstruction. The Portray System is a wall-mounted system while the Lumos 3DX system is on a stand, but both have articulating arms. In both systems, an alignment aid is used to hold the detector in the correct position relative to the x-ray source and that alignment aid is magnetically attached to the front of the nose cone. In dental imaging Panoramic and Cone Beam CT systems are used to obtain 3D images of patient's oral structures. This is possible because the x-ray source and detector are external and rotate around the patient's head. These systems are large and expose the patient to a significant amount of radiation. The Lumos 3DX system is a smaller system that can take images of a more focused area using less radiation. Its portability also allows it to be used for unconscious patients while they lay in the chair rather than needing to move them to the x-ray device. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the title of a document. The title is "Document Title: Lumos 3DX 510(k) Summary". The text is in a clear, sans-serif font and is easy to read. The title suggests that the document is a summary of the Lumos 3DX 510(k) application. Image /page/7/Picture/1 description: The image is a logo for 3Dio, a Turner Company. The logo features a stylized tooth inside of a circle that is split into two colors, gray and light blue. To the right of the circle is the text "3Dio" in a light blue color, with the words "a Turner Company" underneath in a smaller font. 510k #: K223780 ### Bench and Radiation Safety Testing Summary: An Image Quality Performance test was completed using image quality phantoms for spatial resolution, contrast, and noise. The 3D volume voxel size was also verified. > The effect of patient motion was evaluated to verify that typical movements induced by a patient during imaging do not significantly affect the system or the resulting 3D volume. The results of the patient motion studies justify the use of dental phantoms and cadaver subjects for the analysis of clinical image quality. > In addition to the image quality bench studies, system verification and validation testing including hazard mitigation has been performed to demonstrate the Lumos 3DX meets design input and user needs. > The Lumos 3DX has been tested to show compliance with the applicable IEC series of x-ray performance standards, including IEC60601-2-65. It also meets all applicable 21CFR Subchapter J performance standards including those for radiation safety, such as dosimetry, leakage, and stray radiation. ### Clinical Image Quality Testing Summary: The clinical utility of the Lumos 3DX was demonstrated by performing a Clinical Imaging Evaluation with dental professionals. Dental phantoms with human teeth and simulated bone as well as Cadaver subjects were selected to represent typical use cases for the Lumos 3DX. A number of 3D images were obtained for analysis and review. > Based on the evaluations made by the dental professionals, the images obtained with the Lumos 3DX were of diagnostic quality for clinical use. - Based on successful verification and validation testing, conformance to recognized Conclusion: performance standards and FDA guidance, and development under the 3Dio Quality Management System, we conclude that the Lumos 3DX Imaging System is substantially equivalent to the predicate device Surround Medical, Portray System (K211014) and is safe and effective for its intended use.