ON3D

{0}------------------------------------------------ May 23, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 3D ONS, Inc. % DongHa Lee Regulatory Affairs Consultant KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 KOREA Re: K221000 Trade/Device Name: ON3D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 30, 2022 Received: April 4, 2022 Dear DongHa Lee: 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 {1}------------------------------------------------ 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 (OS) 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, Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging 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) K221000 Device Name ON3D #### Indications for Use (Describe) ON3D is software that is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> | <div> <span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </div> | ption 303 (Part 2 of 11:303 Support B) ## 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 is a logo for 3D ONS, which stands for 3Dimension Orthodontics & Surgery. The logo is in white text on a black background. The "O" in ONS is stylized with a circular design around it. # 510(k) Summary (K221000) This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: May 9, 2022 #### 1. Applicant / Submission Sponsor 3D ONS, Inc. Address: 18, EONJU-RO171-GIL, GANGNAM-GU, SEOUL, 06023, SOUTH KOREA Tel: +82-2-511-8254 Fax: +82-2-511-8120 Email: drcho@3dons.net ### 2. Submission Correspondent DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, South Korea Tel: +82-70-8965-5554 Fax: +82-2-856-5904 Email: dhlee@kmcerti.com ### 3. Device Identification - Trade/Proprietary Name: ON3D - Classification Name: Medical image management and processing system i - Classification Regulation: 21 CFR 892.2050 ı - Product Code: LLZ ı - Device Class: 2 - #### 4. Predicate Devices | Manufacturer | Patterson Dental Supply, Inc. | |---------------|-------------------------------| | Device Name | Dolphin Imaging | | 510(k) number | K110430 | | Product Code | LLZ | ### 5. Device Description ON3D is a stand-alone software that captures, stores and present patient data in volumetric views to assist specialized dental practitioners for treatment and surgical planning and case {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for "3D ONS 3Dimension Orthodontics & Surgery". The logo is white text on a black background. The "3D" and "ONS" are in large, bold letters, with a stylized atom symbol between them. Below the main text is the phrase "3Dimension Orthodontics & Surgery" in a smaller font. diagnosis. With a user-friendly graphical user interface, ON3D makes processing 3D data extremely simple, enabling dental specialists from a wide variety of disciplines to diagnose, plan treatment, document and present cases. ON3D allows visualization and analysis of craniofacial anatomy from data produced by 3D dataset format, such as cone beam computed tomography (CBCT), and it creates a personalized 3D model for the dentists with the optimal pre-surgical information necessary for the surgeries. It features tools for the manipulation and analysis of volumetric datasets, and the images are easily oriented and rotated. Tissue density thresholds can be adjusted for detailed views of craniofacial anatomy. ON3D product features include 3D airway analysis, multiple planar views, volume stitching, 2D/3D facial photo wrap onto the volumetric model, 3D neural canal markings, TMJ analysis, 3D/2D measurements, export images to other applications, such as STL or PLY, and more. ### 6. Indication for use ON3D is software that is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners. ### 7. Substantial Equivalence | - | Subject Device | Predicate Device | Remarks | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | 510(k) Number | K221000 | K110430 | - | | Trade/Device Name | ON3D | Dolphin Imaging | - | | Manufacturer | 3D ONS, Inc. | Patterson Dental Supply, Inc.<br>(doing business as Dolphin<br>Imaging & Management) | - | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | | Regulatory Class | Class II | Class II | Same | | Product Code | LLZ | LLZ | Same | | Intended Use | ON3D is software that is<br>designed for use by specialized<br>dental practices for capturing,<br>storing and presenting patient<br>images and assisting in<br>treatment planning and case<br>diagnosis. Results produced by<br>the software's diagnostic and<br>treatment planning tools are<br>dependent on the interpretation<br>of trained and licensed dental<br>practitioners. | Dolphin Imaging is software<br>that is designed for use by<br>specialized dental practices for<br>capturing, storing and<br>presenting patient images and<br>assisting in treatment planning<br>and case diagnosis. Results<br>produced by the software's<br>diagnostic and treatment<br>planning tools are dependent on<br>the interpretation of trained and<br>licensed dental practitioners. | Same | | Standalone<br>Software | Yes | Yes | Same | ON3D is substantially equivalent to the predicate devices, Dolphin Imaging (K110430). The following comparison table is presented to demonstrate substantial equivalence. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for 3D ONS, which stands for 3Dimension Orthodontics & Surgery. The logo is in white text on a black background. The "O" in ONS is stylized with a circular design. | Operation System | Windows | Windows or Mac OS | Same | |-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | User Interface | Mouse, Keyboard | Mouse, Keyboard | Same | | Image rendering | 2D and 3D | 2D and 3D | Same | | Image<br>manipulation | Preview, Rotate, Enhance, Zoom, Brightness, Contrast, Sharpness | Preview, Rotate, Enhance, Zoom, Brightness, Contrast, Sharpness | Same | | Basic image<br>measurement | Distance, angle | Distance, angle | Same | | 3D airway analysis | Yes | Yes | Same | | Cross sections in<br>multiple planar<br>views (MPV) | Yes | Yes | Same | | Volume orientation<br>control | Yes | Yes | Same | | Volume stitching | Combine two separate volumes<br>into one | Combine two separate volumes<br>into one | Same | | Volume-to-volume<br>superimposition | Yes | Yes | Same | | Cephalometric<br>tracing and<br>analysis | None | Manual point picking and automatic structure templates Software provides predefined landmarks and tracing structures. Can trace on 3D volume and 2D photo. | Difference does not affect SE<br>(Note 1.) | | 3D/2D analysis | Provide both 3D and 2D analysis. 3D analysis is performed on 3D volume. 2D analysis is performed on a pre-determined plane (mid-sagittal plane) using 3D landmarks that are projected on the 2D plane. | Provide both 3D and 2D analysis. 3D analysis is performed on 3D volume. 2D analysis is performed on 2D photo or x-ray. Standard orthodontic tracing analyses and user-configurable analysis: | Difference does not affect SE<br>(Note 2.) | | 3D neural canal<br>marking | Yes | Yes | Same | | TMJ analysis | Yes | Yes | Same | | Surgical planning<br>and simulation | Orthodontic and orthognathic applications using maxillary, mandible, and chin and cheek cuts. User can translate, rotate the cuts. | Orthodontic and orthognathic applications using maxillary, mandible, and chin and cheek cuts. User can translate, rotate the cuts. | Same | | Distinguish<br>biological<br>structures via their<br>radiolucency | Yes | Yes | Same | | Soft tissue<br>deformation | Yes. 2D and 3D | Yes. 2D and 3D | Same | | Photo wrapping | Can wrap 2D and 3D photos on volume image | Can wrap 2D and 3D photos on volume image | Same | | and TAD treatment<br>planning and<br>simulation | | | does not<br>affect SE<br>(Note 3.) | | Generate<br>panoramic<br>radiographs | Yes | Yes | Same | | Scanner connection | Yes | Yes | Same | | Export images/data<br>to other<br>applications | Yes. | Yes | Same | | DICOM support | Yes | Yes | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for "3D ONS 3Dimension Orthodontics & Surgery". The logo is in white text on a black background. The text is stacked, with "3D ONS" on top and "3Dimension Orthodontics & Surgery" on the bottom. #### (Note 1.) Cephalometric tracing and analysis : Although the subject device can display a simple outline of mandible and maxilla by enabling the users to draw lines by connecting landmarks selected for the analysis, the subject device does not have cephalometric tracing and analysis feature. This difference does not raise any risks in the safety and effectiveness of the device for the proposed intended use as it is demonstrated in the software verification and validation documents, and performance test reports. #### (Note 2.) 3D/2D analysis : Both devices provide both 3D and 2D analysis. Although the 3D analysis method is the same, the input image for 2D analysis is different. The predicate device performs 2D analysis on 2D photo or x-ray but the subject device performs 2D analysis on a pre-determined plane (mid-sagittal plane) of the 3D volume using landmarks (3D) that are projected on the 2D plane. The subject device uses 3D image data only and does not use 2D photo or x-ray images (cephalogram). Although there is no 2D image data input, the predicate device generates 2D images from the 3D volume and perform 2D analysis on the generated 2D images. This difference does not raise any risks in the safety and effectiveness of the device for the proposed intended use as it is demonstrated in the software verification and validation documents, and performance test reports. #### (Note 3.) Dental Implant and TAD treatment planning and simulation : The subject device does not have applications for dental implant and TAD treatment planning and simulation. This difference does not raise any risks in the safety and effectiveness of the device for the proposed intended use. ### 8. Software Verification and Validation The Software Verification and Validation were performed to assess the effectiveness of the medical purpose software in accordance with IEC 62304 standard requirements. The testing was performed at the system level, the integration level, and the unit level tests. ### 9. Performance Testing - Bench Testing {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for "3D ONS 3Dimension Orthodontics & Surgery". The logo is white text on a black background. The "O" in "ONS" is stylized with a graphic of an atom. The performance testing (bench testing) was performed as the software system-level test to assess the effectiveness of the device (stand-alone software) performance including each UI as Open the study in the Worklist, Basic function for Viewer, Button function, Hot-key function, Main function simulation, Environmental setting, System setting, Worklist. #### 10. Conclusion In substantial equivalence discussion between the subject device and the predicate device, there are the same characteristics such as product code, regulation number, intended use, prescription-only indication, product main features/functions, operation environment and operation system. Although there are some different characteristics (such as cephalometric tracing and analysis, input image for 2D analysis, and absence of the dental implant and TAD treatment planning and simulation), the safety and performance test results provide a reasonable assurance of safety and effectiveness with respect to the intended users and the conditions of use prescribed, recommended, or suggested in the labeling of the device. Therefore, we believe that the subject device does not raise concerns in safety and effectiveness for the proposed intended use and that the subject device is substantially equivalent to the predicate device.