Will3D

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, composed of three interconnected profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 8, 2017 HDX WILL CORP. Seung-Il Chun General Manager #105.201.202.203.204.38. Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si. Chungcheongbuk-do. 28161 REPUBLIC OF KOREA Re: K170180 Trade/Device Name: Will3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: March 7, 2017 Received: March 14, 2017 Dear Seung-Il Chun: 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. 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 {1}------------------------------------------------ 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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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 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, Michael D'Hara For Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170180 Device Name Will3D Indications for Use (Describe) Will3D is a software application used for the display and 3D visualization of medical image files from scanning devices, such as Dental CT scanner. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. 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) #### 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 HDX Will. The logo consists of a blue square with a white "W" inside, followed by the text "HDX Will" in a bold, blue font. The "W" in the square is stylized with a green curve above it. # 510(k) Summary [As required by 21 CFR 807.92] ## 1. Date Prepared [21 CFR 807.92(a)(a)] May 8, 2017 ## 2. Submitter's Information [21 CFR 807.92(a)(1)] | Name of Sponsor: | HDX WILL CORP. | |------------------|-------------------------------------------------| | Address: | #105, 201, 202, 203, 204, 38, | | | Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, | | | Cheongju-si, Chungcheongbuk-do, 28161, Korea | | Contact Name: | Seung-Il Chun / General Manager | |----------------|---------------------------------| | Telephone No.: | +82-43-710-7318 | | Fax No.: | +82-43-710-7312 | | Email Address: | sichun@iwillmed.com | | | | | • Name of Manufacturer: | Same as sponsor | |-------------------------|-----------------| | - Address: | Same as sponsor | ### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Trade Name:<br>Will3D | | |-----------------------|--| |-----------------------|--| - . Common Name: PACS Software - Classification: . | Classification Name | System, Image Processing, Radiological | |---------------------------|----------------------------------------| | Classification Regulation | 21 CFR 892.2050 | | Product Code | LLZ | | Device Class | II | | Classification Panel | Radiology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font. ### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[ The identified predicate devices within this submission are shown as follow: #### Primary Predicate | | 510(k) Number: | K070803 | | | |---------------------|----------------------|---------------------------|--|--| | | Applicant: | Anatomage Inc. | | | | | Classification Name: | Imaging Processing System | | | | | Trade Name: | InVivoDental™ | | | | | | | | | | Reference Predicate | | | | | | | 510(k) Number: | K113543 | | | - Applicant: CyberMed Inc. ● Classification Name: Imaging Processing System - Trade Name: OnDemand3DG2 ● ### 5. Description of the Device [21 CFR 807.92(a)(4)] The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting. | No. | Feature/<br>Functionality | Description | | | |-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--|--| | 1 | File | Register the required data in the database and search the data | | | | 2 | MPR | Display the image visualized in 2D/3D and show the image from a<br>selected direction | | | | 3 | Reconfigure the panoramic and cross-sectional images and draw the<br>Panorama<br>nerve in the panoramic image | | | | | 4 | Display the Implant Model registered in a database and virtually place<br>Implant<br>implants in the ideal position | | | | | 5 | TMI | Display the 2D/ 3D images for a TMJ field | | | | б | Orthodontic | Display a 2D image for horizontal symmetry check | | | | 7 | 3D Ceph | Provide the cephalometric analysis and surgical simulation functions | | | | 8 | Map a 3D photo to the entered volume and compare the resultant<br>Face<br>image of a surgical simulation conducted in 3D Ceph against the<br>Simulation<br>existing images | | | | | 9 | Super<br>imposition | Display two different volumes on one screen | | | | 10 | Endoscopy | Provide a virtual endoscopic function for airway observation | | | | 11 | Report | Create the patient report | | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for HDXWill. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDXWill" in blue. The text is bold and slightly italicized. ### 6. Intended Use/Indications for Use [21 CFR 807.92(a)(5)] Will3D is a software application used for the display and 3D visualization of medical image files from scanning devices, such as Dental CT scanner. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. ## 7. Technological Characteristics [21 CFR 807.92(a)(6)] There are no significant differences in the technological characteristics of this device compared to the predicate devices which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the Will3D and the predicate devices: | | Proposed Device | Primary Predicate | Reference Predicate | |----------------|---------------------------|----------------------------|--------------------------| | K Number | Not known | K070803 | K113543 | | Model Name | Will3D | InVivoDental™ | OnDemand3DG2 | | Manufacturer | HDX WILL CORP. | Anatomage Inc. | CyberMed Inc. | | Classification | System, Image | System, Image | System, Image | | Name | Processing, Radiological | Processing, Radiological | Processing, Radiological | | Regulatory | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | | Number | | | | | Product Code | LLZ | LLZ | LLZ | | Classification | II | II | II | | Intended Use | Will3D is a software | InVivoDental is intended | The OnDemand3D62 is | | | application used for the | for use as a front-end | intended for use as a | | | display and 3D | software interface for | software package which | | | visualization of medical | the transfer of imaging | loads DICOM images | | | image files from | information from a | from CT, MR, X-Ray, | | | scanning devices, such | medical scanner such as | stores those and | | | as Dental CT scanner. It | a Dental CT scanner. It is | provides 3D | | | is intended for use by | also intended for use as | visualization and | | | radiologists, clinicians, | a planning and | 20 analysis, various MPR | | | referring physicians and | simulation software in | (Multi-Planar | | | other qualified | the placement of dental | Reconstruction) | | | individuals to retrieve, | implants, orthodontics | functions for further | | | process, render, review, | and surgical treatment. | rapid and precise | | | store, print, assist in | | diagnosis. | | | diagnosis, and distribute | | 1) Functions for implant | | | images utilizing | | surgery planning and | | | standard PC hardware. | | fabricating a surgical | | | Additionally, Will3D is a | | guide according to the | | | preoperative software | | plan | | | application used for the | | 2) Functions to combine | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a square with a green top half and a blue bottom half, with a white "W" in the center. To the right of the square is the text "HDX Will" in a bold, blue font. The text is slightly slanted to the right, giving the logo a dynamic appearance. | | Proposed Device | Primary Predicate | Reference Predicate | |------------------|------------------------|------------------------|---------------------------| | | simulation and | | and show the image data | | | evaluation of dental | | from different | | | implants, orthodontic | | modalities such as CT, | | | planning and surgical | | MRI and PET in one | | | treatments. | | window at the same | | | | | time | | | | | 3) Functions to create | | | | | orthodontic analysis | | | | | using 3D volume data | | | | | 4) Functions to sort and | | | | | save DICOM files, Project | | | | | Files and 2D image files | | | | | from different modality | | | | | [Panorama, | | | | | | | | | | Cephalometric, | | | | | intraoral] under a single | | | | | patient name | | Type of Use | Prescription Use | Prescription Use | Prescription Use | | Component | Standalone software | Standalone software | Standalone software | | Modality Support | Dental CT scanner | Dental CT scanner | CT, MR, and X-Ray | | Operating System | Window 7 or higher and | Windows XP and | Window XP/Vista/7/8 | | | Mac os Yosemite or | Windows 7 | | | | higher | | | | Image | | | | | Communication | DICOM | DICOM | DICOM | | Standard | | | | | Feature/ | File, | Section (MPR), | File, | | Functionality | MPR, | Volume Render | MPR, | | | Panorama, | (Endoscopy), | Panorama, | | | Implant, | Arch Section | Implant, | | | TMJ, | (Panorama), | TMJ, | | | Orthodontic, | Implant, | 3D Ceph, | | | 3D Ceph, | Restoration, | Orthodontic, | | | Face Simulation, | TML. | Face Simulation and | | | Superimposition, | Super Pano, | Report | | | Endoscopy, and | Super Ceph, | | | | Report | Superimposition, | | | | | Gallery, | | | | | Model, | | | | | 3D Analysis (3D Ceph), | | | | | Orthodontic, | | | | | MD studio, | | | | | Report, and | | | | | Stitching | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for HDXWill. The logo consists of a green square with a white "W" inside, followed by the text "HDXWill" in a bold, blue font. The text is slightly slanted to the right, giving the logo a dynamic appearance. #### Non-Clinical Test Summarv Will3D contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance: the content of premarket submissions for software contained in medical devices, issued on May 11, 2005. ### Clinical Test Summary: No clinical studies were considered necessary and performed. ### 8. Substantial Equivalence [21 CFR 807.92(b)[1] and 807.92] Will3D has the similar technical characteristics with the predicate devices. These devices are a dental imaging software program which provides 3D visualization that are reconstructed data from DICOM files. The subject and primary predicate device share the same intended use, type of use, modality support and image communication standard. They also share equivalent operating systems. However, in terms of features and functionality, the subject device differs from the primary predicate device, and includes features and functionality not found in the primary predicate, such as File and Face Simulation. To address these differences, OnDemand3Di2 was introduced as the reference predicate. In addition, these technological differences do not raise different questions of safety and effectiveness ## 9. Conclusion [21 CFR 807.92(b)(3)] In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification HDX WILL CORP, concludes that the Will3D is substantially equivalent in safety and effectiveness to the predicate devices as described herein.