Will3D

{0}------------------------------------------------ December 15, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The words "U.S. FOOD & DRUG" are on the first line, and "ADMINISTRATION" is on the second line. Hdx Will Corp. % Kim In-Young Staff #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 REPUBLIC OF KOREA Re: K21114 Trade/Device Name: Will3D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: November 2, 2021 Received: November 12, 2021 Dear Kim In-Young: 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 {1}------------------------------------------------ 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 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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211114 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, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application and evaluation and evaluation of dental implants, orthodontic planning and surgical treatments. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|-----------------------------------------------| | X Prescription I Ise (Part 21 CER 801 Subnart D) | Over-The-Counter I lea (21 CER 801 Subnart 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 green square with a white "W" inside, followed by the text "HDX Will" in blue. The logo is simple and modern, and the colors are bright and eye-catching. # 510(k) Summary [As required by 21 CFR 807.92] K211114 # 1. Date Prepared [21 CFR 807.92(a)(1)] November 2th 2021 ## 2. Submitter's Information [21 CFR 807.92(a)(1)] | - Name of Manufacturer: | HDX WILL Corp. | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | - Address: | #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong<br>4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,<br>Chungcheongbuk-do, 28161, Republic of Korea | | - Contact Person: | In Young Kim / Staff | | - Telephone No.: | +82-43-710-7318 | | - Fax No.: | +82-43-710-7312 | | - Email Address: | kiy@iwillmed.com | | - Registration No.: | 3013511605 | # 3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] | Device Name | Will3D | |---------------------|------------------------------------------------| | Regulation Number | 21 CFR 892.2050 | | Common/Usual Name | Medical Image Management and Processing System | | Regulatory Class | Class II | | Product Code | LLZ | | Classification Name | System, Image Processing, Radiological | | Panel | Radiology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with the letter "W" in white inside the square. To the right of the square is the text "HDX Will" in blue. The logo is simple and modern. # 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[ The identified predicate devices within this submission are shown as follow; ### Predicate device K170180 HDX WILL CORP. Will3D There are no significant differences between the Will3D and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, and technical characteristics ## 5. Description of the Device [21 CFR 807.92(a)(4)] Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting. | No. | Feature /<br>Functionality | Description | |-----|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Authentication | Software user authentication process function | | 2 | License | Software license check function | | 3 | Main | Software configuration and execution function<br>View | | 4 | File | Register/search the data desired by the user in the<br>database and load the selected data | | 5 | OTS<br>DICOM | Scan, organize image files and convert from software to<br>DICOM image files, process offline media, and send<br>images over a network connection | | 6 | MPR | Display the image visualized in 2D/3D and show the<br>image from a selected direction<br>A function that visualizes the input DICOM image in<br>2D/3D and outputs it on the screen, allowing the user to<br>view the image from the desired direction. | | 7 | Panorama | Reconfigure the panoramic and cross-sectional images<br>and draw the nerve in the panoramic image | | 8 | Implant | Display the Implant Model registered in a database and<br>virtually place implants in the ideal position | | 9 | TMJ | Display the 2D/3D images of the TMJ field on the screen<br>and provide an interface to easily observe the TMJ area | | 10 | 3D Ceph | Provide the cephalometric analysis and surgical<br>simulation functions | | 11 | Face Simulation | A surface model can be created from the input volume | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a blue square with a green upper-right corner and a white "W" inside the square. To the right of the square is the text "HDX Will" in a stylized blue font. The text is slightly slanted to the right. | | | and 2D photo can be mapped, and the 3D photo created<br>in this way or the 3D photo created by the equipment can<br>be mapped to the input volume.<br>In addition, the function of comparing the image result of<br>surgical simulation performed by 3D Ceph with the<br>existing image. | | |--------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 12 | Super imposition | Visually compare and observe changes before and after<br>surgery by outputting two different volumes on one<br>screen | | | 13 | Endoscopy | Provide a virtual endoscopic function for airway<br>observation | | | 14 | Report | Create the patient report | | | | Common | | | | 15 | View Tool | 'View' motion control function | | | 16 | Measure Tool | Measure function | | | 17 | Common Tool | Commonly used functions such as project saving,<br>printing, screen capture, and software information | | | 18 | OTF Tool | Adjust the color, transparency, and color range of Volume<br>Rendering video | | | Engine | | | | | 19 | MPR Engine | Generate MPR image | | | 20 | VR Engine | Create Volume Rendering and Surface Rendering<br>images (*VR means Volume Rendering) | | | 21 | OTS 3D<br>Rendering | Create a 2D/3D screen with texture mapping, special<br>effects, and other visual functions | | # 6. 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with the letter "W" in white inside the square. To the right of the square is the text "HDX Will" in blue. # 7. Determination of Substantial Equivalence Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)] # a) Technological Characteristics | | Subject Device | Predicate Device | SE Note | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Model Name | Will3D | Will3D (K170180) | - | | Manufacturer | HDX WILL CORP. | HDX WILL CORP. | - | | K Number | K211114 | K170180 | - | | Classification<br>Name | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological | Same | | Regulatory<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | | Product Code | LLZ | LLZ | Same | | Classification | II | II | Same | | Indication for<br>Use | Will3D is a software application<br>used for the display and 3D<br>visualization of medical image<br>files from scanning devices,<br>such as Dental CT scanner. It<br>is intended for use by<br>radiologists, clinicians,<br>referring physicians and other<br>qualified individuals to retrieve,<br>process, render, review, store,<br>print, assist in diagnosis, and<br>distribute images utilizing<br>standard PC hardware.<br>Additionally, Will3D is a<br>preoperative software<br>application used for the<br>simulation and evaluation of<br>dental implants, orthodontic<br>planning and surgical<br>treatments. | Will3D is a software application<br>used for the display and 3D<br>visualization of medical image<br>files from scanning devices,<br>such as Dental CT scanner. It<br>is intended for use by<br>radiologists, clinicians,<br>referring physicians and other<br>qualified individuals to retrieve,<br>process, render, review, store,<br>print, assist in diagnosis, and<br>distribute images utilizing<br>standard PC hardware.<br>Additionally, Will3D is a<br>preoperative software<br>application used for the<br>simulation and evaluation of<br>dental implants, orthodontic<br>planning and surgical<br>treatments. | Same | | Type of Use | Prescription Use | Prescription Use | Same | | Component | Standalone software | Standalone software | Same | | Modality<br>Support | CT image data | CT image data. | Same | | Operating<br>System | Window 7 or higher and Mac<br>os Yosemite or higher | Window 7 or higher and Mac<br>os Yosemite or higher | Same | | | Subject Device | Predicate Device | SE Note | | Model Name | Will3D | Will3D (K170180) | - | | Image<br>Communication<br>Standard | DICOM | DICOM | Same | | Feature/<br>Functionality | - File<br>- MPR<br>- Panorama<br>- Implant<br>- TMJ<br>- 3D Ceph<br>- Face Simulation<br>- Super imposition<br>- Endoscopy<br>- Report | - File<br>- MPR<br>- Panorama<br>- Implant<br>- TMJ<br>- Orthodontic<br>- 3D Ceph<br>- Face Simulation<br>- Super imposition<br>- Endoscopy<br>- Report | Same | {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 logo appears to be for a company or organization. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for HDXWill. The logo consists of a green square with a white "W" inside, followed by the text "HDXWill" in blue. The font is sans-serif and the overall design is modern and professional. ## b) Differences between Subject and Predicate Devices The Will3D is substantially equivalent to the predicate device identified above with respect to intended use and technological characteristics. From the information provided in table above, it is understood that the subject device does not introduce any new technology and/or indications of use. Therefore, the Will3D is considered substantially equivalent to the predicate device. # 8. Non-Clinical Test Summary The 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: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005." Cybersecurity information is provided in accordance with FDA guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014" # 9. Conclusion [21 CFR 807.92(b)(3)] The Will3D has same indications for use and technical characteristic to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness. In addition, performance testing conducted demonstrate that the subject device is as safe as effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.