(245 days)
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.
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.
The provided document describes the Will3D software, a medical image management and processing system. The core of the submission is to demonstrate its substantial equivalence to a previously cleared device, K170180 HDX WILL CORP. Will3D. As a result, the document primarily focuses on comparing the new Will3D with its predicate rather than detailing a specific study to prove new acceptance criteria.
The document does not explicitly state "acceptance criteria" and "reported device performance" in a separate section with specific numerical targets. Instead, it asserts substantial equivalence based on identical indications for use and technological characteristics to the predicate device. The "acceptance criteria" are implied to be that the device performs functionally identically and safely to the predicate.
Here's an attempt to extract and infer the requested information based on the provided text, acknowledging that some details might be missing or indirectly stated due to the nature of a 510(k) summary focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
As the submission focuses on substantial equivalence to a predicate device with identical specifications, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the exact same indications for use and technological characteristics as the predicate. The "reported device performance" is, therefore, that it performs as expected for these features.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Identical Indications for Use to Predicate Device (K170180) | Will3D has the same indications for use as K170180. |
| Identical Technological Characteristics to Predicate Device | Will3D has the same technological characteristics as K170180 (e.g., File, MPR, Panorama, Implant, TMJ, 3D Ceph, Face Simulation, Super imposition, Endoscopy, Report functions, DICOM standard, CT image data support, Windows/Mac OS compatibility). |
| No new technology or indications of use introduced | No new technology or indications of use were introduced. |
| Safe and effective performance (implied through substantial equivalence) | Performance testing demonstrated the subject device is as safe and effective as the predicate. |
| Compliance with software development process | Software was designed and developed according to a software development process and was verified and validated. |
| Compliance with cybersecurity guidance | Cybersecurity information was provided in accordance with FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" or its sample size. The review relies on the assertion that "performance testing conducted demonstrate that the subject device is as safe as effective as the predicate." However, no details about the specific test data (e.g., number of cases, retrospective or prospective nature, country of origin) are provided. This is typical for a 510(k) submission where substantial equivalence is claimed based on identical design and function to a predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given the nature of a substantial equivalence claim for a medical image management and processing system, the "ground truth" for verifying its technical functionalities (like MPR, 3D visualization, measurements) would likely involve comparing output to known standards or expert interpretation, but specific expert involvement for a 'test set' isn't detailed.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on the device's performance and characteristics, not on how human readers improve with or without AI assistance, as the Will3D is described as an image management and processing system rather than a diagnostic AI aid with a comparative effectiveness study.
6. Standalone (Algorithm Only) Performance Study
The device is described as "standalone software" and "one of the components of a Picture Archiving and Communications System(PACS)" that "provides image viewing and manipulation." The performance testing mentioned is implied to be for this standalone software. However, no specific details of a standalone performance study (e.g., metrics, methodologies) are provided beyond the general statement that "performance testing conducted demonstrate that the subject device is as safe as effective as the predicate."
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance testing. For a device like Will3D, which handles display, visualization, and processing of medical images, the "ground truth" for its functionalities would typically involve:
- Technical specifications: Verifying that the software accurately renders images, performs measurements, and generates reconstructions according to predefined technical standards and algorithms.
- Expert Consensus/Clinical Evaluation (implied): Ensuring that the processed images and visualizations are clinically acceptable and provide accurate information for diagnostic and planning purposes, likely through evaluation by radiologists, clinicians, and other qualified individuals, as mentioned in its indications for use.
- Comparison to Predicate (implied): Demonstrating that its output and functionality are identical or equivalent to the predicate device.
8. Sample Size for the Training Set
No information about a training set or its sample size is provided. This is expected as Will3D is described as an image processing and visualization software, not a machine learning or AI algorithm that typically requires a separate training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned for this device.
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December 15, 2021
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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
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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
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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) |
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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]
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, Osongsaengmyeong4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,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 |
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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 /Functionality | Description |
|---|---|---|
| 1 | Authentication | Software user authentication process function |
| 2 | License | Software license check function |
| 3 | Main | Software configuration and execution functionView |
| 4 | File | Register/search the data desired by the user in thedatabase and load the selected data |
| 5 | OTSDICOM | Scan, organize image files and convert from software toDICOM image files, process offline media, and sendimages over a network connection |
| 6 | MPR | Display the image visualized in 2D/3D and show theimage from a selected directionA function that visualizes the input DICOM image in2D/3D and outputs it on the screen, allowing the user toview the image from the desired direction. |
| 7 | Panorama | Reconfigure the panoramic and cross-sectional imagesand draw the nerve in the panoramic image |
| 8 | Implant | Display the Implant Model registered in a database andvirtually place implants in the ideal position |
| 9 | TMJ | Display the 2D/3D images of the TMJ field on the screenand provide an interface to easily observe the TMJ area |
| 10 | 3D Ceph | Provide the cephalometric analysis and surgicalsimulation functions |
| 11 | Face Simulation | A surface model can be created from the input volume |
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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 createdin this way or the 3D photo created by the equipment canbe mapped to the input volume.In addition, the function of comparing the image result ofsurgical simulation performed by 3D Ceph with theexisting image. | |||
|---|---|---|---|
| 12 | Super imposition | Visually compare and observe changes before and aftersurgery by outputting two different volumes on onescreen | |
| 13 | Endoscopy | Provide a virtual endoscopic function for airwayobservation | |
| 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,printing, screen capture, and software information | |
| 18 | OTF Tool | Adjust the color, transparency, and color range of VolumeRendering video | |
| Engine | |||
| 19 | MPR Engine | Generate MPR image | |
| 20 | VR Engine | Create Volume Rendering and Surface Renderingimages (*VR means Volume Rendering) | |
| 21 | OTS 3DRendering | Create a 2D/3D screen with texture mapping, specialeffects, 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.
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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 | - |
| ClassificationName | System, Image Processing,Radiological | System, Image Processing,Radiological | Same |
| RegulatoryNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product Code | LLZ | LLZ | Same |
| Classification | II | II | Same |
| Indication forUse | Will3D is a software applicationused for the display and 3Dvisualization of medical imagefiles from scanning devices,such as Dental CT scanner. Itis intended for use byradiologists, clinicians,referring physicians and otherqualified individuals to retrieve,process, render, review, store,print, assist in diagnosis, anddistribute images utilizingstandard PC hardware.Additionally, Will3D is apreoperative softwareapplication used for thesimulation and evaluation ofdental implants, orthodonticplanning and surgicaltreatments. | Will3D is a software applicationused for the display and 3Dvisualization of medical imagefiles from scanning devices,such as Dental CT scanner. Itis intended for use byradiologists, clinicians,referring physicians and otherqualified individuals to retrieve,process, render, review, store,print, assist in diagnosis, anddistribute images utilizingstandard PC hardware.Additionally, Will3D is apreoperative softwareapplication used for thesimulation and evaluation ofdental implants, orthodonticplanning and surgicaltreatments. | Same |
| Type of Use | Prescription Use | Prescription Use | Same |
| Component | Standalone software | Standalone software | Same |
| ModalitySupport | CT image data | CT image data. | Same |
| OperatingSystem | Window 7 or higher and Macos Yosemite or higher | Window 7 or higher and Macos Yosemite or higher | Same |
| Subject Device | Predicate Device | SE Note | |
| Model Name | Will3D | Will3D (K170180) | - |
| ImageCommunicationStandard | DICOM | DICOM | Same |
| Feature/Functionality | - File- MPR- Panorama- Implant- TMJ- 3D Ceph- Face Simulation- Super imposition- Endoscopy- Report | - File- MPR- Panorama- Implant- TMJ- Orthodontic- 3D Ceph- Face Simulation- Super imposition- Endoscopy- Report | Same |
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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.
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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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).