(246 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional image processing and analysis tools. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as software for analysis, planning, and simulation, not for directly treating a condition or disease. Its output is to be interpreted by trained practitioners, supporting diagnosis and planning rather than providing therapy itself.
Yes
The "Intended Use" section states that WillCeph is intended "to aid in cephalometric analysis, orthodontic treatment planning and case follow-up." Additionally, the "Device Description" mentions "Diagnosis" as one of its functions. These directly indicate a diagnostic purpose.
Yes
The device description explicitly states "WillCeph is a software device" and details its functionalities as software features. The performance studies summary also focuses on software verification and validation, without mentioning any associated hardware components.
Based on the provided information, WillCeph is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- WillCeph's Function: WillCeph is a software device that processes and analyzes medical images (X-rays) and patient data. It aids in diagnosis, planning, and follow-up based on these images and data, not on samples taken from the body.
- Intended Use: The intended use clearly states it's for capturing, storing, presenting patient images and radiographs, and aiding in cephalometric analysis and treatment planning. This is image-based and data-based analysis, not analysis of biological samples.
Therefore, WillCeph falls under the category of a medical device, specifically a software medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
- Cephalometric Analysis & Maxillo-facial Surgical Simulation
- Consulting, Diagnosis, Surgical Planning, Analysis, Growth Forecast
- Specification
- Patient data management : Patient Database
- Various Gallery format & User-defined gallery
- Image Fusion & Comparing : Pre / Post Treatment
- Cephalogram & Tracing on digitized X-ray film
- Treatment Simulation (VTO / STO)
- Chart & Analysis / Export into excel file
- Superimposition
- Photo-Film Image Fusion
- Growth Forecast
- PACS Integration (Option)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
specialized dental practices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary
WillCeph contains MODERATE level of concern 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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March 21, 2018
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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
HDX WILL CORP. % Myoung-Joon Lee General Manager #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup. Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 KOREAN
Re: K172168
Trade/Device Name: WillCeph Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 22, 2018 Received: January 30, 2018
Dear Myoung-Joon 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172168
Device Name WillCeph
Indications for Use (Describe)
WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart 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 and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
July 12, 2017
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • | Name of Sponsor: | HDX WILL CORP. |
|---|---|---|
| - | Address: | #105, 106, 201, 202, 203, 204, 38, |
| Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, | ||
| Cheongju-si, Chungcheongbuk-do, 28161, Korea | ||
| • | Contact Name: | Myoung-Joon Lee / General Manager |
| - | Telephone No.: | +82-43-710-7318 |
| - | Fax No.: | +82-43-710-7312 |
| - | Email Address: | mjlee@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: WillCeph
- 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 |
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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 and is slightly slanted to the right.
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
- 510(k) Number: K131348 Applicant: ● INFOMED SERVICIOS INFORMATICOS Classification Name: Imaging Processing System ● ● Trade Name: ORTOMED
5. Description of the Device [21 CFR 807.92(a)(4)]
■ Overview
- Description
- Cephalometric Analysis & Maxillo-facial Surgical Simulation
- Consulting, Diagnosis, Surgical Planning, Analysis, Growth Forecast
- Specification
- Patient data management : Patient Database
- Various Gallery format & User-defined gallery
- Image Fusion & Comparing : Pre / Post Treatment
- Cephalogram & Tracing on digitized X-ray film
- Treatment Simulation (VTO / STO)
- Chart & Analysis / Export into excel file
- Superimposition
- Photo-Film Image Fusion
- Growth Forecast
- PACS Integration (Option)
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Image /page/5/Picture/0 description: The image shows the logo for HDX WILL. The logo consists of a green and blue square with the letter 'W' inside, followed by the text 'HDX WILL' in blue. The text is bold and slightly slanted to the right.
■ System Requirements
- Client or Standalone
- OS : Microsoft Windows 7 or higher
- CPU : Intel Core2Duo or higher
- Memory : DDR2 2GB or higher
- Storage Installation : 100MB free-space
Data storage: depends on size of a data
- Monitor : 1024 x 768 or higher
- Input device : General keyboard & wheel mouse
- Hardware Lock key
- OS : Microsoft Windows 7 or higher
Program configuration
- Connection method : USB 2.0
Image /page/5/Picture/14 description: The image shows a window with a program's menu. The menu has options such as 'Print' and 'Close'. There is also an 'Exit' button at the bottom of the menu. The number '1' is circled in red twice in the image.
Image /page/5/Picture/15 description: The image shows a software interface, likely for dental or orthodontic analysis, with various panels and data displays. The top section includes menu options such as "Analysis," "Measure," and "Excel," along with methods like "Steiner" and "McNamara Kim." The central area displays a grid of images, including X-rays, photos, and traces, labeled as "Lateral," "Frontal," and "SMV." The left side features patient and study lists, with details like chart number, name, and study date.
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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 a white "W" inside, followed by the text "HDX Will" in a stylized blue font. The logo is simple and modern, and the colors are bright and eye-catching.
- (1) Menu: To print the currently selected screen, or you can exit the program.
- (2) Top toolbar: Diagnostic items, measurements, and environment setting is available
- (3) Patient editing window:
I) Provides functions such as register new patient, modify, and delete.
-
II) Selected patient's information of the Study, and the image files can be exported as one output file.
III) Copy the image data in connection with the Will-Master. -
(4) Study editing window: Provides functions such as Study registration, modification, deletion and importing/exporting of images.
-
(5) Output window:
Output the images of the selected Study in the Consultation screen, and provides functions such as Trace, VTO/STO, Growth Forecast, Super Impose, Chart, Gallery, etc.
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Image /page/7/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in a bold, blue font. The logo is simple and modern, and the colors are eye-catching.
6. Intended Use/Indications for Use [21 CFR 807.92(a)(5)]
WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthognathic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
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 device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the WillCeph and the predicate device:
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known | K131348 |
| Model Name | WillCeph | ORTOMED |
| Manufacturer | HDX WILL CORP. | INFOMED SERVICIOS INFORMATICOS |
| Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological |
| Regulatory Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | LLZ | LLZ |
| Classification | II | II |
| Intended Use | WillCeph is intended for use by specialized | |
| dental practices for capturing, storing and | ||
| presenting patient images and radiographs | ||
| and to aid in cephalometric analysis, | ||
| orthodontic and orthognathic treatment | ||
| planning and case follow-up. Results | ||
| produced by the software tools are to be | ||
| interpreted by trained and licensed dental | ||
| practitioners. | ORTOMED is intended for use by | |
| specialized dental practices for capturing, | ||
| storing and presenting patient images and | ||
| radiographs and to aid in cephalometric | ||
| analysis, orthodontic and orthognathic | ||
| treatment planning and case follow-up. | ||
| Results produced by the software tools are | ||
| to be interpreted by trained and licensed | ||
| dental practitioners. | ||
| Type of Use | Prescription Use | Prescription Use |
| Modality Support | X-ray | X-ray |
| Component | Client or Standalone software | Client or Standalone software |
| Operating System | Windows 7 or higher | Windows 2000/XP, Vista and Windows 7 |
| User Interface | Mouse, Keyboard | Mouse, Keyboard |
| Image | ||
| Communication | ||
| Standard | DICOM | DICOM |
| Patient Data | ||
| Management | Patient module for patient registration and | |
| file management. | ||
| Image module for image management. | GESDEN module for patient registration | |
| and file management. | ||
| GESIMAG module for image management. | ||
| Patient Database | ||
| Engine | My SQL / Microsoft® SQL© | Microsoft® SQL© |
| Proposed Device | Predicate Device | |
| Image | ||
| Measurement | Yes (linear, distance, angle) | Yes (linear, distance, angle) |
| Matching / | ||
| Adjustment of | ||
| Photograph to X-ray | Yes | Yes |
| Cephalometric | ||
| Analyses | In addition to user-configured analysis, | |
| standard orthodontic tracing analyses | ||
| include: |
-
Lateral Analyses
-
Frontal Analyses
-
Models Analyses
-
Photo studies of soft tissues | In addition to user-configured analysis,
standard orthodontic tracing analyses
include: -
Lateral Analyses
-
Frontal Analyses
-
Models Discrepancy Studies
-
Photo studies of soft tissue |
| Treatment
Planning,
Simulation and
Follow-up | Orthodontic treatment -
Translate, tip and rotate incisors,
reposition molars, rotate mandible -
Growth Forecast
-
Growth simulation on a traced x-ray or
tracing overlaid on photograph -
Superimpose one or more growth
tracings over original tracing
VTO – Visual Treatment Objective
STO – Surgical Treatment Objective
(orthognathic surgery)
Warping and Morphing | Orthodontic treatment
-
Translate, tip and rotate incisors,
reposition molars, auto-rotate mandible -
Arch length discrepancy worksheet
-
CO/CR Conversion Growth Forecast
(Ricketts algorithm) -
Growth simulation on a traced x-ray or
tracing overlaid on photograph -
Superimpose one or more growth
tracings over original tracing
VTO – Visual Treatment Objective
SVTO – Surgical Visual Treatment Objective
(orthognathic surgery)
Warping and Morphing |
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Image /page/8/Picture/0 description: The image shows the logo for Hoxwill. 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 "Hoxwill" in blue, with the letters connected to each other.
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Image /page/9/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 and is slightly slanted to the right.
Non-Clinical Test Summary
WillCeph contains MODERATE level of concern 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]
WillCeph has the similar technical characteristics with the predicate devices are intended for use by specialized dental practices for capturing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthognathic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
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. Therefore, WillCeph is substantially equivalent to legally marketed predicate device with respect to indications for use and technology characteristics.
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 WillCeph is substantially equivalent in safety and effectiveness to the predicate devices as described herein.