(142 days)
Not Found
Unknown
The document mentions "anatomical landmark detection support more accurate and easier tracing by enabling the user precisely to adjust the position of the detected landmarks." While landmark detection can be performed using traditional image processing techniques, it is also a common application of AI/ML. Without further information or explicit mention of AI/ML, it's impossible to definitively confirm its use.
No
This device is a software for image analysis, simulation, and treatment planning in orthodontics, not a therapeutic device that directly treats or provides therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists," directly indicating the presence of diagnostic tools within the software.
Yes
The device description explicitly states "WebCeph is a 2D orthodontic analysis program" and describes its functions as software-based image processing, analysis, and management. There is no mention of accompanying hardware components required for its primary function as a medical device. The performance studies focus on software verification and validation.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Web Ceph's Function: Web Ceph is a software that analyzes medical images (X-ray, CT) and patient information for orthodontic treatment planning and simulation. It works with images of the patient's anatomy, not with specimens taken from the patient's body.
- Intended Use: The intended use clearly states it's for image analysis, simulation, and treatment planning by dentists. It doesn't mention analyzing biological samples.
- Device Description: The description focuses on image processing, landmark detection, simulation, and reporting based on images. There is no mention of handling or analyzing biological specimens.
Therefore, Web Ceph falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Web Ceph is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO (Visual Treatment Objective) and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for the use of patients above 7 years old.
Product codes
LLZ
Device Description
WebCeph is a 2D orthodontic analysis program. It manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualized treatment objective) and STO (surgical treatment objective). The analyzed results are saved in chart format so that the users can easily store and track the treatment and records of each patient. This device is designed to provide a simple and straightforward user interface.
WebCeph is used for registering orthodontic medical images and managing the patient information through the features of making schedules and managing patient appointments. This software receives image files (JPG, BMP, PNG) as input source and enables the users to easily calibrate the size of the image or arrange multiple film/photo images.
The feature of anatomical landmark detection support more accurate and easier tracing by enabling the user precisely to adjust the position of the detected landmarks.
After image alignment, orthodontic treatment simulation and Maxillo-facial surgical planning simulation can be performed. The Morphing feature enables the dentist user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the dentist user to establish a treatment plan by comparing photos before and after the treatment.
Cephalometric analysis results are provided as a report. The report can be saved in PDF file or Excel file format. For the evaluation of treatment progress, the software automatically superimposes the lateral cephalographic image.
This software provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays the changes visually due to the treatment and the Gallery feature plays a slide show with multiple images of patients.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, or CT
Anatomical Site
Dental, Maxilla, Mandible
Indicated Patient Age Range
above 7 years old.
Intended User / Care Setting
dentists who provide orthodontic treatment
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)
SW verification/validation and the measurement accuracy test were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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August 17, 2022
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: on the left, there is the Department of Health & Human Services logo, and on the right, there is the FDA logo. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AssembleCircle Corp. % Edward Park CEO LightenBridge LLC 4408 Tortuga Ln MCKINNEY TX 75070
Re: K220903
Trade/Device Name: WebCeph Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 9, 2022 Received: August 9, 2022
Dear Edward Park:
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
1
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) 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 medical devices and radiation-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 DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K220903
Device Name WebCeph
Indications for Use (Describe)
Web Ceph is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO (Visual Treatment Objective) and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for the use of patients above 7 years old.
| 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 Assemble Circle. The logo consists of a colorful circle made up of four different colored sections, followed by the text "assemblecircle" in a sans-serif font. The colors in the circle are yellow, green, red, and blue.
510(k) Summary - Traditional 510(k) K220903
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| Submitter Information | |
|---|---|
| Submitter Name: | AssembleCircle Corp. |
| Address: | R02-ho, 8th floor, 12, Daewangpangyo-ro 645beon-gil, Bundang-gu |
| Seongnam-si, Gyeonggi-do 13487 Republic of Korea | |
| Phone/Fax | +82-31-697-0433 / +82-31-776-4688 |
| Contact Person: | Edward Park, official correspondent of AssembleCircle Corp. |
| Date of submission: | Mar 23, 2022 |
| Device Information | |
| Proprietary Name(s): | WebCeph |
| Common Name: | Medical Imaging Software |
| Classification Name: | Medical image management and processing system per 21 CFR |
| 892.2050 | |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | II |
Device Description
WebCeph is a 2D orthodontic analysis program. It manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualized treatment objective) and STO (surgical treatment objective). The analyzed results are saved in chart format so that the users can easily store and track the treatment and records of each patient. This device is designed to provide a simple and straightforward user interface.
WebCeph is used for registering orthodontic medical images and managing the patient information through the features of making schedules and managing patient appointments. This software receives image files (JPG, BMP, PNG) as input source and enables the users to easily calibrate the size of the image or arrange multiple film/photo images.
4
Image /page/4/Picture/0 description: The image shows the logo for Assemble Circle. The logo consists of a colorful circle made up of four different colored sections: yellow, green, red, and blue. To the right of the circle is the text "assemblecircle" in a sans-serif font.
The feature of anatomical landmark detection support more accurate and easier tracing by enabling the user precisely to adjust the position of the detected landmarks.
After image alignment, orthodontic treatment simulation and Maxillo-facial surgical planning simulation can be performed. The Morphing feature enables the dentist user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the dentist user to establish a treatment plan by comparing photos before and after the treatment.
Cephalometric analysis results are provided as a report. The report can be saved in PDF file or Excel file format. For the evaluation of treatment progress, the software automatically superimposes the lateral cephalographic image.
This software provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays the changes visually due to the treatment and the Gallery feature plays a slide show with multiple images of patients.
Predicate Device
- EzOrtho (Ewoosoft Co., Ltd. K192888, 03/13/2020) ● CFR 892.2050, Medical image management and processing system (Product Code: LLZ)
Indications for Use
WebCeph is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO (Visual Treatment Objective) and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for the use of patients above 7 years old.
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Image /page/5/Picture/0 description: The image shows the logo for Assemble Circle. The logo consists of a colorful circular icon to the left of the text "assemblecircle". The icon is made up of four different colored sections: light green, yellow, red, and blue. The text is in a sans-serif font and is black.
AssembleCircle Corp. R02-ho, 8th floor, 12, Daewangpangyo-ro 645beon-gil, Bundang-gu Seongnam-si, Gyeonggi-do 13487 Republic of Korea Tel. +82-31-697-0433 / Fax. +82-31-776-4688
Device Comparison Table on Features and Functions
| Device Name | WebCeph | EzOrtho |
|---|---|---|
| 510k number | K192888 | |
| Manufacturer | AssembleCircle Corp. | Ewoosoft Co., Ltd. |
| Indications | ||
| for Use | WebCeph is a software indicated for use | |
| by dentists who provide orthodontic | ||
| treatment for image analysis, simulation, | ||
| profilogram, VTO/STO (Visual Treatment | ||
| Objective) and patient consultation. | ||
| Results produced by the software's | ||
| diagnostic, treatment planning and | ||
| simulation tools are dependent on the | ||
| interpretation of trained and licensed | ||
| practitioners or dentists. The device is only | ||
| for the use of patients above 7 years old. | EzOrtho is a software indicated for use by | |
| dentists who provide orthodontic | ||
| treatment for image analysis, simulation, | ||
| profilogram, VTO/STO (Skull Growth | ||
| and Visual Treatment Objective) and | ||
| patient consultation. Results produced by | ||
| the software's diagnostic, treatment | ||
| planning and simulation tools are | ||
| dependent on the interpretation of trained | ||
| and licensed practitioners or dentists. | ||
| Platform | IBM-compatible PC or PC network | IBM-compatible PC or PC network |
| Operating | ||
| System | Microsoft Window 7, 8, 10 | Microsoft Window 7, 8, 10 |
| User Interface | Mouse, Keyboard | Mouse, Keyboard |
| CPU processor | ||
| type | x64-based processor or higher | x32 / x64 - based processor |
| Image | ||
| Communication | ||
| Standard | BMP, JPG, PNG | DICOM BMP, JPG, PNG, TIF |
| Modality | ||
| Support | X-ray, or CT | X-ray, or CT |
| Component | Client (Internet Browser) | Client or Standalone software |
| Database | ||
| Compatibility | PostgreSQL | MS SQL |
| Image | ||
| Measurement | ||
| tools | Linear distance, angle | Linear distance, angle |
| Image viewing | Full, side by side, thumbnail, Zoom | |
| in / out, template | Full, side by side, thumbnail, Zoom | |
| in / out | ||
| Image | ||
| manipulation | Brightness, contrast, flip, rotate, | |
| annotation, cephalometric tracing | Brightness, contrast, equalize flip, | |
| rotate, annotation, cephalometric | ||
| tracing, grayscale, invert, emboss | ||
| Device Name | WebCeph | EzOrtho |
| 510k number | K192888 | |
| Manufacturer | AssembleCircle Corp. | Ewoosoft Co., Ltd. |
| gamma, sharpen, median, despeckle, | ||
| hue, saturation, mirror, masking, | ||
| implant simulations | ||
| Cephalometric | ||
| tracing | In addition to the user-configured | |
| analysis, standard orthodontic tracing | ||
| analysis include: | ||
| Downs, Steiner, Jarabek, McNamara, | ||
| Ricketts, Eastman, Kim, Wits | In addition to the user-configured | |
| analysis, standard orthodontic | ||
| tracing analysis include: | ||
| Downs, Jarabek, McNamara, | ||
| Ricketts, Jefferson | ||
| Implant module | None | Generic |
| 3D imaging | ||
| capability | None | None |
| Image | ||
| annotation | Paint, draw, magnify, line drawing, | |
| distance measure (px or mm), 3-point | ||
| angle, ruler(calibrate), select region | ||
| crop | Text, paint, draw, magnify, line | |
| drawing, distance measure (px or | ||
| mm), ruler, select region, ellipse, | ||
| pointer, rectangle, protractor, brush, | ||
| copy / paste | ||
| Treatment | ||
| Planning, | ||
| Simulation and | ||
| follow up | - Translate, tip and rotate incisors, | |
| reposition molars, rotate mandible |
- Superimpose one or more growth
tracings over original tracing - Treatment result prediction
simulation on a traced x-ray or
tracing overlaid on photograph
VTO – Visual Treatment Objective
STO - Surgical Treatment Objective
(Orthognathic surgery)
Warping and Morphing | - Translate, tip and rotate incisors,
reposition molars, rotate mandible - Superimpose one or more growth
tracings over original tracing - Growth Forecast
- Growth simulation on a traced x-
ray or tracing overlaid on
photograph
VTO – Visual Treatment Objective
STO - Surgical Treatment Objective
(Orthognathic surgery)
Warping and Morphing |
| Supported Area | Dental, Maxilla, Mandible | Dental, Maxilla, Mandible |
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Image /page/6/Picture/0 description: The image contains the logo for Assemble Circle. The logo consists of a colorful circle made up of four different colored sections. To the right of the circle is the text "assemblecircle" in a sans-serif font.
AssembleCircle Corp. R02-ho, 8th floor, 12, Daewangpangyo-ro 645beon-gil, Bundang-gu Seongnam-si, Gyeonggi-do 13487 Republic of Korea Tel. +82-31-697-0433 / Fax. +82-31-776-4688
All the indications for use of the subject device are within those of the predicate device. The only difference in Indications for Use is that the EzOrtho (K192888) includes skull growth, but
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Image /page/7/Picture/0 description: The image shows the logo for Assemble Circle. The logo consists of a colorful circle made up of four different colored sections, followed by the text "assemblecircle" in a sans-serif font. The colors in the circle are yellow, green, red, and blue.
AssembleCircle Corp. R02-ho, 8th floor, 12, Daewangpangyo-ro 645beon-gil, Bundang-gu Seongnam-si, Gyeonggi-do 13487 Republic of Korea Tel. +82-31-697-0433 / Fax. +82-31-776-4688
WebCeph does not. Therefore, the subject device does not have such functions, but the following growth forecast, simulation, or tracing features are available only on the predicate device as treatment planning, simulation, and follow up. For cephalometric tracing, additional standard analysis methods - Steiner, Eastman, Kim, and Wits- are available on the subject device. All the other technical characteristics are identical or similar to each other, because all the other technical characteristics of WebCeph are within the range of the EzOrtho's.
Based on the results of software validation and performance tests, we conclude that the subject device is as safe and effective as the predicate device, and all the features and functions of subject device are substantially equivalent to the predicate device.
Technological Characteristics
WebCeph is a software device that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software's diagnostic, treatment planning tools are dependent on the interpretation of trained and licensed dentists.
Performance Data
SW verification/validation and the measurement accuracy test were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Conclusion
The subject device is substantially equivalent in the areas of technical characteristics, general function, application, and indications for use. The new device does not introduce a fundamentally new scientific technology, and the device has been validated through system level test. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.