(23 days)
Not Found
No
The summary describes standard 3D visualization and analysis tools for dental imaging, with no mention of AI or ML capabilities. The functions listed are typical for dental imaging software and do not inherently require AI/ML.
No
The device is described as diagnostic imaging software for viewing and analyzing dental radiology images, and assisting with treatment planning, but it does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that Ez3D-i is "dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging." It also mentions its use for "prompt and accurate diagnosis dental CT images."
Yes
The device description explicitly states "Ez3D-i is 3D viewing software" and the intended use describes it as "dental imaging software". There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Ez3D-i is "dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging." It is used to "view and interpret a series of DICOM compliant dental radiology images." This describes software for processing and visualizing medical images, not for performing tests on biological samples.
- Device Description: The description details functions related to image processing, 3D visualization, analysis, and simulation based on radiographic images. There is no mention of analyzing biological samples or performing in vitro tests.
- Input: The input is described as "DICOM images from CT, panorama, cephalometric and intraoral imaging equipment," which are medical imaging modalities, not biological samples.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. Ez3D-i operates on medical images, not biological specimens.
N/A
Intended Use / Indications for Use
Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Ez3D-i is 3D viewing software for prompt and accurate diagnosis dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3 dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc for the benefit of effective doctor and patient communication and precise treatment planning. Ez3D-i is a useful tool for an easier diagnosis and analysis by processing a 3D image with simple and convenient user interface. Ez3D-i's main functions are;
- Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP
- Versatile 3D image viewing via MPR Rotating, Curve mode
- "Sculpt" for deleting unnecessary parts to view only the region of interest.
- Implant Simulation for efficient treatment planning and effective patient consultation
- Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
- "Bone Density" test to measure bone density around the site of an implant(s)
- Various utilities such as Measurement, Annotation, Gallery, and Report
- 3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation.
- Provides the Axial View of TMJ, the Condyle/Fossa images in 3D and the Section images, and supports functions to separate the Condyle/Fossa and display the bone density
- STO/VTO Simulation to predict orthodontic treatment/ surgery results with 3D Photo image.
- Segmentation function to get tooth segmentation data from CT, label each segmented tooth data as an object and utilize them in simulation such as tooth extraction, implant simulation, etc.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, panorama, cephalometric and intraoral imaging equipment.
Anatomical Site
maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals such as radiologist and dentist.
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)
Verification, validation and testing activities 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): 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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Indications for Use
510(k) Number (if known)
K190791
Device Name Ez3D-i /E3
Indications for Use (Describe)
Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
| 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)
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510(k) Summary
(K190791)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 04/18/2019
2. Applicant / Submitter
Ewoosoft Co., Ltd. 801-ho. Vatechnetworks Bldg.. 13. Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggido , Republic of Korea Tel: +82 31 8015 6172 Fax: +82 31 8015 6196 Contact person: Young Seok Kim Email: eddie.kim@ewoosoft.com
3. U.S. Designated Agent
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine CA 92620 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com
4. Trade/Proprietary Name:
Ez3D-i / E3
5. Common Name:
Dental Imaging Software
6. Classification:
- Regulation number: 21 CFR 892.2050
- Regulation name: Picture archiving and communications system
- Regulatory class: II ●
- . Product code: LLZ
7. Device Description:
Ez3D-i is 3D viewing software for prompt and accurate diagnosis dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3
2
dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc for the benefit of effective doctor and patient communication and precise treatment planning. Ez3D-i is a useful tool for an easier diagnosis and analysis by processing a 3D image with simple and convenient user interface. Ez3D-i's main functions are;
- · Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP
- · Versatile 3D image viewing via MPR Rotating, Curve mode
- · "Sculpt" for deleting unnecessary parts to view only the region of interest.
- · Implant Simulation for efficient treatment planning and effective patient consultation
- · Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
- · "Bone Density" test to measure bone density around the site of an implant(s)
- · Various utilities such as Measurement, Annotation, Gallery, and Report
- · 3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation.
- . Provides the Axial View of TMJ, the Condyle/Fossa images in 3D and the Section images, and supports functions to separate the Condyle/Fossa and display the bone density
- · STO/VTO Simulation to predict orthodontic treatment/ surgery results with 3D Photo image.
- · Segmentation function to get tooth segmentation data from CT, label each segmented tooth data as an object and utilize them in simulation such as tooth extraction, implant simulation, etc.
8. Indication for use:
Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
Ez3D-i is intended for use as software to load. view and save DICOM images from CT. panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
9. Predicate Device:
- Ez3D-i /E3 (K173863) by Ewoosoft Co., Ltd.
- Regulation number: 21 CFR 892.2050
- Regulation name: Picture archiving and communications system
- Regulatory class: II
- Product code: LLZ
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10. Substantial Equivalence:
Ez3D-i described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device (K173863, Ez3D-i /E3).
The subject device and the predicate devices are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, 3D image construction, image edit, measurements and manipulation.
The differences are that the subject device has additional features such as Privacy Policy and Help Document on the program and also the SEGMENT and REPORT Tabs have been upgraded. The Privacy Policy has been added to the Settings tab of the subject device which the predicate device doesn't have. The Help Document which is the same as the User Manual is now can be viewed on the program of the subject device. The predicate device doesn't have this feature either. For the SEGMENT tab, Quick Segmentation function has been separated into Teeth Segmentation and Bone Segmentation so that the user can segment teeth data only. The Manual segmentation function with various features has been added to this tab as well. This manual segmentation tab provides a range of drawing tools that allow users to adjust the image to show the patient the results of any dental work. It is only intended as a visual aid for the patient. Lastly, the Report tab format has been upgrade for user convenience.
These differences are not significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the test results submitted in this 510K, we conclude that the subject device is substantially equivalent to the predicate devices.
11. Technological Characteristics:
Ez3D-i 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 and simulation tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis.
12. Performance Data:
Verification, validation and testing activities 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.
We have referenced the following standard and FDA guidance when developing and validating the subject device.
- ISO 14971:2012, Application of risk management to medical devices. ●
- ISO 13485 : 2016, Quality Management Systems-Medical Devices-System Requirements .
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for Regulatory Purposes
- IEEE Std 1012-1986, Standard for Software Verification and Validation Plans ●
- IEEE Std 829-1983, Standard for Software Test Documentation
- IEC 62304 : Medical device software - Software life-cycle processes
- FDA Guidance for General Principles of Software Validation
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- FDA Guidance for Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
- FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
13. Conclusion:
The new device and the predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is safe and effective. Therefore, it is our opinion that the Ez3D-i described in this submission is substantially equivalent to the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
April 19, 2019
EwooSoft Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K190791
Trade/Device Name: Ez3D-i/E3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: March 19, 2019 Received: March 27, 2019
Dear Priscilla Chung:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure