(50 days)
Not Found
No
The summary describes standard image analysis and simulation tools without mentioning AI or ML capabilities.
No
EzOrtho is a software for image analysis, simulation, and treatment planning in orthodontics. While it assists dentists in orthodontic treatment, it does not directly provide therapy or interact physically with the patient. It is a diagnostic and planning tool, not a therapeutic device.
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 mentioning "diagnostic" tools.
Yes
The device description explicitly states "EzOrtho is a 2D orthodontic analysis and simulation program developed by Ewoosoft. It is of Moderate level of concern. EzOrtho manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualised treatment objective) and STO (surgical treatment objective) simulations." This clearly defines the device as a software program. While it processes images from various sources, the device itself is the software. The performance studies mention "SW verification/validation," further supporting its software nature.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- EzOrtho's Function: EzOrtho is a software that analyzes and simulates orthodontic treatment based on images (likely radiographic images of the head and face). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for image analysis, simulation, and treatment planning for orthodontic purposes. This is a diagnostic and planning tool based on imaging, not an in vitro test.
Therefore, EzOrtho falls under the category of a medical device, but specifically one used for image analysis and treatment planning, not an IVD.
N/A
Intended Use / Indications for Use
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
EzOrtho is a 2D orthodontic analysis and simulation program developed by Ewoosoft. It is of Moderate level of concern.
EzOrtho manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualised treatment objective) and STO (surgical treatment objective) simulations. The analyzed results are saved in chart format so that the user can easily store and track the treatment and records of each patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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.)
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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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February 23, 2022
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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ewoosoft Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 IRVINE CA 92612
Re: K220003
Trade/Device Name: EzOrtho v1.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: December 27, 2021 Received: January 4, 2022
Dear Ms. 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 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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) K220003
Device Name EzOrtho v1.3
Indications for Use (Describe)
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO 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.
| 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
(K220003)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: Jan 20, 2022
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. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com
4. Trade/Proprietary Name:
EzOrtho v1.3
5. Common Name:
Dental Imaging Software
6. Classification:
Medical Image Management and Processing System (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
7. Device Description:
EzOrtho is a 2D orthodontic analysis and simulation program developed by Ewoosoft. It is of Moderate level of concern.
EzOrtho manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms,
4
superimpositions, and VTO (visualised treatment objective) and STO (surgical treatment objective) simulations. The analyzed results are saved in chart format so that the user can easily store and track the treatment and records of each patient.
8. Indication for use:
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO 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.
9. Predicate Device:
- Manufacturer: Ewoosoft Co., Ltd.
- Device: ● EzOrtho v1.2
- Classification: Medical Image Management and Processing System (21CFR 892.2050, ● Product code LLZ, Class 2, Radiology)
- 510(k) Number: K211793 .
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10. Substantial Equivalence:
| Modified Device | Unmodified Device | |
|---|---|---|
| Device name | EzOrtho v1.3 | EzOrtho v1.2 |
| 510K number | K220003 | K211793 |
| Manufacturer | Ewoosoft | Ewoosoft |
| Indications for | ||
| use | EzOrtho is a software indicated for use by | |
| dentists who provide orthodontic treatment | ||
| for image analysis, simulation, profilogram, | ||
| VTO/STO 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. | EzOrtho is a software indicated for use by | |
| dentists who provide orthodontic treatment | ||
| for image analysis, simulation, profilogram, | ||
| VTO/STO 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 10 | Microsoft Window 10 |
| User Interface | Mouse, Keyboard | Mouse, Keyboard |
| Image Input | ||
| Sources | Images can be scanned, loaded from digital | |
| cameras or card readers, or imported from a | ||
| radiographic imaging device | Images can be scanned, loaded from digital | |
| cameras or card readers, or imported from a | ||
| radiographic imaging device | ||
| 32 bit / 62 bit | 32 bit / 62 bit | 32 bit / 62 bit |
| Image format | DICOM, BMP, JPG, PNG, TIF | DICOM, BMP, JPG, PNG, TIF |
| Patient Database | ||
| Compatibility | SQL | SQL |
| Includes Image | ||
| Measurement | ||
| tools | Linear distance, angle | Linear distance, angle |
| Image viewing | Full, side by side, thumbnail | Full, side by side, thumbnail |
| Image | ||
| manipulation | Grayscale, invert, emboss, brightness, | |
| contrast, gamma, sharpen, median, | ||
| despeckle, hue, saturation, equalize flip, | ||
| mirror, masking, rotate, annotation, | ||
| cephalometric tracing, implant simulations | Grayscale, invert, emboss, brightness, | |
| contrast, gamma, sharpen, median, | ||
| despeckle, hue, saturation, equalize flip, | ||
| mirror, masking, rotate, annotation, | ||
| cephalometric tracing, implant simulations | ||
| Cephalometric | ||
| tracing | In addition to the user-configured analysis, | |
| standard orthodontic tracing analysis | ||
| include: | ||
| Downs | ||
| Jarabek | ||
| McNamara | ||
| Ricketts | ||
| Jefferson | In addition to the user-configured analysis, | |
| standard orthodontic tracing analysis | ||
| include: | ||
| Downs | ||
| Jarabek | ||
| McNamara | ||
| Ricketts | ||
| Jefferson | ||
| Implant module | Generic | Generic |
| 3D imaging | ||
| capability | None. | None. |
| Image annotation | Text, paint, ellipse, pointer, select, draw, | |
| magnify, line, rectangle, ruler, protractor, | ||
| brush, select region, copy / paste | Text, paint, ellipse, pointer, select, draw, | |
| magnify, line, rectangle, ruler, protractor, | ||
| brush, select region, copy / paste |
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EzOrtho v1.3 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device.
The subject device and the unmodified device 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, image edit, measurements and manipulation.
The modifications are changes in PC system requirement information, upgrading the SETTINGS tab (font size change option for analysis chart), upgrading the PATIENT Tab (reset to original DICOM pixel spacing), upgrading the VIEWER Tab (change layouts in presentation mode), upgrading the ANALYSIS Tab (exporting analysis chart), upgrading the PRACTICE Tab (UI upgrade and recurrence option).These differences are not significant since they are additional features for user convenience and do not raise the 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 device.
11. Technological Characteristics:
EzOrtho 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:
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.
13. 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.