(155 days)
No
The description focuses on standard image analysis, tracing, and comparison tools, with no mention of AI or ML algorithms for diagnosis, prediction, or automated analysis beyond basic image processing.
No.
EzOrtho is a software that provides image analysis, simulation, and treatment planning tools for orthodontic treatment, but it does not directly treat or cure any condition. Its output is dependent on interpretation by a trained practitioner.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software includes "diagnostic" tools, and its results are dependent on the interpretation of trained practitioners.
Yes
The device description explicitly states "EzOrtho is a 2D orthodontic analysis program developed by Ewoosoft" and details its functions as software features for image management, analysis, treatment planning, and consultation. There is no mention of accompanying hardware components included with the device itself.
Based on the provided information, EzOrtho is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EzOrtho's Function: EzOrtho analyzes and processes images (radiographs, photos) of a patient's head and face. It uses these images for orthodontic analysis, treatment planning, and simulation. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for image analysis, simulation, profilogram, VTO/STO, and patient consultation by dentists. These are all related to visual and structural analysis, not the analysis of biological samples.
Therefore, EzOrtho falls under the category of medical image analysis software, 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 program developed by Ewoosoft. 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). The analyzed results are saved in chart format so that you can easily store and track the treatment and records of each patient.
EzOrtho is designed to provide a simple and straightforward user interface.
- Managing Patients and Registering Images EzOrtho offers powerful features related to making schedules and managing patient appointments. In addition, EzOrtho enables you to import images from EzDenti(K190087, K172364, K163533, K161117, K150747), Explorer, or a scanner and easily calibrate the size of the image or arrange multiple film/photo images.
- . Analyzing and Tracing Images The Landmark Voice Guide and the improved Landmark Input Interface support more accurate and easier tracing.
- . Establishing Treatment Plans The Morphing feature enables you to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables you to establish a treatment plan by comparing photos before and after the treatment.
- . Assisting with Patient Consultation EzOrtho 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
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 / Not Found.
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): 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.
K190087, K172364, K163533, K161117, K150747
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 13, 2020
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EWOO SOFT Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 IRVINE CA 92620
Re: K192888
Trade/Device Name: EzOrtho Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 5, 2020 Received: February 11, 2020
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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) K192888
Device Name EzOrtho
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) Summarv
(K192888)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 2/5/2020
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 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com
4. Trade/Proprietary Name:
EzOrtho
5. Common Name:
Dental Imaging Software
6. Classification:
System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
7. Device Description:
EzOrtho is a 2D orthodontic analysis program developed by Ewoosoft. 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). The analyzed results are saved in chart format so that you can easily store and track the treatment
Page 1 of 4
4
and records of each patient.
EzOrtho is designed to provide a simple and straightforward user interface.
- Managing Patients and Registering Images EzOrtho offers powerful features related to making schedules and managing patient appointments. In addition, EzOrtho enables you to import images from EzDenti(K190087, K172364, K163533, K161117, K150747), Explorer, or a scanner and easily calibrate the size of the image or arrange multiple film/photo images.
- . Analyzing and Tracing Images The Landmark Voice Guide and the improved Landmark Input Interface support more accurate and easier tracing.
- . Establishing Treatment Plans The Morphing feature enables you to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables you to establish a treatment plan by comparing photos before and after the treatment.
- . Assisting with Patient Consultation EzOrtho 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.
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: OrthoVision ●
- 510(k) Number: K173094
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10. Substantial Equivalence:
| Device name | EzOrtho v1.0 | OrthoVision v2.1 |
|---|---|---|
| 510K number | K192888 | K173094 |
| 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 thepractitioners or dentists. | OtrhoVision software is indicated for use by | |
| orthodontists for image analysis, simulation, | ||
| profilogram, growth forecast, 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 7, 8, 10 | Microsoft Window 7, Window 8 |
| 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 | SQL | SQL |
| Compatibility | ||
| Includes Image | ||
| Measurement tools | Linear distance, angle | Linear distance, angle |
| Image viewing | Full, side by side, thumbnail | Full, side by side, gallery, 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, ceph growth | ||
| projections, 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, polygon, ruler, | ||
| protractor, smile library, smudge, brush, |
The EzOrtho v1.0 described in this 510(k) has the same indications for use and the same technical characteristics as the OrthoVision v2.1(K173094).
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The EzOrtho v1.0 are substantially equivalent to the predicate device, 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 difference between the subject device and the predicate device is the UVUX design, and also some of the additional functions have been removed from the subject device such as gallery, ceph growth projections, and some of the annotation features. It has been found that these functions and features are not really used by users so we decided to remove them to improve usability for ease of use. We believe this difference does not raise a question in substantial equivalence, because these features are merely additional and does not affect the device to achieve the intended use. The other difference is that an automatic cephalometric tracing feature is added to the subject device. With this function, the SW automatically input the cephalometric landmarks for user convenience. The users can still adjust the points manually when necessary. We performed the validation test to evaluate the accuracy of this auto feature.
Based on the results of software validation and performance tests, 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 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.