EzOrtho

K192888 · Ewoosoft Co., Ltd. · LLZ · Mar 13, 2020 · Radiology

Device Facts

• Record ID: K192888
• Device Name: EzOrtho
• Applicant: Ewoosoft Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Cephalometric landmark detection	—	—	—	—	—	—	—

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.

Device Story

EzOrtho is a 2D orthodontic analysis software for dentists; manages patient records and images; imports images from scanners or other imaging software (e.g., EzDenti). Features include landmark tracing, profilograms, superimposition, and VTO/STO simulation; assists in treatment planning and patient consultation via visual morphing and comparison tools. Operates on standard IBM-compatible PCs; provides diagnostic support; results require interpretation by licensed practitioners. Benefits include streamlined orthodontic workflow, improved patient communication, and automated cephalometric landmark identification to assist clinical decision-making.

Clinical Evidence

Bench testing only. Software verification and validation testing, including measurement accuracy tests, were performed to confirm performance, functionality, and reliability. The device met all pre-determined pass/fail criteria.

Technological Characteristics

Software-only device; no patient contact. Runs on IBM-compatible PC/network; supports Windows 7, 8, 10. Compatible with DICOM, BMP, JPG, PNG, TIF formats. Features include cephalometric tracing, implant simulation, and image measurement (linear/angle). Includes automated cephalometric landmark detection.

Indications for Use

Indicated for use by dentists providing orthodontic treatment for image analysis, simulation, profilogram, VTO/STO, and patient consultation. Results require interpretation by trained/licensed practitioners.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• OrthoVision (K173094)

Reference Devices

• EzDenti (K190087)
• EzDenti (K172364)
• EzDenti (K163533)
• EzDenti (K161117)
• EzDenti (K150747)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Fax: [phone] Contact person: Young Seok Kim Email: [e-mail]

#### 3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine, CA 92620 Tel: [phone] Fax: [phone] Email: [e-mail]

#### 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

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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<br>dentists who provide orthodontic<br>treatment for image analysis, simulation,<br>profilogram, VTO/STO and patient<br>consultation. Results produced by the<br>software's diagnostic, treatment planning<br>and simulation tools are dependent on thepractitioners or dentists. | OtrhoVision software is indicated for use by<br>orthodontists for image analysis, simulation,<br>profilogram, growth forecast, VTO/STO and<br>patient consultation. Results produced by the<br>software's diagnostic, treatment planning<br>and simulation tools are dependent on the<br>interpretation of trained and licensed<br>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<br>digital cameras or card readers, or<br>imported from a radiographic imaging<br>device | Images can be scanned, loaded from digital<br>cameras or card readers, or imported from a<br>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<br>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,<br>contrast, gamma, sharpen, median,<br>despeckle, hue, saturation, equalize flip,<br>mirror, masking, rotate, annotation,<br>cephalometric tracing, implant<br>simulations | Grayscale, invert, emboss, brightness,<br>contrast, gamma, sharpen, median,<br>despeckle, hue, saturation, equalize flip,<br>mirror, masking, rotate, annotation,<br>cephalometric tracing, ceph growth<br>projections, implant simulations |
| Cephalometric<br>tracing | In addition to the user-configured<br>analysis, standard orthodontic tracing<br>analysis include:<br>Downs<br>Jarabek<br>McNamara<br>Ricketts<br>Jefferson | In addition to the user-configured analysis,<br>standard orthodontic tracing analysis<br>include:<br>Downs<br>Jarabek<br>McNamara<br>Ricketts<br>Jefferson |
| Implant module | Generic | Generic |
| 3D imaging<br>capability | None. | None. |
| Image annotation | Text, paint, ellipse, pointer, select, draw,<br>magnify, line, rectangle, ruler, protractor,<br>brush, select region, copy / paste | Text, paint, ellipse, pointer, select, draw,<br>magnify, line, rectangle, polygon, ruler,<br>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.