K Number

Device Name

EzOrtho

Manufacturer

Ewoosoft Co., Ltd

Date Cleared

2021-08-23

(74 days)

Product Code

LLZ

Regulation Number

892.2050

Intended 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 Description

EzOrtho is a 2D orthodontic analysis and simulation 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) 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K202948

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image analysis and simulation tools without mentioning AI or ML. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".

Therapeutic

The device is a software for image analysis, simulation, and planning in orthodontics, which assists dentists but does not directly provide therapy. It is an "analysis" and "simulation" program, and its results are "dependent on the interpretation of trained and licensed practitioners or dentists."

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the software provides "diagnostic, treatment planning and simulation tools," with the results "dependent on the interpretation of trained and licensed practitioners or dentists." This indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "EzOrtho is a 2D orthodontic analysis and simulation program developed by Ewoosoft." and focuses solely on software functionalities like image analysis, simulation, and data management. While it interacts with images from various sources, the device itself is described as the software program.

IVD (In Vitro Diagnostic)

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, digital camera images) of a patient's head and face for orthodontic treatment planning and simulation. It does not analyze biological specimens.
Intended Use: The intended use clearly states it's for image analysis, simulation, and treatment planning based on these images, not for analyzing biological samples.

Therefore, EzOrtho falls under the category of medical imaging software or treatment planning software, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

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, trained and licensed practitioners or dentists.

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.

K202948

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

Regulation Number and Section

§ 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).

Summary

August 23, 2021

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.

Ewoosoft Co., Ltd % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 IRVINE CA 92612

Re: K211793

Trade/Device Name: EzOrtho Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: June 2, 2021 Received: June 10, 2021

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

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 (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 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

Indications for Use

510(k) Number (if known) K211793

Device Name EzOrtho

Indications for Use (Describe)

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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510(k) Summary

(K211793)

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Date: 8/9/2021

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. Device Information:

Trade/Device Name: EzOrtho
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management and Processing System ●
Regulatory Class: Class II
Product Code: LLZ

5. Predicate Device:

Manufacturer: Ewoosoft Co., Ltd. ●
Trade/Device name: EzOrtho
510(k) number: K202948
Regulation number 21 CFR 892.2050 ●
. Regulation name: Picture Archiving and Communications System
Regulatory Class: Class II ●
. Classification Product Code: LLZ

Page 1 of 5

6. Device Description:

7. Indication for use:

8. Substantial Equivalence:

	Modified Device	Unmodified Device
Device name	EzOrtho v1.2	EzOrtho v1.1
510K number	K211793	K202948
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 7, 8, 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

EzOrtho v1.2 described in this 510(k) has the same intended use and the same technical chara cteristics 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 Change, Settings upgrade (EzServer Web Console), adding logout. 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.

9. 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.

10. Performance Data:

The subject device user the following FDA guidance documents used in the development of the device.

. Guidance for the Content of Premarket Submissions for Software Contained in Medical (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-content-premarket-submissions-software-contained-medicaldevices)
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/content-premarket-submissions-management-cybersecurity-medicaldevices)

11. 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.