Ez3D-i/E3

• K Number: K222069
• Device Name: Ez3D-i/E3
• Manufacturer: Ewoosoft Co., Ltd
• Date Cleared: 2022-09-06 ( 54 days)
• Product Code: LLZ
• Regulation Number: 892.2050

Intended 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.

Device Description

Ez3D-i is 3D viewing software for dental CT images from CT, panorama, cephalometric and intraoral image equipment 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'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.

Predicate Devices

K211791

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard medical imaging software functionalities and does not mention AI or ML.

Therapeutic

No
The device is described as dental imaging software intended for diagnostic tools, viewing, and analysis of medical images, and to assist with treatment planning. It does not perform any therapeutic or treatment function.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that Ez3D-i is "intended to provide diagnostic tools for maxillofacial radiographic imaging" and is used by trained medical professionals to "view and interpret a series of DICOM compliant dental radiology images."

SaMD (Software as a Medical Device)

Yes

The device is described as "dental imaging software" and its functions are entirely related to processing, viewing, and analyzing digital images (DICOM format) from various imaging modalities. There is no mention of any accompanying hardware component that is part of the medical device itself. The performance studies focus on software verification/validation and measurement accuracy, further supporting its software-only nature.

IVD (In Vitro Diagnostic)

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 for providing diagnostic tools for maxillofacial radiographic imaging. It is used to view and interpret images from various dental imaging equipment.
• Device Description: The description focuses on software for viewing, analyzing, and simulating based on these images. It describes functions like MPR, 3D visualization, implant simulation, and bone density measurement, all of which are performed on the acquired images.
• No mention of biological samples: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue, etc.) to provide information for diagnosis. There is no mention of Ez3D-i interacting with or analyzing any biological samples.

The device is a medical imaging software used for the interpretation and analysis of medical images, which falls under a different regulatory category than IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 dental CT images from CT, panorama, cephalometric and intraoral image equipment 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'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)

Ez3D-i has been tested according to IEC 62304 and ISO 14971. The 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.

K211791

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

0

September 6, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

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

Re: K222069

Trade/Device Name: Ez3D-i/E3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 27, 2022 Received: July 14, 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K222069

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary

(K222069)

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

1. Date: 8/1/2022

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. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: [phone] Tel: [phone] Email: [e-mail]

4. Device Information:

• Trade/Device Name: Ez3D-i /E3
• 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: Ez3D-i /E3 v.5.3
• 510(k) number: K211791
• Regulation number 21 CFR 892.2050 ●
• . Regulation name: Picture Archiving and Communications System
• Regulatory Class: Class II ●
• Classification Product Code: LLZ

4

6. Device Description:

Ez3D-i is 3D viewing software for dental CT images from CT, panorama, cephalometric and intraoral image equipment 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'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.

7. 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.

5

8. Substantial Equivalence:

	Subject Device	Predicate Device
Device Name	Ez3D-i v5.4(E3)	Ez3D-i v5.3(E3)
510K number	K222069	K211791
Manufacturer	Ewoosoft	Ewoosoft
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 | 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 |
| Platform | IBM-compatible PC or PC network | IBM-compatible PC or PC network |
| Operating System | Microsoft Window 10 or higher | 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 / 64 bit | 32 / 64 bit | 32 / 64 bit |
| Image format | DICOM | DICOM |
| Image
Measurement
Tools | Length, Multi Length, Angle, Multi
Angle, Circle, ROI/Area, Volume,
Profile | Length, Multi Length, Angle,
ROI/Area, Volume, Profile |
| Image viewing | Full, side by side, gallery, 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, magnify,
annotation, cephalometric tracing, ceph
growth projections, implant simulations | Grayscale, invert, emboss, brightness,
contrast, gamma, sharpen, median,
despeckle, hue, saturation, equalize,
flip, mirror, masking, rotate, magnify,
annotation, cephalometric tracing, ceph
growth projections, implant simulations |
| 3D imaging
capability | Ez3D-i can view, transfer and process
3D radiographs. Furthermore, it supports
Smart Click, Smart Clipping, Implant
Simulation and Canal Draw. | Ez3D-i can view, transfer and process
3D radiographs. Furthermore, it
supports Smart Click, Smart Clipping,
Implant Simulation and Canal Draw. |
| Image annotation | Text, paint, ellipse, pointer, select, draw,
magnify, line, rectangle, polygon, ruler,
protractor, smile library, smudge, brush, | Text, paint, ellipse, pointer, select,
draw, magnify, line, rectangle, polygon,
ruler, protractor, smile library, smudge, |
| redeye reduction, select region, copy /
paste | brush, redeye reduction, select region,
copy / paste | |

8.1. Comparison chart of features and specifications

6

8.2. Substantial Equivalence Discussion

Ez3D-i described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device (K211791, 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 modifications are changes in PC system requirement information, upgrading Main Button (Exporting Recon Ceph Image to the Server), upgrading the Settings tab (windowing filter, curvature, curve), upgrading the MPR Tab (Region Capture), upgrading the SECTION Tab (Switching L/B direction), upgrading the ENDO Tab (Sculpting Selected Region).

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.

9. 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.

10. Performance Data:

Ez3D-i has been tested according to IEC 62304 and ISO 14971. The 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.

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.