(22 days)
No
The summary describes standard image processing and management features for dental radiography, with no mention of AI or ML technologies.
No
The device is described as dental imaging software intended to provide diagnostic tools and management for medical images, not to provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging." and "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." This unequivocally positions the device as a diagnostic tool.
Yes
The device description explicitly states "EzDent-i is a patient & image management software" and details its functions related to acquiring, transferring, editing, displaying, storing, and processing medical images, all of which are software-based activities. While it interfaces with hardware for image acquisition, the device itself is described as software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- EzDent-i's Function: EzDent-i is software designed to acquire, view, process, and manage medical images (radiographs) of the maxillofacial region. It works with imaging equipment, not biological samples.
- Intended Use: The intended use clearly states it's for providing diagnostic tools for maxillofacial radiographic imaging. This involves interpreting images, not analyzing biological specimens.
The device description and intended use consistently point to it being a medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EzDent-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.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.
EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616 & K150761 & K163533 & K173863 & K190791) but the EzDent-i itself does not view, transfer or process 3D radiographs.
EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor images by interfacing with X-ray capture software.
EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;
- Easy and convenient data search function for patient information and clinical images
- Various image viewing format for 2D dental images
- Various image processing functions including adjustment of brightness and contrast for images
- Measurement function of length and angle for 2D images
- Dental implant simulation for treatment planning and effective patient consultation
- Crown simulation for more effective patient consultation
- Print function supporting various viewing output format
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
panorama, cephalometric, and intra-oral imaging equipment, dental CT Images, intra-oral camera images, CT/Panoramic/Cephalo/Intra-Oral Sensor images.
Anatomical Site
maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals such as radiologist and dentist; clinicians and referring physicians.
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)
Verification, validation and testing activities 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.
K131616, K150761, K163533, K173863, K190791
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).
0
August 21, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Ewoo soft Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 IRVINE CA 92620
Re: K202116
Trade/Device Name: EzDent-i/ E2/ Prora View/ Smart M Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 27, 2020 Received: July 30, 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)
K202116
Device Name EzDent-i / E2 / Prora View / Smart M Viewer
Indications for Use (Describe)
EzDent-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.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
| 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
(K202116)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 08/17/2020
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 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com
4. Trade/Proprietary Name:
EzDent-i / E2 / Prora View / Smart M Viewer
5. Common Name:
Dental Imaging Software
6. Classification:
System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
7. Device Description:
EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides
4
server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.
EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616 & K150761 & K163533 & K173863 & K190791) but the EzDent-i itself does not view, transfer or process 3D radiographs.
EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor images by interfacing with X-ray capture software.
EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;
- · Easy and convenient data search function for patient information and clinical images
- · Various image viewing format for 2D dental images
- Various image processing functions including adjustment of brightness and contrast for images
- · Measurement function of length and angle for 2D images
- · Dental implant simulation for treatment planning and effective patient consultation
- · Crown simulation for more effective patient consultation
- · Print function supporting various viewing output format
8. Indication for use:
EzDent-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.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
9. Predicate Device:
- Manufacturer: Ewoosoft Co., Ltd.
- Device: EzDent-i / E2 / ProraView
- . 510(k) Number: K190087
10. Substantial Equivalence:
EzDent-i v3.1 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device.
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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 adding device name, changing the graphic design of the desktop icon and the start screen, upgrading the Settings (password policy and software link), and upgrading the PATIENT Tab (export icon and export patient information). 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:
EzDent-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.
12. Performance Data:
Verification, validation and testing activities 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 new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the modifications are validated through system level test. Therefore, it is our opinion that the EzDent-i described in this submission is substantially equivalent to the predicate device.