(295 days)
No
The summary describes software for viewing, manipulating, and approving pre-existing dental implant plans generated by a separate device (K190096). There is no mention of the software itself generating plans, performing analysis, or using AI/ML techniques. The focus is on visualization and approval of plans created elsewhere.
No
The device is described as pre-planning software for dental implant placement and surgical treatment, not as a device that provides therapy itself.
No
The device is described as pre-planning software for dental implant placement and surgical treatment, allowing users to view, measure, zoom, and rotate images of already generated dental implant plans. It does not perform diagnostic functions but rather aids in the planning and visualization of treatment.
Yes
The device description explicitly states that R2GATE Lite ™ is a software compatible with Windows PC, MacOS, and Apple iOS tablet platforms, and the performance studies focus solely on software verification and validation. While it interacts with data from a CBCT scanner and facilitates the creation of surgical guides (which are hardware), the device itself is described and validated as a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pre-planning dental implant placement and surgical treatment. This is a surgical planning tool, not a diagnostic test performed on biological samples.
- Device Description: The device is described as an image viewer and planning software. It processes medical images (CBCT scans) to aid in surgical planning.
- Lack of Biological Sample Analysis: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not analyze any biological samples.
The device falls under the category of medical imaging software used for surgical planning, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
R2GATE Lite TM is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only.
R2GATE Lite TM allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).
Product codes
LLZ
Device Description
The proposed device, R2GATE Lite TM software is an image viewer compatible for Windows PC. MacOS and Apple iOS tablet platform to view and approve preoperative planning for dental implant placement and surgery provided by R2GATE Window (K190096).
The software R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review.
R2GATE Lite TM let the user view, measure, zoom and rotate 2D and 3D images of dental implant plans generated by R2GATE Window (K190096). R2GATE Lite TM can be used by dental professionals as a patient consultation tool for planning dental implant surgery and treatment.
R2GATE Lite TM let the user review, revise and approve the implant surgical plan on Windows PC. MacOS and Apple iOS tablet platform before manufacturing a surgical guide.
Mentions image processing
Yes, "Image processing: The image displayed can be manipulated on the 2D or 3D screen with the tool provided by the program."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
The imported CT data can be viewed in the form of axial, coronal, sagittal, cross section, and panorama image.
CT data of mobile data created in R2GATE Windows can be viewed in the form of axial, coronal, and sagittal image.
Anatomical Site
Not Found
Indicated Patient Age Range
adult only
Intended User / Care Setting
R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review.
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)
Software verification and validation was conducted to ensure the functionality and compatibility of all system components and to support the safety and effectiveness of the proposed devices.
The verification and validation tests consist of the following activities:
- Unit test
- Peer Code Review ●
- . Integration test
- Internal release test
- . Formal system test
- Acceptance test .
Verification and validation tests confirm that all user needs and SW performance requirements are fulfilled according to the design input. The comparison tests confirm the functionality, safety and efficacy of the proposed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
October 20, 2023
MegaGen Implant Co. Ltd % Dave Kim President Mtech Group 7505 Fannin St. Suite 610 HOUSTON, TX 77054
Re: K223909
Trade/Device Name: R2GATE Lite TM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 4, 2023 Received: October 4, 2023
Dear Dave Kim:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality
2
Indications for Use
510(k) Number (if known) K223909
Device Name R2GATE Lite TM
Indications for Use (Describe)
R2GATE Lite ™ is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only.
R2GATE Lite ™ allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).
| 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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3
510(k) SUMMARY
| 1. | Submitter Information: | MegaGen Implant Co., Ltd
45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
Daegu, 42921
Republic of Korea |
|----|-----------------------------------------|---------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Tae Gyoun Lee / Manager |
| | Telephone Number: | +82-53-222-3878 |
| | Date Prepared: | 10/11/2023 |
| 2. | Device Name:
Proprietary Name: | R2GATE Lite TM |
| | Regulation Number | 21 CFR §892.2050 |
| | Regulation Name: | Medical image management and processing system |
| | Device Class: | Class II |
| | Product Code: | LLZ |
| 3. | Predicate Device:
Trade/Device Name: | R2GATE |
| | 510k Number: | K190096 |
| | Regulation Number: | 21 CFR 892.2050 |
| | Regulation Name: | Medical image management and processing system |
| | Regulatory Class: | Class II |
| | Product Code: | LLZ |
4
-
- Description of Device:
The proposed device, R2GATE Lite ™ software is an image viewer compatible for Windows PC. MacOS and Apple iOS tablet platform to view and approve preoperative planning for dental implant placement and surgery provided by R2GATE Window (K190096).
- Description of Device:
The software R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review.
R2GATE Lite TM let the user view, measure, zoom and rotate 2D and 3D images of dental implant plans generated by R2GATE Window (K190096). R2GATE Lite TM can be used by dental professionals as a patient consultation tool for planning dental implant surgery and treatment.
R2GATE Lite TM let the user review, revise and approve the implant surgical plan on Windows PC. MacOS and Apple iOS tablet platform before manufacturing a surgical guide.
-
- Indications for Use:
R2GATE Lite ™ is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only.
- Indications for Use:
R2GATE Lite TM allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).
-
- Substantial Equivalence:
| Criteria | Predicate Devices | Device under Consideration | Equivalency |
|---|---|---|---|
| Element of Comparison | MegaGen Implant Co., Ltd, | MegaGen Implant Co., Ltd, | |
| Device Name | R2GATE Windows | R2GATE LiteTM | |
| 510(k) Number | K190096 | K223909 | |
| Intended Use | Create, edit and review online | ||
| implant plan case for approval. | Create, edit and review online implant | ||
| plan case for approval. | Same | ||
| Indications for Use | R2GATE is intended for use as a | ||
| software interface and image | |||
| segmentation system for the transfer of | |||
| imaging information from a CBCT | |||
| scanner. It is also intended as pre- | |||
| planning software for dental implant | |||
| placement and surgical treatment. | R2GATE LiteTM is intended for use as a pre- | ||
| planning software for dental implant | |||
| placement and surgical treatment for adult | |||
| only. | |||
| R2GATE Lite TM allows for surgical guides | |||
| to be export to a validated manufacturing | |||
| center or to the point of care. | |||
| Manufacturing at the point of care requires | |||
| FDA cleared or legally marketed 3D | |||
| printing fabrication method and compatible | |||
| material (biocompatible and sterilizable ). | reduced | ||
| functionality | |||
| Media for Delivery | Download installation software file | Download installation software file | Same |
Table 6-1 Substantial equivalence comparison table
5
| Operating
Platform | Software application for online
Software application for desktop | Software application for online
Software application for desktop
Software application for mobile device | Difference |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Program language | C# C++ | C# | Same |
| Operating System | Windows PC | Windows PC, macOS, iOS | Different |
| | software functionalities | | |
| Nerve canal | The user can create a nerve canal model
using the tools provided on the
panoramic screen. The cross section of
the model created is displayed in 2D and
3D volumetric view. | A 3D model of the nerve canal can be
created using the information of the nerve
canal model created in R2GATE
Windows. The cross section of the
created model is displayed in the 2D view
and 3D volumetric view. | Same |
| 3D model scan
implant planning | A scanned 3D model (STL file) can be
imported and used for implant treatment
planning. | A 3D model (STL file) of mobile data
created in R2GATE Window scan be
imported and used for implant treatment
planning. | Same |
| Image processing | The image displayed can be
manipulated on the 2D or 3D screen
with the tool provided by the program. | The image displayed can be manipulated
on the 2D or 3D screen with the tool
provided by the program. | Same |
| Measurement Tools | Angles and lengths can be measured on
a 2D screen using tools provided by the
program. Measure the length of two
points and measure the angle using the
slope of the two points. | Angles and lengths can be measured on a
2D screen using tools provided by the
program. Measure the length of two
points and measure the angle using the
slope of the two points. | Same |
6
| Implant Control | Implant models can be added, deleted,
moved and rotated on the screen.
Different implant products are available
to choose. The implant products can
only be provided by the program. | Implant models can be added, deleted,
moved and rotated on the screen.
Different implant products are available to
choose. The implant products can only be
provided by the program. | Same |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Anchor pin Control | Anchor-pin can be added, deleted,
moved and rotated on the screen.
Different Anchor-pin products that are
only provided by the program are
available to choose. | Anchor-pin can be added, deleted, moved
and rotated on the screen. Different
Anchor-pin products that are only
provided by the program are available to
choose. | Same |
| 2D Image View | The imported CT data can be viewed in
the form of axial, coronal, sagittal, cross
section, and panorama image. | CT data of mobile data created in
R2GATE Windows can be viewed in the
form of axial, coronal, and sagittal image. | reduced
functionality |
| View Management | 2D/3D view can be enlarged / reduced,
moved and rotated. | 2D/3D view can be enlarged / reduced,
moved and rotated. | Same |
| Project Management | The user can create a new project, save
or load the existing project. | The user can proceed with the project
already created in R2GATE Windows,
save or load the existing project in
R2GATE Windows. | reduced
functionality |
7. Analysis of differences
The proposed device has same indications for use and partly the same basic functionalities compared to the predicate device. The functions, view, and module for both the subject and predicate devices are used for review of radiographic images, creation of a dental treatment plan and implant surgical guide. The differences include that R2GATE Lite TM utilizes Windows PC, Apple MacOS, iOS tablet to review, revise and approve a pre-loaded implant image data generated by R2GATE Window (K190096) for an implant surgical simulation and treatment guide.
Both R2GATE Lite ™ and R2GATE Windows can be downloaded to a local computer from the website allowing the dental professional flexible and convenient way to plan and review implant surgical guide.
Software testing 8.
Software verification and validation was conducted to ensure the functionality and compatibility of all system components and to support the safety and effectiveness of the proposed devices.
The verification and validation tests consist of the following activities:
- Unit test
- Peer Code Review ●
- . Integration test
- Internal release test
- . Formal system test
- Acceptance test .
7
Verification and validation tests confirm that all user needs and SW performance requirements are fulfilled according to the design input. The comparison tests confirm the functionality, safety and efficacy of the proposed devices.
Conclusion Regarding Substantial Equivalence 9.
The R2GATE Lite TM has similar indications for use and incorporate the same fundamental functions, views and module as the predicate device R2GATE Windows cleared under premarket notification K190096. The performance test for both the subject and the predicate device has been conducted and the test outcome support substantial equivalence between R2GATE Lite ™ and R2GATE Windows without raising any new issues of safety or effectiveness.