R2GATE

K190096 · Megagen Implant Co., Ltd. · LLZ · Jun 26, 2019 · Radiology

Device Facts

• Record ID: K190096
• Device Name: R2GATE
• Applicant: Megagen Implant Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jun 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

R2GATE is a web and desktop-based software application used by licensed dentists for pre-operative dental implant planning. It ingests CBCT scan data (DICOM) and 3D surface models (STL files). The software provides tools for image segmentation, nerve canal tracing, and 2D/3D visualization (axial, coronal, sagittal, cross-section, panorama). Dentists use the interface to manipulate and position virtual dental implants from a pre-loaded library, perform cephalometric analysis, and measure anatomical dimensions. The output consists of treatment plans and STL files compatible with 3D printers or milling machines for surgical guide fabrication. By enabling precise virtual placement and visualization of anatomical structures, the device assists clinicians in treatment evaluation and surgical planning, potentially improving implant placement accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Validation included verification of CBCT data integrity (DICOM), comparison of physical measurements (distance/angle) against the predicate, and precision measurement of STL-based surgical guide models. All results met acceptance criteria.

Technological Characteristics

Web and desktop application (Windows OS). Programming languages: C#, C++. Functions include image segmentation, 2D/3D visualization, nerve canal tracing, and implant library management. Connectivity: imports DICOM and STL files; exports STL for CAM/3D printing. Software-based image processing and measurement tools.

Indications for Use

Indicated for use as a software interface and image segmentation system for transferring CBCT imaging data and as pre-planning software for dental implant placement and surgical treatment in patients requiring dental implant procedures.

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

• Blue Sky Bio Plan (K090607)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

MegaGen Implant Co., Ltd. % Mr. Dave Kim President Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

June 26, 2019

Re: K190096

Trade/Device Name: R2GATE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 4, 2019 Received: June 4, 2019

Dear Mr. 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 (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) K190096

Device Name R2GATE

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 16px;">☑</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) SUMMARY |
|----|------------------------|---------------------------------------------|
| | | K190096 |
| | | R2GATE Picture Archiving and Communication |
| | | System |
| 1. | Submitter Information: | MEGAGEN IMPLANT CO., LTD |
| | | 41940, 10F, 12 Gong Pyeong Ro |
| | | Jung Gu Daegu, 41940 |
| | | Republic of Korea |
| | Contact Person: | HyeJin Jung |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date Prepared: | 1/13/2019 |
| 2. | Device Name: | |
| | Proprietary Name: | R2GATE |
| | Classification Name: | Picture Archiving and Communication System |
| | CFR Number: | 21 CFR §892.2050 |
| | Device Class: | Class II |
| | Product Code: | LLZ |
| 3. | Predicate Device: | |
| | Trade/Device Name: | Blue Sky Bio Plan |
| | 510k Number: | K090607 |
| | Regulation Number: | 21 CFR 892.2050 |
| | Regulation Name: | Picture archiving and communications system |
| | Regulatory Class: | Class II |
| | Product Code: | LLZ. |

#### 4. Description of Device:

R2GATE is a web application and is intended for pre-operative planning to create and review plans for dental implant placement and surgical treatment, using MEGAGEN Implants. A dental implant plan can be edited with R2GATE Editor, a desktop software application, by a licensed dentist with clinical experience in implant surgery and medical image review.

The implant surgery plan can be used for manufacturing a surgical guide or for evaluation of treatment options by a licensed dentist.

5. 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.

6. Substantial Equivalence:

Table 6-1 Substantial equivalence comparison table

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| Criteria | Predicate Devices | Device under<br>Consideration | K190096<br>Equivalency |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Element of<br>Comparison | Blue Sky Bio, LLC (K090607) | MegaGen Implant Co., Ltd, | Equivalency |
| Device Name | Blue Sky Bio Plan | R2GATE Windows | |
| Intended Use | Review and approve implant plan, Edit implant<br>plan for approval in online case review. | Create, edit and approve implant<br>plan. For approval in online case<br>review. | Same |
| Indications for Use | Blue Sky Plan is intended to be used as<br>conversion software for Computed<br>Tomography (CT) generated DICOM images<br>into a format that allows a dentist to assess the<br>anatomic topography of the maxilla and<br>mandible as well as location of important<br>structures. It allows the information to be used<br>for pre- surgical treatment planning of dental<br>implant procedures. The Blue Sky Plan<br>software is deployed on standard personal<br>computer hardware using a Windows operating<br>system. | R2GATE is intended for use as a software<br>interface and image segmentation system<br>for the transfer of imaging information<br>from a CBCT scanner. It is also intended<br>as pre-planning software for dental implant<br>placement and surgical treatment. | Same |
| Media for Delivery | - Software-File for download | - Software-File for download | Same |
| Principles of<br>operation | Online software application<br>Desktop software application | Online software application<br>Desktop software application | Same |
| Program language | C# C++ | C# C++ | Same |
| Operating System | Windows | Windows | Same |
| | software functionalities | | |
| Reorientation | Reorientation function to change the<br>direction of the CT image on display. | Reorientation function to change the<br>direction of the CT image on display. | Same |
| Nerve canal | Create a nerve carnal tracing model using the<br>tools provided on the 2D image. The cross<br>section of the model is displayed as a 3D image<br>on the volumetric rendering view. | Create a nerve carnal tracing model using<br>the tools provided on the 2D image. The<br>cross section of the model is displayed as a<br>3D image on the volumetric rendering<br>view. | Same |
| 3D model scan<br>implant planning | The scanned 3D model (STL file) can be<br>reconstructed and used for implant planning. | The scanned 3D model (STL file) can be<br>reconstructed and used for implant | Same |
| Image processing | Change the image displayed on the 2D or 3D<br>screen using a tool provided by the program. | Change the image displayed on the 2D or<br>3D screen using a tool provided by the<br>program. | Same |
| Printing output | Output data that can be used for implant surgical<br>guide fabrication. | Output data that can be used for implant<br>surgical guide fabrication. | Same |
| Output compatibility | The STL file generated can be loaded form<br>other software in conformity with the<br>standard. | The STL file generated can be loaded<br>form other software in conformity with<br>the standard. | Same |
| Screenshot | A screen view on a program can be stored as<br>an image file. | A screen view on a program can be<br>stored as an image file | Same |
| | | | K190096 |
| Measurement Tools | Measure the angle and length on a 2D<br>screen using the tool available in the<br>program. Measure the length using 2 points<br>and measure the angle between the two line<br>segments using 3 points. | Measure the angle and length on a 2D<br>screen using the tool available in the<br>program. Measure the length using 2<br>points and measure the angle between the<br>two line segments using 3 points. | Same |
| Implant Control | Implant model can be added, deleted, moved<br>and rotated on the screen. Only the implant<br>models in the implant library can be used. | Implant model can be added, deleted,<br>moved and rotated on the screen. Only<br>the implant models in the implant<br>library can be used. | Same |
| Anchor pin Control | Anchor-pins can be added, deleted, moved and<br>rotated on the screen. The user may use the<br>product provided by the program or enter the<br>diameter and length setting. | Anchor-pins can be added, deleted,<br>moved and rotated on the screen. The<br>user may use the product provided by<br>the program only. | Same |
| Cephalo analysis | The user can set points of the analysis<br>using the cephalon analysis method<br>provided by the program. | The user can set points of the analysis<br>using the cephalon analysis method<br>provided by the program. | Same |
| 2D Image View | The CT image data can be loaded for axial,<br>coronal, sagittal, cross section and<br>panorama view mode. | The CT image data can be loaded for<br>axial, coronal, sagittal, cross section and<br>panorama view mode. | Same |
| STL file<br>Management | Load a STL file or save a 3D model<br>created in the program as an STL file. | Load a STL file or save a 3D model<br>created in the program as an STL file. | Same |
| View Management | 2D/3D view can be zoomed, moved,<br>rotated. | 2D/3D view can be zoomed, moved,<br>rotated. | Same |
| Project Management | Proceed to a new project. Save the current<br>project or recall the previous project. | Proceed to a new project. Save the<br>current project or recall the previous<br>project. | Same |
| Wax Up Fabrication | Create the desired model by adjusting the<br>position, size, and direction of the basic wax<br>up model provided by the program. | No function to make a wax up model | Difference |
| Surgical Guide<br>Fabrication | Using the virtual STL model and implant<br>model, the surgical guide is constructed as a<br>point-set area on the surface of the STL model. | This SW does not provide the surgical<br>guide fabrication function. | Difference |
| Report Template | Includes a report template via PDF export and<br>print setting. A screen shot can be saved for<br>display. | No report document template. A screen<br>shot can be saved for display. | Partially<br>equivalent |
| Printing Output | Dental Surgical Guide | Dental Surgical Guide | Same |
| Output<br>Compatibility | Compatible with dental 3D printers,<br>milling machines and CAM equipment<br>that support the STL file format. | Compatible with dental 3D printers,<br>milling machines and CAM equipment<br>that support the STL file format. | Same |

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### Analysis of differences

The proposed device has similar indications for use and mostly same basic functionalities in comparison with the predicate device. The functions, view, and module for both the subject and predicate device are used for review of radiographic images, creation of a dental treatment plan and implant surgical guide. The differences include the proposed implant devices that each program depends on. For an implant surgical guide and treatment simulation, R2GATE utilizes a pre-loaded implant device library featuring MEGAGEN IMPLANT family whereas Blue Sky Bio may have different implant library other than MEGAGEN Implant.

## 7. Software testing

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.

Also the following comparison tests confirm the functionality, safety and efficacy of the proposed devices.

#### 8. Non-Clinical Performance Data

Non-clinical tests have been developed in-house including acceptance criteria. The test results demonstrated substantial equivalence between the subject device and the predicate device. (Document No: R2W-D34-PER-001)

(i) Validation of CBCT data (DICOM Image Data): Physical measurement values and numerical values (Hounsfield unit, HU) of distance and angle between specific points of CBCT data of R2GATE Windows and Blue Sky Plan Software. The distance and angle value between the Blue Sky Plan and R2GATE Windows were measured within the acceptable range

(ii) Verification of integrity of CBCT data (DICOM Image Data): Experiments on modification of CBCT data of R2GATE Windows and Blue Sky Plan Software. There is no modification or conversion of the DICOM file between the Blue Sky Plan and R2GATE Windows.

(iii) Verification of the surgical guide model of the dental implant procedure using the STL file. The degree of bonding or precision measurement between the design file and the actual structure were reviewed and compared., The differences were within the acceptable range.

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The test results met the acceptance criteria and demonstrated equivalence between the subject and predicate device.

## 9. Conclusion Regarding Substantial Equivalence

The R2GATE has similar indications for use and incorporate the same fundamental functions, views and module as the predicate device Blue Sky Bio Plan cleared under premarket notification K090607. The performance test for both the subject and the predicate device has been conducted and the test outcome support substantial equivalence between R2GATE and Blue Sky Bio Plan without raising any new issues of safety or effectiveness.