(155 days)
Not Found
No
The summary does not mention AI, ML, or any related terms like deep learning or neural networks. The description focuses on image segmentation, pre-operative planning, and surgical guide manufacturing, which are standard functionalities for dental implant planning software. The performance studies described are focused on data integrity and measurement accuracy, not on the performance of an AI/ML algorithm.
No
The device is described as pre-planning software for dental implant placement and surgical treatment, not a device that directly treats a condition or disease.
No
Explanation: The device is described as pre-planning software for dental implant placement and surgical treatment, using imaging information from a CBCT scanner. It helps create and review plans and can be used for manufacturing surgical guides or evaluating treatment options. It does not provide a diagnosis or identify a disease or condition.
Yes
The device is described as a "web application" and a "desktop software application" used for pre-operative planning and image segmentation. While it utilizes data from a CBCT scanner and can be used for manufacturing a surgical guide, the device itself is presented solely as software for processing and planning, without mention of any accompanying hardware components that are part of the regulated device.
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 using imaging information from a CBCT scanner. This is a planning tool for a surgical procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device is described as a web application and desktop software for pre-operative planning and creating/reviewing dental implant plans. This aligns with surgical planning, not in vitro testing.
- Anatomical Site: The device is used for planning procedures on the maxilla and mandible, which are parts of the patient's body. IVDs typically analyze samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's health status based on laboratory testing.
The device is clearly intended as a medical device for surgical planning, specifically for dental implant procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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.
Mentions image processing
Change the image displayed on the 2D or 3D screen using a tool provided by the program.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CBCT scanner, CT image data
Anatomical Site
maxilla and mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed dentist with clinical experience in implant surgery and 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
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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.
Also the following comparison tests confirm the functionality, safety and efficacy of the proposed devices.
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.
The test results met the acceptance criteria and demonstrated equivalence between the subject and predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
§ 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).
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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 (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) 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | +82-70-4352-1120 | |
| Fax Number: | +82-70-7469-1120 | |
| 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.
- 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.
- Substantial Equivalence:
Table 6-1 Substantial equivalence comparison table
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| Criteria | Predicate Devices | Device under
Consideration | K190096
Equivalency |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Element of
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
plan for approval in online case review. | Create, edit and approve implant
plan. For approval in online case
review. | Same |
| Indications for Use | Blue Sky Plan is intended to be used as
conversion software for Computed
Tomography (CT) generated DICOM images
into a format that allows a dentist to assess the
anatomic topography of the maxilla and
mandible as well as location of important
structures. It allows the information to be used
for pre- surgical treatment planning of dental
implant procedures. The Blue Sky Plan
software is deployed on standard personal
computer hardware using a Windows operating
system. | 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. | Same |
| Media for Delivery | - Software-File for download | - Software-File for download | Same |
| Principles of
operation | Online software application
Desktop software application | Online software application
Desktop software application | Same |
| Program language | C# C++ | C# C++ | Same |
| Operating System | Windows | Windows | Same |
| | software functionalities | | |
| Reorientation | Reorientation function to change the
direction of the CT image on display. | Reorientation function to change the
direction of the CT image on display. | Same |
| Nerve canal | Create a nerve carnal tracing model using the
tools provided on the 2D image. The cross
section of the model is displayed as a 3D image
on the volumetric rendering view. | Create a nerve carnal tracing model using
the tools provided on the 2D image. The
cross section of the model is displayed as a
3D image on the volumetric rendering
view. | Same |
| 3D model scan
implant planning | The scanned 3D model (STL file) can be
reconstructed and used for implant planning. | The scanned 3D model (STL file) can be
reconstructed and used for implant | Same |
| Image processing | Change the image displayed on the 2D or 3D
screen using a tool provided by the program. | Change the image displayed on the 2D or
3D screen using a tool provided by the
program. | Same |
| Printing output | Output data that can be used for implant surgical
guide fabrication. | Output data that can be used for implant
surgical guide fabrication. | Same |
| Output compatibility | The STL file generated can be loaded form
other software in conformity with the
standard. | The STL file generated can be loaded
form other software in conformity with
the standard. | Same |
| Screenshot | A screen view on a program can be stored as
an image file. | A screen view on a program can be
stored as an image file | Same |
| | | | K190096 |
| Measurement Tools | Measure the angle and length on a 2D
screen using the tool available in the
program. Measure the length using 2 points
and measure the angle between the two line
segments using 3 points. | Measure the angle and length on a 2D
screen using the tool available in the
program. Measure the length using 2
points and measure the angle between the
two line segments using 3 points. | Same |
| Implant Control | Implant model can be added, deleted, moved
and rotated on the screen. Only the implant
models in the implant library can be used. | Implant model can be added, deleted,
moved and rotated on the screen. Only
the implant models in the implant
library can be used. | Same |
| Anchor pin Control | Anchor-pins can be added, deleted, moved and
rotated on the screen. The user may use the
product provided by the program or enter the
diameter and length setting. | Anchor-pins can be added, deleted,
moved and rotated on the screen. The
user may use the product provided by
the program only. | Same |
| Cephalo analysis | The user can set points of the analysis
using the cephalon analysis method
provided by the program. | The user can set points of the analysis
using the cephalon analysis method
provided by the program. | Same |
| 2D Image View | The CT image data can be loaded for axial,
coronal, sagittal, cross section and
panorama view mode. | The CT image data can be loaded for
axial, coronal, sagittal, cross section and
panorama view mode. | Same |
| STL file
Management | Load a STL file or save a 3D model
created in the program as an STL file. | Load a STL file or save a 3D model
created in the program as an STL file. | Same |
| View Management | 2D/3D view can be zoomed, moved,
rotated. | 2D/3D view can be zoomed, moved,
rotated. | Same |
| Project Management | Proceed to a new project. Save the current
project or recall the previous project. | Proceed to a new project. Save the
current project or recall the previous
project. | Same |
| Wax Up Fabrication | Create the desired model by adjusting the
position, size, and direction of the basic wax
up model provided by the program. | No function to make a wax up model | Difference |
| Surgical Guide
Fabrication | Using the virtual STL model and implant
model, the surgical guide is constructed as a
point-set area on the surface of the STL model. | This SW does not provide the surgical
guide fabrication function. | Difference |
| Report Template | Includes a report template via PDF export and
print setting. A screen shot can be saved for
display. | No report document template. A screen
shot can be saved for display. | Partially
equivalent |
| Printing Output | Dental Surgical Guide | Dental Surgical Guide | Same |
| Output
Compatibility | Compatible with dental 3D printers,
milling machines and CAM equipment
that support the STL file format. | Compatible with dental 3D printers,
milling machines and CAM equipment
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.