VARO Plan
Device Facts
| Record ID | K200078 |
|---|---|
| Device Name | VARO Plan |
| Applicant | 3D Industrial Imaging Co., Ltd. |
| Product Code | LLZ · Radiology |
| Decision Date | Apr 10, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
Device Story
VARO Plan is a standalone Windows-based software for dental implant surgical guide design. It imports patient DICOM CT/CBCT data, optionally aligned with optical 3D surface scans. Practitioners use the software to visualize anatomy, perform multi-planar reconstruction (MPR), identify the inferior alveolar nerve, and simulate implant placement using a library of certified implants and sleeves. Virtual crowns assist in optimizing implant positioning. The software generates a 3D model of a surgical guide, which is exported as an STL file for external manufacturing. Used in dental clinics or labs by trained professionals, the software serves as an adjunctive tool for treatment planning. It does not contact the patient or control life-sustaining equipment. Clinical decisions remain the responsibility of the practitioner based on their interpretation of the software's output.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via accuracy tests for measurements (length, angle, HU, surgical guide model) and implant library dimensions using phantoms. Pass/fail criteria set at <2% average and maximum absolute difference.
Technological Characteristics
Standalone Windows-based software (Windows 7 64-bit or higher). Minimum requirements: Intel i3 Dual Core, 16GB RAM, 2GB HDD, DirectX 11 compatible graphics. Inputs: DICOM (CT/CBCT), optical 3D surface scans. Outputs: STL files for surgical guides. No patient contact. Non-invasive.
Indications for Use
Indicated for pre-operative planning and simulation of dental implant placement in the maxilla or mandible. Intended for use by qualified dental practitioners (dentists, lab technicians) with training in implantology and surgical dentistry.
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
Submission Summary (Full Text)
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April 10, 2020
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 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.
3D Industrial Imaging Co., Ltd. % Sanglok Lee Manager, Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-Gu 08507 REPUBLIC OF KOREA
Re: K200078
Trade/Device Name: VARO Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: January 8, 2020 Received: January 14, 2020
Dear Sanglok Lee:
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 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)
Device Name
Indications for Use (Describe)
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)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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### K200078
### 3D Industrial Imaging Co. Ltd
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
### 510(k) Summary - Traditional 510(K)
### The assigned 510(k) Number: Not yet assigned
01. Date of Submission: 2020.01.08
### 02. Applicant / Submitter
3D Industrial Imaging Co., Ltd. Bldg.138, Rm.413, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826) Tel. +82-70-8766-9192
### 03. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 2 831 3615 Email: info@wisecompany.org
### 04. Proposed Device Identification
### Device Identification and Regulatory information
Proprietary Name: VARO Plan Common Name: Radiological Imaging Software Device Class: Class II Requlation Number: 21 CFR 892.2050 Product Code: PNN (Orthodontic Software); LLZ
Indication for use: VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical quide for a quided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with quided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
### 05. Predicate Device Identification
- Predicate device 1 510(k) Number: K180629 Device Name: Dentiq Guide Manufacturer: 3D Industrial Imaging Co. Ltd
- Predicate device 2 510(k) Number: K152078 Device Name: Implant Studio™ Manufacturer: 3Shape Medical A/S
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Bldg.138, Rm.413, Seoul National University,
- 1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
### 06. Device Description
VARO Plan is a pure software device.
VARO Plan is a dental implant surgical guide design software that is used to design surgical procedure guidelines for implanting one or more dental implants based on CT and the Tray data. Implant library, which includes certified implants, and sleeve libraries are provided. The guide model designed in accordance with the established dental implant operation plan can be exported as STL files.
The followings are the major functions of VARO Plan.
- Patient Management and Surgical Plan Management ●
- Data Management and Matching
- Crown Model Management and Mesh Edit
- Panoramic Screen Generation and Nerve Setting
- Implant Simulation
- . Surgical Guide Design
- Results output.
- Report
- Project Information Management
### 07. Technological Characteristics:
VARO Plan requires Windows 7 64bit OS or above. To ensure proper operation, we recommend installing the subject device on a system with the following specifications or higher.
| ltem | Specifications |
|---------------|-----------------------------------------------------|
| Processor | Intel i3 Dual Core or Higher |
| System Memory | 16 GB or Higher |
| HDD | 2 GB free hard disk space or Higher |
| Graphics Card | Graphics cards compatible with DirectX 11 or Higher |
| Display | 1600 x 900 or Higher |
Table 1. Minimum PC Specification Requirements for VARO Plan
The device does not contact the patient, nor does it control any life sustaining devices.
VARO Plan 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.
### 08. Substantially Equivalent
VARO Plan has the same intended uses, principle of operation and similar technical characteristics and functionality as predicate devices.
| | Subject Device | Predicate Device 1 | Predicate Device 2 | Substantial<br>Equivalence |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Device Name | VARO Plan | Dentiq Guide | Implant Studio™ | - |
| 510K number | - | K180629 | K152078 | - |
| Classification | Regulation number:<br>21 CFR 892.2050<br>Product code: LLZ | Regulation number:<br>21 CFR 892.20503<br>Product code: LLZ | Regulation number:<br>21 CFR 892.2050<br>Product code: LLZ | Equivalent |
| Manufacturer | 3D Industrial<br>Imaging Co. Ltd | 3D Industrial<br>Imaging Co. Ltd | 3Shape Medical<br>A/S | - |
| | VARO Plan Software is a stand-alone Windows-based software | | | Equivalent |
| Indications<br>for Use | application to support the treatment planning for dental<br>implantation. It is designed for qualified dental practitioners,<br>including dentists and lab technicians. The software imports the<br>medical image dataset of the patient in DICOM format from<br>medical CT or dental CBCT scanners for pre-operative planning<br>and simulation of dental placement. It is intended for use as pre-<br>operative planning software for the placement of dental<br>implant(s) based on imported CT image data, optionally aligned<br>to an optical 3D surface scan. Virtual Crowns can be used for<br>optimized implant positioning under the prosthetic aspect. The<br>digital three dimensional model of a surgical guide for a guided<br>surgery can be designed based on the approved implant position.<br>This 3D data can be exported to manufacture a separate physical<br>product. Indications of the dental implants do not change with<br>guided surgery compared to conventional surgery. Use of the<br>software requires that the user has the necessary medical<br>training in implantology and surgical dentistry.<br>Dentiq Guide Software is a stand-alone Windows-based software<br>application to support the treatment planning for dental<br>implantation. It is designed for qualified dental practitioners,<br>including dentists and lab technicians. The software imports the<br>medical image dataset of the patient in DICOM format from<br>medical CT or dental CBCT scanners for pre-operative planning<br>and simulation of dental placement. It is intended for use as pre-<br>operative planning software for the placement of dental<br>implant(s) based on imported CT image data, optionally aligned<br>to an optical 3D surface scan. Virtual Crowns can be used for<br>optimized implant positioning under the prosthetic aspect. The<br>digital three dimensional model of a surgical guide for a guided<br>surgery can be designed based on the approved implant position.<br>This 3D data can be exported to manufacture a separate physical<br>product.<br>Implant Studio™ is indicated for use as medical front-end<br>software that can be used by medically trained professionals for<br>the purpose of visualizing gray value images.<br>It is intended for use as pre-operative planning software for the<br>placement of dental implant(s) based on imported CT image data,<br>optionally aligned to an optical 3D surface scan. Virtual Crowns<br>can be used for optimized implant positioning under the<br>prosthetic aspect. The digital three dimensional model of a<br>surgical guide for a guided surgery can be designed based on the<br>approved implant position. This 3D data can be exported to<br>manufacture a separate physical product.<br>Indications of the dental implants do not change with guided<br>surgery compared to conventional surgery.<br>Use of the software requires that the user has the necessary<br>medical training in implantology and surgical dentistry. | application to support the treatment planning for dental<br>implantation. It is designed for qualified dental practitioners,<br>including dentists and lab technicians. The software imports the<br>medical image dataset of the patient in DICOM format from<br>medical CT or dental CBCT scanners for pre-operative planning<br>and simulation of dental placement. It is intended for use as pre-<br>operative planning software for the placement of dental<br>implant(s) based on imported CT image data, optionally aligned<br>to an optical 3D surface scan. Virtual Crowns can be used for<br>optimized implant positioning under the prosthetic aspect. The<br>digital three dimensional model of a surgical guide for a guided<br>surgery can be designed based on the approved implant position.<br>This 3D data can be exported to manufacture a separate physical<br>product. Indications of the dental implants do not change with<br>guided surgery compared to conventional surgery. Use of the<br>software requires that the user has the necessary medical<br>training in implantology and surgical dentistry.<br>Dentiq Guide Software is a stand-alone Windows-based software<br>application to support the treatment planning for dental<br>implantation. It is designed for qualified dental practitioners,<br>including dentists and lab technicians. The software imports the<br>medical image dataset of the patient in DICOM format from<br>medical CT or dental CBCT scanners for pre-operative planning<br>and simulation of dental placement. It is intended for use as pre-<br>operative planning software for the placement of dental<br>implant(s) based on imported CT image data, optionally aligned<br>to an optical 3D surface scan. Virtual Crowns can be used for<br>optimized implant positioning under the prosthetic aspect. The<br>digital three dimensional model of a surgical guide for a guided<br>surgery can be designed based on the approved implant position.<br>This 3D data can be exported to manufacture a separate physical<br>product.<br>Implant Studio™ is indicated for use as medical front-end<br>software that can be used by medically trained professionals for<br>the purpose of visualizing gray value images.<br>It is intended for use as pre-operative planning software for the<br>placement of dental implant(s) based on imported CT image data,<br>optionally aligned to an optical 3D surface scan. Virtual Crowns<br>can be used for optimized implant positioning under the<br>prosthetic aspect. The digital three dimensional model of a<br>surgical guide for a guided surgery can be designed based on the<br>approved implant position. This 3D data can be exported to<br>manufacture a separate physical product.<br>Indications of the dental implants do not change with guided<br>surgery compared to conventional surgery.<br>Use of the software requires that the user has the necessary<br>medical training in implantology and surgical dentistry. | application to support the treatment planning for dental<br>implantation. It is designed for qualified dental practitioners,<br>including dentists and lab technicians. The software imports the<br>medical image dataset of the patient in DICOM format from<br>medical CT or dental CBCT scanners for pre-operative planning<br>and simulation of dental placement. It is intended for use as pre-<br>operative planning software for the placement of dental<br>implant(s) based on imported CT image data, optionally aligned<br>to an optical 3D surface scan. Virtual Crowns can be used for<br>optimized implant positioning under the prost…
