(87 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the described functions are typical of traditional medical imaging and planning software.
No
The device is a pre-operative planning software used to design surgical guides for dental implants, not to provide therapy itself.
No
This device is described as pre-operative planning software for dental implant placement and surgical guide design. It does not perform diagnosis; instead, it uses existing diagnostic images (CT/CBCT) to plan a surgical procedure.
Yes
The device description explicitly states "VARO Plan is a pure software device." The functions described are all software-based operations on imported data, and the output is a digital model for manufacturing a separate physical product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- VARO Plan's Function: VARO Plan is a software application used for pre-operative planning and simulation of dental implant placement based on medical imaging data (CT, CBCT, and optical scans). It helps design surgical guides.
- No Specimen Analysis: The software does not analyze any biological specimens from the patient. It processes medical images and design data.
Therefore, based on the provided information, VARO Plan falls under the category of medical device software used for surgical planning and guide design, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, PNN
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM format from medical CT or dental CBCT scanners, optical 3D surface scan
Anatomical Site
Maxilla, Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified dental practitioners, including dentists and lab technicians.
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
- Accuracy test for measurement made in the subject device from loaded CT datasets using phantom by comparing the true values of the phantom and the measured values (Length, Angle, HU and Surgical guide model) in the subject device. The P/F criteria was less than 2% average and maximum absolute difference. Accuracy test of Surgical guide model demonstrate that the generated output surgical guide by the subject device matches the user input requirements (Guide thickness, Offset from teeth to quide, Offset from sleeve to quide).
- Accuracy test to verify the size of the implants (Diameter and Length) which the implant library of the subject device provides by comparing them to the real size values of the implant. The P/F criteria was less than 2% average and maximum absolute difference.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing activities such as code review, module review, and dynamic tests were conducted to establish the performance, functionality and reliability characteristics of the subject device. The testing results support that the subject device is substantially equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
0
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills 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
2
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)
3
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4
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
- 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
5
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
Equivalence |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Device Name | VARO Plan | Dentiq Guide | Implant Studio™ | - |
| 510K number | - | K180629 | K152078 | - |
| Classification | Regulation number:
21 CFR 892.2050
Product code: LLZ | Regulation number:
21 CFR 892.20503
Product code: LLZ | Regulation number:
21 CFR 892.2050
Product code: LLZ | Equivalent |
| Manufacturer | 3D Industrial
Imaging Co. Ltd | 3D Industrial
Imaging Co. Ltd | 3Shape Medical
A/S | - |
| | VARO Plan Software is a stand-alone Windows-based software | | | Equivalent |
| Indications
for Use | 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.
Dentiq Guide 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.
Implant Studio™ is indicated for use as medical front-end
software that can be used by medically trained professionals for
the purpose of visualizing gray value images.
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. | 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.
Dentiq Guide 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.
Implant Studio™ is indicated for use as medical front-end
software that can be used by medically trained professionals for
the purpose of visualizing gray value images.
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. | 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.
Dentiq Guide 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.
Implant Studio™ is indicated for use as medical front-end
software that can be used by medically trained professionals for
the purpose of visualizing gray value images.
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. | |
| Platform | IBM-compatible PC
or PC network | IBM-compatible PC
or PC network | IBM-compatible PC
or PC network | Equivalent |
| Computer | OS: Microsoft | OS: Microsoft | OS: Windows 7 or | Equivalent |
| System
Requirement | Window 7, 8 or 10
64-bit
CPU: Inter i-3 core
or higher
RAM: 2 GB
Monitor
Resolution:1600 x
900 or Higher
Video Card:
compatible with
DirectX 10.1 or
Higher
HDD: 2 GB free
hard disk space
Network: Network
Internet connection
Mouse: With the
wheel button | Window 7, 8 or 10
64-bit
CPU: Inter i-3 core
or higher
RAM: 2 GB
Monitor
Resolution:1600 x
900 or Higher
Video Card:
compatible with
DirectX 10.1 or
Higher
HDD: 2 GB free
hard disk space
Network: Network
Internet connection
Mouse: With the
wheel button | 8 64-bit
CPU: IntelCore i7
or higher
RAM: 16GB or
better
Monitor Resolution:
1920x1200 or
higher
Video Card
Memory: 2GB
GeForce or better
Available HDD
Space: 500GB
Network: Network
Internet connection
Mouse: With the
wheel button | |
| User
Interface | Monitor, Mouse,
Keyboard | Monitor, Mouse,
Keyboard | Monitor, Mouse,
Keyboard | Equivalent |
| Image Input
Sources | Images can be
scanned, loaded
from card readers,
or imported from a
radiographic
imaging device. | Images can be
scanned, loaded
from card readers,
or imported from a
radiographic
imaging device. | Images can be
scanned, loaded
from card readers,
or imported from a
radiographic
imaging device. | Equivalent |
| Data Format | DICOM, STL | DICOM, STL | DICOM, STL, DCM | Different
The Implant
StudioTM
supports its
own format as
well which is
DCM format. |
| Software
Function | MPR (multi-planar
reconstruction),
panoramic, and, 3D
image
reconstruction for
analyzing
anatomical
condition | MPR (multi-planar
reconstruction),
panoramic, and, 3D
image
reconstruction for
analyzing
anatomical
condition | Axial, cross-
sectional,
tangential,
panoramic, 3D
views for displaying
the 3D volumetric
data for analyzing
anatomical
condition | Equivalent |
6
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826)
7
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826)
8
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826)
| Graphic
visualization
interface for placing
the implant in
mandible or maxilla
images, | Graphic
visualization
interface for placing
the implant in
mandible or maxilla
images, | Various image
views, such as
axial, cross-
sectional,
tangential, and
panoramic,
provided for placing
the implant |
|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Nerve module for
assisting users in
distinguishing
inferior alveolar
nerve (passing
through mandibular
canal) | Nerve module for
assisting users in
distinguishing
inferior alveolar
nerve (passing
through mandibular
canal) | Nerve module to
assist in
distinguishing the
nerve mandibular
channel |
| Simulation of
different sized
implants | Simulation of
different sized
implants | Different implants
selected from
implant database.
Change the
diameter and
length of the
implant selected. |
| Adjustment of
implant location,
including position
and direction | Adjustment of
implant location,
including position
and direction | Aligning implant by
moving and
rotating the implant
with the mouse |
| Alignment function
for multiple
implants, | Alignment function
for multiple
implants, | Alignment function
for multiple
implants, |
| Simulation of crown | Simulation of crown | Abutment and
virtual teeth tools
provided |
| Measurement tools
for measuring
length and angle | Measurement tools
for measuring
length and angle | Active
measurement
tools, length and
angle, for individual
measuring of
implant position |
| Bone quality
(indicated by CT
number) displayed
in the point around
the implant | Bone quality
(indicated by CT
number) displayed
in the point around
the implant | Bone densitometry
with a density
statistic for density
measuring in the
point around the
positioned implant |
9
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
| | The treatment plan
of the patient can
be saved in the
computer storage
media. The plan
can be retrieved
later on for
revision. | The treatment plan
of the patient can
be saved in the
computer storage
media. The plan
can be retrieved
later on for
revision. | All working steps
are saved
automatically to the
patient file, called
the plan. | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. | Compatible with
dental 3D printers,
milling machines
and CAM
equipment that
support the STL file
format. | |
| | - | - | Gingiva supported
surgical
guide design
possible | Different
VARO Plan
Software does
not provide
edentulous
treatment and
subsequent
design of
gingiva
supported
guides. |
| Anatomic
Area | Maxilla, Mandible | Maxilla, Mandible | Maxilla, Mandible | Equivalent |
Comparing to as Implant Studio™ (K152078), the differences are such that the predicate device supports its own format additionally and the subject device does not have the feature for edentulous treatment and subsequent design of gingiva supported quides. However, these differences do not raise questions of safety or effectiveness since the two features of the predicate devices are additional options.
Based on the results of software validation and performance tests and the information provided herein, we conclude that the proposed device is substantially equivalent to the predicate devices.
09. Non clinical Testing
SW verification and validation testing activities such as code review, module review, and dynamic tests were conducted to establish the performance, functionality and reliability characteristics of the subject device.
Also the following performance tests were conducted to verify the performance of the subject device and find out any limitations.
- Accuracy test for measurement made in the subject device from loaded CT datasets using phantom by comparing the true values of the phantom and the measured values (Length, Angle, HU and Surgical
10
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
guide model) in the subject device. The P/F criteria was less than 2% average and maximum absolute difference. Accuracy test of Surgical guide model demonstrate that the generated output surgical guide by the subject device matches the user input requirements (Guide thickness, Offset from teeth to quide, Offset from sleeve to quide).
- Accuracy test to verify the size of the implants (Diameter and Length) which the implant library of the subject device provides by comparing them to the real size values of the implant. The P/F criteria was less than 2% average and maximum absolute difference.
The testing results support that the subject device is substantially equivalence to the predicate device.
10. Clinical Testing
Clinical testing is not a requirement and has not been performed.
11. Conclusion
The subject device and the predicate device are substantially equivalent in the areas of technical characteristics, general function, and intended use. The new device does not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the VARO Plan described in this submission is substantially equivalent to the predicate device.