(295 days)
Not Found
No
The document describes software for orthodontic treatment planning and appliance design based on 3D scans, but it does not mention or describe the use of AI or ML algorithms for any of its functions. The process described is based on user input and standard file formats for manufacturing.
No
This device is a software suite used for planning and designing orthodontic treatments and devices, not directly for therapy. The actual therapeutic devices (nitinol wires, etc.) are fabricated based on the software's output.
No
The device is described as an "orthodontic appliance design and treatment simulation software." While it allows for "systematic inspection" and "analysis the progress of the treatment," its primary function is not to diagnose a condition but rather to plan and design solutions for an existing orthodontic condition. It assists in treatment planning and evaluation, not in determining the presence or nature of a disease.
Yes
The device is described as "BRIUS Software Suite" and its function is entirely based on processing digital scans and generating digital outputs (STL, DXF files) for subsequent manufacturing. There is no mention of any accompanying hardware component that is part of the regulated device itself.
Based on the provided information, the BRIUS Software Suite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BRIUS Software Suite's Function: The BRIUS Software Suite works with 3D digital scans of a patient's dentition (teeth and surrounding structures). It's used for treatment planning, simulation, and designing orthodontic appliances. It does not analyze biological specimens.
- Intended Use: The intended use clearly states its purpose is for managing orthodontic models, inspection, simulation, and virtual appliance design based on 3D models of the patient's dentition. This is a treatment planning and design tool, not a diagnostic tool based on biological samples.
- Device Description: The description reinforces that it uses digital scans of the patient's denture to create treatment plans and design appliances.
Therefore, the BRIUS Software Suite falls under the category of a medical device used for treatment planning and design, not an IVD.
N/A
Intended Use / Indications for Use
BRIUS Software Suite is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual applians (Patient-Specific Nitinol Wires, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the BRIUS Software Suite requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
Product codes
PNN
Device Description
The BRIUS Software Suite is an orthodontic appliance design and treatment simulation software. Until recently, this software was used only as a manufacturing software for nitinol wires, indirect bonding transfer media, and export of models. This software is now for use by professional technicians or physicians to design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and a technician or physician can then create treatment plans for each individual patient and their needs. After approval by the patient's physician, the system can be used to fabricate patient-specific nitinol wires, indirect bonding transfer media, and export of models using standard stereolithographic (STL) and drawing exchange format (DXF) files for the design of custom shape-set nitinol wires. A 2D rendering of the nitinol wires needed for the patient can be created in the form of a DXF file and a 3D representation of the ideal tooth alignment for the patient can be created in the form of an STL file. The 2D rendering can then be used to laser cut a nitinol sheet to form a 2D version of the patient-specific nitinol wire shape. Finally, a high-temperature mold can be fabricated from the STL file to shape set the 2D cut nitinol wire for a specific fit for patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital scans (3D)
Anatomical Site
dentition, Maxilla/Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional technicians or physicians; in the practice of orthodontics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015), the BRIUS Software Suite underwent appropriate integration, verification, and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3Shape OrthoSystem (K171634)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
April 17, 2020
BRIUS % Breanne Butler Consultant Medavice. Inc 1321 Upland Suite 6792 Dr. Houston, Texas 77043
Re: K191720
Trade/Device Name: BRIUS Software Suite Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: March 16, 2020 Received: March 17, 2020
Dear Breanne Butler:
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
1
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 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 (OS) 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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191720
Device Name BRIUS Software Suite
Indications for Use (Describe)
BRIUS Software Suite is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual applians (Patient-Specific Nitinol Wires, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the BRIUS Software Suite requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
| Submitter: | BRIUS
4553 Westgrove Dr.
Addison TX 75001 |
|------------------------------|-----------------------------------------------------------------|
| Company Contact
Person: | Mehdi Roein-Peikar |
| Phone: | (888) 755.8320 |
| Email: | mehdi@brius.com |
| Submission
Correspondent: | Medavice, Inc.
Breanne Butler, Regulatory Affairs Consultant |
| Address: | 1321 Upland Suite 6792 Dr. Houston TX 77043 |
| Phone: | (860) 810-5594 |
| Email: | bbutler@medavice.com |
| Date Prepared: | 04/16/2020 |
| Proprietary Name: | BRIUS Software Suite |
| Common Name: | Orthodontic Software |
| Product Code: | PNN – Orthodontic Software |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Predicate Devices: | 3Shape OrthoSystem (K171634) |
Device Description:
The BRIUS Software Suite is an orthodontic appliance design and treatment simulation software. Until recently, this software was used only as a manufacturing software for nitinol wires, indirect bonding transfer media, and export of models. This software is now for use by professional technicians or physicians to design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and a technician or physician can then create treatment plans for each individual patient and their needs. After approval by the patient's physician, the system can be used to fabricate patientspecific nitinol wires, indirect bonding transfer media, and export of models using standard stereolithographic (STL) and drawing exchange format (DXF) files for the design of custom shape-set nitinol wires. A 2D rendering of the nitinol wires needed for the patient can be created in the form of a DXF file and a 3D representation of the ideal tooth
4
alignment for the patient can be created in the form of an STL file. The 2D rendering can then be used to laser cut a nitinol sheet to form a 2D version of the patient-specific nitinol wire shape. Finally, a high-temperature mold can be fabricated from the STL file to shape set the 2D cut nitinol wire for a specific fit for patients.
Indications for Use:
BRIUS Software Suite is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options (Patient-Specific Nitinol Wires, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the BRIUS Software Suite requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
Comparison to Predicate Devices:
BRIUS Software Suite is functionally equivalent to the following predicate device: 3Shape OrthoSystem (K171634 cleared January 31st, 2017).
The following table demonstrates the functional specifications of BRIUS Software Suite are substantially equivalent to the predicate devices.
| Specificati
on | BRIUS Software Suite | 3Shape OrthoSystem | Comparison
Result |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Indication
for Use | BRIUS Software Suite is
intended for use as a medical
front-end device providing tools
for management of orthodontic
models, systematic inspection,
treatment simulation and virtual
appliance design options
(Patient-Specific Nitinol Wires,
Export of Models, Indirect
Bonding Transfer Media) based
on 3D models of the patient's
dentition before the start of an
orthodontic treatment. It can
also be applied during the
treatment to inspect and | The 3Shape Ortho System™
is intended for use as a
medical front-end device
providing tools for
management of orthodontic
models, systematic inspection,
detailed analysis, treatment
simulation and virtual
appliance design options
(Custom Metal Bands, Export
of Models, Indirect Bonding
Transfer Media) based on 3D
models of the patient's
dentition before the start of an
orthodontic treatment. It can | Similar |
| | analyze the progress of the
treatment. It can be used at the
end of the treatment to
evaluate if the outcome is
consistent with the
planned/desired treatment
objectives.
The use of BRIUS Software
Suite requires the user to have
the necessary training and
domain knowledge in the
practice of orthodontics, as well
as to have received a
dedicated training in the use of
the software. | also be applied during the
treatment to inspect and
analyze the progress of the
treatment. It can be used at
the end of the treatment to
evaluate if the outcome is
consistent with the
planned/desired treatment
objectives.
The use of the Ortho
SystemTM requires the user to
have the necessary training
and domain knowledge in the
practice of orthodontics, as
well as to have received a
dedicated training in the use of
the software. | |
| Technology
Features | Stand Alone Software
Module Imports Digital Patient
Scans Can be used to design
Dental Casts Useful for Diagnosis,
treatment planning, and
CAD design Virtual Planning of tooth
movement Supports STL Files | Stand Alone Software
Module Imports Digital Patient
Scans Can be used to design
Dental Casts Useful for Diagnosis,
treatment planning, and
CAD design Virtual Planning of tooth
movement Supports STL Files | Same |
| Minimum
Hardware/Soft
ware
Requirements | OS: Windows 10 64-bit RAM: 8 GB Monitor Resolution:1280 X 800 Video Card Memory: 1 GB Hard Drive Space: 10 GB CPU: Intel compatible 2.6
GHz/Dual or Quad core 2.6 GHz Mouse: Any Mouse with scrolling
wheel or button | OS: Windows 7, 8, 10 64-bit RAM: 8 GB Monitor Resolution:1280 X
800 Video Card Memory: 1 GB Hard Drive Space: 10 GB CPU: Intel Core i5 or equivalent Mouse: with wheel button | Similar; No effect to
the indication for use. |
| Login Method | Username and Password | Username and Password | Same |
Table 1: Functional Specification Comparison
5
| Table 2. Feature Comparison Table for BRIUS and 3Shape | |
|---|---|
| -- | -------------------------------------------------------- |
| Feature Comparison | BRIUS | 3Shape (K171634) |
|---|---|---|
| Supported anatomic | ||
| areas | Maxilla/Mandible | Maxilla/Mandible |
6
| Intended Use | ||
|---|---|---|
| Managing Patient and | ||
| case base data | Yes | Yes |
| Collection of study | ||
| material | Yes | Yes |
| Alignment of study | ||
| material | Yes | Yes |
| Measuring study | ||
| material | Yes | Yes |
| Analyzing Study | ||
| Material | Yes | Yes |
| Treatment Simulation | Yes | Yes |
| Virtual Appliance | ||
| Design | Yes | Yes |
| Supported PC formats | Windows/Mac: Internet | |
| Browser-based | Windows | |
| Managing patient and case base data | ||
| Creating, editing, | ||
| deleting and copying | ||
| patient data | Yes | Yes |
| Creating, editing, | ||
| deleting and copying | ||
| case data | Yes | Yes |
| Collection of study material | ||
| Surface scan for | ||
| intraoral scanner | Yes | Yes |
| Surface scan from STL | ||
| file | Yes | Yes |
| CT image data | ||
| (DICOM) | No | Yes |
| 2D overlay (PNG, JPG, | ||
| BMP) | No | Yes |
| Alignment of study material | ||
| Aligning surface scan | ||
| and CT image | No | Yes |
| Aligning Cephalometric | ||
| Images | No | Yes |
| Alignment of 2D | ||
| overlays | No | Yes |
| Ability to check/adjust | ||
| DICOM visibility | No | Yes |
| DICOM scan | ||
| Segmentation | No | No |
| 2D Measurement tool | ||
| box | No | Yes |
| 3D Measurement tool | ||
| box | No | Yes |
| Analyzing study material | ||
| Arch shape | Yes | Yes |
| Wire length | No | Yes |
| Tooth width | No | Yes |
| Bolton | No | Yes |
| Space Analysis | No | Yes |
| Overjet/Overbite | Yes | Yes |
| Occlusion Map | Yes | Yes |
| Treatment Simulation | ||
| 2D | Yes | Yes |
| 3D | Yes | Yes |
| Virtual Appliance Design | ||
| Orthodontic Appliance | ||
| Search | No | Yes |
| Orthodontic Appliance | ||
| Virtual Preparation | Yes | Yes |
| Orthodontic Appliance | ||
| Design | Yes | Yes |
| Orthodontic appliance | ||
| Export | Yes | Yes |
7
Comparison of Indications for Use to Predicate Devices:
Based on the above comparison, the indications for use of the BRIUS Software Suite is similar to that of the 3Shape OrthoSystem. The 3Shape system is different in that it produces custom metal bands while the BRIUS system produces patient-specific nitinol wires. Otherwise, the indications for use for both devices are similar. Therefore, the BRIUS Software Suite can be considered substantially equivalent to its predicate device.
Comparison of Technological Features to Predicate Devices:
the above comparison, the design. construction, Based on and performance characteristics of the BRIUS Software Suite is similar to that of 3Shape OrthoSystem. The BRIUS system does not include some measurement and search tools which are included in the 3Shape system. These tools do not affect the ability of users to perform necessary functions within the software. Additionally, both systems use CAD/CAM technology to produce digital models patient-specific orthodontic devices. Therefore, the BRIUS Software Suite can be considered substantially equivalent to its predicate devices.
Summary of Performance Data and Substantial Equivalence:
Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015), the BRIUS Software Suite underwent appropriate integration, verification, and validation testing.
Conclusion:
Based on comparison of indications for use, technological features, performance testing, and software validation testing, the BRIUS Software Suite have been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate device.