BRUIS Software Suite

K191720 · Mechanodontics, Inc. · PNN · Apr 17, 2020 · Dental

Device Facts

• Record ID: K191720
• Device Name: BRUIS Software Suite
• Applicant: Mechanodontics, Inc.
• Product Code: PNN · Dental
• Decision Date: Apr 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

BRIUS Software Suite is a browser-based orthodontic CAD/CAM software for treatment planning and appliance design. Input consists of 3D digital dental scans (STL files). Users (orthodontists/technicians) perform systematic inspection, treatment simulation, and virtual appliance design. Output includes 2D DXF files for laser-cutting nitinol sheets and 3D STL files for fabricating high-temperature molds to shape-set nitinol wires. The software facilitates the creation of patient-specific nitinol wires and indirect bonding transfer media. Clinicians use the software to plan tooth movement, approve designs, and evaluate treatment progress or outcomes against objectives. The system supports clinical decision-making by providing a digital environment for virtual orthodontic planning and custom device fabrication.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including integration, verification, and validation testing performed in accordance with the FDA guidance document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'.

Technological Characteristics

Standalone software module; browser-based (Windows/Mac). Supports STL file import/export. CAD/CAM technology for virtual tooth movement planning and appliance design. No hardware components; requires Windows 10 64-bit, 8GB RAM, 10GB disk space. Login via username/password.

Indications for Use

Indicated for orthodontic patients requiring management of dental models, treatment simulation, and design of patient-specific nitinol wires, indirect bonding transfer media, and model exports. Requires trained orthodontic professionals.

Regulatory Classification

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.

Predicate Devices

• 3Shape OrthoSystem (K171634)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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## 510(k) SUMMARY

| Submitter: | BRIUS<br>4553 Westgrove Dr.<br>Addison TX 75001 |
|------------------------------|-----------------------------------------------------------------|
| Company Contact<br>Person: | Mehdi Roein-Peikar |
| Phone: | [phone] |
| Email: | [e-mail] |
| Submission<br>Correspondent: | Medavice, Inc.<br>Breanne Butler, Regulatory Affairs Consultant |
| Address: | 1321 Upland Suite 6792 Dr. Houston TX 77043 |
| Phone: | [phone] |
| Email: | [e-mail] |
| 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

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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<br>on | BRIUS Software Suite | 3Shape OrthoSystem | Comparison<br>Result |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Indication<br>for Use | BRIUS Software Suite is<br>intended for use as a medical<br>front-end device providing tools<br>for management of orthodontic<br>models, systematic inspection,<br>treatment simulation and virtual<br>appliance design options<br>(Patient-Specific Nitinol Wires,<br>Export of Models, Indirect<br>Bonding Transfer Media) based<br>on 3D models of the patient's<br>dentition before the start of an<br>orthodontic treatment. It can<br>also be applied during the<br>treatment to inspect and | The 3Shape Ortho System™<br>is intended for use as a<br>medical front-end device<br>providing tools for<br>management of orthodontic<br>models, systematic inspection,<br>detailed analysis, treatment<br>simulation and virtual<br>appliance design options<br>(Custom Metal Bands, Export<br>of Models, Indirect Bonding<br>Transfer Media) based on 3D<br>models of the patient's<br>dentition before the start of an<br>orthodontic treatment. It can | Similar |
| | analyze the progress of the<br>treatment. It can be used at the<br>end of the treatment to<br>evaluate if the outcome is<br>consistent with the<br>planned/desired treatment<br>objectives.<br>The use of BRIUS Software<br>Suite requires the user to have<br>the necessary training and<br>domain knowledge in the<br>practice of orthodontics, as well<br>as to have received a<br>dedicated training in the use of<br>the software. | also be applied during the<br>treatment to inspect and<br>analyze the progress of the<br>treatment. It can be used at<br>the end of the treatment to<br>evaluate if the outcome is<br>consistent with the<br>planned/desired treatment<br>objectives.<br>The use of the Ortho<br>SystemTM requires the user to<br>have the necessary training<br>and domain knowledge in the<br>practice of orthodontics, as<br>well as to have received a<br>dedicated training in the use of<br>the software. | |
| Technology<br>Features | Stand Alone Software<br>Module Imports Digital Patient<br>Scans Can be used to design<br>Dental Casts Useful for Diagnosis,<br>treatment planning, and<br>CAD design Virtual Planning of tooth<br>movement Supports STL Files | Stand Alone Software<br>Module Imports Digital Patient<br>Scans Can be used to design<br>Dental Casts Useful for Diagnosis,<br>treatment planning, and<br>CAD design Virtual Planning of tooth<br>movement Supports STL Files | Same |
| Minimum<br>Hardware/Soft<br>ware<br>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<br>GHz/Dual or Quad core 2.6 GHz Mouse: Any Mouse with scrolling<br>wheel or button | OS: Windows 7, 8, 10 64-bit RAM: 8 GB Monitor Resolution:1280 X<br>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<br>the indication for use. |
| Login Method | Username and Password | Username and Password | Same |

## Table 1: Functional Specification Comparison

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| | Table 2. Feature Comparison Table for BRIUS and 3Shape |
|--|--------------------------------------------------------|
|--|--------------------------------------------------------|

| Feature Comparison | BRIUS | 3Shape (K171634) |
|-----------------------------|------------------|------------------|
| Supported anatomic<br>areas | Maxilla/Mandible | Maxilla/Mandible |

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| | Intended Use | |
|------------------------------------------------------------|----------------------------------------|---------|
| Managing Patient and<br>case base data | Yes | Yes |
| Collection of study<br>material | Yes | Yes |
| Alignment of study<br>material | Yes | Yes |
| Measuring study<br>material | Yes | Yes |
| Analyzing Study<br>Material | Yes | Yes |
| Treatment Simulation | Yes | Yes |
| Virtual Appliance<br>Design | Yes | Yes |
| Supported PC formats | Windows/Mac: Internet<br>Browser-based | Windows |
| Managing patient and case base data | | |
| Creating, editing,<br>deleting and copying<br>patient data | Yes | Yes |
| Creating, editing,<br>deleting and copying<br>case data | Yes | Yes |
| Collection of study material | | |
| Surface scan for<br>intraoral scanner | Yes | Yes |
| Surface scan from STL<br>file | Yes | Yes |
| CT image data<br>(DICOM) | No | Yes |
| 2D overlay (PNG, JPG,<br>BMP) | No | Yes |
| Alignment of study material | | |
| Aligning surface scan<br>and CT image | No | Yes |
| Aligning Cephalometric<br>Images | No | Yes |
| Alignment of 2D<br>overlays | No | Yes |
| Ability to check/adjust<br>DICOM visibility | No | Yes |
| DICOM scan<br>Segmentation | No | No |
| 2D Measurement tool<br>box | No | Yes |
| 3D Measurement tool<br>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<br>Search | No | Yes |
| Orthodontic Appliance<br>Virtual Preparation | Yes | Yes |
| Orthodontic Appliance<br>Design | Yes | Yes |
| Orthodontic appliance<br>Export | Yes | Yes |

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## 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.