(28 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on user-driven design and simulation tools.
No
The device is a medical front-end device providing tools for management, inspection, simulation, and design options for orthodontic treatment, but it does not directly treat or diagnose a disease or condition. It is used to plan and design appliances that a therapeutic device would then create or use.
No
The device is described as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options." It is used to create treatment plans and design orthodontic appliances, not to diagnose a condition. While it can "inspect and analyze the progress of the treatment" and "evaluate if the outcome is consistent with the planned/desired treatment objectives," these functions are related to treatment planning and monitoring rather than initial diagnosis of a disease or condition.
Yes
The device description explicitly states "The BRIUS Planner Software is an orthodontic appliance design and treatment simulation software." and describes its function as processing digital scans and creating treatment plans and designs for manufacturing, without mentioning any accompanying hardware components that are part of the regulated device.
Based on the provided information, the BRIUS Planner is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The BRIUS Planner's intended use and device description clearly state it works with 3D models of the patient's dentition (digital scans, STL files, CT data) and is used for orthodontic treatment planning, simulation, and appliance design. It does not analyze biological specimens.
- The focus is on planning and designing physical appliances and simulating treatment outcomes based on anatomical data. This falls under the category of medical device software used for treatment planning and manufacturing, not in vitro diagnostics.
The information provided aligns with a software device used in the field of orthodontics for treatment planning and design, which is distinct from the function of an IVD device.
N/A
Intended Use / Indications for Use
BRIUS Planner 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, Sequential Aligners, 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 treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the BRIUS Planner 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 Planner Software is an orthodontic appliance design and treatment simulation software. This software is used as a manufacturing software for orthodontic appliances. It is also used 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 dental appliances using standard stereolithographic (STL) for the design of custom shape-set nitinol appliances or clear aligners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital scans (3D) of a patient denture
Surface scan for intraoral scanner
Surface scan from STL file
CT image data (DICOM)
Anatomical Site
Maxilla/Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional technicians or physicians with necessary training and domain knowledge in the practice of orthodontics, as well as dedicated training in the use of the software.
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), BRIUS Planner Software underwent appropriate integration, verification, and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BRIUS Software Suite (K191720)
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.
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October 1, 2021
BRIUS Technologies Inc % Breanne Butler Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043
Re: K212828
Trade/Device Name: BRIUS Planner Software Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: September 2, 2021 Received: September 3, 2021
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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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)
K212828
Device Name BRIUS Planner Software
Indications for Use (Describe)
BRIUS Planner 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, Sequential Aligners, 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 treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the BRIUS Planner 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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Section 5. 510(k) Summary
510(k) SUMMARY
A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | BRIUS Technologies
2611 Westgrove Drive
Carrollton TX 75006 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact
Person:
Phone:
Email: | Mehdi Roein-Peikar
(312) 479-1449
mehdi@brius.com |
| Submission
Correspondent:
Address:
Phone:
Email: | Breanne Butler, Regulatory Affairs Consultant
1321 Upland Dr. Suite 6792 Houston, TX 77043
(860) 810-5594
bbutler@medavice.com |
| Date Prepared: | October 1, 2021 |
| Proprietary Name: | BRIUS Planner Software |
| Common Name: | Orthodontic Software |
| Product Code: | PNN - Orthodontic Software |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Predicate Devices: | BRIUS Software Suite (K191720) (Primary Predicate) |
Device Description:
The BRIUS Planner Software is an orthodontic appliance design and treatment simulation software. This software is used as a manufacturing software for orthodontic appliances. It is also used 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 dental appliances using standard stereolithographic (STL) for the design of custom shape-set nitinol appliances or clear aligners.
4
Indications for Use:
BRIUS Planner 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, Sequential Aliqners, 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 Planner 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 Planner Software is functionally equivalent to the following predicate device: BRIUS Software Suite (K191720 cleared April 2020).
The following table demonstrates the functional specifications of BRIUS Planner Software are substantially equivalent to the predicate devices.
| Specification | BRIUS Planner Software | BRIUS Software Suite (K191720) | Comparison Result |
|---|---|---|---|
| Indication | |||
| for Use | BRIUS Planner 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, Sequential | |||
| Aligners, 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 | 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 | Similar | ||
| planned/desired treatment | |||
| objectives. | planned/desired treatment | ||
| objectives. | |||
| The use of the BRIUS Planner | |||
| 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. | 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. | |||
| 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 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 | Same |
| 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 Planner and K191720
| Feature Comparison | BRIUS Planner | BRIUS Software
(K191720) |
|------------------------------------------------------|-------------------------------------|-------------------------------------|
| Supported anatomic
areas | Maxilla/Mandible | Maxilla/Mandible |
| 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/Mac: Internet Browser-based |
| 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) | Yes | Yes |
| Analyzing study material | | |
| Arch shape | Yes | Yes |
| Wire length | No | No |
| Tooth width | No | No |
| Bolton | No | No |
| Space Analysis | No | No |
| Overjet/Overbite | Yes | Yes |
| Occlusion Map | Yes | Yes |
| Treatment Simulation | | |
| 2D | Yes | Yes |
| 3D | Yes | Yes |
| Virtual Appliance Design | | |
| Orthodontic Appliance Search | Yes | Yes |
| Orthodontic Appliance Virtual Preparation | Yes | Yes |
| Orthodontic Appliance Design | Yes | Yes |
| Orthodontic appliance 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 BRIUS Planner Software is similar to that of the BRIUS Software Suite (K191720). The only change is the addition of Sequential Aligners to the appliance design options. This difference uses the same
7
technology to produce similar files for the production of orthodontic appliances. Therefore, BRIUS Planner Software can be considered substantially equivalent to its predicate device.
Comparison of Technological Features to Predicate Devices:
Based on the above comparison, the design, construction, and performance characteristics of BRIUS Planner Software is the same as that of BRIUS Software Suite Therefore. BRIUS Planner Software can be considered (K191720). substantially equivalent to its predicate device.
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), BRIUS Planner Software underwent appropriate integration, verification, and validation testing.
Conclusion:
Based on comparison of indications for use, technological features, performance testing, and software validation testing, BRIUS Planner Software have been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate device.