(295 days)
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.
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.
The provided text (K191720) describes the BRIUS Software Suite, an orthodontic appliance design and treatment simulation software, submitted for 510(k) clearance. The submission focuses on demonstrating substantial equivalence to a predicate device, the 3Shape OrthoSystem (K171634).
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in the manner typically seen for diagnostic performance studies (e.g., sensitivity, specificity, accuracy). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on functional specifications, technological features, and indications for use.
The "acceptance criteria" can be inferred as being functionally equivalent to the predicate device and performing as intended through verification and validation testing.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as per comparison to predicate) |
|---|---|
| Indications for Use: Similar to predicate device. | Similar: 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. It can also be applied during treatment to inspect and analyze progress and at the end of treatment to evaluate outcome consistency. Users require necessary training and domain knowledge in orthodontics. |
| Technology Features: Similar to predicate device. | Same/Similar: 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. Minimum Hardware/Software Requirements are similar. Login method is the same. |
| Functional Features: Similar to predicate device. | Similar: Manages patient/case base data, collects study material (surface scan for intraoral scanner, STL file), aligns study material, allows for treatment simulation (2D/3D), and virtual appliance design. Some differences noted in specific measurement/analysis tools (e.g., wire length, tooth width, Bolton, Space Analysis, CT image data support, specific alignment tools) and appliance search, but these differences "do not affect the ability of users to perform necessary functions within the software." |
| Safety and Effectiveness: Demonstrated through V&V testing. | Stated: "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." The conclusion states it is "appropriate for its indications for use." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any clinical test set, nor does it describe data provenance (country of origin, retrospective/prospective). The submission primarily relies on comparisons of functional and technological specifications to a predicate device and general statements about verification and validation testing of the software itself. There is no mention of a particular "test set" in the context of patient data or clinical performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. Given that the submission focuses on substantial equivalence through feature comparison and software V&V rather than a clinical performance study with a test set requiring expert ground truth, such details would not typically be included.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. As there's no described clinical test set requiring expert ground truth, no adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study being done. The document focuses on the software as a tool for orthodontists, not as an AI-assisted diagnostic aid that would typically involve a human-in-the-loop performance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the BRIUS Software Suite as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options." It is explicitly stated that "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." This indicates it's designed to be used by a qualified human user, not as a standalone AI algorithm making decisions without human oversight. Therefore, standalone (algorithm-only) performance in the sense of an independent diagnostic decision is not applicable and not reported. The "standalone software" mentioned refers to it being an independent software application, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a type of ground truth used for performance evaluation in a clinical sense. The "ground truth" implicitly referred to in the context of software validation would be that the software functions according to its specifications and requirements (e.g., calculations are correct, designs are accurate representations of inputs, outputs are in correct formats). There is no mention of ground truth established from expert consensus, pathology, or outcomes data related to patient diagnosis or treatment efficacy; the software is a planning and design tool, not a diagnostic one.
8. The sample size for the training set
The document does not mention a training set or its sample size. This type of information is typically provided for AI/ML-based devices that learn from data. While the software is for "treatment simulation" and "virtual appliance design options," it's described in terms of CAD/CAM technology rather than a machine learning model.
9. How the ground truth for the training set was established
Since there is no mention of a training set, the method for establishing its ground truth is also not provided.
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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
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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 (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
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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: | BRIUS4553 Westgrove Dr.Addison TX 75001 |
|---|---|
| Company ContactPerson: | Mehdi Roein-Peikar |
| Phone: | (888) 755.8320 |
| Email: | mehdi@brius.com |
| SubmissionCorrespondent: | 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
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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.
| Specification | BRIUS Software Suite | 3Shape OrthoSystem | ComparisonResult |
|---|---|---|---|
| Indicationfor Use | BRIUS Software Suite isintended for use as a medicalfront-end device providing toolsfor management of orthodonticmodels, systematic inspection,treatment simulation and virtualappliance design options(Patient-Specific Nitinol Wires,Export of Models, IndirectBonding Transfer Media) basedon 3D models of the patient'sdentition before the start of anorthodontic treatment. It canalso be applied during thetreatment to inspect and | The 3Shape Ortho System™is intended for use as amedical front-end deviceproviding tools formanagement of orthodonticmodels, systematic inspection,detailed analysis, treatmentsimulation and virtualappliance design options(Custom Metal Bands, Exportof Models, Indirect BondingTransfer Media) based on 3Dmodels of the patient'sdentition before the start of anorthodontic treatment. It can | Similar |
| analyze the progress of thetreatment. It can be used at theend of the treatment toevaluate if the outcome isconsistent with theplanned/desired treatmentobjectives.The use of BRIUS SoftwareSuite requires the user to havethe necessary training anddomain knowledge in thepractice of orthodontics, as wellas to have received adedicated training in the use ofthe software. | also be applied during thetreatment to inspect andanalyze the progress of thetreatment. It can be used atthe end of the treatment toevaluate if the outcome isconsistent with theplanned/desired treatmentobjectives.The use of the OrthoSystemTM requires the user tohave the necessary trainingand domain knowledge in thepractice of orthodontics, aswell as to have received adedicated training in the use ofthe software. | ||
| TechnologyFeatures | Stand Alone SoftwareModule Imports Digital PatientScans Can be used to designDental Casts Useful for Diagnosis,treatment planning, andCAD design Virtual Planning of toothmovement Supports STL Files | Stand Alone SoftwareModule Imports Digital PatientScans Can be used to designDental Casts Useful for Diagnosis,treatment planning, andCAD design Virtual Planning of toothmovement Supports STL Files | Same |
| MinimumHardware/SoftwareRequirements | 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 2.6GHz/Dual or Quad core 2.6 GHz Mouse: Any Mouse with scrollingwheel or button | OS: Windows 7, 8, 10 64-bit RAM: 8 GB Monitor Resolution:1280 X800 Video Card Memory: 1 GB Hard Drive Space: 10 GB CPU: Intel Core i5 or equivalent Mouse: with wheel button | Similar; No effect tothe 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 anatomicareas | Maxilla/Mandible | Maxilla/Mandible |
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| Intended Use | ||
|---|---|---|
| Managing Patient andcase base data | Yes | Yes |
| Collection of studymaterial | Yes | Yes |
| Alignment of studymaterial | Yes | Yes |
| Measuring studymaterial | Yes | Yes |
| Analyzing StudyMaterial | Yes | Yes |
| Treatment Simulation | Yes | Yes |
| Virtual ApplianceDesign | Yes | Yes |
| Supported PC formats | Windows/Mac: InternetBrowser-based | Windows |
| Managing patient and case base data | ||
| Creating, editing,deleting and copyingpatient data | Yes | Yes |
| Creating, editing,deleting and copyingcase data | Yes | Yes |
| Collection of study material | ||
| Surface scan forintraoral scanner | Yes | Yes |
| Surface scan from STLfile | Yes | Yes |
| CT image data(DICOM) | No | Yes |
| 2D overlay (PNG, JPG,BMP) | No | Yes |
| Alignment of study material | ||
| Aligning surface scanand CT image | No | Yes |
| Aligning CephalometricImages | No | Yes |
| Alignment of 2Doverlays | No | Yes |
| Ability to check/adjustDICOM visibility | No | Yes |
| DICOM scanSegmentation | No | No |
| 2D Measurement toolbox | No | Yes |
| 3D Measurement toolbox | 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 ApplianceSearch | No | Yes |
| Orthodontic ApplianceVirtual Preparation | Yes | Yes |
| Orthodontic ApplianceDesign | Yes | Yes |
| Orthodontic applianceExport | 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.
§ 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.