(213 days)
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No
The document does not mention AI, ML, or related terms like deep learning or neural networks. The description focuses on traditional software functionalities for orthodontic planning and design.
No
The device is a software tool used for analysis, simulation, and design in orthodontics, not a physical device that delivers therapy or treatment itself.
Yes
The 'Device Description' explicitly states, "This software is for use by Dental professionals to diagnose and design solutions for patients." Additionally, the 'Intended Use / Indications for Use' states the software is used for "systematic inspection, detailed analysis, and treatment simulation." These functions are consistent with a diagnostic device.
Yes
The device description explicitly states "The Orchestrate 3D Orthodontic Software is an orthodontic appliance design and treatment simulation software." and the intended use and device description focus solely on the software's functions and outputs (STL files for 3D printing), without mentioning any accompanying hardware components that are part of the regulated device.
Based on the provided information, the Orchestrate 3D Orthodontic Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Orchestrate 3D's Function: The software processes 3D digital scans of a patient's dentition (teeth and jaws). It's used for treatment planning, simulation, and designing orthodontic appliances. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's a "front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options." This is focused on the physical structure of the teeth and jaws, not on analyzing biological samples.
- Input: The input is "Digital scans (3D) of a patient denture," which are digital representations of the physical structure, not biological specimens.
Therefore, the Orchestrate 3D Orthodontic Software falls under the category of a medical device, specifically software used in the planning and design of orthodontic treatment, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Orchestrate 3D Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 Orchestrate 3D 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 (comma separated list FDA assigned to the subject device)
PNN, LLZ
Device Description
The Orchestrate 3D Orthodontic Software is an orthodontic appliance design and treatment simulation software. This software is for use by Dental professionals to diagnose and design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate dental casts using standard stereolithographic (STL) files for use in 3D printers. Dental casts printed can then be used to manufacture sequential aligner trays and retainers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Digital scans (3D), Surface scan for intraoral scanner, Surface scan from STL file
Anatomical Site
dentition, Maxilla/Mandible
Indicated Patient Age Range
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Intended User / Care Setting
Dental professionals. The use of the Orchestrate 3D 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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 Orchestrate 3D Orthodontic Software underwent appropriate integration, verification testing. The software passed the testing and performed per its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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Orchestrate 3D % Bill Jacqmein Consultant JCO Consulting 11218 Zest Court NE Blaine, Minnesota 55449
Re: K181112
Trade/Device Name: Orchestrate 3D Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Second Product Code: LLZ Dated: October 17, 2018 Received: October 23, 2018
Dear Bill Jacqmein:
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.
11.26.18
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 07:57:41 -05'00'
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181112
Device Name Orchestrate 3D
Indications for Use (Describe)
The Orchestrate 3D Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 Orchestrate 3D 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)
| ☑ 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
K181112
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | | Orchestrate 3D
1747 North Riverside Ave
Rialto, CA 92376 |
|-------------------------------|------------------------------|-------------------------------------------------------------------------------------|
| Company Contact
Person: | | Todd Ehrler, DDS, MS |
| | Phone:
Email: | (888) 755.8320
Todd.Erhler@orchestrate3d.com |
| Submission
Correspondent: | | Bill Jacqmein, Regulatory Affairs Consultant |
| | Address:
Phone:
Email: | 11218 Zest Ct. NE, Blaine, MN 55449
(404) 216-6190
bjacqmein@rcqsolutions.com |
| Date Prepared: | | October 17, 2018 |
| Proprietary Name: | | Orchestrate 3D Orthodontic Software |
| Common Name: | | Orthodontic Plastic Brackets (Software) |
| Product Code: | | PNN – Orthodontic Plastic Brackets, LLZ – System, Image
Processing, Radiological |
| Device Classification: | | Class II, 21 CFR 872.5470 |
| Primary Predicate
Devices: | | 3Shape Ortho System (K171634) |
Device Description:
The Orchestrate 3D Orthodontic Software is an orthodontic appliance design and treatment simulation software. This software is for use by Dental professionals to diagnose and design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate dental casts using standard stereolithographic (STL) files for use in 3D printers. Dental casts printed can then be used to manufacture sequential aligner trays and retainers.
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Indications for Use:
The Orchestrate 3D Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 Orchestrate 3D 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:
Orchestrate 3D Orthodontic Software is functionally equivalent to the following predicate device: 3Shape Ortho System (K171634) cleared January 17th, 2018).
The following table demonstrates the functional specifications of Orchestrate 3D Orthodontic Software are substantially equivalent to the predicate devices.
| Specification | Orchestrate 3D Orthodontic Software | 3Shape Ortho System (K171634) | Comparison
Result |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indication for
Use | The Orchestrate 3D Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 Orchestrate 3D requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have | 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 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 System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have | Similar |
Table 1: Functional Specification Comparison
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| | received a dedicated training in the
use of the software. | 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/Software
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 | Same |
| Login Method | None Required; Uses Windows 10
Log in Security for User ID | Username and Password | Similar; No effect to the
indication for use |
| Feature Comparison | Orchestrate 3D | 3Shape (K171634) | |
|---|---|---|---|
| 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 | 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 | No | 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 |
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Comparison of Indications for Use to Predicate Devices:
Based on the above comparison, the indications for use of the Orchestrate 3D Orthodontic Software is similar to that of the 3Shape Software. The Orchestrate 3D Orthodontic 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 the
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Orchestrate 3D Orthodontic Software is similar to that of 3Shape Software. Therefore, the Orchestrate 3D Orthodontic Software 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 Orchestrate 3D Orthodontic Software underwent appropriate integration, verification testing. The software passed the testing and performed per its intended use.
Conclusion:
Based on comparison of indications for use, technological features, performance testing, and software validation testing, the Orchestrate 3D Orthodontic Software have been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate device.