(229 days)
No
The document describes software for orthodontic planning and analysis based on 3D models, but there is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on traditional software tools for measurement, simulation, and design.
No.
The device is described as a medical front-end device providing tools for management, analysis, simulation, and virtual appliance design based on 3D models of the patient's dentition for orthodontic treatment planning and evaluation, but it does not directly treat a disease or condition. It explicitly states that "All devices are to be fabricated from FDA cleared materials by third party under the responsibility of the user." meaning it produces output for others to create the actual therapeutic devices.
Yes
The "Intended Use / Indications for Use" section states that the device provides tools for "systematic inspection, detailed analysis" and the "Device Description" explicitly mentions "orthodontic diagnosis by measuring, analysing, inspecting and visualize 3D scanned orthodontic models." These terms indicate a diagnostic function.
Yes
The device description explicitly states "3Shape's Ortho System™ is a software system". While it processes data from hardware (scanners, CT), the device itself, as described, is the software for analysis, planning, and design. The output is data for fabrication by a third party, not a physical device produced by the system itself. The performance studies mention software, hardware, and integration testing, but this is likely testing the software's interaction with necessary input hardware, not the software itself containing hardware components.
Based on the provided information, the 3Shape Ortho System™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the 3Shape Ortho System™ works with 3D models of the patient's dentition, which are derived from surface scans or CT image data. While these models represent the patient's anatomy, they are not biological specimens being examined for diagnostic purposes in the way an IVD device would analyze blood, urine, tissue, etc.
- The purpose of the device is orthodontic treatment planning and analysis. The system is used for managing models, inspection, analysis, treatment simulation, and virtual appliance design. These are activities related to planning and monitoring orthodontic treatment, not diagnosing a disease or condition by examining a biological sample.
- The output is related to treatment aids. The output includes models, metal bands, and indirect bonding transfer trays, which are used in the actual orthodontic treatment process.
Therefore, the 3Shape Ortho System™ falls under the category of a medical device used for treatment planning and design, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 applians (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 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 received a dedicated training in the use of the software.
Product codes
PNN
Device Description
3Shape's Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analysing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials by third party under the responsibility of the user.
The device has no patient contact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface scan for intra-oral scanner, Surface scan from STL file, CT image data (DICOM), 2D overlay (PNG, JPG, BMP)
Anatomical Site
Maxilla, Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical Testing: Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005). The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures. All test results have been reviewed and approved, showing the Ortho System™ to be substantially equivalent to the primary predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Janmuary 17, 2018
Image /page/0/Picture/1 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.
3Shape A/S Antje Marquardsen Director Regulatory Affairs Holmens Kanal 7 Copenhagen, 1060 Dk
Re: K171634
Trade/Device Name: Ortho System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: November 21, 2017 Received: November 24, 2017
Dear Antje Marquardsen:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Antje Marquardsen
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Mary S. Runner -S
ForTina 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
2
Indications for Use
510(k) Number (if known) K171634
Device Name Ortho System™
Indications for Use (Describe)
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 applians (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 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 received a dedicated training in the use of the software.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY – Special 510(K) – K171634
Submitter Information
| Company Name: | 3Shape A/S |
|---|---|
| Company Address: | Holmens Kanal 7 |
| DK-1060 Copenhagen K | |
| Company Phone: | |
| Company Fax: | +45 7027 2620 |
| +45 7027 2621 | |
| Contact Person: | Antje Marquardsen |
| Director, Regulatory Affairs | |
| Date Summary Prepared: | January 16, 2018 |
| Device Identification | |
| 510(k) number: | K171634 |
| Trade/proprietary Name: | Ortho System™ |
| Regulation Number: | 872.5470 |
| Regulation Name: | Orthodontic Plastic Bracket |
| Classification: | Class II |
Primary Predicate Device
The Ortho System™ intended for dental retainers has the same intended use, scientific concept, performance specification and technical characteristics as the primary predicate device 3Shape Ortho System™ (K152086) from 3Shape A/S.
Based on the information and supporting documentation provided, the Ortho System™ and the primary predicate device (K152086) have same intended use.
Both software devices are used by Dental Professionals in orthodontic treatment planning (before, during, after treatment) covering management of patients and models, inspection, 2D and 3D measurement and orthodontic analysis of models, 2D & 3D treatment simulation, as well as virtual appliance preparation, handling and export, and they are both providing device output.
Additionally, the indirect bonding functionality of both systems is intended for use with commercially available brackets and wires.
The only modifications compared to the primary predicate device, besides look and feel of the user interface, are:
-
- A workflow improvement to view present and ideal position of teeth at
4
the same time (dual view) with the introduction of arch wire in Indirect Bonding.
sshar
-
- The ScanIt Manager is used for all scanners instead of ScanIt Orthodontics and ScanIt Ortho Impression that both are retracted.
Therefore, the Ortho System™ and the predicate (K152086) are found to be similar in their intended use, supported anatomic areas and the majority of the available features and functionalities.
- The ScanIt Manager is used for all scanners instead of ScanIt Orthodontics and ScanIt Ortho Impression that both are retracted.
Reference Predicate devices
The Ortho System have two reference predicate devices K161884 and K163677, which uses the functions and tools of Ortho System™ to produce different orthodontic dental treatments than the primary predicate device. Both of these devices have the same fundamental scientific technology as the primary predicate device, as they are consolidated in the single medical software.
Based on the on the information and supporting documentation provided, the reference predicate devices do not alter the performance specification nor technical characteristics of the primary predicate device.
Indications for Use
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 received a dedicated training in the use of the software.
Device Description
3Shape's Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analysing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials by third party under the responsibility of the user.
The device has no patient contact.
5
Scientific Concept
The underlying scientific concept of the Ortho System™ is to apply digital imaging tools for in orthodontic case archiving, diagnosis, treatment planning and CAD design of customized appliances.
Virtual positioning of brackets is possible with the use of encrypted libraries of the bracket geometry provided by the manufacturers and available through a dedicated download center in the software.
The system supports the following types of digital data: DICOM, STL, JPG, BMP, PNG.
Summary of the technological characteristics
Ortho System™ is a software only device programmed in Delphi and has the following PC/laptop hardware requirements:
| Item | Minimum Requirements
Ortho System
(K171634) | Minimum Requirements
3Shape Ortho System
(K152086) |
|-------------------------|---------------------------------------------------|----------------------------------------------------------|
| OS: | Windows 7, 8 or 10 64-bit | Windows 7, 8 or 10, 64-bit |
| RAM: | 8 GB | 8 GB |
| Monitor
Resolution: | 1280x800 or similar | 1280x800 or similar |
| Video Card
Memory: | 1 GB | 1 GB |
| Available
HDD Space: | 250 GB | 250 GB |
| CPU: | Intel Core i5 or equivalent | Intel Core i5 or equivalent |
| Network: | Network Internet connection | Network Internet connection |
| Mouse: | With wheel button | With wheel button |
The Ortho System™ Software has the same intended uses and technical characteristics as the 3Shape Ortho System™ (K152086) from 3Shape A/S:
| Feature name | Ortho
System™
(K171634) | 3Shape
Ortho
System™
(K152086) |
|------------------------------------------------------|-------------------------------|-----------------------------------------|
| Supported anatomic areas | Maxilla | Maxilla |
| | Mandible | 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 |
| Feature name | Ortho
System™
(K171634) | 3Shape
Ortho
System™
(K152086) |
| Collection of study material | | |
| Surface scan for intra-oral scanner | Yes | Yes |
| Surface scan from STL file | Yes | Yes |
| CT image data | DICOM | DICOM |
| 2D overlay | PNG, JPG,
BMP | PNG, JPG, BMP |
| Alignment of study material | | |
| Aligning surface scan and CT image | Yes | Yes |
| Aligning cephalometric images | Yes | Yes |
| Alignment of 2D overlays (e.g. ideal arch) | Yes | Yes |
| Ability to check/adjust DICOM visibility | Yes | Yes |
| DICOM scan segmentation | No | No |
| Measuring study material | | |
| 2D measurement toolbox | Yes | Yes |
| 3D measurement toolbox | Yes | Yes |
| Analyzing study material | | |
| Arch shape | Yes | Yes |
| Wire length | Yes | Yes |
| Tooth width | Yes | Yes |
| Bolton | Yes | Yes |
| Space analysis | Yes | Yes |
| Overjet/overbite | Yes | Yes |
| Occlusion map | Yes | Yes |
| Treatment simulation | | |
| 2D & 3D simulation | Yes | Yes |
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ORTHO SYSTEM™ SOFTWARE - SPECIAL 510(K) SUBMISSION
зshap
7
ORTHO SYSTEM™ SOFTWARE - SPECIAL 510(K) SUBMISSION
| Feature name | Ortho
System™
(K171634) | 3Shape
Ortho
System™
(K152086) |
|-------------------------------------------|-------------------------------|-----------------------------------------|
| Virtual appliance design | | |
| Orthodontic appliance search | Yes | Yes |
| Orthodontic appliance virtual preparation | Yes | Yes |
| Orthodontic appliance design | Yes | Yes |
| Orthodontic appliance export | Yes | Yes |
Nonclinical Testing
Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005).
The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.
All test results have been reviewed and approved, showing the Ortho System™ to be substantially equivalent to the primary predicate device.
Clinical Testing
Clinical testing is not a requirement and has not been performed.
Conclusion
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Image /page/8/Picture/1 description: The image shows the logo for 3Shape. The text "3shape" is written in a dark blue sans-serif font. To the right of the text is a red triangle made up of three smaller triangles.
Based on a comparison of intended use, indications, principle of operations, features and technical data, and the test results, the Ortho System™ is found to be as safe and as effective as the primary predicate device.
Intended use and performance is found to be substantially equivalent to the primary predicate Device.