(246 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional software functions like measurement, analysis, simulation, and design based on user input and 3D models. There is no mention of learning, adaptation, or data-driven decision making characteristic of AI/ML.
No
The device is orthodontic software used for management, analysis, and simulation, not for direct therapeutic intervention. It aids in the design of therapeutic devices, but is not one itself.
Yes
The "Device Description" section states that the software is used for "orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models".
Yes
The device description explicitly states it is a "software system" and the performance studies section mentions "Software, hardware, and integration verification and validation testing," implying the software is a distinct component that is validated, even if it interacts with hardware (scanners, potentially computers). The core functionality described is software-based manipulation and analysis of 3D models.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The PlaniMax Orthodontic Software works with 3D models of the patient's dentition, which are derived from surface scans. These are not biological specimens taken from the body for analysis of disease or condition.
- The intended use is for orthodontic planning and design. The software is used for managing models, analysis, treatment simulation, and designing appliances. This is a planning and design tool for a medical procedure (orthodontics), not a diagnostic test performed on a biological sample.
- The input modalities are surface scans and image files. These are not typical inputs for IVD devices, which usually involve analyzing biological samples like blood, urine, or tissue.
The software is clearly intended as a tool for orthodontic practitioners to plan and manage treatment based on anatomical models, not to diagnose a condition by analyzing biological samples.
N/A
Intended Use / Indications for Use
The PlaniMax 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 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 PlaniMax 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 PlaniMax Orthodontic Software for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models , virtual planning of orthodontic treatments by simulating tooth movements , and design of orthodontic appliances based on 3D scanned orthodontic models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface scan for intraoral scanner, Surface scan from STL file, 2D overlay (PNG, JPG, BMP)
Anatomical Site
Maxilla/Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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)
Non-Clinical 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 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 PlaniMax to be substantially equivalent to the reference devices.
Clinical Testing: Clinical testing is not a requirement and has not been performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
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December 22, 2020
Choice Biotech Inc. Tyler Kuo RD Vice President Rm. C. 4F. No.13. Nanke 3rd Rd., Xinshi Dist. Tainan City, 74147 Taiwan
Re: K201036
Trade/Device Name: PlaniMax Orthodontic Software Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: July 20, 2020 Received: July 27, 2020
Dear Tyler Kuo:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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 Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201036
Device Name PlaniMax
Indications for Use (Describe)
The PlaniMax 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 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 PlaniMax 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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3
Image /page/3/Picture/0 description: The image shows the logo for CHOICE Biotech. The word "CHOICE" is written in a stylized font, with the "O" replaced by a circle with a plus sign inside. To the right of "CHOICE" is the word "Biotech", with some smaller Chinese characters above it. The logo is in a dark color, possibly black or dark blue, against a white background.
510(k) Summary
This summary of 510(k) safety and effectiveness information in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR 807.92. The assigned 510(k) number is_K201036
| Submitter: | CHOICE BIOTECH INC.
Rm. C, 4F, No.13, Nanke 3rd Rd., Xinshi Dist.,
Tainan City 74147, Taiwan
Phone: +886-6-505-7289
Fax: +886-6-505-7301 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tyler Kuo / RD Vice President
Email: tylerkuo@mail.wearechoice.com
Phone: +886-6-505-7289 |
| Date Prepared: | December 21st, 2020 |
| Proprietary Name: | PlaniMax Orthodontic Software |
| Common Name: | Orthodontic Plastic Bracket (Software) |
| CFR Classification: | 21 CFR 872.5470 |
| Device Class: | II |
| Product Code: | PNN |
| Panel: | Dental |
| Primary Predicate: | Ortho System from 3ShapeA/S (K171634) |
4
Device Description:
The PlaniMax Orthodontic Software for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models , virtual planning of orthodontic treatments by simulating tooth movements , and design of orthodontic appliances based on 3D scanned orthodontic models.
Indications for Use:
The PlaniMax 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 PlaniMax 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.
Summary of the technological characteristics:
PlaniMax Orthodontic Software is functionally equivalent to the following predicate device: Ortho System (K171634) cleared January 17th, 2018.
The following tables demonstrates the intended uses and technical characteristics of PlaniMax Orthodontic Software are substantially equivalent to the predicate devices.
5
CHOICE
Functional Specification Comparison Table for the PlaniMax Software and Ortho System (K171634) :
| Specification | PlaniMax | Ortho System
(K171634) | Comparison
Result |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The PlaniMax 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 PlaniMax
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 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
received a dedicated training in the
use of the software. | Similar.
Compare to the
predicate device,
the virtual
appliance design
options of
PlaniMax is
including dental
casts, which
may be used for
sequential
aligner trays or
retainers. |
| 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 7 32-bit or later
• RAM: 4 GB
• Monitor Resolution: 1024 X
768
• Video Card Memory: 1 GB
• Hard Drive Space: 100 GB
• CPU: Intel Core i3 or
equivalent
• Network: Network Internet
connection
• Mouse: Any Mouse with
scrolling wheel or button | • OS: Windows 7, 8 or 10 64-bit
• RAM: 8 GB
• Monitor Resolution: 1280 X
800
• Video Card Memory: 1 GB
• Hard Drive Space: 250 GB
• CPU: Intel Core i5 or
equivalent
• Network: Network Internet
connection
• Mouse: Any Mouse with
scrolling wheel or button | Similar. No
effect to the
indications for
use. |
| Feature | PlaniMax | Ortho System
(K171634) | |
| Supported anatomic | 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 | |
| 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) | Yes | Yes | |
| Alignment of study material | | | |
| Aligning surface scan and CT image | No | Yes | |
| Aligning Cephalometric Images | Yes | Yes | |
| Alignment of 2D overlays | Yes | Yes | |
| Ability to check/adjust DICOM visibility | No | Yes | |
| DICOM scan Segmentation | No | No | |
| Measuring study material | | | |
| 2D Measurement tool box | Yes | Yes | |
| 3D Measurement tool box | 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 | |
| Feature | PlaniMax | Ortho System
(K171634) | |
| Occlusion Map | Yes | Yes | |
| Treatment Simulation | | | |
| 2D & 3D simulation | 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 | |
The PlaniMax Software has the same intended uses and technical characteristics as the Ortho
6
CHGICE智慧
System (K171634):
7
Non-Clinical 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 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 PlaniMax to be substantially equivalent to the reference devices.
Clinical Testing:
Clinical testing is not a requirement and has not been performed.
Conclusion:
Based on comparison of indications for use, technological features, performance testing, and software validation test results, the PlaniMax Orthodontic Software is found to be substantially equivalent to the predicate device.