(112 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the software as providing "tools for management," "systematic inspection," "detailed analysis," "treatment simulation," and "virtual design," all of which can be achieved with traditional algorithms and user input without necessarily employing AI/ML. The focus is on user-driven planning and simulation based on imported 3D scans.
No.
The "Intended Use / Indications for Use" and "Device Description" sections clearly state that the device is a planning and simulation software that provides tools for managing and analyzing orthodontic models, simulating treatment, and designing virtual dental casts. It outputs files for fabrication of aligners or retainers, but it does not directly treat the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design" and can be used for "diagnosis" as mentioned in "Mentions image processing." These functions are consistent with a diagnostic device.
Yes
The device description explicitly states it is "orthodontic planning and treatment simulation software" and its output is digital files for fabrication, indicating it is a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SoftSmile Vision's Intended Use: The intended use of SoftSmile Vision is focused on orthodontic planning, treatment simulation, and virtual design of dental casts based on 3D models of the patient's dentition. It uses surface scans of the teeth and jaw.
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from the patient's body. It works with digital models derived from scans.
- Focus on Planning and Design: The core function is to assist dental professionals in planning and designing orthodontic treatments and appliances, not to diagnose conditions based on biological samples.
Therefore, SoftSmile Vision falls under the category of a medical device used for treatment planning and design, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SoftSmile Vision 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 SoftSmile Vision requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well 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
SoftSmile Vision is orthodontic planning and treatment simulation software for use by dental professionals. SoftSmile Vision imports patient 3-D digital scans and allows the user to plan the orthodontic treatment needs of the patient and develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate by a manufacturer sequential aligner trays or retainers.
Mentions image processing
Apply digital imaging tools for use in orthodontic case archiving, diagnosis, treatment planning and CAD design of customized appliances.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface scan for intra-oral scanner
Surface scan from STL or OBJ file
2D overlay: PNG, JPG, BMP
Anatomical Site
Maxilla, Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by dental professionals in orthodontic treatment planning (before, during, and after treatment)
Dental office
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)
Software and integration verification and validation testing were 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) for a moderate level of concern software. The testing includes validation of implemented mitigations related to device hazards identified in the risk management procedures. All test results met acceptance criteria, demonstrating the Vision software performs as intended, raises no new or different questions of safety or effectiveness and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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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December 21, 2021
SoftSmile, Inc. % Allyson Mullen Director Hyman, Phelps & McNamara 700 Thirteenth Street NW. Suite 1200 Washington, District of Columbia 20005
Re: K212770
Trade/Device Name: Vision Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: September 29, 2021 Received: September 30, 2021
Dear Allyson Mullen:
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,
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) K212770
Device Name Vision
Indications for Use (Describe)
The SoftSmile Vision 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 SoftSmile Vision requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well 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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510(k) Summary: K212770
In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:
DATE: December 13, 2021
SUBMITTER:
SoftSmile, Inc. 16192 Coastal Highway, Lewes, DE 19958
PRIMARY CONTACT PERSON:
Allyson B. Mullen Hyman, Phelps, & McNamara, P.C. T 202-737-9639 F 202-737-9329
SECONDARY CONTACT PERSON:
Khamzat Asabaev CEO T (929) 289-8777
DEVICE:
TRADE NAME: Vision COMMON/USUAL NAME: Orthodontic Software CLASSIFICATION NAMES: Orthodontic Plastic Bracket REVIEW PANEL: Dental PRIMARY PRODUCT CODE: PNN ADDITIONAL PRODUCT CODE: LLZ CLASSIFICATION REGULATION: 21 C.F.R. § 872.5470 CLASS: II
PREDICATE DEVICE(S):
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DEVICE DESCRIPTION:
SoftSmile Vision is orthodontic planning and treatment simulation software for use by dental professionals. SoftSmile Vision imports patient 3-D digital scans and allows the user to plan the orthodontic treatment needs of the patient and develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate by a manufacturer sequential aligner trays or retainers.
INDICATIONS FOR USE:
The SoftSmile Vision 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 SoftSmile Vision requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
TECHNOLOGY:
The proposed Vision software has similar indications for use and uses the same fundamental technology as the legally marketed predicate devices to which substantial equivalency is claimed, the ULab Systems UDesign software (K171295).
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| Predicate Device | New Device | |
|---|---|---|
| ULab Systems UDesign | SoftSmile, Inc. Vision | |
| (K171295) | (K212770) | |
| Indications for Use | The ULab Systems UDesign 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 ULab Systems UDesign requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software. | The SoftSmile Vision 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 SoftSmile Vision requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software. |
| Predicate Device | New Device | |
| ULab Systems UDesign | SoftSmile, Inc. Vision | |
| (K171295) | (K212770) | |
| Intended Use | Used by dental professionals in orthodontic treatment planning (before, during and after treatment) Management of patients and models Inspection, measurement and analysis of orthodontic models Treatment simulation Virtual appliance preparation, handling and export Provides device output | Used by dental professionals in orthodontic treatment planning (before, during, and after treatment) Management of patients and models Inspection, measurement, and analysis of orthodontic models Treatment simulation Virtual preparation of dental casts, handling and export Provides digital file |
| Software | ||
| Environment of | ||
| Use | Dental office | Dental office |
| Software | ||
| Intended User | Dental professional | Dental professional |
| Intended Patient | ||
| Population | Patients with malocclusion | Patients with malocclusion |
| Target | ||
| Anatomic Area | Maxilla, Mandible | Maxilla, Mandible |
| Type of Patient | ||
| Contact | None | None |
| Principle of | ||
| Operation | Apply digital imaging tools for use in orthodontic case archiving, diagnosis, treatment planning and CAD design of customized appliances. The system supports the followign types of digital data: STL, JPG, BMP, PNG. | Apply digital imaging tools for use in orthodontic case archiving, treatment planning and CAD design of customized appliances. The system supports the followign types of digital data: STL, OBJ, JPG, BMP, PNG. |
| The subject device is available in OBJ file format whereas the predicate is not. | ||
| Predicate Device | ||
| ULab Systems UDesign | ||
| (K171295) | New Device | |
| SoftSmile, Inc. Vision | ||
| (K212770) | ||
| Technical | ||
| attributes | Supported PC formats: Windows 64-bit RAM: 4GB required; 8 GB recommended Monitor resolution: 1024×768 24 bit color (True Color) (Recommended – 1920 x 1080 Full HD monitor) Video Card Memory: Directx 11 or Later Compatible (Recommended – Dedicated Nvidia 1 GB) Available HDD Space: 2 GB CPU: Intel i3 3rd Generation Processor or Equivalent (Recommended – IntelCore i5 4th Generation or equivalent) | Minimum Requirements: Supported PC formats: Windows 10 64-bit RAM: 4 GB Monitor Resolution: 1280x800 or similar Video Card Memory: 2 GB or more discrete graphics card Available HDD Space: 120 GB or more CPU: IntelCore i3, AMD FX-4300 or higher |
| Management of | ||
| patient/case base | ||
| data | Allows creating, editing, deleting, copying patient/case data | Allows creating, editing, deleting, copying patient/case data |
| Collection of | ||
| Input | Surface scan for intra-oral scanner Surface scan from STL file 2D overlay: PNG, JPG, BMP | Surface scan for intra-oral scanner Surface scan from STL or OBJ file 2D overlay: PNG, JPG, BMP |
| Alignment of | ||
| Input | Aligning surface scan image Alignment of 2D overlays (e.g., ideal arch) | Aligning surface scan image Alignment of 2D overlays (e.g., ideal arch) |
| Measurement of | ||
| Input | 3D measurement toolbox | 3D measurement toolbox |
| Predicate Device | New Device | |
| ULab Systems UDesign | SoftSmile, Inc. Vision | |
| (K171295) | (K212770) | |
| Analysis of | ||
| Input | Arch shape Tooth width Bolton Space analysis Overjet/overbite Occlusion map | Arch shape Tooth width Bolton Space analysis Overjet/overbite Occlusion map |
| Treatment | ||
| simulation | 3D simulation | 3D simulation |
| Virtual | ||
| appliance design | Orthodontic dental cast search Orthodontic dental cast virtual preparation Orthodontic dental cast design Orthodontic dental cast export | Orthodontic dental cast search Orthodontic dental cast virtual preparation Orthodontic dental cast design Orthodontic dental cast export |
| Virtual | ||
| appliance | ||
| options | Dental casts | Dental casts |
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DETERMINATION OF SUBSTANTIAL EQUIVALENCE NON-CLINICAL TESTS:
Software and integration verification and validation testing were 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) for a moderate level of concern software. The testing includes validation of implemented mitigations related to device hazards identified in the risk management procedures. All test results met acceptance criteria, demonstrating the Vision software performs as intended, raises no new or different questions of safety or effectiveness and is substantially equivalent to the predicate device.
CONCLUSION:
SoftSmile, Inc. considers the Vision software to be substantially equivalent to the predicate device.