(252 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on user-driven tools and simulation, not automated decision-making or learning.
No
The device is described as "orthodontic diagnosis and treatment simulation software" that provides "tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design." It helps in planning and analyzing treatment but does not directly provide therapy.
Yes
The "Device Description" explicitly states, "The ULab Systems UDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals." The "Intended Use" section also mentions "systematic inspection, detailed analysis" and its application "to inspect and analyze the progress of the treatment" and "to evaluate if the outcome is consistent with the planned/desired treatment objectives," all of which fall under diagnostic activities.
Yes
The device description explicitly states "The ULab Systems UDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals." and the output is digital files for fabrication, indicating it is a software-only device.
Based on the provided information, the ULab Systems UDesign is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- ULab Systems UDesign's Function: The ULab Systems UDesign software works with 3D digital scans of the patient's dentition. It provides tools for managing, analyzing, simulating, and designing based on these digital models. It does not involve the examination of biological specimens in vitro.
- Intended Use: The intended use clearly states its purpose is for managing orthodontic models, inspection, analysis, treatment simulation, and virtual design of dental casts based on 3D models of the dentition. This is focused on planning and designing treatment based on anatomical structure, not on analyzing biological samples for diagnostic information.
Therefore, the ULab Systems UDesign falls under the category of a medical device, specifically software for orthodontic diagnosis and treatment planning, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
PNN, LLZ
Device Description
The ULab Systems UDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. UDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly 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 sequential aligner trays or retainers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
3D digital scans
Anatomical Site
Dentition
Indicated Patient Age Range
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Intended User / Care Setting
Dental professionals / Not Found
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)
Software 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 testing includes validation of implemented mitigations related to device hazards identified in the risk management procedures. All test results met acceptance criteria, demonstrating the ULab Systems UDesign performs as intended, raises no new or different questions of risk and is substantially equivalent to the predicate device.
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 9, 2018
ULab Systems, Inc. Charlie Wen President & Chief Technology Officer 101 Jefferson Drive, Suite 212A Menlo Park, California 94025
Re: K171295
Trade/Device Name: Ulab Systems UDesign Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: November 27, 2017 Received: November 29, 2017
Dear Charlie Wen:
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.
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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 (OS) regulation (21 CFR Part 820); 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
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K171295
Device Name
ULab Systems UDesign
Indications for Use (Describe)
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 travs 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 plamed/desired treatment objectives. The use of ULab Systems UDesign requires 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
| I. Submitter Information | |
|---|---|
| Submitter name: | ULab Systems, Inc. |
| 101 Jefferson Drive | |
| Suite 212A | |
| Menlo Park, CA 95025 | |
| Contact person: | Charlie Wen |
| President & CTO of ULab Systems, Inc, | |
| Email: charlie@ulabsystems.com | |
| Phone : (650) 868-4935 | |
| Date Prepared: | 27 November 2017 |
| II. Product Classification | |
| t | TY 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
| TT |
| Device Name: | ULab Systems UDesign |
|---|---|
| Common Name: | Orthodontic Software |
| CFR Classification: | 21 CRF 872.5470 |
| Device Class: | II |
| Product Code: | PNN, LLZ |
III. Predicate Device
Predicate: 3Shape Ortho System (K152086), 3Shape A/S
IV. Device Description
The ULab Systems UDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. UDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly 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 sequential aligner trays or retainers.
V. 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.
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VI. Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device
The subject and the predicate devices share the same intended use as software used by dental professionals in orthodontic treatment planning for management of patients and orthodontic models; inspection, measurement and analysis of the models; treatment simulation; preparation and export of a series of virtual dental casts.
The subject and predicate device are based on the following same technological elements:
- . Both are stand-alone software designed for use in management of 3D orthodontic models from patient scans;
- Both may be used to design a series of dental casts;
- Both apply digital imaging tools based on 3D orthodontic models for in orthodontic case archiving, diagnosis, treatment planning and CAD design;
- . Both provide virtual planning of orthodontic treatments simulating tooth movements;
- Both support stereolithography (STL file format).
Whereas the predicate device designs custom metal bands, indirect bonding transfer trays and dental casts, the subject device designs only dental casts. The predicate device additionally accepts inputs in multiple formats; the subject device only accepts STL file formats.
VII. Performance Data
Software 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 testing includes validation of implemented mitigations related to device hazards identified in the risk management procedures.
All test results met acceptance criteria, demonstrating the ULab Systems UDesign performs as intended, raises no new or different questions of risk and is substantially equivalent to the predicate device.
VIII. Conclusions
The ULab Systems UDesign has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the ULab Systems UDesign is substantially equivalent to the cleared predicate device.