(201 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on automated segmentation and basic analysis without mentioning AI/ML techniques.
No.
The Align Studio is described as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options." It is a PC-based software for virtual orthodontics; it does not directly apply therapy to a patient.
No
The device is described as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options." It assists in digital orthodontic procedures and treatment planning, rather than diagnosing a disease or condition. While it performs "basic model analysis," its primary function is geared towards treatment preparation and simulation for orthodontics, not disease diagnosis.
Yes
The device is described as "PC-based software" and its function is centered around processing digital models and images for orthodontic planning, without mentioning any accompanying hardware components developed or sold as part of the device.
Based on the provided information, the Align Studio is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Align Studio's Function: The Align Studio works with images and 3D models of the patient's dentition. It processes surface scans, CT data, and 2D overlays. It does not analyze biological specimens.
- Intended Use: The intended use is for managing orthodontic models, analysis, treatment simulation, and virtual appliance design based on these models. This is related to planning and designing treatment based on anatomical structure, not analyzing biological markers.
Therefore, the Align Studio falls under the category of a medical device used for planning and design based on imaging data, not an IVD device.
N/A
Intended Use / Indications for Use
The Align Studio 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 based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment.
The use of the Align Studio requres 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
Align Studio is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
Mentions image processing
Yes
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)
Anatomical Site
Dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 Test Summary:
-
Software Validation
Align Studio contains Basic Documentation Level software was designed and developed according to a software development process and was verified and validated.
The software information is provided in accordance with FDA guidance: Content of premarket submissions for Device Software Functions, on November 04, 2021. -
Performance Testing
Through the performance test, it was confirmed that Align Studio meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 12, 2024
Laon Medi Inc. Mina Yun Quality Management Representative 404, Bundang Techno Park B, 723, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do 13511 SOUTH KOREA
Re: K232564
Trade/Device Name: Align Studio Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: January 12, 2024 Received: January 12, 2024
Dear Mina Yun:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
510(k) Number (if known) K232564
Device Name Align Studio
Indications for Use (Describe)
The Align Studio 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 based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment.
The use of the Align Studio requres 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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4
Image /page/4/Picture/0 description: The image shows the logo for LAON iMEDI. The text is in a sans-serif font, with the letters "LAON" and "MEDI" in green. The "i" in "iMEDI" is orange. The logo is simple and modern.
404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongna
+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com
K232564
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
August 24, 2023
Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2.
-
Name of Manufacturer: LAON MEDI Inc.
-
Address: 404, Bundang Techno Park B, 723, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggido, 13511 Republic of Korea / Tel: 031-8017-7145
-
Contact Name: Mina Yun
-
Telephone No.: +82 10 3953 4808
-
Fax No.: +82 31 701 8863
-
may@laon-medi.com - Email Address:
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade name: Align Studio
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Orthodontic Software | 872.5470 | PNN |
| System, Image Processing, Radiological | 892.2050 | LLZ |
As stated in 21 CFR, parts 872.5470 and 892.2050, this generic types of devices has been classified as Class II.
5
Image /page/5/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in green, followed by "iMEDI" also in green, but with a small orange square above the "i". The logo is simple and modern, with a focus on the company name.
404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, C
+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow:
Predicate device #1
- 510(k) Number: K180941
- . 3Shape A/S Applicant:
- Classification Name: Orthodontic Software
- Trade Name: Ortho System
Predicate device #2
- 510(k) Number: K171122
- Applicant: Dentsply Sirona
- Classification Name: ● Orthodontic Software
- Trade Name: CEREC Ortho Software ●
ട. Description of the Device [21 CFR 807.92(a)(4)]
Align Studio is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
Indications for Use [21 CFR 807.92(a)(5)] 6.
The Align Studio 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 (Export of Models, Indirect Bonding Transfer Media) based on 3Dmodels 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 Align Studio 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.
6
Image /page/6/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in large, green, sans-serif font. To the left of the "M" in "MEDI" is a small orange square. The rest of the text, "MEDI", is in the same green font as "LAON".
404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, Gyeonggi-do, 13511 Korea
+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences between Align Studio and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE
Decision |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| K Number | - | K180941 | K171122 | - |
| Manufacturer | LAON MEDI Inc. | 3Shape A/S | Dentsply Sirona | - |
| Model | Align Studio | Ortho System | CEREC Ortho Software | - |
| Intended Use | The Align Studio 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 (Export of
Models, Indirect
Bonding Transfer Media)
based on 3Dmodels 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 Align
Studio 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. | Ortho System™ for
dental retainers and
dental cast for sequential
aligners 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 based on 3D
models of the patient's
dentition before the start
of an orthodontic
treatment.
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. | CEREC Ortho Software
is intended for use with
image data acquired from
handheld intra oral 3D
cameras and desktop
laboratory scanners to
create 3D virtual models
to be used for data
acquisition and modeling
analysis for orthodontic
patients and conditions.
The CEREC Ortho
Software 3D model data
can be exported to
orthodontic design
software to aid in the
design of orthodontic
appliances. | Same |
| Module | Imports scanned image
of patient | Imports scanned image
of patient | Imports scanned image
of patient | Same |
| | Stand-alone software
module | Stand-alone software
module | Stand-alone software
module | |
| | Can be used to design
dental casts | Can be used to design
dental casts | Can be used to design
dental casts | |
| | Useful for diagnosis,
treatment planning, and
CAD design | Useful for diagnosis,
treatment planning, and
CAD design | Useful for diagnosis,
treatment planning, and
CAD design | |
| | Virtual planning of tooth
movement | Virtual planning of tooth
movement | Virtual planning of tooth
movement | Same |
| | Supports .stl files | Supports .stl files | Supports .stl files | |
| Managing
patient and
case base data | Creating, editing,
deleting and copying
patient data | Creating, editing,
deleting and copying
patient data | Creating, editing,
deleting and copying
patient data | Same |
| | Creating, editing,
deleting and copying
case data | Creating, editing,
deleting and copying
case data | Creating, editing,
deleting and copying
case data | |
| Collection of
study material | - | Surface scan for intra-
oral scanner | Surface scan for intra-
oral scanner | Same |
| | Surface scan from STL
file | Surface scan from STL
file | Surface scan from STL
file | |
| | CT image data(DICOM) | CT image data(DICOM) | - | |
| | - | 2D overlay(PNG, JPG,
BMP) | - | |
| | Creation of virtual 3D
virtual dental models | Creation of virtual 3D
virtual dental models | Creation of virtual 3D
virtual dental models | |
| Alignment of
study material | Aligning surface scan or
CT image | Aligning surface scan or
CT image | Creation of virtual 3D
virtual dental models | Same |
| | Aligning cephalometric
images | Aligning cephalometric
images | - | |
| | - | Alignment of 2D
overlays | - | |
| | Ability to check/adjust
DICOM visibility | Ability to check/adjust
DICOM visibility | | |
| Measuring
study material | - | 2D measurement toolbox | - | Same |
| | 3D measurement toolbox | 3D measurement toolbox | 3D measurement toolbox | |
| | Definition of dental Arch shape & length | Definition of dental Arch shape & length | - | |
| Analyzing
study material | - | Wire length | Wire length | |
| | Tooth width
measurements | Tooth width
measurements | - | |
| | Tooth and gingiva
separation/segmentation | - | Tooth and gingiva
separation/segmentation | Same |
| | Bolton's analysis | Bolton's analysis | Bolton's analysis | |
| | Space analysis | Space analysis | Space analysis | |
| | Overjet/overbite | Overjet/overbite | - | |
| | Occlusal mapping | Occlusal mapping | Occlusal mapping | |
| | Treatment
simulation | - | 2D simulation | - |
| 3D simulation | | 3D simulation | - | |
7
Image /page/7/Picture/0 description: The image shows the logo for LAON iMEDI. The text is in a sans-serif font, with the letters "LAON" and "MEDI" in green. The "i" in "iMEDI" has a small orange square above it, in place of the dot. The logo is simple and modern, and the colors are eye-catching.
404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, Gyeonggi-do, 13511 Korea
+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com
8
Image /page/8/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in green, followed by "iMEDI" also in green, but with a small orange square above the "i". The font is bold and sans-serif.
404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, Gyeonggi-do, 13511 Korea
+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com
9
Image /page/9/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in green, followed by a small orange square above the "i" in "iMEDI", which is also in green. The logo is simple and modern, with a focus on the company name.
404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si,
+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
1) Software Validation
Align Studio contains Basic Documentation Level software was designed and developed according to a software development process and was verified and validated.
The software information is provided in accordance with FDA guidance: Content of premarket submissions for Device Software Functions, on November 04, 2021.
-
- Performance Testing
Through the performance test, it was confirmed that Align Studio meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device.
- Performance Testing
Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
Conclusion [21 CFR 807.92(b)(3)]
Based on a comparison of intended use, indications, principle of operations, features and technical data, and the test results, the Align Studio is found to be as safe and as effective as the predicate device.
Intended use and performance is found to be substantially equivalent to the predicate device, Ortho System (K180941) from 3Shape A/S and CEREC Ortho Software (K171122) from Dentsply Sirona.