(564 days)
No
The description focuses on traditional image processing, segmentation, measurement, and design tools. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or automated decision-making based on learned patterns. The performance studies also focus on geometrical accuracy and equivalence to predicate devices, not on AI/ML performance metrics.
No.
This device is a software for diagnostic and treatment planning of maxillofacial procedures, and its output can be used for fabrication of diagnostic models; it does not directly perform therapy.
Yes
The intended use explicitly states, "The fabricated output can be used for diagnostic purposes in the field of maxillofacial applications," and the device description mentions it is "an image processing software for the diagnosis and treatment planning of maxillofacial procedures."
Yes
The device description explicitly states it is "image processing software" and details various software functionalities like importing, visualizing, segmenting, measuring, planning, and designing. While it mentions outputting files for fabrication of physical models, the device itself is the software that creates these digital models. The performance studies focus on software verification and validation and comparisons of virtual models, further supporting its software-only nature.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside of the body (in vitro).
- Intended Use and Device Description: The intended use and device description clearly state that Mimics Enlight CMF is a software interface and imaging segmentation system used for processing medical images (like DICOM) and creating digital 3D models for diagnostic and treatment planning purposes in maxillofacial procedures. It also facilitates the fabrication of physical anatomical models from these digital models.
- Lack of Biological Sample Testing: There is no mention of the device being used to analyze biological samples or perform any tests on bodily fluids or tissues. Its function is centered around processing and visualizing medical imaging data.
- Focus on Imaging and Planning: The core functionalities described are image import, visualization, segmentation, measurement, treatment planning, and design of digital models. These are all related to the interpretation and manipulation of medical images and the planning of surgical procedures, not the analysis of biological samples.
While the output file can be used for the fabrication of physical models that can be used for "diagnostic purposes," this refers to the use of the physical model itself as a visual aid or tool in the diagnostic process, not the device performing an in vitro diagnostic test on a sample.
Therefore, Mimics Enlight CMF falls under the category of medical imaging software and surgical planning software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Materialise Mimics Enlight CMF:
Mimics Enlight CMF is intended for use as a software interface and imaging segmentation system for the transfer of medical imaging information to an output file.
Mimics Enlight CMF is also intended to support the diagnostic and treatment planning process of maxillofacial procedures. For this purpose, Mimics Enlight CMF provides visualization, measurement and design tools.
The Mimics Enlight CMF output file can be used for the fabrication of the output file using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of maxillofacial applications.
Mimics Enlight CMF should be used in conjunction with other diagnostic tools and expert clinical judgement.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, DZJ
Device Description
Mimics Enlight CMF is an image processing software for the diagnosis and treatment planning of maxillofacial procedures. Mimics Enlight CMF allows the user to import, visualize and segment medical images. Mimics Enlight CMF also allows the user to perform measurements, treatment planning and occlusal splint design. Mimics Enlight CMF allows the user to output digital 3D models of the anatomy to be used for fabrication of physical anatomical models. Mimics Enlight CMF is structured as a modular package consisting of separate workflows for the diagnosis and treatment planning of various indications within the maxillofacial field. The workflows in Mimics Enlight CMF are built on the Mimics Enlight platform. The workflows in Mimics Enlight CMF cover following steps and functionality in the diagnostic and treatment planning process of maxillofacial procedures:
Digital 3D model creation
- . Importing medical images in DICOM format and other formats
- Viewing images and DICOM data
- Selecting a region of interest using generic segmentation tools
- . Verifying and editing a region of interest
- . Calculating a digital 3D model and editing the model
- . Creating composite models by combining medical image information and dental information using registration tools
- Exporting digital 3D models for additive manufacturing (3D printing) of physical replicas (anatomical models)
Planning
- Indicating nerves and cephalometric landmarks
- . Setting the natural head position
- Planning the treatment by cutting the models and repositioning the parts
- Setting the occlusion digitally or by importing an occlusion model ●
- Measuring on images and digital 3D models
- Simulating the soft tissue of the face after the planned treatment
Design
- Designing personalized digital occlusal splints using generic design and finishing tools ●
User fabrication using additive manufacturing (3D printing) of physical replicas includes only fabrication of anatomical models and does not include additive manufacturing of occlusal splints.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM format and other formats
Anatomical Site
maxillofacial
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)
Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user validation and bench testing were performed.
To evaluate the geometrical accuracy of the subject device, virtual models were compared with those of the predicate device. The results revealed no deviations in the virtual models, demonstrating substantial equivalency between the two devices.
For the predicate device, the geometrical accuracy of physical replicas was assessed by comparing virtual models with the optical scans of the physical models. The deviations were found to be within the acceptance criteria, indicating that the virtual models can be printed accurately using one of the compatible 3D printers.
As the virtual models of the predicate and subject devices showed no significant deviations, it can be concluded that compatible 3D printers can produce accurate results for the subject device as well.
Additional testing was done for the soft tissue simulation in the subject device Mimics Enlight CMF. The test demonstrated that the soft tissue simulation in Mimics Enlight CMF is equivalent to the soft tissue simulation in the reference device Proplan CMF (K111641).
In conclusion, all performance testing conducted device performance and substantial equivalence 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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
May 31, 2024
Materialise NV Victoria Becheva Regulatory Affairs Specialist, Medical Technologielaan 15 Leuven, 3001 Belgium
Re: K223427
Trade/Device Name: Mimics Enlight CMF Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, DZJ Dated: Mav 24, 2024 Received: May 24, 2024
Dear Victoria Becheva:
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.
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"
1
(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 OS 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).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
2
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) K223427
Device Name Materialise Mimics Enlight CMF
Indications for Use (Describe) Materialise Mimics Enlight CMF:
Mimics Enlight CMF is intended for use as a software interface and imaging segmentation system for the transfer of medical imaging information to an output file.
Mimics Enlight CMF is also intended to support the diagnostic and treatment planning process of maxillofacial procedures. For this purpose, Mimics Enlight CMF provides visualization, measurement and design tools.
The Mimics Enlight CMF output file can be used for the fabrication of the output file using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of maxillofacial applications.
Mimics Enlight CMF should be used in conjunction with other diagnostic tools and expert clinical judgement.
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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510(k) Summary - K223427
510(k) Summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | +32 16 744 571 |
| Fax number | +32 16 39 66 06 |
| Principal Contact person | Victoria Becheva |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | Regulatory. Affairs@materialise.be |
| Additional contact person | Polliane Carvalho |
| Contact title | Regulatory Affairs Specialist |
| Additional contact person | Jenny Jones |
| Contact title | Global Quality & Regulatory Manager, Medical |
| Contact e-mail address | Jenny.Jones@materialise.com |
Submission date
The date of the Traditional 510(k) submission is November 09, 2022. The Summary was prepared on May 23, 2024.
Submission information
| Trade Name | Mimics Enlight CMF |
|---|---|
| Common Name | Image processing system |
| Classification Name | System, Image processing, Radiological |
| Classification product code | LLZ (892.2050), DZJ (872.4120) |
Predicate Devices
The primary predicate device to which substantial equivalence is claimed:
| Trade or proprietary or model name | Materialise Mimics Medical, Mimics Medical, Mimics |
|---|---|
| 510(k) number | K183105 |
| Decision date | 03/27/2019 |
| Classification product code | LLZ (892.2050) |
| Manufacturer | Materialise N.V. |
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Reference device
| Trade or proprietary or model name | SurgiCase, SurgiCase CMF, ProPlan CMF |
|---|---|
| 510(k) number | K111641 |
| Decision date | 09/26/2011 |
| Classification product code | LLZ (892.2050) |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | OsteoPlan System |
|---|---|
| 510(k) number | K212570 |
| Decision date | 02/12/2022 |
| Classification product code | DZJ (872.4120) |
| Manufacturer | OsteoMed |
Description and functioning of the device
Mimics Enlight CMF is an image processing software for the diagnosis and treatment planning of maxillofacial procedures. Mimics Enlight CMF allows the user to import, visualize and segment medical images. Mimics Enlight CMF also allows the user to perform measurements, treatment planning and occlusal splint design. Mimics Enlight CMF allows the user to output digital 3D models of the anatomy to be used for fabrication of physical anatomical models. Mimics Enlight CMF is structured as a modular package consisting of separate workflows for the diagnosis and treatment planning of various indications within the maxillofacial field. The workflows in Mimics Enlight CMF are built on the Mimics Enlight platform. The workflows in Mimics Enlight CMF cover following steps and functionality in the diagnostic and treatment planning process of maxillofacial procedures:
Image /page/5/Figure/5 description: This image shows a diagram of the process for creating personalized splints using 3D printing. The process starts with a patient, who undergoes imaging. The images are then used for segmentation and 3D model creation, followed by planning and design of personalized splints using Mimics Enlight CMF. Finally, the splints are 3D printed and used for treatment.
Digital 3D model creation
- . Importing medical images in DICOM format and other formats
- Viewing images and DICOM data
- Selecting a region of interest using generic segmentation tools
- . Verifying and editing a region of interest
6
- . Calculating a digital 3D model and editing the model
- . Creating composite models by combining medical image information and dental information using registration tools
- Exporting digital 3D models for additive manufacturing (3D printing) of physical replicas (anatomical models)
Planning
- Indicating nerves and cephalometric landmarks
- . Setting the natural head position
- Planning the treatment by cutting the models and repositioning the parts
- Setting the occlusion digitally or by importing an occlusion model ●
- Measuring on images and digital 3D models
- Simulating the soft tissue of the face after the planned treatment
Design
- Designing personalized digital occlusal splints using generic design and finishing tools ●
User fabrication using additive manufacturing (3D printing) of physical replicas includes only fabrication of anatomical models and does not include additive manufacturing of occlusal splints.
Indications for Use
Mimics Enlight CMF is intended for use as a software interface and imaging segmentation system for the transfer of medical imaging information to an output file.
Mimics Enlight CMF is also intended to support the diagnostic and treatment planning process of maxillofacial procedures. For this purpose, Mimics Enlight CMF provides visualization, measurement and design tools.
The Mimics Enlight CMF output file can be used for the fabrication of physical replicas of the using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of maxillofacial applications.
Mimics Enlight CMF should be used in conjunction with other diagnostic tools and expert clinical judgement.
Comparison of Technological Characteristics with the Predicate Device
The subject device employs similar fundamental technologies as the predicate device.
Technological similarities include:
Device functionality: The image information, the measuring and planning functionality, the processing to output file are the same for the subject device as for the predicate device.
Software technology: The subject device has the same code base as the predicate device and uses the same methods for design and verification and validation as the predicate device.
Following technological differences exist between the subject device software and the predicate device software:
The main difference between the subject device and previously cleared device, K183105 is that the subject device's intended use is limited to -maxillofacial applications, whereas the primary predicate device covers a broader field of orthopedic, maxillofacial and cardiovascular applications.
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The subject software technology differences have been demonstrated that they do not affect the safety or effectiveness, or that they do not raise any new issues regarding to the safety and effectiveness compared to the predicate device.
Performance Data
Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user validation and bench testing were performed.
To evaluate the geometrical accuracy of the subject device, virtual models were compared with those of the predicate device. The results revealed no deviations in the virtual models, demonstrating substantial equivalency between the two devices.
For the predicate device, the geometrical accuracy of physical replicas was assessed by comparing virtual models with the optical scans of the physical models. The deviations were found to be within the acceptance criteria, indicating that the virtual models can be printed accurately using one of the compatible 3D printers.
As the virtual models of the predicate and subject devices showed no significant deviations, it can be concluded that compatible 3D printers can produce accurate results for the subject device as well.
Additional testing was done for the soft tissue simulation in the subject device Mimics Enlight CMF. The test demonstrated that the soft tissue simulation in Mimics Enlight CMF is equivalent to the soft tissue simulation in the reference device Proplan CMF (K111641).
In conclusion, all performance testing conducted device performance and substantial equivalence to the predicate device.
Summary
A comparison of intended use and technological characteristics combined with performance data demonstrates that Mimics Enlight CMF is substantially equivalent to the predicate device Mimics (K183105), the primary predicate device, and also substantially equivalent to its reference devices Proplan CMF (K111641) and OsteoPlan System (K212570). Minor differences in intended use and technological characteristics exist, but performance data demonstrates that Mimics Enlight CMF is as safe and effective and performs as well as the predicate device.