(119 days)
No
The document describes image processing and segmentation software but does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development.
No
The device is described as an image processing and segmentation software used for treatment planning and to create output files for diagnostic physical replicas, not for directly treating a condition.
Yes
The "Intended Use / Indications for Use" section states: "The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools and expert clinical judgement."
Yes
The device description explicitly states that Mimics inPrint is an "image processing and segmentation software." While the output file can be used for the fabrication of physical replicas, the device itself is the software that processes the imaging data and creates the output file. The validation studies also focus on the accuracy of the software's measurements and the ability to print accurate models from the software's output, not on the hardware of the printer itself.
Based on the provided information, Mimics inPrint is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of Mimics inPrint is to process medical imaging data (DICOM) from scanners and create output files for pre-operative planning and fabrication of physical replicas. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The output (physical replica) is used for diagnostic purposes, but the software itself is not performing the diagnostic test. The text states "The physical replica can be used for diagnostic purposes," implying the replica is a tool used in the diagnostic process, not that the software is performing the diagnostic test itself.
- The software is described as an image processing and segmentation system. This aligns with software used for medical imaging analysis and visualization, not IVD testing.
Therefore, while Mimics inPrint is a medical device used in conjunction with diagnostic processes, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mimics inPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. For this purpose, the Mimics inPrint output file can be used for the fabrication of the output file using traditional or additive manufacturing methods.
The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools and expert clinical judgement.
Product codes
LLZ
Device Description
Mimics inPrint is an image processing and segmentation software that was built on top of the Mimics application framework, an image processing and segmentation framework for the transfer of imaging information to an output file.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM imaging information from a medical scanner (CT or MRI scanner)
Anatomical Site
Orthopedic, maxillofacial and cardiovascular
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)
Non-clinical tests:
The Mimics inPrint application has been validated for its intended use to determine substantial equivalence to the predicate device. Measurement accuracy and calculate 3D study were performed and confirmed to be within specification. Validation of printing of physical replicas was performed and demonstrated that anatomical models for cardiovascular, orthopedic and maxillofacial cases can be printed accurately when using any of the compatible 3D printers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
March 21, 2018
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Materialise N.V. % Mr. Oliver Clemens Regulatory Affairs Officer Technologielaan 15 3001 Leuven BELGIUM
Re: K173619
Trade/Device Name: Mimics inPrint Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 21, 2018 Received: February 21, 2018
Dear Mr. Clemens:
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.
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.
1
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,
Michael D. O'Hara
For
Robert Ochs. Ph.L Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173619
Device Name Mimics inPrint
Indications for Use (Describe)
Mimics inPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. For this purpose, the Mimics inPrint output file can be used for the fabrication of the output file using traditional or additive manufacturing methods.
The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint 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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3
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 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Principal Contact person | Oliver Clemens |
| Contact title | Regulatory Affairs Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Mieke Janssen |
| Contact title | Senior Regulatory Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
Submission date
The date of the Traditional 510(k) submission is November 20, 2017
Submission information
| Trade Name | Mimics inPrint |
|---|---|
| Common Name | Image processing system |
| Classification Name | System, Image processing, Radiological |
| Classification product code | LLZ (892.2050) |
Predicate Devices
The primary predicate device to which substantial equivalence is claimed:
| Trade or proprietary or model name | Mimics |
|---|---|
| 510(k) number | K073468 |
| Decision date | April 2nd, 2008 |
4
| Classification product code | LLZ (892.2050) |
|---|---|
| Manufacturer | Materialise N.V. |
The reference device:
| Trade or proprietary or model name | D2P |
|---|---|
| 510(k) number | K161841 |
| Decision date | January 9th, 2017 |
| Classification product code | LLZ (892.2050) |
| Manufacturer | 3D Systems, Inc |
Description and functioning of the device
Mimics inPrint is an image processing and segmentation software that was built on top of the Mimics application framework, an image processing and segmentation framework for the transfer of imaging information to an output file.
Intended Use
Mimics inPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. For this purpose, the Mimics inPrint output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods.
The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools and expert clinical judgement.
Technological Characteristics
A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the predicate device.
Both the predicate and subject device are intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner to an output file, and can both be used as preoperative software. Both devices use the same image segmentation functionalities. Both devices generate an output file. Both devices have functionalities to perform pre-surgical planning. The subject device originates from the same code base as the predicate device; and follows the same development cycle, and testing procedures as the predicate device. The verification and validation of both predicates and subject device has been done following the same procedures and workflows.
5
The following technological differences exist between the subject and predicate device:
- . The subject device's intended use explicitly reflects 3D printing of the which can be used for diagnostic purposes in orthopedic, maxillofacial and cardiovascular applications, whereas this was only implicitly included for the primary predicate device
- . The subject device only intends to be a software for treatment planning and does not include the simulation of treatment options.
- . Whereas the primary predicate device was intended to import imaging information from a medical scanner such as CT or MRI scanner, the subject device is intended to import DICOM compliant types of imaging information.
- The subject device shares the same technology and functionality as the primary predicate device, however, functionality is organized into a user guided workflow for better user experience.
Performance Data
Non-clinical tests
The Mimics inPrint application has been validated for its intended use to determine substantial equivalence to the predicate device. Measurement accuracy and calculate 3D study were performed and confirmed to be within specification. Validation of printing of physical replicas was performed and demonstrated that anatomical models for cardiovascular, orthopedic and maxillofacial cases can be printed accurately when using any of the compatible 3D printers.
Summary
The characteristics that determine the functionality and performance of the Mimics inPrint are substantially equivalent to the devices cleared under K073468. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicate device.