(208 days)
Not Found
No
The document describes standard image viewing, manipulation, storage, and analysis tools common in PACS and medical imaging software. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or other sections. The functionality described is based on user-controlled tools and standard image processing techniques.
No.
The device is described as a medical diagnostic application for viewing, manipulation, and comparison of medical images, and for providing analytical tools to help assess and document disease stages and response to therapy. It does not provide treatment or therapy directly.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Mint Lesion is a medical diagnostic application for viewing, manipulation and comparison of medical images..."
Yes
The device description explicitly states "Mint Lesion is a software only medical device" and "mint Lesion™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware". It is delivered on CDROM/DVD for installation, further indicating it is a software product.
Based on the provided information, Mint Lesion is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Mint Lesion's Function: Mint Lesion is a software solution that processes and visualizes medical images (CT, MR, PET, SPECT). It works with images acquired from imaging modalities, not with samples taken from the body.
- Intended Use: The intended use clearly states it's for "viewing, manipulation, storage, 3Dvisualization and comparison of medical images." It supports the interpretation and evaluation of examinations and follow-up documentation, but it does not perform tests on biological samples.
- Device Description: The device description reinforces that it's a "software based Picture Archiving and Communication System (PACS)" for displaying and visualizing medical image data.
Therefore, Mint Lesion falls under the category of medical imaging software or a PACS system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mint Lesion is a software solution intended to be used for viewing, manipulation, storage, 3Dvisualization and comparison of medical images from multiple imaging multiple time-points. Mint Lesion is a software only medical device which will be delivered on CDROM / DVD to be installed by trained service personnel.
Mint Lesion is a medical diagnostic application for viewing, manipulation and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MPR, MIP and volume rendering.
Mint Lesion enables visualization of information that would otherwise have to be visually compared disjointedly. Mint Lesion provides analytical tools to help the user assess, and document the stage of a disease and/or the response to therapy in accordance with user selected standards. Mint Lesion supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and Nuclear Medicine environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Mint Lesion is a complement to these standard procedures. Mint Lesion is not to be used in mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
mint Lesion™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It runs on either a native or a virtualized Microsoft Windows platform.
mint Lesion™ functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including anatomical datasets (e.g. CT, MRI) and functional datasets (e.g. PET), lesion measurement, tabulation and summation of measurements, lesion categorization and standard evaluation in accordance with radiological staging and response criteria, and generation of a structured report. The user controls these functions with a system of interactive menus and tools.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare institutions, for example, in Radiology, Oncology, and Nuclear Medicine environments.
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)
Not Found
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
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mint Medical GmbH % Mr. Matthew Stevens Counsel 135 Montgomery Street, Suite 18J JERSEY CITY NJ 07302
Re: K142647 Trade/Device Name: mint Lesion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 9, 2015 Received: March 9, 2015
Dear Mr. Stevens:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number K142647
Device Name mint Lesion
Indications for Use
Mint Lesion is a software solution intended to be used for viewing, manipulation, storage, 3Dvisualization and comparison of medical images from multiple imaging multiple time-points. Mint Lesion is a software only medical device which will be delivered on CDROM / DVD to be installed by trained service personnel.
Mint Lesion is a medical diagnostic application for viewing, manipulation and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MPR, MIP and volume rendering.
Mint Lesion enables visualization of information that would otherwise have to be visually compared disjointedly. Mint Lesion provides analytical tools to help the user assess, and document the stage of a disease and/or the response to therapy in accordance with user selected standards. Mint Lesion supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and Nuclear Medicine environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Mint Lesion is a complement to these standard procedures. Mint Lesion is not to be used in mammography.
| Type of Use | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Mint Medical. The logo consists of a green leaf on the left side and the words "mint medical" on the right side. The word "mint" is in a larger, bolder, and lighter green font than the word "medical", which is in a smaller, thinner, and darker gray font.
5 510(k) Summary
Identification of the Submitter
| Submitter: | Dr. Jochen Neuhaus, Regulatory Affairs Manager
Mint Medical GmbH
Friedrich-Ebert-Str. 2
69221 Dossenheim / Heidelberg
Baden-Württemberg
Germany |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Phone: | (+49) 622-164-797-60 |
| Submitter's Fax: | (+49) 622-164-797-68 |
| Name / Address of Manufacturer: | Mint Medical GmbH
Friedrich-Ebert-Str. 2
69221 Dossenheim / Heidelberg
Baden-Württemberg
Germany |
| Date of Submission: | 12th of September 2014 |
Identification of the product
| Proprietary Name: | mint Lesion |
|---|---|
| Common Name: | Image Processing Software |
| Classification: | Picture Archiving and Communication System per 21 |
| CFR 892.2050 | |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | Class II |
4
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| OncoTrac | ||
| (Primary Predicative Device) | Mint Medical GmbH | |
| Germany | K111642 (Nov 18, 2011) | |
| Syngo.via MI Workflows | Siemens Medical | |
| Solutions USA, Inc | K133644 (Feb 25, 2014) |
Marketed Devices to which Equivalence is claimed
Device Description
mint Lesion™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It runs on either a native or a virtualized Microsoft Windows platform.
mint Lesion™ functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including anatomical datasets (e.g. CT, MRI) and functional datasets (e.g. PET), lesion measurement, tabulation and summation of measurements, lesion categorization and standard evaluation in accordance with radiological staging and response criteria, and generation of a structured report. The user controls these functions with a system of interactive menus and tools.
The mint Lesion™ software has been extensively tested on Windows 64 bit systems by members of the development and quality control teams. A hazard analysis has been conducted and the level of concern has been classified as moderate. The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance.
Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk Management has been ensured via risk analysis in compliance with ISO 14971:2012 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Mint Medical GmbH adheres to recognized and established industry standards for development including ISO 13485 and IEC 62304.
Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed and that all hazard mitigations have been fully implemented.
5
Image /page/5/Picture/0 description: The image shows the logo for Mint Medical. The logo consists of a green leaf on the left side and the words "mint medical" on the right side. The word "mint" is in green, and the word "medical" is in gray.
Indications for Use
Mint Lesion is a software solution intended to be used for viewing, manipulation, communication, storage, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. Mint Lesion is a software only medical device which will be delivered on CDROM/ DVD to be installed by trained service personnel.
Mint Lesion is a medical diagnostic application for viewing, manipulation, 3D visualization and comparison of medical images from multiple imaging modalities and/or multiple timepoints. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MPR, MIP and volume rendering.
Mint Lesion enables visualization of information that would otherwise have to be visually compared disjointedly. Mint Lesion provides analytical tools to help the user assess, and document the stage of a disease and/or the response to therapy in accordance with user selected standards. Mint Lesion supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and Nuclear Medicine environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Mint Lesion is a complement to these standard procedures. Mint Lesion is not to be used in mammography.
Substantial Equivalence Comparisons to Predicate Devices
The mint Lesion extended functionalities addressed in this premarket notification, is substantially equivalent to the following commercially available devices:
| Manufacturer | Predicate Device Name | FDA Clearance Number |
|---|---|---|
| Mint Medical, Germany | OncoTrac | K111642 |
| Siemens Medical Solutions | ||
| USA, Inc | Syngo.via MI Workflows | K133644 |
The added capabilities to mint Lesion described in this 510(k) has similar functionalities that can be found in the predicate devices listed above. In comparison to the primary predicate device, the indications for use have been updated to include nuclear imaging modalities and to clarify and limit the scope of application to the purpose of assessment, staging and
6
Image /page/6/Picture/0 description: The image contains the logo for Mint Medical. The logo consists of a green leaf on the left side, followed by the word "mint" in green, and the word "medical" in gray underneath it. The leaf is a simple, stylized design with a white line running through the center to create the impression of veins.
documentation of a disease and/or the response to therapy. No change of technology was required to support the new imaging modalities. The additional predicate devices support all imaging modalities that mint Lesion supports. No new use was introduced by the change in the indications for use statement compared to the primary predicate device.
In summary, Mint Medical GmbH is of the opinion that mint Lesion does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate devices.
Conclusion
There are no differences in the Fundamental Technological Characteristics of the mint Lesion software as compared to the currently commercially available software listed above. Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device. Based on this information, as well as the documentation in support of the modifications, it is Mint Medicals opinion that the mint Lesion software with the modifications outlined in this application is substantially equivalent to the predicate device.