(241 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on Monte Carlo dose calculation, which is a physics-based simulation method, not AI/ML.
No
The device aids in evaluation and information management of medical images for diagnosis, treatment evaluation, and planning. It calculates absorbed radiation dose and assists with planning and evaluation of procedures, but it does not directly apply or deliver therapy.
Yes
The device is described as aiding in the "diagnosis" of medical images, as stated in the "Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning" indication.
Yes
The device is described as a "standalone software application" that operates on standard computer systems (Windows, Mac, and Linux) and extends the functionality of a predicate software device. While it processes medical images, the description focuses solely on the software's features and performance, with no mention of proprietary hardware components required for its operation.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software is used to process and analyze medical images (CT, MR, PET, etc.) and DICOM objects. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The functions described are related to image processing, analysis, and treatment planning. These are typical functions of medical imaging software and radiation therapy planning systems, not IVDs.
- The predicate and reference devices are also medical imaging and dosimetry software. K220256 MIM – Ablation and K033960 OLINDA/EXM are both software used in medical imaging and radiation dosimetry, further supporting that this device falls within that category, not IVD.
Therefore, the device described is a medical imaging and dosimetry software, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical imaqe modalities include, but are not limited to, CT. MR. CR. DX. MG. US. SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
- · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. · Create, display, and print reports from medical images.
- · Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
- · Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
- · Localization and definition of objects such as tumors and normal tissues in medical images.
- · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
- · Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
- · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
- · Calculating absorbed radiation dose as a result of administering a radionuclide.
- Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDAapproved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MIM - Monte Carlo Dosimetry (K232862) extends the features of MIM - Ablation (K220256). It is designed for use in medical imaging and operates on Windows, Mac, and Linux computer systems. The intended use and indications for use in MIM - Monte Carlo Dosimetry are unchanged from the predicate device, MIM - Ablation (K220256).
MIM - Monte Carlo Dosimetry (K232862) is a standalone software application that extends the functionality of the predicate device by providing:
- · Dose calculation of radionuclides performed using a Monte Carlo method
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, DX, MG, US, SPECT, PET, XA, and other DICOM modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicists.
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
MIM - Monte Carlo Dosimetry was compared to model-based dosimetry with Monte Carlo derived S-values in OLINDA/EXM (K033960) for Lu-177, I-131, and Y-90 activity maps. A testing dataset was created from an existing CT scan of the patient that was of height (1.7m) and weight (77kg) similar to the default Adult Male model in OLINDA (1.7m, 70kg). Each region was masked to a realistic relative activity per isotope with the rest-of-body reqion normalized to 1. Mean absorbed doses were compared for kidneys, spleen, lungs, liver, salivary glands, lacrimal glands, thyroid and tumors.
Dose calculation in MIM - Monte Carlo Dosimetry was also compared to the predicate Voxel S-value (VSV) dose calculation in MIM – Ablation (K220256). The same patient data from the model-based dosimetry comparison was used for the VSV comparison.
Lastly, MIM - Monte Carlo Dosimetry was compared directly to a well-established Monte Carlo dose calculation algorithm, GATE (GEANT4 Application for Tomographic Emission). The same patient data from the model-based dosimetry comparison was used in this comparison.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing included 4 main sections: 1) Comparison to model-based dose calculation with Monte Carlo derived S-values, 2) Comparison to voxel-based dose calculation with Monte Carlo derived voxel S-value (VSV), 3) Comparison to a well-established Monte Carlo dose calculation algorithm, 4) Characterization of user inputs for number of simulated particle histories, number of computational threads, and the simulation starting point.
For all structures and isotopes, the average, absolute percent difference between MI M - Monte Carlo Dosimetry and OLINDA was 4.3%. The differences observed between MIM - Monte Carlo Dosimetry and OLINDA is within the expected range based on a similar study conducted with 171Lu-DOTATATE data where the two methods differed by 5% on average.
There were high differences in lung dose at 18.1%, and 10.8% for Lu-177, I-131, and Y-90, respectively. Without those comparisons, the average difference drops to 2.5% across the other structures. The differences for Lu-177 and Y-90 lung dose can be attributed to the model-based dosimetry in OLINDA underestimating lung dose by not accounting for the cross-dose from the nearby tumors in the liver. The larger difference in lung dose for I-131 can be attributed to the greater amount of high energy photons in addition to differences in the OLINDA model and the patient-specific lung geometry (30% smaller) leading to the significantly higher amount of cross-dose from nearby high-activity structures to be underestimated.
For all structures and isotopes, the average, absolute percent difference between Monte Carlo and VSV was 6.0%. This difference between a VSV method and a Monte Carlo method is consistent with previously published results for another commercial, voxel-based VSV software where organ dosimetry differed by ~10%.
The largest difference was seen for the lung dose using I-131 (61%). The average difference across all structures drops to 4.0% without the lung comparison for I-131. Larger differences in lung dose are expected when comparing Monte Carlo methods to VSV methods due to the overestimation of dose in structures significantly lower in density than the simulation material.
Lastly, MIM - Monte Carlo Dosimetry was compared directly to a well-established Monte Carlo dose calculation algorithm, GATE (GEANT4 Application for Tomographic Emission). The two methods were in high agreement, with an average, absolute difference of 1.4% across all structures and isotopes. It was found that the Monte Carlo calculations differed by 2-3% for Lu-177, I-131, and Y-90.
Characterization of the user inputs to the simulation showed that the default setting for 1 x 10^ particles histories is appropriate for accurate dose calculation and provided characterization for using more or less particles than the default. 1 x 10^ particles histories results in less than 1% uncertainty in regions of interest and less than 1% difference between results when running multiple simulations with random simulation seeds.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 13, 2024
MIM Software Inc. Sydney Lindner Clinical Engineer II 25800 Science Park Drive Suite 180 Cleveland, Ohio 44122
Re: K232862
Trade/Device Name: MIM - Monte Carlo Dosimetry Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 9, 2024 Received: April 9, 2024
Dear Sydney Lindner:
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" (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).
1
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).
Sincerely,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
MIM - Monte Carlo Dosimetry
Indications for Use (Describe)
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical imaqe modalities include, but are not limited to, CT. MR. CR. DX. MG. US. SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
- · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. · Create, display, and print reports from medical images.
- · Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
- · Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
- · Localization and definition of objects such as tumors and normal tissues in medical images.
- · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
- · Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
- · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
- · Calculating absorbed radiation dose as a result of administering a radionuclide.
- Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDAapproved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
Image /page/3/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the word "SOFTWARE" in a smaller, sans-serif font.
510(k) Summary of Safety and Effectiveness (The following information is in conformance with 21 CFR 807.92)
Submitter
K232862
MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122
| Phone: | 216-455-0600 |
|---|---|
| Fax: | 216-455-0601 |
| Contact Person: | Sydney Lindner |
| Date Summary Prepared: | April 9, 2024 |
Device Name
Trade Name:
Common Name:
Regulation Number / Product Code:
Classification Name:
MIM - Monte Carlo Dosimetry (K232862)
Medical Imaging Software
21 CFR 892.2050 Product Code LLZ
System, Imaging Processing, Radiological
Predicate Devices
| Primary: | K220256 | MIM – Ablation | MIM Software Inc. |
|---|---|---|---|
| Reference: | K033960 | OLINDA/EXM | Vanderbilt University |
4
Image /page/4/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a simple color palette.
Intended Use
MIM software is intended for trained medical professionals including, but not limited to. radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicists.
MIM is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display, and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0.
MIM provides the user with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
The Region of Interest (ROI) feature reduces the time necessary for the user to define objects in medical image volumes by providing an initial definition of object contours. The objects include, but are not limited to, tumors and normal tissues.
MIM provides tools to quickly create, transform, and modify contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems and archiving contours for patient follow-up and management.
MIM aids in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel-by-voxel basis, within stereotactic surface projections or standardized regions of interest.
MIM allows the dose distribution of an implant to be individually shaped for each patient and is a general-purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes (not including radioactive microspheres).
MIM allows voxel-based dose calculations for patients who have been administered radioisotopes or radioactive microspheres. MIM assists with the planning and evaluation of ablation procedures by allowing the energy zone that comprises the ablation zone to be visualized on medical imaging through the placement of virtual ablation devices for the purpose of confirming ablation zone placement.
5
Image /page/5/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a focus on the company's name.
Indications for Use
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
- Receive, transmit, store, retrieve, display, print, and process medical images and . DICOM objects.
- Create, display, and print reports from medical images.
- Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
- Evaluation of cardiac left ventricular function and perfusion, including left . ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
- . Localization and definition of objects such as tumors and normal tissues in medical images.
- Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
- Quantitative and statistical analysis of PET/SPECT brain scans by comparing to ● other registered PET/SPECT brain scans.
- . Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
- . Calculating absorbed radiation dose as a result of administering a radionuclide.
- . Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.
6
Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
Device Description
MIM - Monte Carlo Dosimetry (K232862) extends the features of MIM - Ablation (K220256). It is designed for use in medical imaging and operates on Windows, Mac, and Linux computer systems. The intended use and indications for use in MIM - Monte Carlo Dosimetry are unchanged from the predicate device, MIM - Ablation (K220256).
MIM - Monte Carlo Dosimetry (K232862) is a standalone software application that extends the functionality of the predicate device by providing:
- · Dose calculation of radionuclides performed using a Monte Carlo method
Substantial Equivalence
MIM - Monte Carlo Dosimetry is substantially equivalent to the predicate devices, MIM – Ablation (K220256) and OLINDA/EXM (K033960).
| ITEM | Subject Device:
MIM - Monte Carlo
Dosimetry
(K232862) | Predicate Device:
MIM - Ablation
(K220256) | Reference Predicate:
OLINDA/EXM
(K033960) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance Date | TBD | October 7, 2022 | June 15, 2004 |
| Intended Use | MIM software is intended for
trained medical professionals
including, but not limited to,
radiologists, oncologists,
physicians, medical
technologists, dosimetrists,
and physicists.
MIM is a medical image and
information management
system that is intended to
receive, transmit, store, | MIM software is intended for
trained medical professionals
including, but not limited to,
radiologists, oncologists,
physicians, medical
technologists, dosimetrists,
and physicists.
MIM is a medical image and
information management
system that is intended to
receive, transmit, store, | The purpose of
OLINDA/EXM is to estimate
radiation doses received by
internal organs as a result of
administering a
radiopharmaceutical. |
7
Image /page/7/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font.
25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com
| retrieve, display, print and
process digital medical
images, as well as create,
display, and print reports
from those images. The
medical modalities of these
medical imaging systems
include, but are not limited to,
CT, MR, CR, DX, MG, US,
SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0. | retrieve, display, print and
process digital medical
images, as well as create,
display, and print reports
from those images. The
medical modalities of these
medical imaging systems
include, but are not limited to,
CT, MR, CR, DX, MG, US,
SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MIM provides the user with
the means to display, register
and fuse medical images
from multiple modalities.
Additionally, it evaluates
cardiac left ventricular
function and perfusion,
including left ventricular
end-diastolic volume,
end-systolic volume, and
ejection fraction. | MIM provides the user with
the means to display, register
and fuse medical images
from multiple modalities.
Additionally, it evaluates
cardiac left ventricular
function and perfusion,
including left ventricular
end-diastolic volume,
end-systolic volume, and
ejection fraction. |
| The Region of Interest (ROI)
feature reduces the time
necessary for the user to
define objects in medical
image volumes by providing
an initial definition of object
contours. The objects
include, but are not limited to,
tumors and normal tissues. | The Region of Interest (ROI)
feature reduces the time
necessary for the user to
define objects in medical
image volumes by providing
an initial definition of object
contours. The objects
include, but are not limited to,
tumors and normal tissues. |
| MIM provides tools to quickly
create, transform, and modify
contours for applications
including, but not limited to,
quantitative analysis, aiding
adaptive therapy, transferring
contours to radiation therapy
treatment planning systems
and archiving contours for
patient follow-up and
management. | MIM provides tools to quickly
create, transform, and modify
contours for applications
including, but not limited to,
quantitative analysis, aiding
adaptive therapy, transferring
contours to radiation therapy
treatment planning systems
and archiving contours for
patient follow-up and
management. |
| MIM aids in the assessment
of PET/SPECT brain scans.
It provides automated
quantitative and statistical
analysis by automatically
registering PET/SPECT brain
scans to a standard template
and comparing intensity
values to a reference | MIM aids in the assessment
of PET/SPECT brain scans.
It provides automated
quantitative and statistical
analysis by automatically
registering PET/SPECT brain
scans to a standard template
and comparing intensity
values to a reference |
8
Image /page/8/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.
| | database or to other
PET/SPECT scans on a
voxel-by-voxel basis, within
stereotactic surface
projections or standardized
regions of interest. | database or to other
PET/SPECT scans on a
voxel-by-voxel basis, within
stereotactic surface
projections or standardized
regions of interest. | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | MIM allows the dose
distribution of an implant to
be individually shaped for
each patient and is a
general-purpose
brachytherapy planning
system used for prospective
and confirmation dose
calculations for patients
undergoing a course of
brachytherapy using
permanent implants of
various radioisotopes (not
including radioactive
microspheres). | MIM allows the dose
distribution of an implant to
be individually shaped for
each patient and is a
general-purpose
brachytherapy planning
system used for prospective
and confirmation dose
calculations for patients
undergoing a course of
brachytherapy using
permanent implants of
various radioisotopes (not
including radioactive
microspheres). | |
| | MIM allows voxel-based
dose calculations for patients
who have been administered
radioisotopes or radioactive
microspheres. MIM assists
with the planning and
evaluation of ablation
procedures by allowing the
energy zone that comprises
the ablation zone to be
visualized on medical
imaging through the
placement of virtual ablation
devices for the purpose of
confirming ablation zone
placement. | MIM allows voxel-based
dose calculations for patients
who have been administered
radioisotopes or radioactive
microspheres. MIM assists
with the planning and
evaluation of ablation
procedures by allowing the
energy zone that comprises
the ablation zone to be
visualized on medical
imaging through the
placement of virtual ablation
devices for the purpose of
confirming ablation zone
placement. | |
| Indications for Use | MIM software is used by
trained medical professionals
as a tool to aid in evaluation
and information management
of digital medical images.
The medical image
modalities include, but are
not limited to, CT, MR, CR,
DX, MG, US, SPECT, PET
and XA as supported by
ACR/NEMA DICOM 3.0. MIM
assists in the following
indications:
• Receive, transmit, store. | MIM software is used by
trained medical professionals
as a tool to aid in evaluation
and information management
of digital medical images.
The medical image
modalities include, but are
not limited to, CT, MR, CR,
DX, MG, US, SPECT, PET
and XA as supported by
ACR/NEMA DICOM 3.0. MIM
assists in the following
indications:
• Receive, transmit, store. | Estimates the absorbed
doses to several tissues of a
reference patient for a
specified
radiopharmaceutical
dosage. |
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Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a sans-serif font, with the word "SOFTWARE" below it in a smaller font. The logo is simple and modern, with a focus on the company's name.
| process medical images and
DICOM objects. | process medical images and
DICOM objects. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Create, display, and print
reports from medical images. | • Create, display, and print
reports from medical images. |
| • Registration, fusion display,
and review of medical
images for diagnosis,
treatment evaluation, and
treatment planning. | • Registration, fusion display,
and review of medical
images for diagnosis,
treatment evaluation, and
treatment planning. |
| • Evaluation of cardiac left
ventricular function and
perfusion, including left
ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction. | • Evaluation of cardiac left
ventricular function and
perfusion, including left
ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction. |
| • Localization and definition
of objects such as tumors
and normal tissues in
medical images. | • Localization and definition
of objects such as tumors
and normal tissues in
medical images. |
| • Creation, transformation,
and modification of contours
for applications including, but
not limited to, quantitative
analysis, aiding adaptive
therapy, transferring contours
to radiation therapy treatment
planning systems, and
archiving contours for patient
follow-up and management. | • Creation, transformation,
and modification of contours
for applications including, but
not limited to, quantitative
analysis, aiding adaptive
therapy, transferring contours
to radiation therapy treatment
planning systems, and
archiving contours for patient
follow-up and management. |
| • Quantitative and statistical
analysis of PET/SPECT brain
scans by comparing to other
registered PET/SPECT brain
scans. | • Quantitative and statistical
analysis of PET/SPECT brain
scans by comparing to other
registered PET/SPECT brain
scans. |
| • Planning and evaluation of
permanent implant
brachytherapy procedures
(not including radioactive
microspheres). | • Planning and evaluation of
permanent implant
brachytherapy procedures
(not including radioactive
microspheres). |
| • Calculating absorbed
radiation dose as a result of
administering a radionuclide. | • Calculating absorbed
radiation dose as a result of
administering a radionuclide. |
| • Assist with the planning and
evaluation of ablation
procedures by providing
visualization and analysis,
including energy zone | • Assist with the planning and
evaluation of ablation
procedures by providing
visualization and analysis,
including energy zone |
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Image /page/10/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a focus on simplicity and readability.
| | visualization through the
placement of virtual ablation
devices validated for
inclusion in MIM-Ablation.
The software is not intended
to predict specific ablation
zone volumes or predict
ablation success. | visualization through the
placement of virtual ablation
devices validated for
inclusion in MIM-Ablation.
The software is not intended
to predict specific ablation
zone volumes or predict
ablation success. | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| | When using the device
clinically, within the United
States, the user should only
use FDA approved
radiopharmaceuticals. If used
with unapproved ones, this
device should only be used
for research purposes. | When using device clinically,
within the United States, the
user should only use FDA
approved
radiopharmaceuticals. If
using with unapproved ones,
this device should only be
used for research purposes. | |
| | Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image
interpretations. Images that
are printed to film must be
printed using an
FDA-approved printer for the
diagnosis of digital
mammography images.
Mammographic images must
be viewed on a display
system that has been cleared
by the FDA for the diagnosis
of digital mammography
images. The software is not
to be used for mammography
CAD. | Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image
interpretations. Images that
are printed to film must be
printed using an
FDA-approved printer for the
diagnosis of digital
mammography images.
Mammographic images must
be viewed on a display
system that has been cleared
by the FDA for the diagnosis
of digital mammography
images. The software is not
to be used for mammography
CAD. | |
| Operating
Platform | Microsoft Windows, Apple®
OS X, Linux-based OS | Microsoft Windows, Apple®
OS X, Linux-based OS | Microsoft Windows |
| Supported
Imaging
Modalities | CT, MR, CR, DX, MG, US,
NM, PET, XA, and other
DICOM modalities | CT, MR, CR, DX, MG, US,
NM, PET, XA, and other
DICOM modalities | None |
| Receive, transmit,
display, general
manipulation
(window/level,
pan, zoom,
cross-hairs, slice
navigation), and
co-registration of
medical images | Yes | Yes | No |
| 3D image | Yes | Yes | No |
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Image /page/11/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in black, with the word "SOFTWARE" in smaller black letters below it. The logo is simple and modern, and the colors are eye-catching.
| segmentation | |||
|---|---|---|---|
| Dose calculation | |||
| of radionuclides | |||
| from activity | |||
| images | LDM, Monte Carlo derived | ||
| VSV, and full Monte Carlo | LDM and Monte Carlo | ||
| derived VSV | Model-based with Monte | ||
| Carlo derived S-values |
Testing and Performance Data
Software verification and validation testing included 4 main sections: 1) Comparison to model-based dose calculation with Monte Carlo derived S-values, 2) Comparison to voxel-based dose calculation with Monte Carlo derived voxel S-value (VSV), 3) Comparison to a well-established Monte Carlo dose calculation algorithm, 4) Characterization of user inputs for number of simulated particle histories, number of computational threads, and the simulation starting point.
MIM - Monte Carlo Dosimetry was compared to model-based dosimetry with Monte Carlo derived S-values in OLINDA/EXM (K033960) for Lu-177, I-131, and Y-90 activity maps. A testing dataset was created from an existing CT scan of the patient that was of height (1.7m) and weight (77kg) similar to the default Adult Male model in OLINDA (1.7m, 70kg). Each region was masked to a realistic relative activity per isotope with the rest-of-body reqion normalized to 1. Mean absorbed doses were compared for kidneys, spleen, lungs, liver, salivary glands, lacrimal glands, thyroid and tumors. For all structures and isotopes, the average, absolute percent difference between the dose calculation methods was 4.3%. The differences observed between MIM - Monte Carlo Dosimetry and OLINDA is within the expected range based on a similar study' conducted with 171Lu-DOTATATE data where the two methods differed by 5% on average.
There were high differences in lung dose at 18.1%, and 10.8% for Lu-177, I-131, and Y-90, respectively. Without those comparisons, the average difference drops to 2.5% across the other structures. The differences for Lu-177 and Y-90 lung dose can be attributed to the model-based dosimetry in OLINDA underestimating lung dose by not accounting for the cross-dose from the nearby tumors in the liver. The larger difference in lung dose for I-131 can be attributed to the greater amount of high energy photons in addition to differences in the OLINDA model and the patient-specific lung geometry (30% smaller) leading to the significantly higher amount of cross-dose from nearby high-activity structures to be underestimated.
Dose calculation in MIM - Monte Carlo Dosimetry was also compared to the predicate Voxel S-value (VSV) dose calculation in MIM – Ablation (K220256). The same patient data from the model-based dosimetry comparison was used for the VSV comparison.
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Image /page/12/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the word "mim" in black, sans-serif font. Below the word "mim" is the word "SOFTWARE" in a smaller, sans-serif font, with a registered trademark symbol to the right.
For all structures and isotopes, the average, absolute percent difference was 6.0%. This difference between a VSV method and a Monte Carlo method is consistent with previously published2 results for another commercial, voxel-based VSV software where organ dosimetry differed by ~10%.
The largest difference was seen for the lung dose using I-131 (61%). The average difference across all structures drops to 4.0% without the lung comparison for I-131. Larger differences in lung dose are expected when comparing Monte Carlo methods to VSV methods due to the overestimation of dose in structures significantly lower in density than the simulation material. The VSV kernel was generated assuming water density, thus, for energy deposited by beta and gamma particles in low density regions the VSV method overestimates dose as the particles travel further before being absorbed than they would in soft tissue. Whereas the Monte Carlo dose calculations account for density with the material simulation and more accurately estimate the deposited energy from beta and gamma particles in the low density tissue of the lungs. For I-131, there is a greater amount of high energy particles so the effect of nearby high-activity structures on the lung dose with the VSV approach is greater than Lu-177 or Y-90. This difference in lung dosimetry was expected and within the range of previously reported discrepancies in a study that investigated the effects of tissue inhomogeneities on the VSV method, where lung dose differed by 30-60% when compared to Monte Carlo dosimetry.
Lastly, MIM - Monte Carlo Dosimetry was compared directly to a well-established Monte Carlo dose calculation algorithm, GATE (GEANT4 Application for Tomographic Emission). The same patient data from the model-based dosimetry comparison was used in this comparison The two methods were in high agreement, with an average, absolute difference of 1.4% across all structures and isotopes. It was found that the Monte Carlo calculations differed by 2-3% for Lu-177, I-131, and Y-90.
Characterization of the user inputs to the simulation showed that the default setting for 1 x 10° particle histories is appropriate for accurate dose calculation and provided characterization for using more or less particles than the default. 1 x 10° particle histories results in less than 1% uncertainty in regions of interest and less than 1% difference between results when running multiple simulations with random simulation seeds.
Conclusion
Based on the Device Description and Testing and Performance Data above, the proposed device is determined to be as safe and effective as the predicate devices, MIM - Ablation (K220256) and OLINDA/EXM (K033960).
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Image /page/13/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a sans-serif font, with the word "SOFTWARE" below it in a smaller font.
References
-
- Kim KM, Lee MS, Suh MS, et al. Comparison of voxel S -value methods for personalized voxel-based dosimetry of 177Lu-DOTATATE. Med Phys. 2022;49(3):1888-1901. doi:10.1002/mp.15444
-
- Stamouli I, Nanos T, Chatzipapas K, et al. Dosimetric Evaluation of 171Lu Peptide Receptor Radionuclide Therapy Using GATE and Planet Dose. Appl Sci. 2023;13(17):9836. doi:10.3390/app13179836
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- Götz T, Schmidkonz C, Lang EW, Maier A, Kuwert T, Ritt P. A comparison of methods for adapting 171Lu dose-voxel-kernels to tissue inhomogeneities. Phys Med Biol. 2019;64(24):245011. doi:10.1088/1361-6560/ab5b81