(85 days)
Not Found
No
The summary describes image processing, quantitative analysis, and dose calculations, but there is no mention of AI, ML, deep learning, or any related terms or concepts.
No.
The software is used to aid in evaluation, information management, diagnosis, and treatment planning, rather than directly treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "Registration, fusion display, and review of medical images for diagnosis, treatment planning." and "Localization and definition of objects such as tumors and normal tissues in medical images." These functions directly support the process of diagnosing medical conditions.
Yes
The device description explicitly states it operates on "Windows and Mac computer systems" and extends the functionality of existing software predicates. There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is used to aid in the evaluation and information management of digital medical images from various imaging modalities (CT, MRI, SPECT, PET, etc.). It focuses on image processing, analysis, and reporting related to these images.
- Device Description: The device description reinforces this by detailing features for quantifying planar images, calculating time-integrated activity coefficients, performing voxel-based dose calculations, and correcting for tissue density, all in the context of medical imaging data.
- Lack of Biological Samples: IVD devices are designed to perform tests on in vitro biological samples (like blood, urine, tissue). There is no mention of the device interacting with or analyzing biological samples.
- Focus on Image Analysis: The core function of the device is the processing and analysis of medical images, not the analysis of biological specimens.
Therefore, the device falls under the category of medical imaging software, not an In Vitro Diagnostic device.
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 image modalities include, but are not limited to. CT. MRI, 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 planning.
· Evaluation of cardiac left ventricular function, 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.
When using device clinically, 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 a 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MIM - MRT Dosimetry extends features of MIM SurePlan. It is designed for use in medical imaging and operates on both Windows and Mac computer systems. MIM - MRT Dosimetry extends the functionality of the MIM - Y90 Dosimetry (K172218) software and utilizes functionality of MIM – SPECTRA Quant (K180815). Both of these are predicates for this submission. The following functions have been added to allow calculations of absorbed dose as a result of administering a radionuclide.
- Allows for quantification of planar images
- Allows for calculation of time-integrated activity coefficients
- . Allows for voxel-based dose calculation of radionuclides
- Allows for correction of dose for tissue density .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, CR, DX, MG, US, SPECT, PET, XA
Anatomical Site
Cardiac left ventricular, brain, tumors and normal tissues (general), any anatomy for permanent implant brachytherapy, any anatomy for radionuclide administration.
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 Software Inc. has conducted performance and integration testing on MIM - MRT Dosimetry software with a comparison to a commercially available solution for internal radionuclide dosimetry. Standard quality control phantoms, simulated phantoms based on the NEMA IEC Body Phantom, simulated phantoms based on patient data, and clinical patient data were used for verification testing. All tests were performed using standard clinical acquisition and reconstruction protocols.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: MIM Software Inc. has conducted performance and integration testing on MIM - MRT Dosimetry software with a comparison to a commercially available solution for internal radionuclide dosimetry. Standard quality control phantoms, simulated phantoms based on the NEMA IEC Body Phantom, simulated phantoms based on patient data, and clinical patient data were used for verification testing.
Key Results:
-
The accuracy of planar corrections for attenuation, scatter, and background were verified in simulated phantoms. The average errors were less than 12% for all regions except for the smallest region (2.6 cm) with 21% error for Lu-177 and 17% error for I-131 where the partial volume effect lowered accuracy as expected. In all cases, the software passed its performance requirements and met specifications.
-
The accuracy of area-under-the curve (AUC) calculations were verified for different fitting options using simulated data with differences less than 3.1% compared to manual AUC calculations which met predefined acceptance criteria when considering the presence of Poison noise in the image data.
-
The accuracy of the generation of CT-derived physical density maps were verified in clinical patient data and compared to published results with less than 5% difference for soft tissue regions and less than 10% difference for bone regions. The difference for lung density fell within the range of expected density values.
-
The accuracy dose calculations using MIM - MRT Dosimetry was verified in simulated phantoms and clinical patient data for I-131 and Lu-177. The acceptance criterion for MIM - MRT Dosimetry is a difference of mean dose of smaller or equal to 20% in comparison to a commercially available solution after correction of the standard phantoms in the commercial solution to match the mass of the patient data. Additionally, comparison of the Voxel S Value method in MIM - MRT Dosimetry to Local Deposition Model values for Lu-177 showed a difference less than 1% for all organs tested. In all cases the software demonstrated acceptable agreement between the different dose methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Planar correction errors, AUC calculation differences, CT-derived physical density map differences, dose calculation differences.
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.
K172218, K180815, K163687, K153355
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 18, 2018
MIM Software Inc. % Ms. Lynn Hanigan Ouality Assurance Director 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122
Re: K182624
Trade/Device Name: MIM - MRT Dosimetry Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 21, 2018 Received: September 24, 2018
Dear Ms. Hanigan:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Hole 2. Nils
for Robert A. Ochs, Ph.D. 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) K182624
Device Name MIM - MRT 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 image modalities include, but are not limited to. CT. MRI, 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 planning.
· Evaluation of cardiac left ventricular function, 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.
[X] Prescription Use (Part 21 CFR 801 Subpart D)
When using device clinically, 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 a 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.
Type of Use (Select one or both, as applicable)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/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.
510(k) Summary of Safety and Effectiveness (The following information is in conformance with 21 CFR 807.92)
Submitter:
MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122
| Phone: | 216-455-0600 |
|---|---|
| Fax: | 216-455-0601 |
| Contact Person: | Lynn Hanigan |
| Date Summary Prepared: | 09/21/2018 |
Device Name
| Trade Name: | MIM – MRT Dosimetry |
|---|---|
| Common Name: | Medical Imaging Software |
| Regulation Number / Product Code: | 21 CFR 892.2050 Product Code LLZ |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Devices
| K172218 | MIM – Y90 Dosimetry | MIM Software Inc. |
|---|---|---|
| K180815 | MIM – SPECTRA Quant | MIM Software Inc. |
| K163687 | OLINDA/EXM 2.0 | Hermes |
| K153355 | Xeleris 4.0 | GE Healthcare |
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 imaqes, 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, MRI, 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.
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Image /page/5/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.
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.
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, MRI, 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 enddiastolic 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 manaqement.
- 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.
6
Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of a gray square overlapping a red square with a white circle in the corner. To the right of the squares is the text "mim" in black, block letters. Below the letters is the word "SOFTWARE" in smaller, black letters.
When using device clinically, 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.
Device Description
MIM - MRT Dosimetry extends features of MIM SurePlan. It is designed for use in medical imaging and operates on both Windows and Mac computer systems. MIM - MRT Dosimetry extends the functionality of the MIM - Y90 Dosimetry (K172218) software and utilizes functionality of MIM – SPECTRA Quant (K180815). Both of these are predicates for this submission. The following functions have been added to allow calculations of absorbed dose as a result of administering a radionuclide.
- Allows for quantification of planar images
- Allows for calculation of time-integrated activity coefficients
- . Allows for voxel-based dose calculation of radionuclides
- Allows for correction of dose for tissue density .
Substantial Equivalence
MIM - MRT Dosimetry is substantially equivalent to a combination of the predicate devices MIM -Y90 Dosimetry (K172218), MIM – SPECTRA Quant (K180815), OLINDA/EXM 2.0 (K163687), and Xeleris 4.0 (K153355).
Performance Data
MIM Software Inc. has conducted performance and integration testing on MIM - MRT Dosimetry software with a comparison to a commercially available solution for internal radionuclide dosimetry. Standard quality control phantoms, simulated phantoms based on the NEMA IEC Body Phantom, simulated phantoms based on patient data, and clinical patient data were used for verification testing. All tests were performed using standard clinical acquisition and reconstruction protocols.
The accuracy of planar corrections for attenuation, scatter, and background were verified in simulated phantoms. The average errors were less than 12% for all regions except for the smallest region (2.6 cm) with 21% error for Lu-177 and 17% error for I-131 where the partial volume effect lowered accuracy as expected. In all cases, the software passed its performance requirements and met specifications
The accuracy of area-under-the curve (AUC) calculations were verified for different fitting options using simulated data with differences less than 3.1% compared to manual AUC calculations which met predefined acceptance criteria when considering the presence of Poison noise in the image data.
7
Image /page/7/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 letters are black.
The accuracy of the generation of CT-derived physical density maps were verified in clinical patient data and compared to published results with less than 5% difference for soft tissue regions and less than 10% difference for bone regions. The difference for lung density fell within the range of expected density values.
The accuracy dose calculations using MIM - MRT Dosimetry was verified in simulated phantoms and clinical patient data for I-131 and Lu-177. The acceptance criterion for MIM - MRT Dosimetry is a difference of mean dose of smaller or equal to 20% in comparison to a commercially available solution after correction of the standard phantoms in the commercial solution to match the mass of the patient data. Additionally, comparison of the Voxel S Value method in MIM - MRT Dosimetry to Local Deposition Model values for Lu-177 showed a difference less than 1% for all organs tested. In all cases the software demonstrated acceptable agreement between the different dose methods.
In conclusion, MIM Software Inc. has conducted performance testing on the MIM – MRT Dosimetry software. In all cases, the software passed its performance requirements and met specifications.