MIM – Dose Analysis

{0}------------------------------------------------ May 6, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle, while the FDA part of the logo features the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. MIM Software Inc. % Sydney Lindner Clinical Engineer 25800 Science Park Drive Suite 180 CLEVLAND, OH 44122 Re: K232514 Trade/Device Name: MIM - Dose Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 16, 2023 Received: August 18, 2023 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/cdrb/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). 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 {1}------------------------------------------------ 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 medical devices and radiation-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, Locon Weidner Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team 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) K232514 Device Name MIM - Dose Analysis #### 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, 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 MM-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}------------------------------------------------ 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. 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K232514 ### 510(k) Summary (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: | Sydney Lindner | | Date Summary Prepared: | April 5, 2024 | ## Device Name | Trade Name: | MIM – Dose Analysis | |-----------------------------------|------------------------------------------| | Common Name: | Medical Imaging Software | | Regulation Number / Product Code: | 21 CFR 892.2050 Product Code LLZ | | Classification Name: | System, Imaging Processing, Radiological | # Predicate and Reference Devices | Predicate:<br>K220256 | MIM – Ablation | MIM Software Inc. | |------------------------|----------------|---------------------------| | References:<br>K222312 | RayStation 12A | RaySearch Laboratories AB | | K220583 | ClearCheck | Radformation, Inc. | {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" underneath in a smaller font. # 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 {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 clean and modern, with a focus on the company's name. 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, 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. ● {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 word "SOFTWARE" in a smaller, sans-serif font, followed by a trademark symbol. - 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 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. | ITEM | Subject Device:<br>MIM -<br>Dose Analysis<br>(K232514) | Predicate Device:<br>MIM -<br>Ablation<br>(K220256) | Reference Device:<br>RaySearch<br>RayStation 12A<br>(K222312) | Reference Device:<br>Radformation<br>ClearCheck<br>(K220583) | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clearance Date | TBD | October 7, 2022 | March 29, 2023 | August 23, 2022 | | Intended Use | MIM software is<br>intended for trained<br>medical professionals<br>including, but not<br>limited to,<br>radiologists,<br>oncologists,<br>physicians, medical<br>technologists,<br>dosimetrists, and<br>physicists.<br>MIM is a medical<br>image and information<br>management system<br>that is intended to<br>receive, transmit,<br>store, retrieve, display, | MIM software is<br>intended for trained<br>medical professionals<br>including, but not<br>limited to,<br>radiologists,<br>oncologists,<br>physicians, medical<br>technologists,<br>dosimetrists, and<br>physicists.<br>MIM is a medical<br>image and information<br>management system<br>that is intended to<br>receive, transmit,<br>store, retrieve, display, | RayStation is a<br>software system for<br>radiation therapy and<br>medical oncology.<br>Based on user input,<br>RayStation proposes<br>treatment plans. After<br>a proposed treatment<br>plan is reviewed and<br>approved<br>by authorized intended<br>users, RayStation may<br>also be used to<br>administer treatments.<br>The system<br>functionality can be<br>configured based on | ClearCheck is<br>intended to assist<br>radiation therapy<br>professionals in<br>generating and<br>assessing the quality<br>of radiotherapy<br>treatment plans.<br>ClearCheck is also<br>intended to assist<br>radiation treatment<br>planners in predicting<br>when a treatment plan<br>might result in a<br>collision between the<br>treatment machine and<br>the patient or support<br>structures. | {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 SOFTWARE" in a sans-serif font, with "mim" in a larger font size than "SOFTWARE". | print and process<br>digital medical<br>images, as well as<br>create, display, and<br>print reports from<br>those images. The<br>medical modalities of<br>these medical imaging<br>systems include, but<br>are not limited to, CT,<br>MR, CR, DX, MG,<br>US, SPECT, PET and<br>XA as supported by<br>ACR/NEMA DICOM<br>3.0. | print and process<br>digital medical<br>images, as well as<br>create, display, and<br>print reports from<br>those images. The<br>medical modalities of<br>these medical imaging<br>systems include, but<br>are not limited to, CT,<br>MRI, CR, DX, MG,<br>US, SPECT, PET and<br>XA as supported by<br>ACR/NEMA DICOM<br>3.0. | user needs. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | MIM provides the<br>user with the means to<br>display, register and<br>fuse medical images<br>from multiple<br>modalities.<br>Additionally, it<br>evaluates cardiac left<br>ventricular function<br>and perfusion,<br>including left<br>ventricular<br>end-diastolic volume,<br>end-systolic volume,<br>and ejection fraction. | MIM provides the<br>user with the means to<br>display, register and<br>fuse medical images<br>from multiple<br>modalities.<br>Additionally, it<br>evaluates cardiac left<br>ventricular function<br>and perfusion,<br>including left<br>ventricular<br>end-diastolic volume,<br>end-systolic volume,<br>and ejection fraction. | | | The Region of Interest<br>(ROI) feature reduces<br>the time necessary for<br>the user to define<br>objects in medical<br>image volumes by<br>providing an initial<br>definition of object<br>contours. The objects<br>include, but are not<br>limited to, tumors and<br>normal tissues.<br>MIM provides tools to<br>quickly create,<br>transform, and modify<br>contours for | The Region of Interest<br>(ROI) feature reduces<br>the time necessary for<br>the user to define<br>objects in medical<br>image volumes by<br>providing an initial<br>definition of object<br>contours. The objects<br>include, but are not<br>limited to, tumors and<br>normal tissues.<br>MIM provides tools to<br>quickly create,<br>transform, and modify<br>contours for | | {9}------------------------------------------------ Image /page/9/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 SOFTWARE" in a sans-serif font, with "mim" in a larger font size than "SOFTWARE". | applications including,<br>but not limited to,<br>quantitative analysis,<br>aiding adaptive<br>therapy, transferring<br>contours to radiation<br>therapy treatment<br>planning systems and<br>archiving contours for<br>patient follow-up and<br>management. | applications including,<br>but not limited to,<br>quantitative analysis,<br>aiding adaptive<br>therapy, transferring<br>contours to radiation<br>therapy treatment<br>planning systems and<br>archiving contours for<br>patient follow-up and<br>management. | | various radioisotopes<br>(not including<br>radioactive<br>microspheres).<br><br>MIM allows<br>voxel-based dose<br>calculations for<br>patients who have<br>been administered<br>radioisotopes or<br>radioactive<br>microspheres. MIM<br>assists with the<br>planning and<br>evaluation of ablation<br>procedures by<br>allowing the energy<br>zone that comprises<br>the ablation zone to be<br>visualized on medical<br>imaging through the<br>placement of virtual<br>ablation devices for<br>the purpose of<br>confirming ablation<br>zone placement. | various radioisotopes<br>(not including<br>radioactive<br>microspheres).<br><br>MIM allows<br>voxel-based dose<br>calculations for<br>patients who have<br>been administered<br>radioisotopes or<br>radioactive<br>microspheres. MIM<br>assists with the<br>planning and<br>evaluation of ablation<br>procedures by<br>allowing the energy<br>zone that comprises<br>the ablation zone to be<br>visualized on medical<br>imaging through the<br>placement of virtual<br>ablation devices for<br>the purpose of<br>confirming ablation<br>zone placement. | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MIM aids in the<br>assessment of<br>PET/SPECT brain<br>scans. It provides<br>automated quantitative<br>and statistical analysis<br>by automatically<br>registering<br>PET/SPECT brain<br>scans to a standard<br>template and<br>comparing intensity<br>values to a reference<br>database or to other<br>PET/SPECT scans on<br>a voxel-by-voxel<br>basis, within<br>stereotactic surface<br>projections or<br>standardized regions<br>of interest. | MIM aids in the<br>assessment of<br>PET/SPECT brain<br>scans. It provides<br>automated quantitative<br>and statistical analysis<br>by automatically<br>registering<br>PET/SPECT brain<br>scans to a standard<br>template and<br>comparing intensity<br>values to a reference<br>database or to other<br>PET/SPECT scans on<br>a voxel-by-voxel<br>basis, within<br>stereotactic surface<br>projections or<br>standardized regions<br>of interest. | Indications for Use | MIM software is used<br>by trained medical<br>professionals as a tool<br>to aid in evaluation<br>and information<br>management of digital<br>medical images. The<br>medical image<br>modalities include, but<br>are not limited to, CT,<br>MR, CR, DX, MG,<br>US, SPECT, PET and<br>XA as supported by<br>ACR/NEMA DICOM<br>3.0. MIM assists in<br>the following<br>indications:<br>• Receive, transmit,<br>store, retrieve, display,<br>print, and process | MIM software is used<br>by trained medical<br>professionals as a tool<br>to aid in evaluation<br>and information<br>management of digital<br>medical images. The<br>medical image<br>modalities include, but<br>are not limited to, CT,<br>MR, CR, DX, MG,<br>US, SPECT, PET and<br>XA as supported by<br>ACR/NEMA DICOM<br>3.0. MIM assists in<br>the following<br>indications:<br>• Receive, transmit,<br>store, retrieve, display,<br>print, and process | RayStation is a<br>software system for<br>radiation therapy and<br>medical oncology.<br>Based on user input,<br>RayStation proposes<br>treatment plans. After<br>a proposed treatment<br>plan is reviewed and<br>approved<br>by authorized intended<br>users, RayStation may<br>also be used to<br>administer treatments.<br><br>The system<br>functionality can be<br>configured based on<br>user needs. | ClearCheck is<br>intended to assist<br>radiation therapy<br>professionals in<br>generating and<br>assessing the quality<br>of radiotherapy<br>treatment plans.<br>ClearCheck is also<br>intended to assist<br>radiation treatment<br>planners in predicting<br>when a treatment plan<br>might result in a<br>collision between the<br>treatment machine and<br>the patient or support<br>structures. | | MIM allows the dose<br>distribution of an<br>implant to be<br>individually shaped<br>for each patient and is<br>a general-purpose<br>brachytherapy<br>planning system used<br>for prospective and<br>confirmation dose<br>calculations for<br>patients undergoing a<br>course of<br>brachytherapy using<br>permanent implants of | MIM allows the dose<br>distribution of an<br>implant to be<br>individually shaped<br>for each patient and is<br>a general-purpose<br>brachytherapy<br>planning system used<br>for prospective and<br>confirmation dose<br>calculations for<br>patients undergoing a<br>course of<br>brachytherapy using<br>permanent implants of | | | | | | {10}------------------------------------------------ Image /page/10/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 cut out of the red square. 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, and the colors are eye-catching. {11}------------------------------------------------ Image /page/11/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. | medical images and<br>DICOM objects. | medical images and<br>DICOM objects. | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | • Create, display, and<br>print reports from<br>medical images. | • Create, display, and<br>print reports from<br>medical images. | | | • Registration, fusion<br>display, and review of | • Registration, fusion<br>display, and review of | | | medical images for<br>diagnosis, treatment | medical images for<br>diagnosis, treatment | | | evaluation, and<br>treatment planning. | evaluation, and<br>treatment planning. | | | • Evaluation of cardiac<br>left ventricular | • Evaluation of cardiac<br>left ventricular | | | function and<br>perfusion, including<br>left ventricular | function and<br>perfusion, including<br>left ventricular | | | end-diastolic volume,<br>end-systolic volume, | end-diastolic volume,<br>end-systolic volume, | | | and ejection fraction.<br>• Localization and | and ejection fraction.<br>• Localization and | | | definition of objects<br>such as tumors and | definition of objects<br>such as tumors and | | | normal tissues in<br>medical images. | normal tissues in<br>medical images. | | | • Creation,<br>transformation, and | • Creation,<br>transformation, and | | | modification of<br>contours for<br>applications including, | modification of<br>contours for<br>applications including, | | | but not limited to,<br>quantitative analysis, | but not limited to,<br>quantitative analysis, | | | aiding adaptive<br>therapy, transferring<br>contours to radiation | aiding adaptive<br>therapy, transferring<br>contours to radiation | | | therapy treatment<br>planning systems, and | therapy treatment<br>planning systems, and | | | archiving contours for<br>patient follow-up and<br>management. | archiving contours for<br>patient follow-up and<br>management. | | | • Quantitative and<br>statistical analysis of<br>PET/SPECT brain | • Quantitative and<br>statistical analysis of<br>PET/SPECT brain | | | scans by comparing to | scans by comparing to | | | other registered<br>PET/SPECT brain<br>scans. | other registered<br>PET/SPECT brain<br>scans. | | | • Planning and<br>evaluation of<br>permanent implant<br>brachytherapy<br>procedures (not<br>including radioactive<br>microspheres). | • Planning and<br>evaluation of<br>permanent implant<br>brachytherapy<br>procedures (not<br>including radioactive<br>microspheres). | | | • Calculating absorbed<br>radiation dose as a<br>result of administering<br>a radionuclide. | • Calculating absorbed<br>radiation dose as a<br>result of administering<br>a radionuclide. | | | • Assist with the<br>planning and<br>evaluation of ablation<br>procedures by<br>providing<br>visualization and<br>analysis, including<br>energy zone<br>visualization through<br>the placement of<br>virtual ablation<br>devices validated for<br>inclusion in<br>MIM-Ablation. The<br>software is not<br>intended to predict<br>specific ablation zone<br>volumes or predict<br>ablation success. | • Assist with the<br>planning and<br>evaluation of ablation<br>procedures by<br>providing<br>visualization and<br>analysis, including<br>energy zone<br>visualization through<br>the placement of<br>virtual ablation<br>devices validated for<br>inclusion in<br>MIM-Ablation. The<br>software is not<br>intended to predict<br>specific ablation zone<br>volumes or predict<br>ablation success. | | | When using the device<br>clinically, within the<br>United States, the user<br>should only use FDA<br>approved<br>radiopharmaceuticals.<br>If used with<br>unapproved ones, this<br>device should only be<br>used for research<br>purposes. | When using device<br>clinically, within the<br>United States, the user<br>should only use FDA<br>approved<br>radiopharmaceuticals.<br>If using with<br>unapproved ones, this<br>device should only be<br>used for research<br>purposes. | | {12}------------------------------------------------ Image /page/12/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, with a clean design. {13}------------------------------------------------ Image /page/13/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<br>mammographic<br>images and digitized<br>film screen images<br>must not be reviewed<br>for primary image<br>interpretations. Images<br>that are printed to film<br>must be printed using<br>an FDA-approved<br>printer for the<br>diagnosis of digital<br>mammography<br>images.<br>Mammographic<br>images must be<br>viewed on a display<br>system that has been<br>cleared by the FDA<br>for the diagnosis of<br>digital mammography<br>images. The software<br>is not to be used for<br>mammography CAD. | Lossy compressed<br>mammographic<br>images and digitized<br>film screen images<br>must not be reviewed<br>for primary image<br>interpretations. Images<br>that are printed to film<br>must be printed using<br>an FDA-approved<br>printer for the<br>diagnosis of digital<br>mammography<br>images.<br>Mammographic<br>images must be<br>viewed on a display<br>system that has been<br>cleared by the FDA<br>for the diagnosis of<br>digital mammography<br>images. The software<br>is not to be used for<br>mammography CAD. | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------| | Operating Platform | Microsoft Windows,<br>Apple® OS X | Microsoft Windows,<br>Apple® OS X | Windows 10<br>Professional (or<br>higher), Windows<br>Server 2012 R2 (or<br>higher) | Windows Operating<br>System | | Receive, transmit,<br>display, general<br>manipulation<br>(window/level, pan,<br>zoom, cross-hairs,<br>slice navigation), and<br>co-registration of<br>medical images | Yes | Yes | Yes | Yes | | Supported Imaging<br>Modalities | CT, MR, CR, DX,<br>MG, US, NM, PET,<br>XA, and other<br>DICOM modalities | CT, MR, CR, DX,<br>MG, US, NM, PET,<br>XA, and other<br>DICOM modalities | CT, MR, XA, PET,<br>and other DICOM<br>modalities | CT, MR, XA, and<br>other DICOM<br>modalities | | Evaluation of<br>radiation dose on<br>different image sets<br>through the use of | Yes | No | Yes | Yes | | rigid and deformable<br>registration objects | | | | | | Accumulation of dose<br>from multiple images | Yes | No | Yes | Yes | | Calculation of<br>Biologically Effective<br>Dose (BED) and<br>Equieffective Dose in<br>specified fractions<br>(e.g., EQD2) | Yes | No | Yes — added in<br>Raystation 11B<br>(K220141) | Yes | {14}------------------------------------------------ Image /page/14/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. # Device Description MIM – Dose Analysis extends features of MIM – Ablation (K220256). It is designed for use in medical imaging and operates on both Windows and Mac computer systems. MIM - Dose Analysis is a standalone software application that provides: - Calculation of Biologically Effective Dose (BED) and Equieffective Dose in specified fractions (e.g., EQD2) - Evaluation of radiation dose on different image sets through the use of rigid and deformable ● registration objects - Accumulation of doses ● ## Substantial Equivalence MIM - Dose Analysis is substantially equivalent to the predicate device, MIM - Ablation (K220256). The technological characteristics of MIM - Dose Analysis are supported by the methods in the reference devices, RaySearch RayStation 12A (K222312) and Radformation ClearCheck (K220583). {15}------------------------------------------------ Image /page/15/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. Below the text "mim" is the word "SOFTWARE" in a smaller, sans-serif font. # Testing and Performance Data Software verification and validation testing included 2 main sections: BED, EQD, and TCP calculations; and dose accumulation. BED, EQD, and TCP calculations implemented in MIM were compared against manual calculations using the same equations referenced in literature. Several different applications of the standard Linear-Quadratic (LQ) BED Model were tested. All test results yielded dose and TCP results within acceptable clinical limits when compared to manual calculations. Dose accumulation was tested by accumulating radiation doses delivered at separate timepoints for each patient dataset. Testing included dose accumulation between separate treatment timepoints linked via rigid and deformable registration objects. Accumulated dose was calculated in MIM at multiple data points within physician-contoured anatomical structures of interest in treatment planning and evaluation, and these dose results were compared against manual dose accumulation calculations. These test results showed consistent and accurate dose accumulation methods applied in MIM. Altogether, the testing performed validates the adequacy of MIM - Dose Analysis for clinical use and verifies alignment between MIM software, standardized equations referenced in literature, and previously FDA-cleared softwares. ## 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 device, MIM - Ablation (K220256). The technological characteristics of the proposed device are adequately supported by the methods in the reference devices. RaySearch RayStation 12A (K222312) and Radformation ClearCheck (K220583).