(262 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on calculations and image processing techniques without mentioning AI/ML.
No.
The device is a software tool used by medical professionals to aid in the evaluation and information management of medical images. It assists with tasks like image processing, registration, quantitative analysis, and dose calculation for treatment planning and evaluation. It does not directly provide therapy or interact physically with a patient for a therapeutic purpose.
No
The device is described as a tool to aid in the evaluation and information management of medical images, and for treatment planning and evaluation, not for diagnosis itself. While it assists in tasks that inform diagnosis (e.g., registration, fusion display, and review of medical images for diagnosis), its primary stated functions are image and information management, quantitative analysis, and aiding treatment. The device description for MIM – Dose Analysis explicitly states it "extends features of MIM – Ablation," which is for "planning and evaluation of ablation procedures."
Yes
The device description explicitly states it is a "standalone software application" and the performance studies focus solely on software verification and validation, comparing its calculations to manual methods and previously cleared software, without mentioning any associated hardware.
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 processes and analyzes medical images (CT, MR, PET, etc.) and radiation dose data. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use focuses on image processing, analysis, and treatment planning/evaluation. This aligns with the definition of medical image analysis software, not IVDs.
- The performance studies described involve comparing software calculations to manual calculations and previously cleared software. This is typical for medical image processing software validation, not IVD validation which would involve clinical studies with patient samples.
Therefore, this device falls under the category of medical image analysis 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 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 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 – 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 ●
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, DX, MG, US, SPECT, PET, XA, NM
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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
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)
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
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4
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 simple and modern, with a focus on clean lines and geometric shapes.
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:
| K220256 | MIM – Ablation | MIM Software Inc. |
|---|---|---|
| References: | ||
| 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:
MIM -
Dose Analysis
(K232514) | Predicate Device:
MIM -
Ablation
(K220256) | Reference Device:
RaySearch
RayStation 12A
(K222312) | Reference Device:
Radformation
ClearCheck
(K220583) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance Date | TBD | October 7, 2022 | March 29, 2023 | August 23, 2022 |
| 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, | 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, | RayStation is a
software system for
radiation therapy and
medical oncology.
Based on user input,
RayStation proposes
treatment plans. After
a proposed treatment
plan is reviewed and
approved
by authorized intended
users, RayStation may
also be used to
administer treatments.
The system
functionality can be
configured based on | ClearCheck is
intended to assist
radiation therapy
professionals in
generating and
assessing the quality
of radiotherapy
treatment plans.
ClearCheck is also
intended to assist
radiation treatment
planners in predicting
when a treatment plan
might result in a
collision between the
treatment machine and
the patient or support
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
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. | 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,
MRI, CR, DX, MG,
US, SPECT, PET and
XA as supported by
ACR/NEMA DICOM
3.0. | user needs. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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.
MIM provides tools to
quickly create,
transform, and modify
contours for | 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 | |
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,
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. | 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. | | 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. | 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 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 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. | 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 | 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 | RayStation is a
software system for
radiation therapy and
medical oncology.
Based on user input,
RayStation proposes
treatment plans. After
a proposed treatment
plan is reviewed and
approved
by authorized intended
users, RayStation may
also be used to
administer treatments.
The system
functionality can be
configured based on
user needs. | ClearCheck is
intended to assist
radiation therapy
professionals in
generating and
assessing the quality
of radiotherapy
treatment plans.
ClearCheck is also
intended to assist
radiation treatment
planners in predicting
when a treatment plan
might result in a
collision between the
treatment machine and
the patient or support
structures. |
| 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 | 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 | | | | | |
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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.
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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
DICOM objects. | 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 | • Registration, fusion
display, and review of | |
| medical images for
diagnosis, treatment | medical images for
diagnosis, treatment | |
| evaluation, and
treatment planning. | evaluation, and
treatment planning. | |
| • Evaluation of cardiac
left ventricular | • Evaluation of cardiac
left ventricular | |
| function and
perfusion, including
left ventricular | function and
perfusion, including
left ventricular | |
| end-diastolic volume,
end-systolic volume, | end-diastolic volume,
end-systolic volume, | |
| and ejection fraction.
• Localization and | and ejection fraction.
• Localization and | |
| definition of objects
such as tumors and | definition of objects
such as tumors and | |
| normal tissues in
medical images. | normal tissues in
medical images. | |
| • Creation,
transformation, and | • Creation,
transformation, and | |
| modification of
contours for
applications including, | modification of
contours for
applications including, | |
| but not limited to,
quantitative analysis, | but not limited to,
quantitative analysis, | |
| aiding adaptive
therapy, transferring
contours to radiation | aiding adaptive
therapy, transferring
contours to radiation | |
| therapy treatment
planning systems, and | therapy treatment
planning systems, and | |
| archiving contours for
patient follow-up and
management. | archiving contours for
patient follow-up and
management. | |
| • Quantitative and
statistical analysis of
PET/SPECT brain | • Quantitative and
statistical analysis of
PET/SPECT brain | |
| scans by comparing to | scans by comparing to | |
| other registered
PET/SPECT brain
scans. | 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
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. | • 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. | 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. | |
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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.
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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
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 | Microsoft Windows,
Apple® OS X | Windows 10
Professional (or
higher), Windows
Server 2012 R2 (or
higher) | Windows Operating
System |
| Receive, transmit,
display, general
manipulation
(window/level, pan,
zoom, cross-hairs,
slice navigation), and
co-registration of
medical images | Yes | Yes | Yes | Yes |
| 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 | CT, MR, XA, PET,
and other DICOM
modalities | CT, MR, XA, and
other DICOM
modalities |
| Evaluation of
radiation dose on
different image sets
through the use of | Yes | No | Yes | Yes |
| rigid and deformable
registration objects | | | | |
| Accumulation of dose
from multiple images | Yes | No | Yes | Yes |
| Calculation of
Biologically Effective
Dose (BED) and
Equieffective Dose in
specified fractions
(e.g., EQD2) | Yes | No | Yes — added in
Raystation 11B
(K220141) | Yes |
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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).
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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).