(29 days)
No
The document describes image processing, registration, quantitative analysis, and database comparisons, but does not explicitly mention or describe the use of AI or ML algorithms. The "Description of the training set" and "Description of the test set" sections describe the curation and evaluation of normal patient scans for comparison, which is a standard practice for quantitative analysis and does not necessarily indicate the use of AI/ML.
No
The device is a software tool used by medical professionals for processing, evaluating, and managing medical images for diagnosis, treatment evaluation, and planning. It is not directly involved in providing therapy.
Yes
The document explicitly states that the software is used for "diagnosis, treatment evaluation, and treatment planning" of medical images, and also mentions specific diagnostic evaluations like "Evaluation of cardiac left ventricular function and perfusion" and "Localization and definition of objects such as tumors and normal tissues."
Yes
The device is described as a "standalone software application" and explicitly states that "engineering drawings, schematics, etc. are not applicable to the device," indicating it does not include hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The intended use of this software is to process and analyze medical images of the human body, not biological samples.
- The device description focuses on image processing and analysis. It describes receiving, transmitting, storing, retrieving, displaying, printing, and processing medical images.
- The specific applications listed are image-based. These include image registration, fusion, quantitative analysis of scans, localization of objects in images, and contour creation.
- The device interacts with imaging modalities (CT, MRI, PET, etc.). These are external imaging techniques, not methods for analyzing biological samples.
Therefore, while this is a medical device used for diagnosis and treatment planning, it falls under the category of medical image processing and analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FDA has provided two separate sections for "Intended Use" and "Indications for Use". I will provide both.
Indications for Use
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
· Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
- · Create, display and print reports from medical images.
· Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
· Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-systolic volume, and ejection fraction.
· Localization and definition of objects such as tumors and normal tissues in medical images.
· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
· Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
· Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
- · Calculating absorbed radiation dose as a result of administering a radionuclide.
When using this 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 a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
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, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0.
MIM provides the user with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. The Reqion 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-byvoxel 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.
Product codes
LLZ
Device Description
MIM - Additional Tracers is an expansion of the standalone software application MIM - On Linux (K190379). MIM - Additional Tracers Indications for Use have not been modified, and the Intended Use is the same as in MIM - On Linux. With the addition of additional tracers to the standalone MIM software, engineering drawings, schematics, etc. are not applicable to the device.
These Indications for Use include quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. MIM - Additional Tracers includes the above features and capabilities and adds support for new PET/SPECT new tracers. While MIM - On Linux supported FDG and HMPAO tracers, this special 510k submission includes new tracers support for: Amyvid™ (Florbetapir), Vizamyl™ (Flutemetamol), Neuraceq™ (Florbetaben), and DaTscan™ (Joflupane).
MIM - Additional Tracers operates on Windows, Mac, and Linux computer systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, CR, DX, MG, US, SPECT, PET, XA
Anatomical Site
Brain, Cardiac Left Ventricle (LV)
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
Normal patient scans were curated to span demographics appropriate for each tracer. After selection, these series were then aligned to template space to create databases for each tracer. Alignment to template space and accuracy of analysis contours for each tracer were approved by a radiologist and MIM technical experts before each series could be included in the normals database.
Description of the test set, sample size, data source, and annotation protocol
Quantitative analysis results on a selection of scans representative of the population for each tracer were compared to expert reads and reviewed by physicians and MIM technical experts. Discrepancies were only acceptable for misregistered, borderline, or poor-quality scans.
Summary of Performance Studies
Template registration accuracy for each tracer and corresponding clinical use case was assessed by a radiologist and MIM technical experts. Risk mitigation for automatic registration error is built-in to the software with registration adjustment and verification steps. For amyloid PET registration, the user inspects and adjusts affine registration to template space with displayed fusions to an amyloid positive, amyloid negative, and mean template. There is a secondary verification step to confirm registration accuracy as well. For DaTscan registration, there is built-in affine registration to the template and individual hemisphere verification and adjustment to ensure accurate placement of the reference and analysis regions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2023
MIM Software Inc. % Megan Fontanez Clinical Science Team Lead 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122
Re: K223800
Trade/Device Name: MIM - Additional Tracers Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: December 16, 2022 Received: December 19, 2022
Dear Megan Fontanez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
D. G. K.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine 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
Enclosure
2
Indications for Use
510(k) Number (if known) K223800
Device Name MIM - Additional Tracers
Indications for Use (Describe)
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
· Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
- · Create, display and print reports from medical images.
· Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
· Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-systolic volume, and ejection fraction.
· Localization and definition of objects such as tumors and normal tissues in medical images.
· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
· Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
· Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
- · Calculating absorbed radiation dose as a result of administering a radionuclide.
When using this 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 a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
Type of Use (Select one or both, as applicable)
X 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 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 the registered trademark symbol.
K223800
510(k) Summary of Safety and Effectiveness
(The following information is in conformance with 21 CFR 807.92)
Submitter
MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122
Phone: 216-455-0600 Fax: 216-455-0601
Contact Person: Date Summary Prepared: Megan Fontanez December 16, 2022
Device Name
Trade Name: MIM – Additional Tracers Common Name: Medical Imaging Software Regulation Number / Product Code: 21 CFR 892.2050 / Product Code LLZ Classification Name: System, Imaging Processing, Radiological
Predicate Device
MIM — On Linux
Reference Device
MIM 4.0 (NEURO)
MIMvista Corp.
MIM Software Inc.
5
Image /page/5/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, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.
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, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0.
MIM provides the user with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. The Reqion 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-byvoxel basis, within stereotactic surface projections or standardized regions of interest.
MIM allows the dose distribution of an implant to be individually shaped for each patient and is a general-purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes (not including radioactive microspheres).
MIM allows voxel-based dose calculations for patients who have been administered radioisotopes or radioactive microspheres.
Indications for Use
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
6
Image /page/6/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 in the red square. To the right of the squares is the text "mim SOFTWARE" in black. The word "mim" is in a larger font than the word "SOFTWARE".
• 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 reqistered PET/SPECT brain scans.
- Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
· Calculating absorbed radiation dose as a result of administering a radionuclide.
When using this device clinically within the United States, the user should only use FDAapproved 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 a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
7
Image /page/7/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle in the center. To the right of the squares is the text "mim" in black, with the word "SOFTWARE" in smaller black letters below it. The logo is simple and modern, and the colors are eye-catching.
Device Description
MIM - Additional Tracers is an expansion of the standalone software application MIM -On Linux (K190379). MIM - Additional Tracers Indications for Use have not been modified, and the Intended Use is the same as in MIM - On Linux. With the addition of additional tracers to the standalone MIM software, engineering drawings, schematics, etc. are not applicable to the device.
These Indications for Use include quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. MIM - Additional Tracers includes the above features and capabilities and adds support for new PET/SPECT new tracers. While MIM - On Linux supported FDG and HMPAO tracers, this special 510k submission includes new tracers support for: Amyvid™ (Florbetapir), Vizamyl™ (Flutemetamol), Neuraceq™ (Florbetaben), and DaTscan™ (Joflupane).
MIM - Additional Tracers operates on Windows, Mac, and Linux computer systems.
| ITEM | MIM - ADDITIONAL
TRACERS
(K# - TBD) | MIM ON LINUX
(K190379) | MIM 4.0 NEURO
(K060816) |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance
Dates | TBD | March 19, 2019 | March 24, 2006 |
| 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 | 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 | MIM 4.0 (NEURO) is a
software package that
provides the physician
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
physician to define
objects in medical |
| ITEM | MIM - ADDITIONAL
TRACERS
(K# - TBD) | MIM ON LINUX
(K190379) | MIM 4.0 NEURO
(K060816) |
| | CR, DX, MG, US, SPECT,
PET and XA as supported by
ACR/NEMA DICOM 3.0. | CR, DX, MG, US, SPECT,
PET and XA as supported by
ACR/NEMA DICOM 3.0. | image volumes by
providing an initial
definition of object
contours. The objects
include but are not
limited to tumors and
organs. |
| | 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 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 4.0 (NEURO) also
aids the physician 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 |
| | MIM provides tools to quickly
create, transform, and modify
contours for applications
including, but not limited to,
quantitative analysis, aiding
adaptive therapy, transferring
contours to radiation therapy
treatment planning systems
and archiving contours for
patient follow-up and
management. | MIM provides tools to quickly
create, transform, and modify
contours for applications
including, but not limited to,
quantitative analysis, aiding
adaptive therapy, transferring
contours to radiation therapy
treatment planning systems
and archiving contours for
patient follow-up and
management. | a voxel-by-voxel basis,
within stereotactic
surface projections, or
within 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 | 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 | |
| ITEM | MIM - ADDITIONAL
TRACERS
(K# - TBD) | MIM ON LINUX
(K190379) | MIM 4.0 NEURO
(K060816) |
| | stereotactic surface
projections or standardized
regions of interest. | stereotactic surface
projections or standardized
regions of interest. | stereotactic surface
projections or standardized
regions of interest. |
| | MIM allows the dose
distribution of an implant to be
individually shaped for each
patient and is a general-
purpose brachytherapy
planning system used for
prospective and confirmation
dose calculations for patients
undergoing a course of
brachytherapy using
permanent implants of various
radioisotopes (not including
radioactive microspheres). | MIM allows the dose
distribution of an implant to be
individually shaped for each
patient and is a general-
purpose brachytherapy
planning system used for
prospective and confirmation
dose calculations for patients
undergoing a course of
brachytherapy using
permanent implants of various
radioisotopes (not including
radioactive microspheres). | MIM allows 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 allows voxel-based dose
calculations for patients who
have been administered
radioisotopes or radioactive
microspheres. | MIM allows voxel-based dose
calculations for patients who
have been administered
radioisotopes or radioactive
microspheres. |
| Indications
for Use | MIM software is used by
trained medical professionals
as a tool to aid in evaluation
and information management
of digital medical images. The
medical image modalities
include, but are not limited to,
CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0. MIM assists in the
following indications:
• Receive, transmit, store, | MIM software is used by
trained medical professionals
as a tool to aid in evaluation
and information management
of digital medical images. The
medical image modalities
include, but are not limited to,
CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0. MIM assists in the
following indications:
• Receive, transmit, store, | The MIM software
program should be
used for the
registration, fusion and
display of
medical images from
multi-modalities, such
as SPECT, PET, CT,
and MRI. MIM assists
in definition of
structures in medical
images including
tumors, organs, and
cardiac left |
| | retrieve, display, print, and
process medical images and
DICOM objects.
• Create, display and print
reports from medical images. | retrieve, display, print, and
process medical images and
DICOM objects.
• Create, display and print
reports from medical images. | ventricular cavity. MIM
aids in the assessment
of PET/SPECT brain
scans by providing
quantitative and
statistical comparisons
to other registered |
| ITEM | MIM - ADDITIONAL
TRACERS
(K# - TBD) | MIM ON LINUX
(K190379) | MIM 4.0 NEURO
(K060816) |
| | • Registration, fusion display,
and review of medical images
for diagnosis, treatment
evaluation, and treatment
planning. | • Registration, fusion display,
and review of medical images
for diagnosis, treatment
evaluation, and treatment
planning. | PET/SPECT brain
scans. |
| | • Evaluation of cardiac left
ventricular function and
perfusion, including left
ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction. | • Evaluation of cardiac left
ventricular function and
perfusion, including left
ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction. | |
| | • Localization and definition of
objects such as tumors and
normal tissues in medical
images. | • Localization and definition of
objects such as tumors and
normal tissues in medical
images. | |
| | • Creation, transformation, and
modification of contours for
applications including, but not
limited to, quantitative
analysis, aiding adaptive
therapy, transferring contours
to radiation therapy treatment
planning systems, and
archiving contours for patient
follow-up and management. | • Creation, transformation, and
modification of contours for
applications including, but not
limited to, quantitative
analysis, aiding adaptive
therapy, transferring contours
to radiation therapy treatment
planning systems, and
archiving contours for patient
follow-up and management. | |
| | • Quantitative and statistical
analysis of PET/SPECT brain
scans by comparing to other
registered PET/SPECT brain
scans. | • Quantitative and statistical
analysis of PET/SPECT brain
scans by comparing to other
registered PET/SPECT brain
scans. | |
| | • Planning and evaluation of
permanent implant
brachytherapy procedures
(not including radioactive
microspheres). | • Planning and evaluation of
permanent implant
brachytherapy procedures
(Not including radioactive
microspheres). | |
| | • Calculating absorbed
radiation dose as a result of
administering a radionuclide. | • Calculating absorbed
radiation dose as a result of
administering a radionuclide. | |
| | When using this device
clinically within the United | When using device clinically,
the user should only use FDA | |
| ITEM | MIM - ADDITIONAL
TRACERS
(K# - TBD) | MIM ON LINUX
(K190379) | MIM 4.0 NEURO
(K060816) |
| | States, the user should only
use FDA-approved
radiopharmaceuticals. If used
with unapproved ones, this
device should only be used for
research purposes. | approved
radiopharmaceuticals. If using
with unapproved ones, this
device should only be used for
research purposes. | |
| | Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image interpretations.
Images that are printed to film
must be printed using a FDA-
approved printer for the
diagnosis of digital
mammography images.
Mammographic images must
be viewed on a display system
that has been cleared by the
FDA for the diagnosis of digital
mammography images. The
software is not to be used for
mammography CAD. | Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image interpretations.
Images that are printed to film
must be printed using a FDA-
approved printer for the
diagnosis of digital
mammography images.
Mammographic images must
be viewed on a display system
that has been cleared by the
FDA for the diagnosis of digital
mammography images. The
software is not to be used for
mammography CAD. | |
| Receive,
Transmit,
Retrieve,
Display,
Print Digital
Medical
Images | Yes | Yes | Yes |
| MIM
workstation
features
and
functionality | Yes | Yes | Yes |
| Operating
Platform | Microsoft Windows,
Apple® OS
Linux-based OS | Microsoft Windows,
Apple® OS
Linux-based OS | Microsoft Windows,
Apple® OS |
| Tracer
Support | PET
• FDG
• Amyvid™
• (Florbetapir), | PET
• FDG
SPECT
• HMPAO | PET
• FDG
SPECT
• HMPAO |
| ITEM | MIM - ADDITIONAL
TRACERS
(K# - TBD) | MIM ON LINUX
(K190379) | MIM 4.0 NEURO
(K060816) |
| | Vizamyl™
(Flutemetamol) Neuraceq™
(Florbetaben) | | |
| | SPECT HMPAO DaTscan™ (Ioflupane) | | |
Substantial Equivalence
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Image /page/8/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.
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Image /page/9/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 SOFTWARE" in black. The letters "mim" are in a larger, bolder font than the word "SOFTWARE".
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Image /page/10/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath 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 is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, on the left side of the logo. To the right of the squares is the text "mim SOFTWARE" in black font. The word "mim" is in a larger font than the word "SOFTWARE".
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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 clean and modern, with a focus on simplicity and readability.
Discussion
MIM - Additional Tracers is substantially equivalent to past MIM software 510(k) clearances. MIM - on Linux was chosen as the predicate device to represent the broad range of indications for use and intended uses that encompasses MIM software. The comparison chart above shows that the only difference within this catch-up special 510(k) is the additional tracer support.
Testing and Performance Data
Template registration accuracy for each tracer and corresponding clinical use case was assessed by a radiologist and MIM technical experts. Risk mitigation for automatic registration error is built-in to the software with registration adjustment and verification steps. For amyloid PET registration, the user inspects and adjusts affine registration to template space with displayed fusions to an amyloid positive, amyloid negative, and mean template. There is a secondary verification step to confirm registration accuracy as well. For DaTscan registration, there is built-in affine registration to the template and individual hemisphere verification and adjustment to ensure accurate placement of the reference and analysis regions.
Normal patient scans were curated to span demographics appropriate for each tracer. After selection, these series were then aligned to template space to create databases for each tracer. Alignment to template space and accuracy of analysis contours for each tracer were approved by a radiologist and MIM technical experts before each series could be included in the normals database.
Quantitative analysis results on a selection of scans representative of the population for each tracer were compared to expert reads and reviewed by physicians and MIM technical experts. Discrepancies were only acceptable for misregistered, borderline, or poor-quality scans.
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Image /page/13/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, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a simple color palette.
Conclusion
Based on the Discussion and Testing and Performance Data, the proposed device is determined to be as safe and effective as its predicate device, K190379 (MIM – On Linux), and its reference device, K060816 (MIM 4.0 Neuro).