(249 days)
No
The document mentions "automatic tools for normal structure, target region, and ablation zone segmentation" and "constraint-driven placement of virtual ablation devices," but it does not explicitly mention or describe the use of AI or ML algorithms for these functions. The performance studies focus on geometric measurements and consistency, not on the performance of an AI/ML model. The predicate device K202297 "Aline Ablation Intelligence" might suggest AI, but the description of the subject device does not elaborate on any such capabilities.
No.
Explanation: The device is a software application designed to aid medical professionals in planning and evaluating ablation procedures by processing and analyzing medical images. It does not directly produce a therapeutic effect on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states "Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning." This directly indicates that the software is used in the diagnostic process.
Yes
The device is described as a "standalone software application" and its functionality is entirely based on processing and displaying medical images and related data. While it interacts with medical images from various modalities and is used in conjunction with physical ablation devices (mentioned in the performance studies), the device itself is the software. The description focuses on software features like segmentation, image re-slicing, virtual device placement, and calculations, without mentioning any accompanying hardware components that are part of the device itself.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software is used to process and analyze medical images (CT, MRI, PET, etc.) of the human body, not biological samples like blood, urine, or tissue.
- The purpose is image analysis and planning, not testing biological samples. The software aids in image evaluation, information management, registration, fusion, segmentation, quantitative analysis of images, and planning/evaluation of procedures like brachytherapy and ablation. These are all related to interpreting and utilizing medical images, not performing tests on biological specimens.
Therefore, based on the standard definition of an In Vitro Diagnostic device, this software does not fit that category. It is a medical image processing and analysis software.
N/A
Intended Use / Indications for Use
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
• Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
· Create, display, and print reports from medical images.
· Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
• Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
· Localization and definition of objects such as tumors and normal tissues in medical images.
· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
• Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
• Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
· Calculating absorbed radiation dose as a result of administering a radionuclide.
• Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If using with unapproved ones, this device should only be used for research purposes.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
Product codes (comma separated list FDA assigned to the subject device)
QTZ, LLZ
Device Description
MIM - Ablation is a standalone software application that allows for the planning and evaluation of ablation procedures. This is achieved by utilizing the following functionality:
- . Manual and automatic tools for normal structure, target region, and ablation zone segmentation
- lmage re-slicing and reorientation orthogonally to a user-defined angle to give a . "probe's-eye view" image for planning
- Manual and constraint-driven placement of virtual ablation devices on medical . imaging in order to visualize the ablation energy zones.
- . The calculation of the percentage of designated structures that are covered by each energy zone during planning, as well as a calculation of the final ablation zone coverage after the ablation has been performed
- Multimodality image registration, including rigid and deformable fusion, for the . comparison of images taken at different times during the ablation planning and treatment administration
MIM - Ablation is run on a dedicated workstation in the hospital healthcare environment and can be used with an 3D DICOM image. The software can be used on image data for any patient demographic that is undergoing ablation treatment with devices validated for inclusion in MIM - Ablation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, CR, DX, MG, US, SPECT, PET and XA
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MIM software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicists.
Hospital healthcare environment
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)
MIM Software Inc. has conducted performance and integration testing on MIM -Ablation software that fully evaluated all the functions. The data support verification in energy zone dimensions, image resolution independence, contour resolution independence, image modality independence, percent coverage of regions, HIFU energy zone dimensions, and constraint driven planning. The verification and validation testing follow 21 CFR part 820.30 and satisfies the FDA "Guidance on Software Contained in Medical Devices" requirements. Potential risks were mitigated and reflected in the device labeling and design.
The ablation devices that were included in the verification and validation of MIM-Ablation are the Varian V-Probes (part of the CryoCare Touch System, K201588) and the SonaBlate HIFU system (K160942). The specific energy zone characteristics that were used to generate models and import into MIM-Ablation were taken from user quides and marketing material for each ablation device.
The dimensions of the energy zones that are imported as 3D objects in MIM match the dimensions for that energy zone as specified by the ablation device manufacturer. The measurements of the initial 3D models of the energy zones in the CAD (computer-aided design) software and the MIM contour measurements fell within the range of the manufacturer tolerance. In addition, the CAD measurement had a range of -3.75% to 1.53% percent difference compared to MIM contour measurements.
The volume of the energy zones that are imported as 3D objects in MIM are independent of image resolution. This work compared expected volumes to MIM volume at 0.5 mm. 1.0 mm. and 1.5 mm image resolutions to verify consistency. Percent difference ranged from -1.65 % to 0.29%, at 0.5 mm. -0.87% to -0.6% at 1.0 mm, and -0.70% to 0.00% at 1.5 mm image resolution.
The dimensions of the energy zones that are imported as 3D objects in MIM match the dimensions for that energy zone as specified by the ablation device manufacturer independent of contour resolution. Percent difference ranged from -1.43% to -0.43% at 0.25 mm, -1.16% to 0.00% at 0.5 mm, and -2.15% to -0.38% at 1.0 mm contour resolution.
The dimensions of the energy zones as 3D objects in MIM match the dimensions of the energy zone as specified by the ablation device manufacturer across four image modalities. Percent difference ranged from 0.64% - 0.89%. This highlights the minimal effect image modality has on contour dimensions.
MIM provides the statistic "Percent Coverage" that indicates the volume of the structure being covered by the volume of the energy zone. The percent coverage statistic with one or multiple ablation probes placed on an image was verified. Percent difference ranged from 0.00% to 1.57%. with one ablation probe and 0.00% to 0.19% with two ablation probes.
The dimensions of the unique energy zone, HIFU, are generated as specified by the ablation probe manufacturer. The 3cm transducer treatment zone height, 4cm transducer treatment zone height, and overlap were measured in MIM and in Sonablate to verify that they matched the manufacturer's dimensions. Percent error ranged from 0.00% to 6.00%. These measurements fell within the range of the manufacturer tolerance. This work verified the consistency in HIFU dimensions compared to the manufacturer's measurements.
This work verified that the constraint-driven planning functionality places energy zones that adhere to the constraints as set by the user. These constraints ensure ablation probes target the appropriate region of interest. In addition, this work verified that an unattainable plan occurs when the scenario is not possible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent difference ranged from -3.75% to 1.53% (CAD measurement vs. MIM contour measurements).
Percent difference ranged from -1.65 % to 0.29% (at 0.5 mm image resolution), -0.87% to -0.6% (at 1.0 mm image resolution), and -0.70% to 0.00% (at 1.5 mm image resolution) for volume of energy zones.
Percent difference ranged from -1.43% to -0.43% (at 0.25 mm contour resolution), -1.16% to 0.00% (at 0.5 mm contour resolution), and -2.15% to -0.38% (at 1.0 mm contour resolution) for dimensions of energy zones.
Percent difference ranged from 0.64% - 0.89% for dimensions of energy zones across image modalities.
Percent difference ranged from 0.00% to 1.57% (with one ablation probe) and 0.00% to 0.19% (with two ablation probes) for percent coverage.
Percent error ranged from 0.00% to 6.00% for HIFU dimensions.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
MIM Software, Inc. % Daniel Darkow Clinical Science Team Lead 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122
Re: K220256
October 7, 2022
Trade/Device Name: MIM-Ablation Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QTZ, LLZ Dated: September 2, 2022 Received: September 6, 2022
Dear Daniel Darkow:
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 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)
1
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,
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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) K220256
Device Name MIM - Ablation
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, 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 PE7/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 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 device clinically, within the United States, the user should only use FDA approved radionly, If using with unapproved ones, this device should only be used for research purposes.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
Type of Use (Select one or both, as applicable)
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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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 in the red square. To the right of the squares is the text "mim SOFTWARE" in black, with "SOFTWARE" in a smaller font size than "mim".
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 216-455-0601 Fax:
Contact Person:
Daniel Darkow
Date Summary Prepared:
10/04/2022
Device Name
| 510(k) Number: | K220256 |
|---|---|
| Trade Name: | MIM – Ablation |
| Common Name: | Medical Imaging Software |
| Primary Regulation Number/Product Code: | 21 CFR 892.2050 Product Code QTZ |
| Primary Classification Name: | Radiological Image Processing Software for Ablation Therapy Planning and Evaluation |
| Secondary Regulation Number / Product Code: | 21 CFR 892.2050 Product Code LLZ |
| Secondary Classification Name: | System, Imaging Processing, Radiological |
Predicate Devices
Predicate Devices
| Primary:
| K190379 | MIM on Linux | MIM Software Inc. |
|---|---|---|
| Secondaries: | ||
| K202297 | Aline Ablation Intelligence | Mirada Medical Ltd. |
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
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Image /page/5/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a gray square overlapping a red square with a white circle cut out of the corner. To the right of the squares is the text "mim SOFTWARE" in black font. The word "SOFTWARE" is in a smaller font than "mim".
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 eiection fraction.
The Region of Interest (ROI) feature reduces the time necessary for the user to define objects in medical image volumes by providing an initial definition of object contours. The objects include, but are not limited to, tumors and normal tissues.
MIM provides tools to quickly create, transform, and modify contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems and archiving contours for patient follow-up and management.
MIM aids in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel-by-voxel basis, within stereotactic surface projections or standardized regions of interest.
MIM allows the dose distribution of an implant to be individually shaped for each patient and is a general-purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes (not including radioactive microspheres).
MIM allows voxel-based dose calculations for patients who have been administered radioisotopes or radioactive microspheres.
MIM assists with the planning and evaluation of ablation procedures by allowing the energy zone that comprises the ablation zone to be visualized on medical imaging through the placement of virtual ablation devices for the purpose of confirming ablation zone placement.
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:
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Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of a red square with rounded corners and a white circle in the lower left corner. A gray square with rounded corners is behind the red square. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font.
• Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
· Create, display, and print reports from medical images.
· Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
• Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
· Localization and definition of objects such as tumors and normal tissues in medical images.
· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
• Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
• Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
· Calculating absorbed radiation dose as a result of administering a radionuclide.
• Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If using with unapproved ones, this device should only be used for research purposes.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
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Image /page/7/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a red square with rounded corners and a white circle cut out of the top right corner. To the left of the red square is a gray square with rounded corners. To the right of the squares is the text "mim SOFTWARE" in black font.
| ITEM | MIM – Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance Date | TBD | 03-19-2019 | 09-11-2020 |
| 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 | 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 | Not listed |
| ITEM | MIM - Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
| | end-diastolic volume, end-
systolic volume, and
ejection fraction. | end-diastolic volume, end-
systolic volume, and
ejection fraction. | |
| | The Region of Interest
(ROI) feature reduces the
time necessary for the
user to define objects in
medical image volumes
by providing an initial
definition of object
contours. The objects
include, but are not limited
to, tumors and normal
tissues. | The Region of Interest
(ROI) feature reduces the
time necessary for the
user to define objects in
medical image volumes
by providing an initial
definition of object
contours. The objects
include, but are not limited
to, tumors and normal
tissues. | |
| | MIM provides tools to
quickly create, transform,
and modify contours for
applications including, but
not limited to, quantitative
analysis, aiding
adaptive therapy,
transferring contours to
radiation therapy
treatment planning
systems and archiving
contours for patient follow-
up and management. | MIM provides tools to
quickly create, transform,
and modify contours for
applications including, but
not limited to, quantitative
analysis, aiding adaptive
therapy, transferring
contours to radiation
therapy treatment
planning systems and
archiving contours for
patient follow-up and
management. | |
| | MIM aids in the
assessment of
PET/SPECT brain scans.
It provides automated
quantitative and
statistical analysis by
automatically registering
PET/SPECT brain scans
to a standard template
and comparing intensity
values to a reference | MIM aids in the
assessment of
PET/SPECT brain scans.
It provides automated
quantitative and statistical
analysis by automatically
registering PET/SPECT
brain scans to a standard
template and comparing
intensity values to a
reference database or to | |
| ITEM | MIM – Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
| | database or to other
PET/SPECT scans on a
voxel by voxel basis,
within stereotactic surface
projections or
standardized regions of
interest.
MIM allows the dose
distribution of an implant
to be individually shaped
for each patient and is a
general purpose
brachytherapy
planning system used for
prospective and
confirmation dose
calculations for patients
undergoing a course of
brachytherapy using
permanent implants of
various radioisotopes (not
including radioactive
microspheres).
MIM allows voxel-based
dose calculations for
patients who have been
administered
radioisotopes or
radioactive microspheres.
MIM assists with the
planning and evaluation of
ablation procedures by
allowing the energy zone
that comprises the
ablation zone to be
visualized on medical
imaging through the
placement of virtual | 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. | |
| ITEM | MIM – Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
| | 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. | 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-
diastolic volume, end-
systolic volume, and
ejection fraction. | Aline Ablation Intelligence
is a Computed
Tomography (CT) and
Magnetic Resonance
(MR) image processing
software package
available for use with
ablation procedures.
Aline Ablation Intelligence
is controlled by the user
via a user interface on a
workstation.
Aline Ablation Intelligence
imports images from CT
and MR scanners and
facility PACS systems for
display and processing
during ablation
procedures.
Aline Ablation Intelligence
is used to assist
physicians in planning
ablation procedures,
including identifying
ablation targets and virtual
ablation needle
placement. Aline Ablation
Intelligence is used to
assist physicians in
confirming ablation zones.
The software is not
intended for diagnosis. |
| ITEM | MIM – Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
| | • Localization and
definition of objects such
as tumors and normal
tissues in medical images.
• Creation,
transformation, and
modification of contours
for applications including,
but not limited to,
quantitative analysis,
aiding adaptive therapy,
transferring contours to
radiation therapy
treatment planning
systems, and archiving
contours for patient follow-
up and management.
• Quantitative and
statistical analysis of
PET/SPECT brain scans
by comparing to other
registered PET/SPECT
brain scans.
• Planning and
evaluation of permanent
implant brachytherapy
procedures (not including
radioactive microspheres).
• Calculating absorbed
radiation dose as a result
of administering a
radionuclide.
• Assist with the
planning and evaluation of
ablation procedures by
providing visualization and
analysis, including energy
zone visualization through
the placement of virtual
ablation devices validated
for inclusion in MIM- | • 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. | The software is not
intended to predict
ablation volumes or
predict ablation success. |
| ITEM | MIM - Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
| | Ablation. The software is
not intended to predict
specific ablation zone
volumes or predict
ablation success. | When using device
clinically, the user should
only use FDA approved
radiopharmaceuticals. | |
| | When using the 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. | |
| | 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. | |
| | 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. | |
| | 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. | |
| | 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. | The software is not to be
used for mammography
CAD. | |
| ITEM | MIM – Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
| Operating Platform | Microsoft Windows,
Apple® OS X | Microsoft Windows,
Apple® OS X | Unknown |
| Receive, transmit, display
and general manipulation
(window/level, pan, zoon,
cross-hairs, slice
navigation) of medical
images | 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 and MR |
| Image Segmentation | Tools for segmenting 3D
structures, including
normal structures, lesions,
and ablation zones.
(This functionality is
unchanged from MIM on
Linux) | Tools for segmenting 3D
structures, including
normal structures, and
lesions. | Tools for segmenting 3D
VOIs, including target
tissues and ablation
zones. |
| ITEM | MIM - Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
| Derive volume statistics
from segmentations | Yes
(This functionality is
unchanged from MIM on
Linux) | Yes | Yes |
| Automated ablation
margin creation through
the expansion of a
designated segmentation | Yes
(This functionality is
unchanged from MIM on
Linux) | Yes | Yes |
| Image re-slicing
orthogonally to a user-
defined angle to give a
"probe's-eye view" image
for planning | Yes
(This functionality is
unchanged from MIM-
Brachy (K103576) which
is a precursor 510(k) to
MIM on Linux) | Yes | No |
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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. The logo is simple and modern, with a focus on clean lines and geometric shapes.
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Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim SOFTWARE" in black. The font is sans-serif and the word "SOFTWARE" is smaller than "mim".
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Image /page/10/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a gray square overlapping a red rounded square with a white circle cut out of it, followed by the text "mim SOFTWARE" in black. The "mim" is in a larger, bolder font than the "SOFTWARE" text.
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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" underneath in a smaller font. The logo is simple and modern, with a focus on the company's name.
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Image /page/12/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, with a focus on clean lines and geometric shapes.
13
Image /page/13/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 cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" below it in a smaller font.
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Image /page/14/Picture/0 description: The image is a logo for MIM Software. The logo consists of a red square with rounded corners and a white circle cut out of the top right corner. To the left of the red square is a gray square that is partially obscured by the red square. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font.
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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, on the left side. 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.
| ITEM | MIM = Ablation
(K220256) | MIM on Linux
(K190379) | Mirada Aline
Ablation Intelligence
(K202297) |
|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------|----------------------------------------------------|
| Placement of pre-defined
energy zone volumes per
specified grid locations on
a medical image | Yes | No | Yes |
| Registration of planning
imaging to in-procedure
and/or post-ablation
imaging for the purpose of
ablation zone confirmation | Yes
(Image registration
functionality is unchanged
from MIM on Linux) | Yes | Yes |
Device Description
MIM - Ablation is a standalone software application that allows for the planning and evaluation of ablation procedures. This is achieved by utilizing the following functionality:
- . Manual and automatic tools for normal structure, target region, and ablation zone segmentation
- lmage re-slicing and reorientation orthogonally to a user-defined angle to give a . "probe's-eye view" image for planning
- Manual and constraint-driven placement of virtual ablation devices on medical . imaging in order to visualize the ablation energy zones.
- . The calculation of the percentage of designated structures that are covered by each energy zone during planning, as well as a calculation of the final ablation zone coverage after the ablation has been performed
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Image /page/16/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a red square with a white circle in the corner, and a gray square overlapping the red square. 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".
- Multimodality image registration, including rigid and deformable fusion, for the . comparison of images taken at different times during the ablation planning and treatment administration
MIM - Ablation is run on a dedicated workstation in the hospital healthcare environment and can be used with an 3D DICOM image. The software can be used on image data for any patient demographic that is undergoing ablation treatment with devices validated for inclusion in MIM - Ablation.
Substantial Equivalence
MIM - Ablation is substantially equivalent to a combination of the primary predicate device MIM on Linux (K190379) and Aline Ablation Intelligence (K202297).
Testing and Performance Data
MIM Software Inc. has conducted performance and integration testing on MIM -Ablation software that fully evaluated all the functions. The data support verification in energy zone dimensions, image resolution independence, contour resolution independence, image modality independence, percent coverage of regions, HIFU energy zone dimensions, and constraint driven planning. The verification and validation testing follow 21 CFR part 820.30 and satisfies the FDA "Guidance on Software Contained in Medical Devices" requirements. Potential risks were mitigated and reflected in the device labeling and design.
The ablation devices that were included in the verification and validation of MIM-Ablation are the Varian V-Probes (part of the CryoCare Touch System, K201588) and the SonaBlate HIFU system (K160942). The specific energy zone characteristics that were used to generate models and import into MIM-Ablation were taken from user quides and marketing material for each ablation device.
The dimensions of the energy zones that are imported as 3D objects in MIM match the dimensions for that energy zone as specified by the ablation device manufacturer. The measurements of the initial 3D models of the energy zones in the CAD (computer-aided design) software and the MIM contour measurements fell within the range of the manufacturer tolerance. In addition, the CAD measurement had a range of -3.75% to 1.53% percent difference compared to MIM contour measurements.
The volume of the energy zones that are imported as 3D objects in MIM are independent of image resolution. This work compared expected volumes to MIM volume at 0.5 mm. 1.0 mm. and 1.5 mm image resolutions to verify consistency. Percent difference ranged from -1.65 % to 0.29%, at 0.5 mm. -0.87% to -0.6% at 1.0 mm, and -0.70% to 0.00% at 1.5 mm image resolution.
17
Image /page/17/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a gray square overlapping a red square with a white circle in the corner. To the right of the squares is the text "mim SOFTWARE" in black font.
The dimensions of the energy zones that are imported as 3D objects in MIM match the dimensions for that energy zone as specified by the ablation device manufacturer independent of contour resolution. Percent difference ranged from -1.43% to -0.43% at 0.25 mm, -1.16% to 0.00% at 0.5 mm, and -2.15% to -0.38% at 1.0 mm contour resolution.
The dimensions of the energy zones as 3D objects in MIM match the dimensions of the energy zone as specified by the ablation device manufacturer across four image modalities. Percent difference ranged from 0.64% - 0.89%. This highlights the minimal effect image modality has on contour dimensions.
MIM provides the statistic "Percent Coverage" that indicates the volume of the structure being covered by the volume of the energy zone. The percent coverage statistic with one or multiple ablation probes placed on an image was verified. Percent difference ranged from 0.00% to 1.57%. with one ablation probe and 0.00% to 0.19% with two ablation probes.
The dimensions of the unique energy zone, HIFU, are generated as specified by the ablation probe manufacturer. The 3cm transducer treatment zone height, 4cm transducer treatment zone height, and overlap were measured in MIM and in Sonablate to verify that they matched the manufacturer's dimensions. Percent error ranged from 0.00% to 6.00%. These measurements fell within the range of the manufacturer tolerance. This work verified the consistency in HIFU dimensions compared to the manufacturer's measurements.
This work verified that the constraint-driven planning functionality places energy zones that adhere to the constraints as set by the user. These constraints ensure ablation probes target the appropriate region of interest. In addition, this work verified that an unattainable plan occurs when the scenario is not possible.
Conclusion
Based on the Device Description and Testing and Performance Data above, the proposed device is determined to be as safe and effective as the predicate devices MIM on Linux (K190379) and Aline Ablation Intelligence (K202297).