(39 days)
The Mobile MIM software program is used for the registration, fusion, and/or display for diagnosis of medical images from only the following modalities: SPECT, PET, CT, and MRI.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
The Mobile MIM software program is used for the registration, fusion, and/or display for diagnosis of medical images from only the following modalities: SPECT, PET, CT, and MRI.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
The software is not to be used for mammography.
It includes the capability to measure distance and image intensity values such as Standardized Uptake Value, displays measurement lines, annotations and regions of interest, and provides window/level, zoom/pan, and fusion blending control functionality.
Mobile MIM retrieves patient image data securely via a network connection with a MIM workstation or server. Processed DICOM images from the workstation or server are losslessly compressed for network transfer and downloaded by Mobile MIM for display.
Mobile MIM operates on "off-the-shelf" portable hardware devices and is therefore subject to factors not typical for reading room workstations (e.g. screen size, environmental variability, network dependencies, etc.). It is therefore required that the user follows the operating instructions properly and utilizes the risk mitigation features in order to make decisions safely and effectively.
The provided document describes the Mobile MIM software, a medical imaging software for display and diagnosis of medical images (SPECT, PET, CT, and MRI). It is intended for wireless and portable access when a full workstation is unavailable and is not for mammography.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Display Performance: Contrast response, luminosity, resolution, and noise according to IEC 62563-1 and TG18 guidelines, after calibration. | All testing passed requirements following the Mobile MIM's calibration procedure. |
| Diagnostic Image Viewing Capabilities: Performance for diagnosis with qualified radiologists using various modalities (MRI, CT, SPECT, PET) under different environmental conditions. | Results of these studies affirm the diagnostic image viewing capabilities of Mobile MIM when used as indicated. |
| Software Functionality: Verification, validation, and functional testing to meet performance requirements and specifications. | In all cases, the software passed its performance requirements and met specifications. |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set (number of images or cases).
The data provenance is also not explicitly detailed, but the studies were conducted internally by MIM Software Inc. with "qualified radiologists" and "a variety of modalities, specifically MRI, CT, SPECT, and PET." No information on the country of origin or whether the data was retrospective or prospective is provided.
3. Number of Experts and Qualifications for Ground Truth Establishment:
The document mentions "multiple studies with qualified radiologists." It does not specify the exact number of radiologists or their specific qualifications (e.g., years of experience, subspecialty) beyond being "qualified."
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth from the radiologists' readings. It simply states that "results of these studies affirm the diagnostic image viewing capabilities."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not explicitly mention a multi-reader, multi-case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance. The testing focused on the standalone performance and diagnostic viewing capabilities of Mobile MIM.
6. Standalone Performance Study:
Yes, a standalone study (algorithm only without human-in-the-loop performance) was done for display performance, measuring contrast response, luminosity, resolution, and noise using objective standards (IEC 62563-1 and TG18 guidelines). The document also mentions "functional testing on the Mobile MIM software" which implies standalone software performance evaluation.
7. Type of Ground Truth Used:
For the "diagnostic image viewing capabilities" studies, the ground truth was implicitly established by expert consensus/opinion from "qualified radiologists" who affirmed the capabilities. For display performance, the ground truth was based on objective measurements against established standards (IEC 62563-1 and TG18 guidelines).
8. Sample Size for the Training Set:
The document does not provide any information about the sample size for a training set. Given that Mobile MIM is described as medical imaging software for display, registration, fusion, and measurement, rather than an AI-driven diagnostic algorithm, it's highly probable that a "training set" in the machine learning sense was not applicable or not the primary focus of these performance data. The device's function is more akin to a viewing and manipulation tool than an automated diagnostic tool requiring extensive AI model training.
9. How Ground Truth for the Training Set Was Established:
As no training set is mentioned or implied for an AI model, the method for establishing ground truth for a training set is not applicable and not provided in the document.
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Image /page/0/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one light and one dark, with a white circle in the center 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.
FEB - 4 2011
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510(k) Summary of Safety and Effectiveness
(The following information is in conformance with 21 CFR 807.92)
Submitter:
MIM Software Inc. 25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122
| Phone: | 216-455-0600 |
|---|---|
| Fax: | 216-455-0601 |
| Contact Person: | Lynn Hanigan |
| Date Summary Prepared: | Jan 26, 2011 |
| Device Name | |
| Trade Name: | Mobile MIM |
| Common Name: | Medical Imaging Software |
| Trade Name: | Mobile MIM |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Device
MIM Software Inc. (formerly MIMvista Corp.) K062163 MIMviewer 1.0
Intended Use / Indications for Use
The Mobile MIM software program is used for the registration, fusion, and/or display for diagnosis of medical images from only the following modalities: SPECT, PET, CT, and MRI.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
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Image /page/1/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one light and one dark, with a circle in the middle where they overlap. To the right of the squares is the text "mim" in lowercase letters, with the word "SOFTWARE" in smaller letters below.
Device Description
The Mobile MIM software program is used for the registration, fusion, and/or display for diagnosis of medical images from only the following modalities: SPECT, PET, CT, and MRI.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
The software is not to be used for mammography.
It includes the capability to measure distance and image intensity values such as Standardized Uptake Value, displays measurement lines, annotations and regions of interest, and provides window/level, zoom/pan, and fusion blending control functionality.
Mobile MIM retrieves patient image data securely via a network connection with a MIM workstation or server. Processed DICOM images from the workstation or server are losslessly compressed for network transfer and downloaded by Mobile MIM for display.
Mobile MIM operates on "off-the-shelf" portable hardware devices and is therefore subject to factors not typical for reading room workstations (e.g. screen size, environmental variability, network dependencies, etc.). It is therefore required that the user follows the operating instructions properly and utilizes the risk mitigation features in order to make decisions safely and effectively.
| ITEM | Mobile MIM | MIMviewer |
|---|---|---|
| Intended Use /Indications For Use | The Mobile MIM softwareprogram is used for theregistration, fusion, and/ordisplay for diagnosis ofmedical images from only thefollowing modalities: SPECT,PET, CT, and MRI.Mobile MIM provideswireless and portable access | MIMviewer is a softwarepackage that aids thephysician in the diagnosis ofpatients by means of medicalimages. MIMviewer is used todisplay, register and fusemedical images from multiplemodalities.The MIMviewer software |
| ITEM | Mobile MIM | MIMviewer |
| to medical images. Thisdevice is not intended toreplace full workstations andshould be used only whenthere is no access to aworkstation.This device is not to be usedfor mammography. | program is used for theregistration, fusion anddisplay of medical imagesfrom multi-modalities, suchas SPECT, PET, CT, andMRI. MIMviewer providestools for image review,manipulation, and analysisthat assist physicians bothinside and outside the medicalenvironment. | |
| Receive, Store,Retrieve, Display,and Process DigitalMedical Images | Yes | Yes |
| Display of ClinicalPatient Data WhenNo Access to aWorkstation | Yes | Yes |
| Image Fusion | Yes | Yes |
| Multi-PlanarReconstruction(MPR) | Yes | Yes |
| Maximum IntensityProjection (MIP) | Yes | Yes |
| Standardized UptakeValue (SUV) | Yes | Yes |
| DistanceMeasurements | Yes | Yes |
| ITEM | Mobile MIM | MIMviewer |
| Window/Level | Yes | Yes |
| Zoom/Pan | Yes | Yes |
| User Authentication | Yes | Yes |
| Modalities | SPECT, PET, CT, MRI | SPECT, PET, CT, MRI |
| Remote HandheldViewing Device | Yes | No |
| Operating Platform | Apple® iOS | Windows® 2000/XPMacOS X® 10.4+Linux® |
| HardwareRequirements | Apple® iOShandheld devices | Pentium® 4+G4+ |
Device Comparison Table between new device and predicate:
25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122
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25200 Chagrin Blvd. Suite 200
Cleveland, OH 44122
:
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Image /page/3/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically 'K163785'. The characters are handwritten and appear to be part of a code or identification number. The number is written in black ink on a white background.
Image /page/3/Picture/10 description: The image shows a logo for MIM Software. The logo consists of two overlapping squares, one light and one dark, with a circle in the center. 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.
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Substantial Equivalence
The comparison chart above provides evidence to facilitate the substantial equivalence determination between Mobile MIM and our chosen predicate device, MIMviewer (K062163)
The differences in the Indication Statements between Mobile MIM and MIMviewer describe specific restrictions on how Mobile MIM is to be used, given the hardware and portability differences between these two devices. Mobile MIM adds the explicate requirement that it should only be used when there is no access to a workstation, and that it is not to be used for mammography.
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Image /page/4/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a square with rounded corners, with a circle inside of it. To the right of the square is the text "mim SOFTWARE" in a sans-serif font.
K103 785
The technological characteristics between Mobile MIM and MIMviewer are different. as the software operates on different hardware. These differences are addressed through the labeling and additional software features of Mobile MIM.
Performance Data
MIM Software Inc. has conducted display performance testing using Mobile MIM software on various portable devices, both prior to and after utilizing the application's calibration procedure. Testing measured contrast response and evaluated test patterns for luminosity, resolution, and noise according to IEC 62563-1 and TG18 guidelines. All testing passed requirements following the Mobile MIM's calibration procedure.
MIM Software Inc. also performed multiple studies with qualified radiologists using a variety of modalities, specifically MRJ, CT, SPECT, and PET, under different environmental conditions. Results of these studies affirm the diagnostic image viewing capabilities of Mobile MIM when used as indicated.
Furthermore, MIM Software Inc. has conducted verification, validation, and functional testing on the Mobile MIM software. In all cases, the software passed its performance requirements and met specifications.
Conclusion
Therefore, from all evidence gathered, it is our belief that Mobile MIM provides a diagnostic viewer of medical images substantially equivalent to the MIMviewer software, with portable device characteristics and functionality.
25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lynn Hanigan Quality Manager MIM Software 25200 Chargrin Blvd., Suite 200 CLEVELAND OH 44122
FEB - 4 201
Re: K103785
Trade/Device Name: Mobile MIM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 22, 2010 Received: December 27, 2010
Dear Ms. Hanigan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
.
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): TBD KIO3785
Device Name: Mobile MIM
Indications for Use:
The Mobile MIM software program is used for the registration, fusion, and/or display for diagnosis of medical images from only the following modalities: SPECT, PET, CT, and MRI.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K163785
§ 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).