(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on porting existing functionality to a new operating system without mentioning new technological characteristics related to AI/ML.
No
The device is a software tool used to aid in the evaluation and information management of digital medical images for diagnosis, treatment evaluation, and treatment planning, but it does not directly apply therapy or directly treat medical conditions.
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 indicates that the device aids in the diagnostic process.
Yes
The device description explicitly states "MIM on Linux is a standalone medical device software application". While it runs on a Linux-based workstation, the submission focuses on the software itself and its functionality, not the hardware it runs on.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device's intended use: The intended use of this MIM software is to process, display, and analyze medical images obtained from various imaging modalities (CT, MRI, PET, etc.). It works directly with the images themselves, not with biological specimens.
- Lack of mention of biological specimens: The entire description focuses on image processing, analysis, and management. There is no mention of handling or analyzing biological samples.
Therefore, while it is a medical device used for diagnosis and treatment planning, it falls under the category of medical image processing and analysis software, not In Vitro Diagnostics.
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.
When using device clinically, 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 interretations. Images that are printed to film must be printed using a FDA-approved printer for the diagital mammography images.
Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MIM on Linux is a standalone medical device software application that provides the same functionality of previous MIM predicates. MIM software was originally designed for use on both Windows and Mac computer systems. For this Special 510(k) submission, MIM has the capability to run on Linux-based operating systems. The rationale to allow MIM to run on Linux based workstations is to provide more flexibility and workstation options for end users.
Indications for use have not been modified. The intended use is the same as last 510(k) clearance for MIM software (K182624).
MIM on Linux utilizes the same technological characteristics that are included in past predicates, therefore, no engineering drawings, schematics, etc. are not applicable to the device.
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
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.
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. conducted functional testing as a means of verification and validation on MIM software running on a Linux-based operating system workstation. The Linux distribution used was specifically Ubuntu 18.04. Functional testing was identical to that which is done with all major releases of MIM software running on Windows and Mac operating systems workstations. In all cases, MIM on Linux passed its performance requirements and met specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K182624, K180815, K103576, K071964, K060816, K052379
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MIM Software Inc. % Ms. Lynn Hanigan Quality Assurance Director 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122
March 19, 2019
Re: K190379
Trade/Device Name: MIM on Linux Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 14, 2019 Received: February 19, 2019
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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name MIM on Linux
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-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.
When using device clinically, 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 interretations. Images that are printed to film must be printed using a FDA-approved printer for the diagital 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.
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Image /page/4/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 cut out of the red square where it overlaps the gray square. To the right of the squares is the text "mim" in black, with the word "SOFTWARE" in smaller black letters below it.
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: | Lynn Hanigan |
| Date Summary Prepared: | 02/14/2019 |
| Date Updated: | 03/15/2019 |
Device Name
| Trade Name: | MIM on Linux |
|---|---|
| Common Name: | Medical Imaging Software |
| Regulation Number / Product Code: | 21 CFR 892.2050 Product Code LLZ |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Devices
Primary Predicate K182624 MIM - MRT Dosimetry
MIM Software Inc.
(Past) Additional Predicates
| K180815 | MIM – SPECTRA Quant | MIM Software Inc. |
|---|---|---|
| K103576 | MIM 5.2 (Brachy) | MIM Software Inc. |
| K071964 | MIM 4.1 (SEASTAR) – Pacs, Contouring | MIMvista Corp. |
| K060816 | MIM 4.0 (NEURO) | MIMvista Corp. |
| K052379 | MIM 3.5 (CIRCA) – Cardiac | MIMvista Corp. |
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.
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Image /page/5/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 SOFTWARE" in black. The word "mim" is in a larger font than the word "SOFTWARE".
MIM provides the user with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
The Region of Interest (ROI) feature reduces the time necessary for the user to define objects in medical image volumes by providing an initial definition of object contours. The objects include, but are not limited to, tumors and normal tissues.
MIM provides tools to quickly create, transform, and modify contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems and archiving contours for patient follow-up and management.
MIM aids in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel by voxel basis, within stereotactic surface projections or standardized regions of interest.
MIM allows the dose distribution of an implant to be individually shaped for each patient and is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes (not including radioactive microspheres).
MIM allows voxel-based dose calculations for patients who have been administered radioisotopes or radioactive microspheres.
Indications for Use
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical imaqes. The medical imaqe 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 enddiastolic 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.
6
Image /page/6/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 cut out of the red square. 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.
- . 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 device clinically, 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 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.
Device Description
MIM on Linux is a standalone medical device software application that provides the same functionality of previous MIM predicates. MIM software was originally designed for use on both Windows and Mac computer systems. For this Special 510(k) submission, MIM has the capability to run on Linux-based operating systems. The rationale to allow MIM to run on Linux based workstations is to provide more flexibility and workstation options for end users.
Indications for use have not been modified. The intended use is the same as last 510(k) clearance for MIM software (K182624).
MIM on Linux utilizes the same technological characteristics that are included in past predicates, therefore, no engineering drawings, schematics, etc. are not applicable to the device.
Substantial Equivalence
MIM on Linux is substantially equivalent to past MIM Software 510(k) clearances. The predicate devices chosen represent the broad range of indications for use and intended uses that encompasses MIM software. All predicates were manufactured by MIM Software Inc. MIMvista Corp. is a former company name.
Performance Data
MIM Software Inc. conducted functional testing as a means of verification and validation on MIM software running on a Linux-based operating system workstation. The Linux distribution used was specifically Ubuntu 18.04. Functional testing was identical to that which is done with all major releases of MIM software running on Windows and Mac operating systems workstations. In all cases, MIM on Linux passed its performance requirements and met specifications.
In conclusion, MIM Software Inc. believes that MIM on Linux is safe and effective when used for purposes indicated.