(50 days)
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No
The document describes standard image processing and analysis techniques without mentioning AI or ML.
No
The device is a software package designed for diagnostic imaging, specifically for displaying, registering, fusing, and analyzing medical images. It assists physicians in assessment and definition of structures, but it does not directly treat or prevent a disease.
Yes
The device description explicitly states, "MIM 4.0 (NEURO) is a software package designed for use in diagnostic imaging." Additionally, the intended use describes aiding in the "definition of structures in medical images including tumors, organs," and providing "quantitative and statistical comparisons to other registered PET/SPECT brain scans," which are activities performed for diagnostic purposes.
Yes
The device description explicitly states it is a "standalone software package" operating on a standard computer operating system (Windows 2000/XP) and its function is solely related to processing and displaying medical images. There is no mention of accompanying hardware components required for its primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that MIM 4.0 (NEURO) is a software program used for the registration, fusion, and display of medical images from various modalities (SPECT, PET, CT, MRI). It assists in defining structures and provides quantitative and statistical comparisons of brain scans.
- Input: The input is medical imaging data, not biological samples from the body.
- Output: The output is processed and analyzed imaging data, not a diagnostic result derived from a biological sample.
While the software is used in a diagnostic imaging context and aids physicians in their diagnostic process, its function is centered around the manipulation and analysis of medical images, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
MIM 4.0 (NEURO) is a software package that provides the physician with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. The Region of Interest (ROI) feature reduces the time necessary for the physician to define objects in medical image volumes by providing an initial definition of object contours. The objects include but are not limited to tumors and organs.
MIM 4.0 (NEURO) also aids the physician in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel by voxel basis, within stereotactic surface projections, or within standardized regions of interest.
The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including tumors, organs, and cardiac left ventricular cavity. MIM aids in the assessment of PET/SPECT brain scans by providing quantitative and statistical comparisons to other registered PET/SPECT brain scans.
Product codes
LLZ
Device Description
MIM 4.0 (NEURO) is a software package designed for use in diagnostic imaging. It is a standalone software package which operates on Windows 2000/XP. Its intended function and use is to provide the physician with the means to display, register and fuse medical images from multiple modalities including DICOM FET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve, Region of Interest (ROI) contouring and quantitative/statistical analysis of PET/SPECT brain scans through nonlinear registration to template space.
Mentions image processing
System, Imaging Processing, Radiological
Mentions AI, DNN, or ML
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Input Imaging Modality
multiple modalities including DICOM FET, ECAT PET, SPECT, CT and MRI.
Anatomical Site
cardiac left ventricular, brain
Indicated Patient Age Range
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Intended User / Care Setting
Physician
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MIMvista has conducted performance and functional testing on the MIM 4.0 (NEURO) software. In all cases, the software passed its' performance requirements and met specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052379, K041022, K042863, K010726
Reference Device(s)
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
Koyo814
510(k) Summary of Safety and Effectiveness
(The following information is in conformance with 21 CFR 807.92)
Submitter:
MIMvista Corp. 25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122 Phone: 216-896-9798 Fax: 216-896-9796
Contact Person: Peter Simmelink
Date Summary Prepared: March 24, 2006
Device Name
| Trade Name: | MIM 4.0 (NEURO) |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Devices
| K052379 | MIM® 3.5 | MIMvista Corp. |
|---|---|---|
| K041022 | NeuroQ™ | Syntermed, Inc. |
| K042863 | Scenium™ | Siemens Molecular Imaging Ltd. |
| K010726 | Mirage™ | Segami Corp. |
Intended Use
MIM 4.0 (NEURO) is a software package that provides the physician with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. The Region of Interest (ROI) feature reduces the time necessary for the physician to define objects in medical image volumes by providing an initial definition of object contours. The objects include but are not limited to tumors and organs.
MIM 4.0 (NEURO) also aids the physician in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel by voxel basis, within stereotactic surface projections, or within standardized regions of interest.
25200 Chagrin Blvd. Suite 200 Cleveland. OH 44122
Tele: 216-896-9798 Fax: 216-896-9796
1
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K060814
Device Description
MIM 4.0 (NEURO) is a software package designed for use in diagnostic imaging. It is a standalone software package which operates on Windows 2000/XP. Its intended function and use is to provide the physician with the means to display, register and fuse medical images from multiple modalities including DICOM FET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve, Region of Interest (ROI) contouring and quantitative/statistical analysis of PET/SPECT brain scans through nonlinear registration to template space.
Substantial Equivalence
MIM® 4.0 (NEURO) is substantially equivalent to; MIM® 3.5 (CIRCA) software (K052379), NeuroQ™ software (K041022), Scenium™ software (K042863) and Mirage™ (NeuroGam™, NeuroMatch™) Software (K010726).
Performance Data
MIMvista has conducted performance and functional testing on the MIM 4.0 (NEURO) software. In all cases, the software passed its' performance requirements and met specifications.
25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122
Tele: 216-896-9798 Fax: 216-896-9796
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
MAY 1 6 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Peter Simmelink Chief Operating Officer MIMvista Corportaion 25200 Chagrin Blvd., Suite 200 CLEVELAND OH 44122
Re: K060816
Trade/Device Name: MIM 4.0 (NEURO) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 24, 2006 Received: March 27, 2006
Dear Mr. Simmelink:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" around the edge. In the center of the logo is the acronym "FDA" in bold, black letters. Below the acronym are three stars.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat 1 DA's issualice of a successions of the requirements of the Act or any FDA has made a deceminations administered by other Federal agencies. You must comply with all If collars and regulations as numbed to registration and listing (21 CFR Part 807); the Act 3 requirements, merading, out moremants as set forth in the quality labeling (21 CFR Part 801); good manatalating production the electronic product radiation 375cmb (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceing your was antial equivalence of your device to a legally premarket nothleation: "The I DA miding of bassamal of in the results and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your dovies on our working more of the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Also, please note the regulation entitled, "rhoofamation on your responsibilities under the Act from the CFK 807.97). Tournaly oounly oner generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): ___________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: _MIM
Indications for Use:
The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including tumors, organs, and cardiac left ventricular cavity. MIM aids in the assessment of PET/SPECT brain scans by providing quantitative and statistical comparisons to other registered PET/SPECT brain scans.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
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