(72 days)
MIM 4.1 (SEASTAR) software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.
MIM 4.1 (SEASTAR) 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 4.1 (SEASTAR) 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 4.1 (SEASTAR) 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
MIM 4.1 (SEASTAR) is a software package designed for use in diagnostic imaging. It is a stand-alone software package which operates on Windows 2000/XP. Its intended function and use is to provide medical professionals with the means to display, register and fuse medical images from multiple modalities including DICOM PET, 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.
MIM 4.1 (SEASTAR) aids the efficiency of medical professionals in the creation of contours defining, but not limited to, normal and tumor tissues. The software automatically generates contours using a deformable registration technique which registers pre-contoured patients to target patients. Registrations are either between a serial pair of intra-patient volumes or between a pre-existing atlas of contoured patients and a patient volume. This process facilitates contour creation or re-contouring for adaptive therapy.
MIM 4.1 (SEASTAR) additionally functions as a medical image and information management system 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 system has the ability to send data to DICOM-ready devices for image storage, retrieval and transmission.
The provided document, K071964, describes the MIM 4.1 (SEASTAR) medical imaging software. However, it does not contain specific details regarding acceptance criteria for its performance or a detailed study proving it meets such criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing extensive performance study results.
The document states: "MIMvista has conducted performance and functional testing on the MIM 4.1 (SEASTAR) software. In all cases, the software passed its performance requirements and met specifications." This is a high-level statement without specific metrics or details of the study.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
Acceptance Criteria and Device Performance Study
1. A table of acceptance criteria and the reported device performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | Not specified | "Passed its performance requirements and met specifications." |
| Functional Testing | Not specified | "Passed its performance requirements and met specifications." |
| Specific quantitative metrics | Not specified | Not specified |
Note: The document broadly states that the software "passed its performance requirements and met specifications," but it does not define what those requirements or specifications were, nor does it provide any quantitative performance data (e.g., accuracy, precision, speed, etc.) for any specific feature.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document does not mention the use of experts for establishing ground truth in any performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not mentioned as performed.
- Effect Size: Not applicable, as no MRMC study or AI assistance comparison is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is software intended for use by "trained medical professionals." While it performs automated tasks (e.g., image registration, contour generation, quantitative analysis), the document describes it as a "tool to aid in evaluation and information management," implying human oversight and interaction. A standalone performance study for "algorithm only" is not explicitly described with specific results or metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified.
8. The sample size for the training set
Not specified. The document does not explicitly mention a "training set" in the context of machine learning. It describes a "deformable registration technique which registers pre-contoured patients to target patients" and "between a pre-existing atlas of contoured patients and a patient volume," implying the use of pre-existing data, but details about the size or nature of this data are not provided.
9. How the ground truth for the training set was established
Not specified.
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Image /page/0/Picture/1 description: The image shows the word "MiMvista" in a stylized font. The letters are all capitalized except for the "vista" portion of the word. There is some image noise above the first "M" in the word. The font appears to be a sans-serif font.
Page 1 of 3
510(k) Summary of Safety and Effectiveness
(The following information is in conformance with 21 CFR 807.92)
SEP 2 6 2007
Submitter:
MIMvista Corp. 25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122
Phone: Fax:
216-896-9798 216-896-9796
Peter Simmelink
July 13, 2007
Date Summary Prepared:
Device Name
Contact Person:
| Trade Name: | MIM 4.1 (SEASTAR) |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Devices
| K060816 | MIM™ 4.0 MIMvista Corp. |
|---|---|
| K061006 | IKOEngelo™ IKOEtech, LLC. |
| K043415 | Centricity™ GE Medical Systems |
| PACS System Information Technologies |
Intended Use
MIM 4.1 (SEASTAR) software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.
MIM 4.1 (SEASTAR) 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/1/Picture/1 description: The image shows the word "Avista" in a stylized font. The "A" and "v" are capitalized, while the "ista" is in lowercase. There is some faded text above the "v" in "Avista".
MIM 4.1 (SEASTAR) provides the user with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. The Region of Interest (ROI) feature reduces the time necessary for the user to define objects in medical image volumes by providing an initial definition of object contours. The objects include, but are not limited to, tumors and normal tissues.
MIM 4.1 (SEASTAR) 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 4.1 (SEASTAR) also 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.
Indications for Use
MIM 4.1 (SEASTAR) 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 4.1 (SEASTAR) 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.
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Image /page/2/Picture/1 description: The image shows the word "MIMvista" in a stylized font. The letters are in black and appear to be handwritten. There is some noise or artifacting above the first "M" in the word.
- Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans
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 4.1 (SEASTAR) is a software package designed for use in diagnostic imaging. It is a stand-alone software package which operates on Windows 2000/XP. Its intended function and use is to provide medical professionals with the means to display, register and fuse medical images from multiple modalities including DICOM PET, 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.
MIM 4.1 (SEASTAR) aids the efficiency of medical professionals in the creation of contours defining, but not limited to, normal and tumor tissues. The software automatically generates contours using a deformable registration technique which registers pre-contoured patients to target patients. Registrations are either between a serial pair of intra-patient volumes or between a pre-existing atlas of contoured patients and a patient volume. This process facilitates contour creation or re-contouring for adaptive therapy.
MIM 4.1 (SEASTAR) additionally functions as a medical image and information management system 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 system has the ability to send data to DICOM-ready devices for image storage, retrieval and transmission.
Substantial Equivalence
MIM 4.1 (SEASTAR) is substantially equivalent to the following: MIM™ 4.0 (NEURO) software (K060816), IKOEngelo™ software (K061006) and Centricity™ PACS System software (K043415).
Performance Data
MIMvista has conducted performance and functional testing on the MIM 4.1 (SEASTAR) software. In all cases, the software passed its performance requirements and met specifications.
MIMvista Corp. 25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font.
SEP 26 2007
Mr. Peter Simmelink Chief Operating Officer MIMvista Corporation 25200 Chagrin Blvd., Suite 200 CLEVELAND OH 44122
Re: K071964
Trade/Device Name: MIM 4.1 (SEASTAR) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 13, 2007 Received: July 16, 2007
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/3/Picture/9 description: The image shows the FDA centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health" in a decorative font. The logo is circular and contains the letters FDA in a stylized font. The text is slightly blurred, but still legible.
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Page 2 --
Enclosure
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number (if known): __K071964
Device Name: MIM
Indications for Use:
MIM 4.1 (SEASTAR) 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 4.1 (SEASTAR) 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 teft 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 followup and management.
- Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other ● registered PET/SPECT brain scans.
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.
| 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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal andRadiological Devices | |
| K(k) Number | K071964 |
(Posted November 13, 2003)
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§ 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).