(72 days)
Not Found
No
The document describes image processing techniques like registration, fusion, and quantitative analysis, but does not mention AI or ML. The "automatically generates contours using a deformable registration technique" is a standard image processing method, not necessarily AI/ML.
No
The device is described as a medical image and information management system used as a tool to aid in evaluation and information management, diagnosis, treatment evaluation, and treatment planning. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids in "Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning." The "Device Description" also mentions its use in "diagnostic imaging."
Yes
The device description explicitly states that MIM 4.1 (SEASTAR) is a "software package" and a "stand-alone software package which operates on Windows 2000/XP." The intended use and device description focus solely on the software's functions related to medical image processing, management, and analysis, without mentioning any accompanying hardware components that are part of the regulated device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device processes medical images: The MIM 4.1 (SEASTAR) software is clearly described as a system for receiving, transmitting, storing, retrieving, displaying, printing, and processing digital medical images from various imaging modalities (CT, MRI, PET, etc.). It aids in the evaluation and management of these images.
- No mention of biological sample analysis: The description and intended use do not mention any interaction with or analysis of biological samples.
Therefore, the MIM 4.1 (SEASTAR) software falls under the category of medical image processing and management software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
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
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
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
Cardiac left ventricular, brain, tumors and normal tissues (general)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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.
1
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.
2
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
3
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.
4
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
5
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 and | |
| Radiological Devices | |
| K(k) Number | K071964 |
(Posted November 13, 2003)
Page 1 of 1