(62 days)
Not Found
Unknown
The description mentions "ROI feature reduces the time necessary for the physician to define objects in medical image volumes by providing an initial definition of object contours." While this could potentially be implemented using AI/ML for automated contouring, the document does not explicitly state the use of these technologies. The lack of mention of AI, DNN, or ML, and the absence of details on training or test sets, makes it impossible to definitively confirm or deny the presence of AI/ML.
No.
This device is a software package for medical image display, registration, fusion, and analysis for diagnostic purposes, not for direct therapeutic intervention.
Yes
The device description explicitly states, "MIM 3.5 (CIRCA) is a software package designed for use in diagnostic imaging." Additionally, its functions, such as evaluating cardiac left ventricular function and assisting in the definition of structures like tumors and organs, are indicative of diagnostic purposes.
Yes
The device description explicitly states that MIM 3.5 (CIRCA) is a "standalone software package" that operates on a standard operating system (Windows 2000/XP). Its functions are entirely software-based, involving the display, registration, fusion, and analysis of medical images. There is no mention of any accompanying or integrated hardware component that is part of the device itself.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic) or at least has components that would be considered IVD. Here's why:
- Intended Use: The software is explicitly used to "evaluate cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction." These are measurements and analyses performed on medical images (which are derived from patient data) to provide diagnostic information about the patient's cardiac health. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While the input is imaging data, the analysis of that data to derive diagnostic parameters like ejection fraction falls under the scope of IVD.
- Device Description: It reiterates the evaluation of cardiac function and perfusion, further supporting the diagnostic nature of the software.
- Anatomical Site: The focus on the "cardiac left ventricular cavity" for functional evaluation is a key indicator of a diagnostic application.
- Intended User: The software is intended for use by a "physician," who uses the information for diagnosis and treatment planning.
- Predicate Devices: Several of the listed predicate devices (QGS, QPS, Emory Cardiac Toolbox) are known to be software used for cardiac function analysis, which are typically regulated as IVDs or have IVD components.
However, there are some nuances to consider:
- Image Processing and Display: The software also performs image display, registration, and fusion. These functions, in isolation, might not be considered IVD. However, when these functions are integrated with the diagnostic analysis of cardiac function, the entire system is likely to be considered an IVD or a medical device with IVD components.
- ROI Feature: The ROI feature for defining objects like tumors and organs is a tool that assists in image analysis but doesn't inherently provide a diagnostic result on its own. Its classification would depend on how the defined ROIs are used in subsequent analysis.
In summary:
The core function of evaluating cardiac left ventricular function and perfusion, including specific parameters like ejection fraction, strongly suggests that this device is an IVD. While it also performs other image processing tasks, the diagnostic analysis component is significant enough to likely classify it as an IVD or a medical device with IVD functions.
To definitively confirm its IVD status, one would need to consult the regulatory classification of similar devices in the relevant jurisdiction (e.g., FDA in the US, CE marking in Europe). However, based on the provided information, the diagnostic evaluation of cardiac function is a strong indicator of IVD classification.
N/A
Intended Use / Indications for Use
MIM 3.5 (CIRCA) 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. Finally, the 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 turnors and organs.
Product codes
LLZ
Device Description
MIM 3.5 (CIRCA) 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 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 and ROI contouring.
Mentions image processing
Common Name: Medical Imaging Software
Classification Name: System, Imaging Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM PET, ECAT PET, SPECT, CT and MRI
Anatomical Site
cardiac left ventricular, turnors and organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
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 3.5 (CIRCA) 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)
K001276, K011572, K001026, K040141, K981535
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
MIMvista Corp.
OCT 3 1 2005
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: August 29, 2005
Device Name
| Trade Name: | MIM 3.5 (CIRCA) |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Devices
| K001276 | MIM | MiMvista Corp. |
|---|---|---|
| K011572 | QGS, QPS | Digirad Corp. |
| K001026 | 3D-MSPECT | The Regents of the University of MI |
| K040141 | Emory Cardiac Toolbox v2.6 | Syntermed, Inc. |
| K981535 | FOCUS Pilot Contouring | |
| Workstation | Computerized Medical Systems, Inc. |
Intended Use
MIM 3.5 (CIRCA) 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. Finally, the 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 turnors and organs.
Device Description
MIM 3.5 (CIRCA) 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 PET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular
1
function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve and ROI contouring.
Substantial Equivalence
MIM 3.5 (CIRCA) is substantially equivalent to; Medical Image Merge (MIM) software (K001276), QGS/QPS software (K011572), 3D-MSPECT Software (K001026), Emory ECTb software (K040141) and Focus Pilot software (K981536).
Performance Data
MIMvista has conducted performance and functional testing on the MIM 3.5 (CIRCA) software. In all cases, the software passed its' performance requirements and met specifications.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Public Health Service
OCT 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Simmelink Chief Operating Officer MIMvista Corp. 25200 Chagrin Blvd. Suite 200 CLEVELAND, OH 44122 Re: K052379 Trade/Device Name: MIM 3.5 (CIRCA) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 29, 2005 Received: August 30, 2005
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.
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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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.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 CFR 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 (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
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INDICATIONS FOR USE
510(k) Number (if known): _ TBD
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 turnors, organs, and cardiac left ventricular cavity.
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)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices KD523 510(k) Number ________________________________________________________________________________________________________________________________________________________________
(Posted November 13, 2003)
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