(9 days)
Not Found
No
The description focuses on standard image processing and calculation of predefined parameters from dynamic imaging data, without mentioning AI or ML techniques.
No
The device is described as software for image processing and analysis, providing supplemental information for diagnosis and therapy monitoring, but it does not directly administer treatment or perform a therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that MIStar is "for the rendering clinical diagnosis" and is used in a "diagnostic imaging setting." The software also aids in the assessment of conditions like stroke or tumor angiogenesis, providing "supplemental information to those images extracted from CT and MR temporal datasets" for diagnosis. Additionally, the "Device Description" mentions that the results displayed are for "supplementary information for diagnosis purposes."
Yes
The device is explicitly described as a "software package" that runs on a standard PC platform and performs image manipulation, visualization, and processing. There is no mention of proprietary hardware components being part of the device itself.
Based on the provided information, MIStar is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MIStar operates on medical images acquired directly from the patient (CT, MR, NM, PT scans). It processes and analyzes these images, not biological specimens.
- The intended use and device description clearly state that MIStar is for manipulating, visualizing, and processing medical images in a diagnostic imaging setting. It aids in the assessment of perfusion, blood volume, and capillary permeability changes based on these images.
Therefore, MIStar falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical imaging network, and can receive digital images and data from various sources (including but not limited to CT, MR, NM, and PT).
MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It allows visual inspection of time intensity curves and calculation of parametric parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also calculates various blood perfusion related parameters such as blood flow (BF), blood volume (BV), mean transit time (MTT) and capillary permeability from dynamic CT images. This software provides supplemental information to those images extracted from CT and MR temporal datasets and will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes related but not limited to stroke or tumor angiogenesis and be helpful in therapy monitoring.
MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.
Product codes
90 LLZ
Device Description
MIStar is a software package, which runs on an Intel-based PC platform. It allows manipulation, visualization and processing of medical images acquired with various clinical scanners and stored in DICOM and for other proprietary formats. MIStar allows transfer of DICOM 3.0 images over a medical imaging network.
MIStar also provides post-processing of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer. It allows visual inspection of time intensity curves and calculation of parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also allows calculation of various perfusion related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability) from dynamic CT data. The results are displayed in a user-friendly graphic format as parametric images that provide supplementary information for diagnosis purposes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, NM, PT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.
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
Not Found
Key Metrics
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
| Submitter: | Apollo Medical Imaging Technology Pty. Ltd
26 Hood Street, North Balwyn
Melbourne, Vic 3104, Australia
Phone: 61-3-9859 9316
Fax: 61-3-9859 5701 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | September 30, 2004 |
| Contact Person: | Qing Yang |
| Device Trade Name: | MIStar |
| Device Common Name: | Picture Archiving Communications System (PACS) |
| Regulation Number: | 892.2050 |
| Device Classification: | Class II |
| Classification Name: | Image Processing System |
Predicate Device:
| Manufacturer | Product | 510(k) Number | Clearance Date |
|---|---|---|---|
| Efilm Medical, Inc. | Efilm Workstation with Modules | K020995 | 04/12/2002 |
| General Electric | CT Perfusion 2 | K010042 | 01/30/2001 |
| GE Medical Systems | Advantage Windows with Functool Option | K960265 | 07/03/1996 |
Device Description
MIStar is a software package, which runs on an Intel-based PC platform. It allows manipulation, visualization and processing of medical images acquired with various clinical scanners and stored in DICOM and for other proprietary formats. MIStar allows transfer of DICOM 3.0 images over a medical imaging network.
MIStar also provides post-processing of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer. It allows visual inspection of time intensity curves and calculation of parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also allows calculation of various perfusion related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability) from dynamic CT data. The results are displayed in a user-friendly graphic format as parametric images that provide supplementary information for diagnosis purposes.
1
Indications for Use
MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical imaging network, and can receive digital images and data from various sources (including but not limited to CT, MR, NM, and PT).
MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It allows visual inspection of time intensity curves and calculation of parametric parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also calculates various blood perfusion related parameters such as blood flow (BF), blood volume (BV), mean transit time (MTT) and capillary permeability from dynamic CT images. This software provides supplemental information to those images extracted from CT and MR temporal datasets and will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes related but not limited to stroke or tumor angiogenesis and be helpful in therapy monitoring.
MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.
Conformance to Standard
MIStar provides DICOM functionality in conformance to the ACR-NEMA DICOM 3.0 standard as documented in the MIStar DICOM 3.0 Conformance Statement.
Software Development and Testing
The MIStar software package was designed, developed, verified and validated according to the procedures described in the Software Information section: Software Development Process.
Comparison with Predicate
MIStar is a stand-alone software package that operates on an Intel-based PC platform that satisfies the minimum system requirements. MIStar provide digital image processing and measurement capability. It can also communicate DICOM images with remote viewing stations or server systems over a medical imaging network.
MIStar also provides image post-processing as such does not have contact with the patient, nor does it control any devices that acquire medical images or sustain life. The algorithms used to calculate parametric parameters are similar to CT perfusion2 and Functool. It further requires the intervention of a physician in setting necessary parameters and in assessing resultant images.
The functional features of this package are substantially equivalent to that of eFilm Workstation with Modules (K020995), CT Perfusion 2 (K010042) and Advantage Windows with Functool option (K960265). The use of M1Star does not result in any additional potential hazards when compared to predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes extending from its wing, symbolizing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2004
Apollo Medical Imaging Technology Pty Ltd. % Ms. Laura Danielson Responsible Third Party Official 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K043350 Trade/Device Name: MIStar Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 12, 2004 Received: December 6, 2004
Dear Ms. Danielson:
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/dsma/dsmamain.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: _Koy3350
Device Name: MIStar
Indications For Use:
MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical images in a diagnostic maging couligital images and data from various sources (including but not limited to CT, MR, NM, and PT).
MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It allows visual inspection of time intensity curves and calculation a Computer of contines freana under curve, time to peak, maximum slope of enhancement, etc). It also calculates various blood perfusion related parameters such as blood flow (BF), blood volume (BV), mean transit time (MTT) and capillary permeability from dynamic CT images. This software provides supplemental information to those images extracted from CT and MR temporal datasets and will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability whates related but not limited to stroke or tumor angiogenesis and be helpful in therapy monitoring.
MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.
Prescription Use (Part 21 CFR 801 Subpart D) ATTB/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)
David h. Lyonn
(Division Sian-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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