← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K192912 # AutoMIStar (K192912) _Apollo Medical Imaging Technology Pty. , Ltd. · LLZ · Dec 31, 2019 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K192912 ## Device Facts - **Applicant:** Apollo Medical Imaging Technology Pty. , Ltd. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Dec 31, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device, 3rd-Party Reviewed ## Intended Use AutoMIStar is a medical image post-processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform with Windows operating system, and can be used to perform image viewing, processing and analysis of brain images acquired by DICOM compliant imaging devices. AutoMIStar provides general viewing of DICOM images, with analysis capabilities for functional imaging data including a CT Perfusion Module and a DWI (diffusion-weighted MRI) Module. The CT Perfusion Module is used for visualization and analysis of contrast enhanced CT Perfusion (CTP) dataset, showing properties of changes in contrast over time. This function includes calculation of various parameters related to tissue flow (perfusion) and tissue blood volume. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. ## Device Story AutoMIStar is a PACS-based software package for medical image post-processing; runs on standard Windows PCs or virtual machines. Inputs: DICOM-compliant CT and MRI brain images. Processing: software performs visualization, quantification, and analysis of functional/dynamic datasets, specifically CT Perfusion (CTP) and diffusion-weighted MRI (DWI). Outputs: parameter maps (e.g., cerebral blood flow, blood volume, mean transit time, delay time, apparent diffusion coefficient), time-intensity plots, and volumetric threshold maps. Used in clinical settings by radiologists/technicians to aid diagnosis. Workflow: receives images via hospital network; processes data; sends results to DICOM devices or via secure email. Benefits: provides additional diagnostic information derived from temporal/diffusion features of native images, assisting in clinical decision-making regarding brain tissue status. ## Clinical Evidence Bench testing only. No clinical data. Validation performed using published perfusion and diffusion phantom datasets with known ground truth values. Regression analysis compared AutoMIStar outputs against ground truth and seven other commercial/academic CTP software packages. Results confirmed achievement of pre-established performance goals for CBF, CBV, MTT, DT, and ADC parameters. Software verification and validation confirmed design requirements were met. ## Technological Characteristics DICOM-compliant PACS software; runs on off-the-shelf Windows PC or virtual platform (e.g., VMware). Connectivity: network-based DICOM integration. Processing: deconvolution-based perfusion analysis (delay- and dispersion-corrected), diffusion analysis. Standards: NEMA PS 3.1-3.20 (DICOM). ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - IschemaView RAPID ([K121447](/device/K121447.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font. Apollo Medical Imaging Technology Pty. Ltd. % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 December 31, 2019 Re: K192912 Trade/Device Name: AutoMIStar Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 17, 2019 Received: December 18, 2019 Dear Prithul Bom: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {1}------------------------------------------------ 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia Mills, PhD Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) Device Name AutoMIStar Indications for Use (Describe) AutoMIStar is a medical image post-processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shel" computer or a virtual platform with Windows operating system, and can be used to perform image viewing, processing and analysis of brain images acquired by DICOM compliant imaging devices. AutoMIStar provides general viewing of DICOM images, with analysis capabilities for functional imaging data including a CT Perfusion Module and a DWI (diffusion-weighted MRI) Module. The CT Perfusion Module is used for visualization and analysis of contrast enhanced CT Perfusion (CTP) dataset, showing properties of changes in contrast over time. This function includes calculation of various parameters related to tissue flow (perfusion) and tissue blood volume. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| |
Prescription Use (Part 21 CFR 801 Subpart D)
|
Over-The-Counter Use (21 CFR 801 Subpart C)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | Applicant: | Apollo Medical Imaging Technology Pty. Ltd.
Suite 611, 365 Little Collins Street
Melbourne, Vic 3000, Australia | | |--------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | Contact Person: | Qing Yang, PhD
Director
Phone: 61-3-9995 6190 | | | Date Prepared: | November 27, 2019 | | | Device Trade Name: | AutoMIStar | | | Common Name: | PACS - Picture Archiving Communications System | | | Classification: | Regulation Number:
Classification Panel:
Device Class:
Product Code: | 21 C.F.R.§892.2050
Radiology
Class II
LLZ | | Predicate Devices: | IschemaView RAPID (K121447) | | #### Device Description: AutoMIStar is a software package that provides visualization and processing of medical imagesacquired by CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scanners, as an aid to physician diagnosis. It can be installed and run on a PC, laptop or virtual machine running a Microsoft Windows operating system. It provides viewing, quantification, analysis and reporting capabilities. AutoMIStar also provides processing and analysis of functional and dynamic imaging datasets including CT Perfusion (CTP) and diffusion-weighted MRI (DWI). It provides tools to perform the following type of advanced analysis: - time intensity plots for dynamic time courses; ● - volumetry of threshold maps; - calculation of mismatch between volumes of different threshold maps; ● AutoMIStar can be configured to connect to various DICOM devices (modality scanners, workstations, PACS) via the hospital medical imaging network to receive CT or MRI images as they become available. It supports transfer of DICOM images using the DICOM standard network protocol, and allows import of DICOM images from storage media. It provides automated workflow to processes received data and sends post-processed results to designated DICOM devices. {4}------------------------------------------------ It can also be configured to send post-processed results to designated recipients via email through the hospital email system. ### Intended Use /Indications for Use: AutoMIStar is a medical image post-processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform with Windows operating system, and can be used to perform image viewing, processing and analysis of brain images acquired by DICOM compliant imaging devices. AutoMIStar provides general viewing of DICOM images, with analysis capabilities for functional imaging data including a CT Perfusion Module and a DWI (diffusion-weighted MRI) Module. The CT Perfusion Module is used for visualization and analysis of contrast enhanced CT Perfusion (CTP) dataset, showing properties of changes in contrast over time. This function includes calculation of various parameters related to tissue flow (perfusion) and tissue blood volume. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data. #### Technical Characteristics: AutoMIStar provides the following functions: - receive DICOM images from various DICOM devices (CT/MRI scanners, PACS and . Workstations) and send DICOM images to designated DICOM devices; - process DICOM images received from multiple sources to provide visualization of changes of tissue perfusion and diffusion; - send processed results as DICOM images to designated DICOM devices; - . send summary results to designated recipients via customer approved email server using the SMTP protocol with security extensions to provide secure emailing. AutoMIStar is a DICOM-compliant PACS softwarethat provides functionality to transfer, process, and display of CT and MR imaging data including dynamically acquired CT perfusion imaging data and diffusion-weighted MRI (DWI). AutoMIStar runs on a standard "off-the-shelf" computer with Windows operating system, and can seamlessly integrate into an existing radiological data network. AutoMIStar is entirely independent from CT, MRI, or PACS platforms. The primary users of AutoMIStar software are medical imaging professionals who view and analyse CT and MRI images. The results generated by AutoMIStar provideadditional diagnostic information, which is derived from the temporal/diffusion features of the nativeCT or MRI images. {5}------------------------------------------------ #### Substantial Equivalence: In comparison with RAPID, AutoMIStar has the same intended use and similar indications, technological characteristics and principles of operation as its predicate device as described in the comparison table below. | Device | AutoMIStar | IschemaView's RAPID | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LLZ | | | Regulation | 21 CFR §892.2050 | 21 CFR §892.2050 | | Intended Use
/ Indications
for Use | AutoMIStar is a medical image post-
processing software package to be used by
trained professionals, including but not
limited to physicians and medical
technicians. The software runs on a
standard "off-the-shelf" computer or a
virtual platform with Windows operating
system, and can be used to perform image
viewing, processing and analysis of brain
images acquired by DICOM compliant
imaging devices.

AutoMIStar provides general viewing of
DICOM images, with analysis capabilities
for functional imaging data including a CT
Perfusion Module and a DWI (diffusion-
weighted MRI) Module.

The CT Perfusion Module is used for
visualization and analysis of contrast
enhanced CT Perfusion (CTP) dataset,
showing properties of changes in contrast
over time. This function includes
calculation of various parameters related to
tissue flow (perfusion) and tissue blood
volume.

The DWI Module is used to visualize local
water diffusion properties from the analysis
of diffusion-weighted MRI data. | iSchemaView's RAPID is an image
processing software package to be used by
trained professionals, including but not
limited to physicians and medical
technicians. The software runs on
a standard "off-the-shelf" computer or a
virtual platform, such as VMware, and can
be used to perform image viewing,
processing and analysis of brain images.
Data and images are acquired
through DICOM compliant imaging
devices.

iSchemaView's RAPID provides both
viewing and analysis capabilities for
functional and dynamic imaging datasets
acquired with CT Perfusion and MRI
including a Diffusion Weighted MRI
(DWI) Module and a Dynamic Analysis
Module (dynamic contrast enhanced
imaging data for MRI and CT).

The DWI Module is used to visualize local
water diffusion properties from the analysis
of diffusion weighted MRI data.

The Dynamic Analysis Module is used for
visualization and analysis of dynamic
imaging data, showing properties of
changes in contrast over time. This
functionality includes calculation of
parameters related to tissue flow
(perfusion) and tissue blood volume. | | PACS Functionality | | | | Basic PACS
Functions | View, process and analyze medical images.
Performs standard PACS functions with | Same | | | | | | | respect to querying and listing. | | | Computer
Platform | Standard off-the-shelf PC workstation
Virtual platform such as VMware | Same | | DICOM
Compliance | Yes | Yes | | Functional
Overview | AutoMIStar is a software package that
provides for thevisualization and study of
changes of tissue in digitalimages captured
by CT and MRI. AutoMIStar
providesviewing and quantification. | Same | | Data
Acquisition | Receives medical image data from DICOM
compliant imaging devices and modalities | Same | | Data/Image
Types | Computed Tomography (CT)
Magnetic Image Resonance (MRI) | Same | | | Acquisition and Modalities Features | | | CT | CT Perfusion (CTP) | Yes | | MRI | Diffusion Weighted Image (DWI) | Yes | | | Computed Parameter Maps | | | CT Perfusion | Cerebral blood flow (CBF) | Yes | | | Cerebral blood volume (CBV) | Yes | | | Mean transit time (MTT) | Yes | | | Delay time (DT) | Tmax | | | Isotropic DWI (isoDWI) | Yes | | Diffusion MRI | Apparent diffusion coefficient (ADC) | Yes | | | Exponential ADC (eADC) | Yes | | | Measurement Tools | | | CT and MRI
Tools | Arterial input function (AIF) Venous
output function (VOF) | Yes | | | Time-course | Yes | | | Brain mask | Yes… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K192912](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K192912) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com