Quantitative Total Extensible Imaging (QTxI)

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July 23rd, 2018 AIQ Solutions, Inc. % Mr. Mitch Lewandowski Principal/Consultant EpiReg LLC 3428 John Muir Drive MIDDLETON WI 53562 Re: K173444 Trade/Device Name: Quantitative Total Extensible Imaging (QTxI) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2018 Received: June 12, 2018 Dear Mr. Lewandowski: 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. Iisting 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 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); 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. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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Ballyns -S Date: 2018.07.23 10:41:24 -04'00' for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173444 Device Name Quantitative Total Extensible Imaging (QTxI) ### Indications for Use (Describe) Quantitative Total Extensible Imaging (QTxI) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0. QTxI assists in the following indications: · Receive, store, retrieve, display and process digital medical images. - · Create, display and print reports from those images. · Provide medical professionals with the ability to display, register, and fuse medical images. · Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans. · Evaluate quantitative change in ROIs (total or partial body; individual) with 3D interactive rendering of images with highlighted ROIs. | 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 #### 1. 510(k) Owner: AIQ Solutions Inc. #### 2. Address: 8025 Excelsior Drive Madison, WI 53717 #### Contact Person: 3. Mitch Lewandowski, M.S./ M.P.H; Principal Consultant Email: info@epireq.com Tel: 608 712-8585 Direct: 608 695-9333 #### Date 510(k) Summary Prepared: 4. 05 October 2017 #### 5. Trade Name: Quantitative Total Extensible Imaging (QTxl) Medical Image and Information Management System #### 6. Common Name: Picture archiving and communication system #### Classification Name: 7. 21 CFR 892.2050, Picture archiving and communication system (LLZ) #### 8. Predicate Device(s): Exini Diagnostics AB; EXINI, K122205 #### Device Description: 9. Quantitative Total Extensible Imaging (QTxl) is a software tool designed for use in medical imaging. It is stand-alone software which operates on Windows 7 and Windows 10. 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 and CT. Additionally, it identifies Regions of Interest (ROIs) and performs ROI contouring allowing quantitative/statistical analysis of full or partial-body scans through registration to template space. QTxl is designed to support multiple image analysis modules. Each module is designed for a specific image analysis purpose. Currently QTxl includes only the Quantitative Total Bone Imaging (QTBI) module, which is designed to identify and measure hot-spots on PET scans. QTBI aids the efficiency of medical professionals through automatic quantification of ROIs and changes in those {4}------------------------------------------------ ROIs, including 3D interactive rendering of the patient skeleton with highlighted Regions of Interest. QTxI also functions as a Picture Archive and Communications System (PACS) intended to receive, store, retrieve, display and process digital medical images, as well as create, display and print reports from those images. It also provides platform features for security, workflow and integration. ### 10. Indications for Use and Intended Use Quantitative Total Extensible Imaging (QTxl) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0. QTxl assists in the following indications: - . Receive, store, retrieve, display and process digital medical images. - . Create, display and print reports from those images. - Provide medical professionals with the ability to display, register, and fuse ● medical images. - . Identify Regions of Interest (ROls) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans. - . Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs. ## 11. Technological Characteristics QTxl has substantially equivalent indications for use, principle of operation, and technological characteristics as the Exini Diagnostics AB; EXINI, K122205. The following table summarizes and compares data on the Exini Diagnostics AB; EXINI, K122205, and supporting predicate device MIMvista Corp. MIM4.1 (Seastar), K071964. {5}------------------------------------------------ | Specification /<br>Characteristic | Quantitative Total<br>Extensible Imaging (QTxl) | Exini Diagnostics AB;<br>EXINI, K122205 | MIMvista Corp.<br>MIM4.1 (Seastar), K071964 | Comparison to<br>Predicate(s) | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate Device | Supporting Predicate Device | | | Product Code | LLZ | LLZ | LLZ | No difference | | Regulation<br>Number | 892.2050 | 892.2050 | 892.2050 | No difference | | Regulatory<br>Class | II | II | II | No difference | | Review Panel | Radiology | Radiology | Radiology | No difference | | Predicate<br>Device | Exini Diagnostics AB;<br>EXINI (K122205) | MEQIA, IBIS Explorer and Markup<br>Software (K111319) | MIM4.0 (K060816); IKOEngelo<br>(K061006); Centricity PACS<br>(K043415) | N/A | | 510(k)/ Type | K173444, Traditional | K122205, Traditional | K071964, Traditional | No difference | | Features | Receive, store, retrieve, display<br>and process digital medical<br>images, as well as create,<br>display and print reports from<br>those images | Software tool set for acceptance, transfer,<br>storage, image display, manipulation and<br>quantification of digital medical images. | Receive, transmit, store, retrieve,<br>display, print and process digital<br>medical images, as well as create,<br>display and print reports from those<br>images | No difference | | Medical<br>Modalities | DICOM CT and PET as<br>supported by<br>ACR/NEMA DICOM 3.0 | Nuclear imaging (NM) and computed<br>tomography (CT) as supported by<br>DICOM 3.0 standard. | CT, MRI, CR, DX, MG, US,<br>SPECT, PET and XA as supported<br>by ACR/NEMA DICOM 3.0. | QTXI does not utilize<br>as many medical<br>modalities as<br>predicate, but does<br>utilize equivalent<br>modalities in those<br>used by both systems. | | Operating<br>System | Window 7 or Windows 10 | Microsoft Windows operating system | Windows 2000/XP | QTxl uses newer<br>versions of MicroSoft<br>Windows software | | Methodology | Identifies Regions of Interest<br>(ROI) and performs ROI<br>contouring allowing<br>quantitative/statistical analysis<br>of full or partial-body scans<br>through registration to template<br>space | The device uses image processing<br>techniques for segmentation of skeletal<br>regions, normalization and hotspot<br>contouring/ segmentation. This device is<br>semi-automatic in that it requires a<br>manual step (hotspot verification step)<br>where the user reviews and edits the<br>selection of hotspots that are used as<br>input for quantitative analysis. The device<br>performs quantitative analysis based on<br>2D ROI (regions of interests)<br>measurements in whole body bone scans. | Generates contours using a<br>deformable registration technique<br>which registers pre-contoured<br>patients to target patients.<br>Registrations are either between a<br>serial pair of intra-patient volumes<br>or between a pre-existing atlas of<br>contoured patients and a patient<br>volume | All devices perform<br>centering analyses<br>utilizing a template<br>model. QTXI also<br>registers regions of the<br>patient. | | Specification / Characteristic | Quantitative Total Extensible Imaging (QTxI)<br>Subject Device | Exini Diagnostics AB; EXINI, K122205<br>Predicate Device | MIMvista Corp.<br>MIM4.1 (Seastar), K071964<br>Supporting Predicate Device | Comparison to Predicate(s) | | Indications for Use | Quantitative Total Extensible<br>Imaging (QTxI) is a software<br>tool used to aid in evaluation<br>and information management of<br>digital medical images by<br>trained medical professionals<br>including, but not limited to,<br>radiologists, oncologists,<br>nuclear medicine physicians,<br>medical imaging technologists,<br>dosimetrists and physicists. The<br>medical modalities of these<br>medical images include DICOM<br>CT and PET as supported by<br>ACR/NEMA DICOM 3.0.<br>QTxl assists in the following<br>indications:<br>Receive, store, retrieve,<br>display and process digital<br>medical images Create, display and print<br>reports from those images Provide medical<br>professionals with the<br>ability to display, register,<br>and fuse medical images | EXINI is intended to be used by trained<br>healthcare professionals and researchers<br>for acceptance, transfer, storage, image<br>display, manipulation, quantification and<br>reporting of digital medical images. The<br>system is intended to be used with images<br>acquired using nuclear imaging (NM) and<br>computed tomography (CT). The software<br>provides general<br>Picture Archiving and Communications<br>System (PACS) tools and a clinical<br>application for oncology including lesion<br>marking and analysis. | MIM 4.1 (SEASTAR) software is<br>used by trained medical<br>professionals as a tool to aid in<br>evaluation and information<br>management of digital medical<br>images. The medical image<br>modalities include, but are not<br>limited to, CT, MRI, CR, DX, MG,<br>US, SPECT, PET and XA as<br>supported by ACR/NEMA DICOM<br>3.0. MIM 4.1<br>(SEASTAR) assists in the following<br>indications:<br>Receive, transmit, store,<br>retrieve, display, print, and<br>process medical images and<br>DICOM objects. Create, display and print<br>reports from medical images. Registration, fusion display,<br>and review of medical images<br>for diagnosis, treatment,<br>evaluation, and treatment<br>planning. Evaluation of cardiac left<br>ventricular function and<br>perfusion, including left<br>ventricular end-diastolic<br>volume, end-systolic volume,<br>and ejection fraction. | All systems are used to<br>receive, store, retrieve,<br>display, and process<br>medical images and<br>DICOM objects.<br>This is accomplished<br>via registration to a<br>template space and<br>subsequent analysis of<br>the image data.<br>The predicate device<br>has multiple uses in<br>the therapeutic space,<br>which is not specific to<br>any device. | | Specification /<br>Characteristic | Quantitative Total<br>Extensible Imaging (QTxI)<br>Subject Device | Exini Diagnostics AB;<br>EXINI, K122205<br>Predicate Device | MIMvista Corp.<br>MIM4.1 (Seastar), K071964<br>Supporting Predicate Device | Comparison to<br>Predicate(s) | | Indications for<br>Use<br>(continued) | Identify Regions of<br>Interest (ROIs) and<br>perform ROI contouring<br>allowing quantitative/<br>statistical analysis of full or<br>partial body scans Evaluate quantitative<br>change in ROIs (total or<br>partial body; individual<br>ROI within individual) with<br>3D interactive rendering of<br>images with highlighted<br>ROIs. | | Localization and definition of<br>objects such as tumors and<br>normal tissues in medical<br>images. Creation, transformation, and<br>modification of contours for<br>applications including, but not<br>limited to, quantitative analysis,<br>aiding adaptive therapy,<br>transferring contours to<br>radiation therapy treatment<br>planning systems, and<br>archiving contours for patient<br>follow-up and management Quantitative and statistical<br>analysis of PET/SPECT brain<br>scans by comparing to other<br>registered PET/SPECT brainscans. | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ## 12. Performance Data (Nonclinical) QTxl is a software tool. Non-clinical performance bench tests and simulated clinical performance tests have been performed on the Quantitative Total Extensible Imaging (QTxl) in order to verify the device characteristics. Testing conducted to demonstrate substantial equivalence included: - . Software verification testing that demonstrates the device meets product performance and functional specifications. - . Software verification testing demonstrating that DICOM information collected with medical imaging systems and transmitted through manual or virtual input are captured, transmitted, and stored properly to maintain data integrity (e.g., no loss of data). ### 13. Conclusion QTxl met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols. The Quantitative Total Extensible Imaging (QTxl) software tool is substantially equivalent with respect to product performance, indications for use, intended use, scientific principles, technological characteristics, and materials, as the predicate device, Exini Diagnostics AB; EXINI, K122205.