MeVis Liver Suite

K232045 · MeVis Medical Solutions AG · JAK · Oct 27, 2023 · Radiology

Device Facts

Record IDK232045
Device NameMeVis Liver Suite
ApplicantMeVis Medical Solutions AG
Product CodeJAK · Radiology
Decision DateOct 27, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1750
Device ClassClass 2
AttributesAI/ML, Software as a Medical Device

Intended Use

MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM). MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures. MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRJ, and MRCP. MeVis Liver Suite only allows import of homogenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite. MeVis Liver Suite can be used for manual segmentation, user-defined manual labeling, and 3D visualization of: - abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, and pancreas) - liver related vascular structures (i.e., bile ducts, hepatic vein, portal vein, and inferior vena cava) - lesions inside and adjacent to the liver The tools for manual segmentation and 3D visualization are applicable for CT and MR imaging studies. In addition to the manual segmentation tools, MeVis Liver Suite provides AI based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein restricted to CT scans of potential living liver donors with healthy livers and intended for: - Liver: contrast enhanced late-venous and venous phase - Hepatic vein: contrast enhanced late-venous and venous phase - Portal vein: contrast enhanced late-venous and venous phase - Hepatic artery: contrast enhanced arterial phase Using MeVis Liver Suite, users can evaluate the segmented objects by exploring, and manually correcting: - the volume of the segmented abdominal organs (see above) - the volume of the segmented lesions inside and adjacent to the liver - the volume of the manually defined parts of the liver - by defining separation planes ("separation proposals") - from vascular territories that are derived from the user-defined labeling of the liver related vascular structures - 3D visualizations of user-defined (vascular) tumor margins (coloring of area based on user-defined margin sizes/ distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver) - based on user provided values, calculation of liver volume to body weight ratios (i.e., estimated weight for remnant or graft, body surface area, graft to recipient body weight ratio, graft to SLV ratio, remnant to body weight ratio). Using a manual spatial registration of the images, the segmented objects (created on different CT phases and MRI sequences) can be visualized together.

Device Story

Standalone image analysis software; processes DICOM CT/MR images. Supports manual segmentation/labeling of abdominal organs, vascular structures, and lesions; provides AI-based semi-automatic pre-segmentation for liver/vessels in healthy living donors. Used by radiologists/surgeons in office/hospital settings for treatment planning, surgical strategy, and follow-up. Outputs include 3D visualizations, volume calculations, and liver-to-body-weight ratios. Physicians perform final clinical decisions; software is not for real-time viewing, diagnostic review, or automatic lesion detection. Benefits include improved workflow for surgical planning and assessment of hepatic system.

Clinical Evidence

Bench testing only. Retrospective multi-center study validated AI pre-segmentation performance: Liver DICE > 0.85, 95% Hausdorff < 2.0 mm. Vascular structures validated via bench tests against expert ground truth. Qualitative assessment by 3 board-certified surgeons/radiologists using 5-point Likert scale showed >80% accuracy rating. Volume calculation precision/accuracy verified via simulated phantoms and clinical test data.

Technological Characteristics

Standalone software; Windows 10 (64-bit). Supports DICOM CT/MR. Manual segmentation (freehand, region growing) and AI-based semi-automatic pre-segmentation (locked/non-adaptive). 3D visualization, volume calculation, and manual rigid registration. No direct patient contact. No high-resolution display drivers.

Indications for Use

Indicated for oncologic patients or hepatic donor/transplant patients (age 18+) requiring evaluation of liver, vascular anatomy, and liver volumes. Semi-automatic pre-segmentation tools restricted to CT scans of potential living liver donors with healthy livers.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. MeVis Medical Solutions AG Rolf Rzodeczko Manager Regulatory Affairs Caroline-Herschel-Strasse 1 BREMEN, BREMEN 28359 GERMANY Re: K232045 Trade/Device Name: MeVis Liver Suite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 27, 2023 Received: September 27, 2023 Dear Rolf Rzodeczko: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Digitally signed by for Gabriela M. Rodal -S Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232045 Device Name MeVis Liver Suite #### Indications for Use (Describe) MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM). MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures. Me Vis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRJ, and MRCP. MeVis Liver Suite only allows import of homogenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite. MeVis Liver Suite can be used for manual segmentation, user-defined manual labeling, and 3D visualization of: - abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, and pancreas) - liver related vascular structures (i.e., bile ducts, hepatic vein, portal vein, and inferior vena cava) - lesions inside and adjacent to the liver The tools for manual segmentation and 3D visualization are applicable for CT and MR imaging studies. In addition to the manual segmentation tools, MeVis Liver Suite provides AI based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein restricted to CT scans of potential living liver donors with healthy livers and intended for: - Liver: contrast enhanced late-venous and venous phase - Hepatic vein: contrast enhanced late-venous and venous phase - Portal vein: contrast enhanced late-venous and venous phase - Hepatic artery: contrast enhanced arterial phase Using MeVis Liver Suite, users can evaluate the segmented objects by exploring, and manually correcting: - the volume of the segmented abdominal organs (see above) - the volume of the segmented lesions inside and adjacent to the liver - the volume of the manually defined parts of the liver - by defining separation planes ("separation proposals") - from vascular territories that are derived from the user-defined labeling of the liver related vascular structures - 3D visualizations of user-defined (vascular) tumor margins (coloring of area based on user-defined margin sizes/ distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver) - based on user provided values, calculation of liver volume to body weight ratios (i.e., estimated weight for remnant or graft, body surface area, graft to recipient body weight ratio, graft to SLV ratio, remnant to body weight ratio). Using a manual spatial registration of the images, the segmented objects (created on different CT phases and MRI sequences) can be visualized together. {3}------------------------------------------------ The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, and treatment decisions. MeVis Liver Suite is not intended for the anatomical systems integumentary, skeletal, muscular, lymphatic, respiratory, nervous, reproductive, and cardiovascular (excluding hepatic). MeVis Liver Suite does not support the following application areas: real time viewing, diagnostic review, mage manipulation, optimization, virtual colonoscopy, and automatic lesion detection. MeVis Liver Suite does not utilize high-resolution displays or display drivers and should not be used as a replacement for a PACS workstation. Intended Patient Population: The intended patients for MeVis Liver Suite are oncologic patients or hepatic donor/transplant patients. CT or MR imaging with contrast agents need to be possible for analysis of vascular structures inside the liver. The age group for the intended patient population is 18 or older. In addition, the semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers. Intended Part of the Body: Images supported for the intended medical include the abdominal body part with the liver and related vascular structures (bile ducts, hepatic artery, hepatic vein, inferior vena cava). Intended User Profile: The intended users are radiologists and surgeons. Intended Use Environment: The use environment is expected to be in an office environment under typical office conditions in hospitals or medical practices. Operation Principle: The software acts as modality for display of CT or MR imaging data, and for visualization of the image analysis results on a computer system. MeVis Liver Suite does not come into direct contact with patients or other medical devices. #### Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) #### 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." {4}------------------------------------------------ ## K232045 510(k) Summary #### 1 Submitter | Submitted Name: | MeVis Medical Solutions AG<br>Caroline-Herschel-Straße 1<br>28359 Bremen<br>Germany | |---------------------------------------|-------------------------------------------------------------------------------------| | Establishment Name: | MeVis Medical Solutions AG | | Establishment<br>Registration Number: | 3010601176 | | Date Prepared: | 07/10/2023 | | Contact Person: | Rolf Rzodeczko<br>Manager Regulatory Affairs | | Telephone: | +49 (0)421 22495-120 | | Fax: | +49 (0)421 22495-999 | | 2 Device | | | Device Trade Name: | MeVis Liver Suite | | Device Common Name: | MeVis Liver Suite | | Regulation: | 21 CFR 892.1750 | | Classification Name: | Computed tomography x-ray system | | Product Code: | JAK | | Class: | Class II | | Panel: | Radiology | {5}------------------------------------------------ #### 3 Primary Predicate Device | 510(k) Number | Primary Predicate Device | Product Code | |---------------|--------------------------|--------------| | K133643 | syngo.CT Liver Analysis | JAK | #### 4 Secondary Predicate Device(s) | 510(k) Number | Secondary Predicate Device | Product Code | |---------------|----------------------------|--------------| | K173420 | Radiomics App v1.0 | LLZ | #### 5 Reference Device1 | 510(k) Number | Reference Device | Product Code | |---------------|----------------------------|--------------| | K193562 | Al-Rad Companion Organs RT | QKB | #### 6 Device Description MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM). MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures. The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, assessment, and treatment decisions. ### Software and Operating System MeVis Liver Suite is a standalone software application that can be installed on any PC that runs on Windows 10 which meet the hardware requirements. ### Supported Modalities DICOM compatible CT and MR image data with or without contrast. The tools for manual segmentation and 3D visualization (see below) are applicable for CT and MR image data with the exception of the Al based semi-automatic pre-segmentation tools. The <sup>1</sup> Reference device for liver Al pre-seqmentation performance acceptance criteria {6}------------------------------------------------ semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers. ## lmage import and selection MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homoqenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite. MeVis Liver Suite can be used to manually select DICOM images (CT and MR) for import. The user can visually inspect the images, if the anatomical structures are visible and if the image resolution and image quality is acceptable for the manual segmentation and the user's needs. ### Seqmentation and 3D visualization MeVis Liver Suite provides multiple contouring tools for manual segmentation. The user has full control over the workflow and decides which structures to segment. 3D visualizations are created on demand. The following segmentation workflows are available: #### . Abdominal organs MeVis Liver Suite is intended to be used to manually segment and visualize liver, stomach, duodenum, spleen, kidney, gallbladder, or pancreas using contouring tools. Users can inspect and manually correct, add, and delete their segmentation until they are satisfied with the result. The following tools are available: - o Freehand contouring - o Region Growing #### . Liver related vascular structures MeVis Liver Suite is intended to be used to manually segment and visualize bile ducts. hepatic artery, hepatic vein, portal vein, and inferior vena cava, including the option to manually classify different vessels of the vascular branches by assigning them userdefined labels. Users can inspect and manually correct, add, and delete their segmentation until they are satisfied with the result. The following tools are available: - o Freehand drawing and freehand contouring - Region Growing o - o Edit and label 3D tree #### . Lesions inside and adjacent to the liver MeVis Liver Suite is intended to be used to manually seqment, visualize, and label user identified lesions inside and adjacent to the liver using: - o Freehand contouring Me\/is Liver Suite does not identify or highlight lesions or other abnormalities. Additionally, the user can use Al based semi-automatic pre-segmentation of liver and liver related vascular structures to create a segmentation proposal. The semi-automatic preseqmentation uses locked/non adaptive Al networks. #### ● Semi-automatic pre-segmentation of the liver - Supported modalities - CT, contrast enhanced late-venous and venous phase - o Limitations ■ Only intended for living donor liver transplantation cases (healthy livers) - Semi-automatic pre-segmentation for liver related vascular structures ● {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "MeVis" in a teal color. The font is sans-serif and appears to be bolded. The letters are evenly spaced and the word is horizontally oriented. - Supported modalities o - Hepatic vein: CT, contrast enhanced late-venous and venous phase . - Portal vein: CT, contrast enhanced late-venous and venous phase - . Hepatic artery: CT, contrast enhanced arterial phase - o Limitations - Only intended for living donor liver transplantation cases (healthy livers) ## Evaluation of segmented objects Users can evaluate the segmented objects by exploring, and manually correcting: - Volume MeVis Liver Suite calculates the volume (via voxel-counting of segmentation mask) and displays the volume information to the user for the following manually segmented objects: - o Abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, pancreas) - o Lesions inside and adjacent to the liver - Manually defined parts of the liver o - . "Separation proposals" The user can manually define separation planes that part the liver into virtual parts. The user manually labels the parts as either "resection"," graft" (for coloring the 3D visualization of the user-defined part with a red color), or "remnant" (green color) - = "Vascular territories" Using the user-defined labeling (name and color) of vessel subtrees, the software calculates seqmentation masks for the corresponding vascular territories within the liver - 3D visualizations of user-defined (vascular) tumor margins (coloring of area based . on user-defined margin sizes/distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver) - o The distance of vascular structures to user selected lesions can be visualized with colored 3D visualizations: - · with color coded vascular structures ("vascular tumor margins") - . with color coded voxels around a lesion inside the liver ("tumor margins") - Based on user provided values, calculation of liver volume to body weight ratios ● MeVis Liver Suite provides the following calculations: - Estimated Weight for Remnant and Graft O - Body Surface Area o - Graft to Recipient Body Weight Ratio o - Graft to Standard Liver Volume (SLV) Ratio o - Remnant Volume to Body Weight Ratio o ## Manual spatial registration MeVis Liver Suite supports performing a manual spatial registration of the images from different modalities and studies (CT and MR). The user can manually align the imported images visually in pairs on top of each other using manual rigid registration. ## Reporting Using MeVis Liver Suite, the user can report results of the image analysis in different formats (DICOM for archiving, with DICOM definitions for 2D segmentation and 3D volumes; HTML report). {8}------------------------------------------------ #### 7 Indications for Use MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM). MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures. MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homogenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite. MeVis Liver Suite can be used for manual segmentation, user-defined manual labeling, and 3D visualization of: - abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, and . pancreas). - . liver related vascular structures (i.e., bile ducts, hepatic vein, portal vein, and inferior vena cava) - . lesions inside and adjacent to the liver The tools for manual segmentation and 3D visualization are applicable for CT and MR imaging studies. In addition to the manual segmentation tools. MeVis Liver Suite provides Al based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein, and portal vein restricted to CT scans of potential living liver donors with healthy livers and intended for: - Liver: contrast enhanced late-venous and venous phase ● - . Hepatic vein: contrast enhanced late-venous and venous phase - . Portal vein: contrast enhanced late-venous and venous phase - . Hepatic artery: contrast enhanced arterial phase Using MeVis Liver Suite, users can evaluate the segmented objects by exploring, and manually correcting: - the volume of the segmented abdominal organs (see above) . - . the volume of the segmented lesions inside and adjacent to the liver - . the volume of the manually defined parts of the liver - o by defining separation planes ("separation proposals") - from vascular territories that are derived from the user-defined labeling of the liver o related vascular structures - 3D visualizations of user-defined (vascular) tumor margins (coloring of area - based on user-defined margin sizes/distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver) - . based on user provided values, calculation of liver volume to body weight ratios (i.e., estimated weight for remnant or graft, body surface area, graft to recipient body weight ratio, graft to SLV ratio, remnant to body weight ratio). {9}------------------------------------------------ Using a manual spatial registration of the images, the segmented objects (created on different CT phases and MRI sequences) can be visualized together. The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, assessment, and treatment decisions. MeVis Liver Suite is not intended for the anatomical systems integumentary, skeletal, muscular, lymphatic, respiratory, nervous, reproductive, and cardiovascular (excluding hepatic). MeVis Liver Suite does not support the following application areas: real time viewing, diagnostic review, image manipulation, optimization, virtual colonoscopy, and automatic lesion detection. MeVis Liver Suite does not utilize high-resolution displays or display drivers and should not be used as a replacement for a PACS workstation. ## Intended Patient Population: The intended patients for MeVis Liver Suite are oncologic patients or hepatic donor/transplant patients. CT or MR imaging with contrast agents need to be possible for analysis of vascular structures inside the liver. The age group for the intended patient population is 18 or older. In addition, the semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers. ## Intended Part of the Body: Images supported for the intended medical indication include the abdominal body part with the liver and related vascular structures (bile ducts, hepatic vein, portal vein, inferior vena cava). ### Intended User Profile: The intended users are radiologists and surgeons. ### Intended Use Environment: The use environment is expected to be in an office environment under typical office conditions in hospitals or medical practices. ## Operation Principle: The software acts as modality for display of CT or MR imaging data, and for visualization of the image analysis results on a computer system. MeVis Liver Suite does not come into direct contact or indirect contact with patients or other medical devices. #### 8 Technological Characteristics Comparison The design, function, and specifications of MeVis Liver Suite are similar to the identified legally marketed primary predicate and secondary predicate device. The MeVis Liver Suite software combines functionalities of the predicate devices. MeVis Liver Suite allows the medical professionals to display DICOM CT and MR images, and to do a segmentation of internal structures of interest as organs, lesions, vascular structures, including functionality of automatic pre-segmentation that supports the clinicians for contouring. From a functionality point of view, MeVis Liver Suite and the combination of the predicate devices are substantially equivalent and they cover the same (combined) intended use. {10}------------------------------------------------ Key differences in design and performance between MeVis Liver suite and the predicate devices are solely on a technical level. | Device | Indications for Use | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device<br>MeVis Liver Suite | MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM).<br><br>MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures.<br><br>MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homogenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite.<br><br>MeVis Liver Suite can be used for manual segmentation, user-defined manual labeling, and 3D visualization of: abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, and pancreas). liver related vascular structures (i.e., bile ducts, hepatic artery, hepatic vein, portal vein, and inferior vena cava) lesions inside and adjacent to the liver The tools for manual segmentation and 3D visualization are applicable for CT and MR imaging studies.<br><br>In addition to the manual segmentation tools, MeVis Liver Suite provides Al based semi- automatic pre-segmentation tools for liver, hepatic artery, hepatic vein, and portal vein restricted to CT scans of potential living liver donors with healthy livers and intended for: Liver: contrast enhanced late-venous and venous phase Hepatic vein: contrast enhanced late-venous and venous phase Portal vein: contrast enhanced late-venous and venous phase Hepatic artery: contrast enhanced arterial phase<br><br>Using MeVis Liver Suite, users can evaluate the segmented objects by exploring, calculating, and manually correcting: the volume of the segmented abdominal organs (see above) the volume of the segmented lesions inside and adjacent to the liver the volume of the manually defined parts of the liver by defining separation planes ("separation proposals") from vascular territories that are derived from the user-defined labeling of the liver related vascular structures 3D visualizations of user-defined (vascular) tumor margins (coloring of area - based on user-defined margin sizes/distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver) based on user provided values, calculation of liver volume to body weight ratios (i.e., estimated weight for remnant or graft, body surface area, graft to recipient body weight ratio, graft to SLV ratio, remnant to body weight ratio).<br><br>Using a manual spatial registration of the images, the segmented objects (created on different CT phases and MRI sequences) can be visualized together.<br><br>The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, assessment, and treatment decisions. | | | MeVis Liver Suite is not intended for the anatomical systems integumentary, skeletal,<br>muscular, lymphatic, respiratory, nervous, reproductive, and cardiovascular (excluding<br>hepatic). | | | MeVis Liver Suite does not support the following application areas: real time viewing,<br>diagnostic review, image manipulation, optimization, virtual colonoscopy, and automatic lesion<br>detection. | | | MeVis Liver Suite does not utilize high-resolution displays or display drivers and should not be<br>used as a replacement for a PACS workstation. | | | Intended Patient Population:<br>The intended patients for MeVis Liver Suite are oncologic patients or hepatic donor/transplant<br>patients. CT or MR imaging with contrast agents need to be possible for analysis of vascular<br>structures inside the liver. The age group for the intended patient population is 18 or older.<br>In addition, the semi-automatic pre-segmentation tools are restricted to CT scans of potential<br>living liver donors with healthy livers. | | | Intended Part of the Body:<br>Images supported for the intended medical indication include the abdominal body part with the<br>liver and related vascular structures (bile ducts, hepatic artery, hepatic vein, portal vein, inferior<br>vena cava). | | | Intended User Profile:<br>The intended users are radiologists and surgeons. | | | Intended Use Environment:<br>The use environment is expected to be in an office environment under typical office conditions<br>in hospitals or medical practices. | | | Operation Principle:<br>The software acts as modality for display of CT or MR imaging data, and for visualization of the<br>image analysis results on a computer system. MeVis Liver Suite does not come into direct<br>contact or indirect contact with patients or other medical devices. | | Primary Predicate<br>device:<br>Siemens syngo.<br>CT Liver Analysis<br>(K133643) | syngo.CT Liver Analysis is an image analysis software for CT volume data sets. It analyses the<br>liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel<br>systems in the liver. These regions can be evaluated by exploring the volume of the liver and<br>its vascular territories. | | | Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of<br>the liver. The following evaluation tools are provided: | | | • Computation and manual correction of liver volumes…
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%