syngo.CT Neuro Perfusion

{0}------------------------------------------------ October 11, 2020 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. Siemens Medical Solutions USA, Inc. % Ms. Veronica Padharia Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192 Re: K202213 Trade/Device Name: syngo.CT Neuro Perfusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 5, 2020 Received: August 6, 2020 Dear Ms. Padharia: 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. 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Mills, Ph.D. 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) K202213 Device Name syngo.CT Neuro Perfusion Indications for Use (Describe) The syngo. CT Neuro Perfusion software package is designed to evaluate areas of brain perfusion. The software processes images or volumes that were reconstructed from continuously acquired CT data after the injection of contrast media. It generates the following result volumes: - . Cerebral blood flow (CBF) - Cerebral blood volume (CBV) . - Local bolus timing (time to start (TTS), time to peak (TTP), time to drain (TTD)) . - Mean transit time (MTT) . - o Transit time to the center of the IRF (TMax) - . Flow extraction product (permeability) - . Temporal MIP - . Temporal Average - . Baseline Volume - Modified dynamic input data . The software allows the calculation of mirrored regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke. Areas of decreased perfusion appear as areas of changed signal intensity: - · Lower signal intensity for CBF and CBV - · Higher signal intensity for TTP, TTD, MTT, and TMax A second application is to visualize blood brain barrier disturbances by modeling extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and may be helpful in therapy monitoring. Type of Use (Select one or both, as applicable) X 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 FOR SYNGO.CT NEURO PERFUSION #### Identification of the Submitter I. #### Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869 ### Manufacturing Site Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany #### Establishment Registration Number 3004977335 #### Submitter Contact Person: Veronica Padharia Regulatory Affairs Specialist, CNMT Siemens Medical Solutions USA, Inc. TEL: (630) 877-5761 FAX: (847) 304-6023 veronica.padharia@siemens-healthineers.com #### Device Name and Classification II. | Product Name: | syngo.CT Neuro Perfusion | |-----------------------|----------------------------------| | Propriety Trade Name: | syngo.CT Neuro Perfusion | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | # III. Predicate Device #### Predicate Device | Trade Name: | syngo.CT Neuro Perfusion | |-----------------------|----------------------------------| | 510(k) Number: | K163284 | | Clearance Date: | 03/01/2017 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | {4}------------------------------------------------ | Device Class: | Class II | |---------------|----------| | Product Code: | JAK | #### Reference Device | Trade Name: | iSchemaView RAPID | |-----------------------|----------------------------------------| | 510(k) Number: | K182130 | | Clearance Date: | 12/27/2018 | | Classification Name: | System, Image Processing, Radiological | | Classification Panel: | Radiology | | CFR Section: | 21 CFR § 892.2050 | | Device Class: | Class II | | Product Code: | LLZ | # IV. Device Description The syngo. CT Neuro Perfusion software allows the quantitative evaluation of dynamic CT data of the brain acquired during the injection of a compact bolus of iodinated contrast material. It mainly aids in the early differential diagnosis of acute ischemic stroke. Blood-brain-barrier (BBB) imaging feature supports the diagnostic assessment of brain tumors. By providing images of e.g. cerebral blood flow (CBF), cerebral blood volume (CBV), time to peak (TTP), and Mean Transit Time (MTT) from one set of dynamic CT images or volumes, syngo.CT Neuro Perfusion allows a quick and reliable assessment of the type and extent of cerebral perfusion disturbances, including fast evaluation of the tissue at risk and non-viable tissue in the brain. The underlying approaches for this application were cleared as part of the predicate device and remain unchanged in comparison to the predicate device syngo.CT Neuro Perfusion allows simultaneous multi-slice processing and supports the workflow requirements in a stroke workflow. The availability of flow extraction product imaging extends the option to the diagnosis of brain tumors. A listing of device modifications as part of the new software version VB50 of syngo.CT Neuro Perfusion is as follows: ### Additional Parameters Hypoperfused Area and Mismatch Ratio: These parameters are calculated based on NVT (non-viable tissue) and TAR (tissue at risk). Hypoperfused Area is calculated based on the sum of NVT and TAR while the Mismatch Ratio is calculated by dividing Hypoperfused Area by NVT. #### V. Indications for Use The syngo.CT Neuro Perfusion software package is designed to evaluate areas of brain perfusion. The software processes images or volumes that were reconstructed from continuously acquired CT data after the injection of contrast media. It generates the following result volumes: - Cerebral blood flow (CBF) - Cerebral blood volume (CBV) ● - Local bolus timing (time to start (TTS), time to peak (TTP), time to drain (TTD)) ● - Mean transit time (MTT) - Transit time to the center of the IRF (TMax) - Flow extraction product (permeability) ● - . Temporal MIP {5}------------------------------------------------ - Temporal Average - Baseline Volume - Modified dynamic input data The software allows the calculation of mirrored regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke. Areas of decreased perfusion appear as areas of changed signal intensity: - Lower signal intensity for CBF and CBV . - Higher signal intensity for TTP, TTD, MTT, and TMax A second application is to visualize blood brain barrier disturbances by modeling extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and may be helpful in therapy monitoring. #### Comparison of the IFU Statement and Technological Characteristics with the VI. Predicate Device This section compares the IFU statement as well as the technological characteristics with the predicate device, syngo.CT Neuro Perfusion (K163284), and the reference device, iSchemaView RAPID (K182130). | Subject Device | Predicate Device | Reference Device | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Siemens syngo.CT Neuro<br>Perfusion<br>SOMARIS/8 VB50 | Siemens syngo.CT Neuro<br>Perfusion<br>SOMARIS/8 VB20, K163284 | iSchemaView RAPID<br>K182130 | | The syngo.CT Neuro Perfusion<br>software package is designed to<br>evaluate areas of brain perfusion.<br>The software processes images or<br>volumes that were reconstructed<br>from continuously acquired CT data<br>after the injection of contrast media. | The syngo.CT Neuro Perfusion<br>software package is designed to<br>evaluate areas of brain perfusion.<br>The software processes images or<br>volumes that were reconstructed<br>from continuously acquired CT data<br>after the injection of contrast media. | iSchemaView's RAPID is an image<br>processing software package to be<br>used by trained professionals,<br>including but not limited to<br>physicians and medical technicians.<br>The software runs on a standard off- | | It generates the following result<br>volumes:<br>• Cerebral blood flow (CBF)<br>• Cerebral blood volume (CBV)<br>• Local bolus timing (time to start<br>(TTS), time to peak (TTP), time | It generates the following result<br>volumes:<br>• Cerebral blood flow (CBF)<br>• Cerebral blood volume (CBV)<br>• Local bolus timing (time to start<br>(TTS), time to peak | the-shelf computer or a virtual<br>platform, such as VMware, and can<br>be used to perform image viewing,<br>processing and analysis of images.<br>Data and images are acquired<br>through DICOM compliant imaging<br>devices. | | to drain (TTD))<br>• Mean transit time (MTT)<br>• Transit time to the center of the<br>IRF (TMax)<br>• Flow extraction product<br>(permeability)<br>• Temporal MIP<br>• Temporal Average<br>• Baseline Volume<br>• Modified dynamic input data | • (TTP), time to drain (TTD))<br>• Mean transit time (MTT)<br>• Transit time to the center of the<br>IRF (TMax)<br>• Flow extraction product<br>(permeability)<br>• Temporal MIP<br>• Temporal average<br>• Baseline volume<br>• Modified dynamic input data | The iSchemaView RAPID provides<br>both viewing and analysis<br>capabilities for functional and<br>dynamic imaging datasets acquired<br>with CT Perfusion (CT-P), CT<br>Angiography (CTA), and MRI<br>including a Diffusion Weighted MRI<br>(DWI) Module and a Dynamic<br>Analysis Module (dynamic contrast-<br>enhanced imaging data for MRI and<br>CT). | | The software allows the calculation<br>of mirrored regions of interest and<br>the visual inspection of time<br>attenuation curves. One clinical | The software also allows the<br>calculation of mirrored regions or<br>volumes of interest and the visual | The DWI Module is used to visualize<br>local water diffusion properties from | | application is to visualize the<br>apparent blood perfusion and to<br>calculate Hypoperfused Area and | inspection of time attenuation<br>curves. One clinical application is to<br>visualize the apparent blood | the analysis of diffusion weighted<br>MRI data. | | Mismatch Ratio in the brain tissue<br>affected by acute stroke. | perfusion and the parameter<br>mismatch in brain tissue affected by<br>acute stroke. | The Dynamic Analysis Module is<br>used for visualization and analysis of<br>dynamic imaging data, showing | | Areas of decreased perfusion appear<br>as areas of changed signal intensity:<br>• Lower signal intensity for CBF<br>and CBV<br>• Higher signal intensity for TTP,<br>TTD, MTT, and TMax | Areas of decreased perfusion appear<br>as areas of changed signal intensity:<br>• Lower signal intensity for CBF<br>and CBV<br>• Higher signal intensity for TTP,<br>TTD, MTT, and TMax | properties of changes in contrast over<br>time. This functionality includes<br>calculation of parameters related to<br>tissue flow (perfusion) and tissue<br>blood volume. | | A second application is to visualize<br>blood brain barrier disturbances by<br>modeling extra-vascular leakage of<br>blood into the interstitial space. This<br>additional capability may improve<br>the differential diagnosis of brain<br>tumors and may be helpful in therapy<br>monitoring. | A second application is to visualize<br>blood brain barrier disturbances by<br>modeling extravascular leakage of<br>blood into the interstitial space. This<br>additional capability may improve<br>the differential diagnosis of brain<br>tumors and be helpful in therapy<br>monitoring. | RAPID CT-Perfusion and RAPID<br>MR-Perfusion can be used by<br>physicians to aid in the selection of<br>acute stroke patients (with known<br>occlusion of the intracranial internal<br>carotid artery or proximal middle<br>cerebral artery) for endovascular<br>thrombectomy. | | | | Instructions for use of contrast agents<br>for this indication can be found in<br>Appendix A of the User's Manual.<br>Additional information for safe and<br>effective drug use is available in<br>productspecific iodinated CT and<br>gadolinium-based MR contrast drug<br>labeling. | | | | In addition to the RAPID imaging<br>criteria, patients must meet the<br>clinical requirements for<br>thrombectomy, as assessed by the<br>physician, and have none of the<br>following contraindications or<br>exclusions. | | | | Contraindications/Exclusions:<br>• Bolus Quality: absent or<br>inadequate bolus.<br>• Patient Motion: excessive<br>motion leading to artifacts that<br>make the scan technically<br>inadequate.<br>• Presence of Hemorrhage. | #### IFU Comparison: {6}------------------------------------------------ #### Comparison of the IFU statement related to the Predicate Device syngo.CT Neuro Perfusion (K163284): The IFU statement of the subject device includes both parameters Hypoperfused Area and Mismatch Ratio due to the significance in decision-making during the AIS clinical workflow. The sentence is as follows: "One clinical application is to visualize the apparent blood perfusion and to calculate Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke". This is the relevant difference as compared to the predicate device. {7}------------------------------------------------ #### Comparison of the IFU statement related to the Reference Device iSchemaView RAPID (K182130) The IFU Statement of the reference device is principally divided in eight sections. To simplify the comparison process, a comparison of each section of the reference device against the subject device's IFU statement is provided next: The first two sections as listed in the table (right column) above describe the type of the medical device (image respectively post-processing software application), the target group ("trained professionals") as well as the system environment where the software runs on. We describe the target group and the system environment in our user manual but not in our IFU statement. - 1. iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. - 2. The software runs on a standard off-the-shelf computer or a virtual platform, such as V Mware, and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices. The third and fourth section refer to the modality-specific feature "DWI Modules" which refers to the MR acquisition mode only. Our subject device conducts post-processing on CT data only as described in the second sentence of our IFU statement. The subject device is not intended to work on MR data. - 3. The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). - 4. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion weighted MRI data. The fifth section refers to the analysis of dynamic imaging data of the blood flow. The assessment of dynamic image data is realized by cerebral blood flow (CBF) and cerebral blood volume (CBV) as listed in our IFU statement. - The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, 5. showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. The sixth section describes which specific medical procedure (endovascular thrombectomy) can be applied using the reference device. Our IFU statement does not provide such specific information. - RAPID CT-Perfusion and RAPID MR-Perfusion can be used by physicians to aid in the 6. selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery) for endovascular thrombectomy. The seventh section provides specific information concerning the use of a contrast agent. Our IFU statement explains that the subject device processes images or volumes after the injection of contrast media. Specific information concerning the contrast agent are communicated to the end-user in the user manual. - 7. Instructions for use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in productspecific iodinated CT and gadolinium-based MR contrast drug labeling. {8}------------------------------------------------ The eighth section describes the contraindications. Such information is listed in the user manual of the subject device. - In addition to the RAPID imaging criteria, patients must meet the clinical requirements for 8. thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions. Contraindications/Exclusions: - . Bolus Quality: absent or inadequate bolus. - . Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. - Presence of Hemorrhage. . Additionally, the subject device is able to evaluate brain tumors while the reference device does not provide such functionality. This functionality, the evaluation of brain tumors, is already part of the predicate device (syngo.CT Neuro Perfusion, VB20) as listed in the IFU statement comparison table. {9}------------------------------------------------ ### Comparison of Technological Characteristics The only modification made to syngo.CT Neuro Perfusion VB50 software is the addition of the Hypoperfused Area and Mismatch Ratio parameters. All remaining features are unchanged. Please refer to the table below for a high-level overview of features within Neuro Perfusion: | Feature | Subject Device | Predicate Device | Reference Device | Comments | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | syngo.CT Neuro<br>Perfusion<br>(SOMARIS/8 VB50) | syngo.CT Neuro<br>Perfusion<br>(SOMARIS/8 VB20,<br>K163284) | iSchemaView RAPID<br>(K182130) | | | Tissue at risk<br>and non-<br>viable tissue<br>visualization | The flexible penumbra<br>analysis mode allows<br>highlighting of areas as<br>Non-viable Tissue<br>(NVT) and Tissue-At-<br>Risk (TAR) according<br>to certain user defined<br>thresholds. Thresholds<br>of two different<br>Perfusion maps, e.g.<br>CBF, CBV, MTT, TTP<br>can be used. Results can<br>be smoothed to reduce<br>artefacts. Relative<br>thresholds can be used<br>for CBV and CBF. The<br>visualization is done as<br>color coded overlay on<br>temporal MIP.<br>Additional TAC and<br>statistical values are<br>displayed.<br>Hypoperfused Area<br>(sum of existing<br>parameters TAR and<br>NVT) and Mismatch<br>Ratio parameters<br>(division of<br>Hypoperfused Area by<br>NVT or<br>(TAR+NVT)/NVT)<br>have been added. | The flexible penumbra<br>analysis mode allows<br>highlighting of areas as<br>Non-viable Tissue<br>(NVT) and Tissue At<br>Risk (TAR) according<br>to certain user defined<br>thresholds. Thresholds<br>of two different<br>Perfusion maps, e.g.<br>CBF, CBV, MTT, TTP<br>can be used. Results can<br>be smoothed to reduce<br>artefacts. Relative<br>thresholds can be used<br>for CBV and CBF. The<br>visualization is done as<br>color coded overlay on<br>temporal MIP.<br>Additional TAC and<br>statistical values are<br>displayed | According to both<br>publications Bathla et<br>al. 2019 and Bathla et<br>al. 2020 the definition<br>of the Hypoperfused<br>Area and Mismatch<br>Ratio parameters is<br>considered<br>substantially<br>equivalent to how<br>these parameters are<br>utilized within the<br>reference device,<br>iSchemaView RAPID<br>(K182130). | Modified<br>Addition of<br>Hypoperfused Area<br>and Mismatch Ratio<br>parameters.<br>Both parameters derive<br>from already cleared<br>parameters NVT and<br>TAR.<br>The subject device<br>provides the additional<br>parameters<br>Hypoperfused Area<br>(sum of TAR and<br>NVT) and Mismatch<br>Ratio (division of<br>Hypoperfused Area by<br>NVT or (TAR+NVT) /<br>NVT).<br>The reference device,<br>iSchemaView RAPID<br>(K182130) was used as<br>a comparison marketed<br>software in order to<br>determine how<br>modifications to the<br>thresholds of these<br>parameters resulted in<br>comparable<br>measurements. | | Purpose of<br>the<br>application | Visualization of tissue<br>perfusion using rapid<br>sequences collected<br>after the administration<br>of contrast medium | Visualization of tissue<br>perfusion using rapid<br>sequences collected<br>after the administration<br>of contrast medium | Visualization of tissue<br>perfusion using rapid<br>sequences collected<br>after the administration<br>of contrast medium | Same; No change<br>between the primary<br>predicate and device<br>subject to this review. | | Acquisition | Patient scan following<br>administration of<br>contrast media | Patient scan following<br>administration of<br>contrast media | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | CT Scanning<br>Mode | Scanning at a single<br>table position or using<br>spirals with the same<br>scan range | Scanning at a single<br>table position or using<br>spirals with the same<br>scan range | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Motion<br>Correction | Rigid motion correction<br>which can be used in<br>brain datasets | Rigid motion correction<br>which can be used in<br>brain datasets | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Feature | Subject Device | Predicate Device | Reference Device | Comments | | | syngo.CT Neuro<br>Perfusion<br>(SOMARIS/8 VB50) | syngo.CT Neuro<br>Perfusion<br>(SOMARIS/8 VB20,<br>K163284) | iSchemaView RAPID<br>(K182130) | | | Time Point<br>Removal | On user request time<br>points and time ranges<br>(time point volumes)<br>can be removed from<br>the current evaluation if<br>they show strong patient<br>or organ movement. | On user request time<br>points and time ranges<br>(time point volumes)<br>can be removed from<br>the current evaluation if<br>they show strong patient<br>or organ movement. | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | 4D Noise<br>Reduction | Noise reduction with<br>preservation of time-<br>attenuation information<br>can be performed to<br>improve the image<br>quality of noisy input<br>images and to allow for<br>robust image evaluation | Noise reduction with<br>preservation of time-<br>attenuation information<br>can be performed to<br>improve the image<br>quality of noisy input<br>images and to allow for<br>robust image evaluation | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Brain<br>Segmentation | The task can apply the<br>brain segmentation<br>algorithm | The task can apply the<br>brain segmentation<br>algorithm | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | HU<br>Segmentation | Removes all pixels that<br>lie outside the Min HU<br>and Max HU thresholds | Removes all pixels that<br>lie outside the Min HU<br>and Max HU thresholds | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Reference<br>Vessel<br>Definition | Automatic identification<br>of the reference vessel<br>with simple interactive<br>override if the user does<br>not accept automatic<br>detection | Automatic identification<br>of the reference vessel<br>with simple interactive<br>override if the user does<br>not accept automatic<br>detection | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Vessel and<br>Arteries<br>Definition | Automatic identification<br>of the brain vessels and<br>arteries with simple<br>interactive override<br>possibility | Automatic identification<br>of the brain vessels and<br>arteries with simple<br>interactive override<br>possibility | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Hemisphere<br>Plane<br>Definition | Automatic hemisphere<br>plane definition which<br>can be manually<br>corrected | Automatic hemisphere<br>plane definition which<br>can be manually<br>corrected | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Normalization | Normalization of CBF<br>and CBV values based<br>on a histogram analysis<br>of the non-ischemic<br>hemisphere | Normalization of CBF<br>and CBV values based<br>on a histogram analysis<br>of the non-ischemic<br>hemisphere | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Result<br>Storage | Storage of all result<br>images in the database<br>as DICOM CT<br>grayscale, color RGB,<br>Enhanced CT | Storage of all result<br>images in the database<br>as DICOM CT<br>grayscale, color RGB,<br>Enhanced CT | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | ROI (region<br>of interest)<br>evaluation | ROI (region of interest)<br>measurements with<br>calculation of mean<br>value, standard<br>deviation and area for<br>detailed analysis of<br>specific ischemic areas | ROI (region of interest)<br>measurements with<br>calculation of mean<br>value, standard<br>deviation and area for<br>detailed analysis of<br>specific ischemic areas | N/A | No change between the<br>primary predicate and<br>device subject to this<br>review. | | Feature | Subject Device | Predicate Device | Reference Device | Comments | | syngo.CT Neuro<br>Perfusion<br>(SOMARIS/8 VB50) | syngo.CT Neuro<br>Perfusion<br>(SOMARIS/8 VB20,<br>K163284) | iSchemaView RAPID<br>(K182130) |…