syngo. CT Neuro Perfusion

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 1, 2017 Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Boulevard Mail Code 65-1A MALVERN PA 19355 Re: K163284 Trade/Device Name: syngo.CT Neuro Perfusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 14, 2017 Received: February 16, 2017 Dear Ms. Mangum: 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). 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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 (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}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D.'Hara 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) K163284 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) - · 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 also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and the parameter mismatch in 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 extravascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and 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. 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The color of the text is a light blue or teal color. #### 510(K) SUMMARY FOR SYNGO.CT NEURO PERFUSION Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: January 20, 2017 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. #### l. Submitter 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 #### Contact Person Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448 - 6477 Fax: (610) 640 - 4481 Email: kimberly.mangum@siemens.com #### II. Device Name and Classification 510(k) Number: K163284 Product Name: syngo.CT Neuro Perfusion Propriety Trade Name: syngo.CT Neuro Perfusion Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II 90JAK Product Code: {4}------------------------------------------------ #### III. Predicate Device #### Predicate Device: | Trade Name: | syngo.CT Neuro Perfusion | |-----------------------|----------------------------------| | 510(k) Number: | K123541 | | Clearance Date: | 04/02/2013 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | 90JAK | #### Reference Device: | Trade Name: | |-----------------------| | 510(k) Number: | | Clearance Date: | | Classification Name: | | Classification Panel: | | CFR Section: | | Device Class: | | Product Code: | RAPID K121447 10/04/2013 Picture archiving and communications system Radiologv 21 CFR § 892.2050 Class II 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. The Blood-brain-barrier (BBB) imaging feature supports the diagnostic assessment of brain tumors. By providing images of e.q. 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 VB20 of syngo.CT Neuro Perfusion is as follows: - · Auto Stroke Workflow (Calculation and display of the stroke results without user input) - . Rapid Results Technology (Calculates stroke results and quality control images without user input and sends all images to other DICOM nodes) - Additional Parameters for Penumbra and Core Infarct Calculation This software is designed to operate on at least the syngo.via VB20 hardware/software platform, and should be used with reconstructed images that meet the following minimum requirements: {5}------------------------------------------------ - Images should be reconstructed with the high sampling frequency. Scan modes ● are e. g. adaptive 4D spiral, Dynamic sequence and dynamic multi-scan modes of Siemens CT scanners. - A standard reconstruction kernel should be used - . Images should be reconstructed with an increment smaller than the slice thickness to achieve good resolution #### 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 - Temporal Average - o Baseline Volume - Modified dvnamic input data The software also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and the parameter mismatch in 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 extravascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring. #### VI. Comparison of Technological Characteristics with the Predicate Device The evaluation of tissue perfusion is the technological principle for both the subject and predicate devices. Both devices have the same Intended Use, same Indications for Use and similar visualization and evaluation technological characteristics. At a high-level, the subject and predicate device are based on the following same/similar technological characteristics: | Feature | Subject Device | Predicate Device | Comparison | |-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Purpose of the<br>application | visualization of tissue perfusion<br>using rapid sequences collected<br>after the administration of<br>contrast medium | visualization of tissue perfusion<br>using rapid sequences collected<br>after the administration of<br>contrast medium | Same | | Acquisition | patient scan following<br>administration of contrast media | patient scan following<br>administration of contrast media | Same | | Feature | Subject Device | Predicate Device | Comparison | | CT Scanning Mode | Scanning at a single table<br>position or using spirals with the<br>same scan range | Scanning at a single table<br>position or using spirals with the<br>same scan range | Same | | Motion Correction | Rigid motion correction which<br>can be used in brain datasets | Rigid motion correction which<br>can be used in brain datasets | Same | | Time Point Removal | On user request time points and<br>time ranges (time point volumes)<br>can be removed from the current<br>evaluation if they show strong<br>patient or organ movement. | On user request time points and<br>time ranges (time point volumes)<br>can be removed from the current<br>evaluation if they show strong<br>patient or organ movement. | Same | | 4D Noise Reduction | Noise reduction with<br>preservation of time-attenuation<br>information can be performed to<br>improve the image quality of<br>noisy input images and to allow<br>for robust image evaluation | Noise reduction with<br>preservation of time-attenuation<br>information can be performed to<br>improve the image quality of<br>noisy input images and to allow<br>for robust image evaluation | Same | | Brain Segmentation | The task can apply the brain<br>segmentation algorithm | The task can apply the brain<br>segmentation algorithm | Same | | HU Segmentation | Removes all pixels that lie<br>outside the Min HU and Max HU<br>thresholds | Removes all pixels that lie<br>outside the Min HU and Max HU<br>thresholds | Same | | Reference Vessel Definition | Automatic identification of the<br>reference vessel with simple<br>interactive override if the user<br>does not accept automatic<br>detection | Automatic identification of the<br>reference vessel with simple<br>interactive override if the user<br>does not accept automatic<br>detection | Same | | Vessel and Arteries Definition | Automatic identification of the<br>brain vessels and arteries with<br>simple interactive override<br>possibility | Automatic identification of the<br>brain vessels and arteries with<br>simple interactive override<br>possibility | Same | | Hemisphere Plane Definition | Automatic hemisphere plane<br>definition which can be manually<br>corrected | Automatic hemisphere plane<br>definition which can be manually<br>corrected | Same | | Normalization | Normalization of CBF and CBV<br>values based on a histogram<br>analysis of the non-ischemic<br>hemisphere | Normalization of CBF and CBV<br>values based on a histogram<br>analysis of the non-ischemic<br>hemisphere | Same | | Result Storage | Storage of all result images in<br>the database as DICOM CT<br>grayscale, color RGB, Enhanced<br>CT | Storage of all result images in<br>the database as DICOM CT<br>grayscale, color RGB, Enhanced<br>CT | Same | | ROI (region of interest)<br>evaluation | ROI (region of interest)<br>measurements with calculation<br>of mean value, standard<br>deviation and area for detailed<br>analysis of specific ischemic<br>areas | ROI (region of interest)<br>measurements with calculation<br>of mean value, standard<br>deviation and area for detailed<br>analysis of specific ischemic<br>areas | Same | | ROI mirroring | Mirroring of the ROIs at the<br>hemisphere plane and output of<br>statistical parameters like mean<br>value, standard deviation and<br>area | Mirroring of the ROIs at the<br>hemisphere plane and output of<br>statistical parameters like mean<br>value, standard deviation and<br>area | Same | | Feature | Subject Device | Predicate Device | Comparison | | TAC display | Parallel display of several time<br>attenuation curves | Parallel display of several time<br>attenuation curves | Same | | Automatic<br>Stroke<br>calculation | Automatic calculation of all<br>steps, visualization of all<br>intermediate results allowing a<br>final result check | Manual assessment of each<br>calculation step including a<br>result check | Equivalent | | Sending of<br>Images to<br>PACS | Automatic sending of result<br>images to PACS including<br>quality control images.<br>Possibility to do the evaluation<br>manually. | Sending of images to PACS<br>after manual assessment of the<br>results | Equivalent | | Tissue at risk<br>and non-viable<br>tissue<br>visualization | The flexible penumbra analysis<br>mode allows highlighting of<br>areas as Non-viable Tissue<br>(NVT) and Tissue At Risk (TAR)<br>according to certain user defined<br>thresholds. Thresholds of two<br>different Perfusion maps, e.g.<br>CBF, CBV, MTT, TTP can be<br>used. Results can be smoothed<br>to reduce artifacts. Relative<br>thresholds can be used for CBV<br>and CBF. The visualization is<br>done as color coded overlay on<br>temporal MIP. Additional TAC<br>and statistical values are<br>displayed | The flexible penumbra analysis<br>mode allows highlighting of<br>areas as Non-viable Tissue<br>(NVT) and Tissue At Risk (TAR)<br>according to certain user defined<br>thresholds. Thresholds of two<br>different Perfusion maps, e.g.<br>CBF, CBV, MTT, TTP can be<br>used. The visualization is done<br>as color coded overlay on<br>temporal MIP. Additional TAC<br>and statistical values are<br>displayed | Modified | | User Interface | syngo.via GUI | syngo.via GUI | Same | | Archiving/<br>Storing | CD-R, film, DVD, USB, Network | CD-R, film, DVD, USB, Network | Same | | Hardware | As specified by syngo.via | As specified by syngo.via | Same | | Communicatio<br>n | DICOM compatible | DICOM compatible | Same | {6}------------------------------------------------ {7}------------------------------------------------ #### VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT Neuro Perfusion during product development. The modifications described in this Premarket Notification were supported with verification/validation testing. #### Risk Analysis The risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence #### Software Verification and Validation Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. {8}------------------------------------------------ #### Non-Clinical Testing Summary Performance tests were conducted to test the functionality of the syngo.CT Neuro Perfusion. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. #### General Safety and Effectiveness Concerns The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. syngo.CT Neuro Perfusion is designed to fulfill the requirements of the following safety and performance standards: | Recognition<br>Number | Product<br>Area | Title of Standard | Publication<br>Date | Standards<br>Development<br>Organization | |-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------| | 12-300 | Radiology | Digital Imaging and Communications in<br>Medicine (DICOM) Set; PS 3.1 – 3.20 | 06/27/2016 | NEMA | | 13-32 | Software | Medical Device Software -Software Life<br>Cycle Processes; 62304:2006 (1st<br>Edition) | 08/20/2012 | AAMI, ANSI,<br>IEC | | 5-40 | Software/<br>Informatics | Medical devices - Application of risk<br>management to medical devices; 14971<br>Second Edition 2007-03-01 | 08/20/2012 | ISO | | 5-95 | General I<br>(QS/RM) | Medical devices - Part 1: Application of<br>usability engineering to medical devices<br>IEC 62366-1:2015 | 06/27/2016 | IEC | | 19-4 | General II<br>(ES/EMC) | AAMI / ANSI ES60601-1:2005/(R)2012<br>and A1:2012, Medical electrical<br>equipment - part 1: general<br>requirements for basic safety and<br>essential performance (IEC 60601-<br>1:2005, mod) | 07/09/2014 | AAMI, ANSI | #### VIII. Conclusions syngo.CT Neuro Perfusion has the same intended use and indication for use as the predicate device. The technological characteristics such as image visualization and image manipulation are the same as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The predicate devices were cleared based on non-clinical supportive information. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. For the subject device, syngo.CT Neuro Perfusion, Siemens used the same testing with the same workflows as used to clear the predicate device. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.CT Neuro Perfusion testing supports a finding of substantial equivalence.