AI-Rad Companion (Pulmonary)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. July 26, 2019 Siemens Medical Solutions USA, Inc. Kimberly Rendon 40 Liberty Blvd. MALVERN, PA 19355 Re: K183271 Trade/Device Name: AI-Rad Companion (Pulmonary) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK, LLZ Dated: June 14, 2019 Received: June 17, 2019 Dear Kimberly Rendon: 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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Sincerely, For Thalia 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) K183271 Device Name AI-Rad Companion (Pulmonary) #### Indications for Use (Describe) AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs. It provides the following functionality: - · Segmentation and measurements of complete lung and lung lobes - · Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes - · Providing an interface to external Medical Device syngo.CT Lung CAD - · Segmentation and measurements of found lung lesions and dedication to corresponding lung lobe. The software has been validated for data from Siemens (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction). Only DICOM images of adult patients are considered to be valid input. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b></b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"><b></b></span> Over-The-Counter Use (21 CFR 801 Subpart C) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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To the right of the word "Healthineers" is a cluster of orange dots. # 510(K) SUMMARY AI-RAD COMPANION (PULMONARY) K183271 Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: July 19, 2019 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. #### I. Submitter Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869 #### Manufacturing Site Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen, Germany Establishment Registration Number 3004977335 #### Contact Person Kimberly Rendon Sr. Manager Regulatory Affairs (610) 448-6480 kimberly.rendon@siemens-healthineers.com #### II. Device Name and Classification | Product Name: | AI-Rad Companion (Pulmonary) | |--------------------------------|--------------------------------------------| | Trade Name: | AI-Rad Companion (Pulmonary) | | Classification Name: | Computed Tomography X-ray System | | Secondary Classification Name: | Picture Archiving and Communication System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Secondary Product Code: | LLZ | | III. Predicate Device | | | Primary Predicate Device: | | | Product Name: | syngo.CT Pulmo 3D | | Propriety Trade Name: | syngo CT Pulmo 3D | 510(k) Number: Clearance Date: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: K123540 August 29, 2013 Computed Tomography X-Ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 {4}------------------------------------------------ # Health Device Class: Class II Primary Product Code: JAK Secondary Product Code: LLZ Recall Information: There are currently no recalls for this device ### Secondary Predicate Device: | Product Name: | syngo.PET&CT Oncology | |-----------------------|------------------------------------------------| | Propriety Trade Name: | syngo.PET&CT Oncology | | 510(k) Number: | K093621 | | Clearance Date: | February 23, 2010 | | Classification Name: | Picture Archiving and Communications System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.2050 | | Device Class: | Class II | | Primary Product Code: | LLZ | | Recall Information: | There are currently no recalls for this device | # IV. Device Description This section described the technical features and workflow for subject device Al-Rad Companion (Pulmonary). Al-Rad Companion (Pulmonary) is a software only image processing application that supports quantitative and qualitative analysis of previously acquired CT DICOM Images to support radiologists and physicians from emergency medicine, specialty care, and general practice in the evaluation of and assessment of disease of the thorax. As an update to the previously cleared predicate devices, the following modifications have been made: - 1) - Software version VA10A, including the following features: 2) - Segmentation of the lung (modified) a) - Segmentation of lung lobes based on deep learning algorithm (modified) b) - Parenchyma evaluation (modified) c) - Lesion segmentation (modified) d) - 3) Subject device claims list The subject device AI-Rad Companion (Pulmonary) is an image processing software that provides quantitative and qualitative analysis from previously acquired Tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the thorax. The subject device supports the following device specific functionality: - Segmentation and volume measurements of complete lung and lung lobes ● - . Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes - Detection of solid pulmonary nodules with the assistance of LungCAD (K143196, clearance date 05/12/2015) and dedication to lung lobe - . Segmentation and measurements of identified lung lesions {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern. # V. Indications for Use AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs. It provides the following functionality: - . Segmentation and measurements of complete lung and lung lobes - Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes - Providing an interface to external Medical Device syngo.CT Lung CAD - . Segmentation and measurements of found lung lesions and dedication to corresponding lung lobe. The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction). Only DICOM images of adult patients are considered to be valid input. # VI. Comparison of Technological Characteristics with the Predicate Device In comparison the predicate device, the subject devices provide comparable outputs in terms of lung and lung lobe visualization/segmentation and lung lesion segmentation and labeling. A tabular comparison of the subject device and predicate devices is provided as Table 1 below. | Feature | Subject Device | Predicate Device | Comparison Results | |-------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | | Siemens<br>AI-Rad Companion<br>(Pulmonary) | Siemens<br>syngo.CT Pulmo 3D<br>(K123540, clearance<br>date 8/29/2013) | | | Segmentation of<br>lungs | Segmentation of lungs | Segmentation of left /<br>right lung | Modified<br>subject device: segmentation of<br>complete lungs<br>predicate device: dedicated<br>algorithm for segmentation of<br>both lungs | | Segmentation of<br>lung lobes | Segmentation of lung<br>lobes | Segmentation of lung<br>thirds, lung core/peel,<br>lung lobes | Modified<br>subject device: deep learning-<br>based algorithm for long lobes<br>segmentation<br>predicate device: Model-based<br>segmentation algorithm | | Parenchyma<br>Evaluation | Calculation and<br>visualization of lung<br>tissue below -950 HU | Calculation and<br>visualization of lung<br>tissue below threshold | Modified<br>Subject device: fixed threshold<br>for segmentation<br>Predicate device: Configurable<br>threshold for segmentation | #### Table 1: Predicate Device Comparable Properties {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern. | Feature | Subject Device | Predicate Device | Comparison Results | |------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Visualization of segmentation and parenchyma results | Siemens AI-Rad Companion (Pulmonary) | Siemens syngo.CT Pulmo 3D (K123540, clearance date 8/29/2013) | Same | | Interface to LungCAD | Siemens AI-Rad Companion (Pulmonary) | Siemens syngo.PET&CT Oncology (K093621, clearance date 02/23/2010) | Same | | Lesion Segmentation | Segmentation of lung lesions | Segmentation of lesions of the lung, liver, and lymph nodes | Modified<br>subject device: segmentation of lung lesions and localization of found lesion to lung lobe<br>predicate device: segmentation of lesions of lung, liver, lymph nodes, and general anatomies | | Visualization of lesion segmentation results | Color overlay of MPR and VRT with evaluation results | Color overlay of MPR and VRT with evaluation results | Same | The subject device modifications referenced above do not raise different questions of safety or effectiveness in comparison to the predicate devices. # VII. Performance Data # Non-Clinical Testing Summary Performance tests were conducted to test the functionality of AI-Rad Companion (Pulmonary). Software validations, bench testing, and clinical data-based software validations have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate devices. Al-Rad Companion has been tested to meet the requirements of conformity to multiple industry standards. Nonclinical performance testing demonstrated that AI-Rad Companion complies with the following voluntary FDA recognized Consensus Standards listed in Table 2 on the next page: {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots. | 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 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 | # Table 2: Voluntary Conformance Standards # 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, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device AI-Rad Companion (Pulmonary) software version VA10 during product development. 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 for the device was found acceptable to support the claims of substantial equivalence. Bench testing in the form of Unit, Subsystem and System Integration testing were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans. Electrical safety and EMC testing requirements are addressed as part of the host system (CT device or PACS system) to ensure compliance with the application IEC standards. Siemens conforms to the cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. #### Clinical Data Based Software Validation To validate the AI-Rad Companion (Pulmonary) clinical workflow, the following algorithms underwent a scientific evaluation: - Segmentation of lung lobes - The lung lobe segmentation algorithm computes segmentation masks of the five lung lobes (right upper (RUL), right middle (RML), right lower (RLL), left upper (LUL) and left lower lobe (LLL) for a given CT data set of the chest. - . Evaluation of the lung parenchyma {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots. The algorithm receives a 3D CT data set and binary masks of the segmented lung lobes. It computes, the ratio of voxels below -950 HU (%LAV950) each lobe as well as for the complete lung. ### For each algorithm of AI-Rad Companion the analysis is structured as follows: - Algorithm Description: purpose, functionality, technical description ● - . Data - Training cohort: size and properties of data used for training O - Description of ground truth / annotations generation O - Validation cohort: size and properties of data used for testing/validation o - Performance ● - Choice of performance metric O - Actual performance results O - Assessment of clinical relevance of achieved performance O - Related clinical research, e.g. publications (if applicable) . The results of clinical data-based software validation for the subject device Al-Rad Companion (Pulmonary) demonstrated superior performance in comparison to the primary predicate device for segmentation. A complete scientific evaluation report is provided in support of the device modifications. Performance of lung lobe segmentation of AI-Rad Companion.Pulmonary device has been validated in a retrospective performance study (n>4,500 CT data sets from multiple clinical sites from within and outside United States). In this study DICE coefficients, surface metrics and volume error have been computed by comparing the output of the algorithm to the manually established ground truth. The average DICE coefficients for the individual lung lobes ranged between 0.95 and 0.98 with a standard deviation (SD) <= 0.07. Mean surface distance ranged between 0.5 and 1.0 mm with SD <=1.5 mm. The 95th quantile of the Hausdorff distance ranged between 2.6 and 5.2 mm with SD <=6.7 mm. Volume error was between 1.5 and 3.5 % with SD <= 7.3 %. All performance results were superior to the ones achieved using the predicate device supporting substantial equivalence. Additional analysis was performed for both population-specific subgroups and various technical parameters and consistent performance has been found across all subgroups. #### Summary AI-Rad Companion (Pulmonary) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification process and clinical data-based software validation. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment. #### VIII. General Safety and Effectiveness Concerns: The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related Risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the Risk Management process. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards. # IX. Conclusion AI-Rad Companion (Pulmonary) has the same intended use as the primary predicate device. The indication for use has been modified to include a more succinct summary of device specific performance but is still within the scope of the general intended use and regulatory classification as the predicate devices. The {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots. fundamental technological characteristics such as image visualization and image manipulation are the same as the predicate devices. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The predicate devices were cleared on non-clinical supportive information including bench testing and software validations. 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, AI-Rad Companion (Pulmonary), Siemens used the same testing with the same workflows as used to clear the predicate device to demonstrate safety and performance of the technical workflow. Clinical applicability was demonstrated via software-data based validations that were derived in the same intended environment as the predicate devices. Since both devices were tested using the same methods, Siemens believes that the data generated from the AI-Rad Companion (Pulmonary) software testing supports a finding of substantial equivalence.