QLAB Advanced Quantification Software 13

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Philips Healthcare % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL, MN 55114 June 18, 2019 Re: K190913 Trade/Device Name: QLAB Advanced Quantification Software 13.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 6, 2019 Received: June 10, 2019 Dear Mark Job: 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. 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 located 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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, For Thalia T. 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) K190913 Device Name QLAB Advanced Quantification Software 13.0 Indications for Use (Describe) QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | <span></span> | 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 of Safety and Effectiveness This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92 1) Submitter's name, address, telephone number, contact person | Primary Contact: | Arti Arvind | |------------------|-----------------------------------| | | Philips Ultrasound, Inc. | | | 3000 Minuteman Road | | | Andover, MA 01810-6302 | | | Email: aarathi.arvind@philips.com | | | Tel: 978-659-7364 | | | Fax (978) 975-7324 | Date prepared: June 17, 2019 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known: | Common/Usual Name: | Picture archiving and communications system | |----------------------|-------------------------------------------------------------------------------------| | Proprietary Name: | QLAB Advanced Quantification Software 13.0 | | Classification Name: | 21 CFR 892.2050, System, Image Processing, Radiological, Product code LLZ, Class II | | 3) Substantially Equivalent Devices | | | |--------------------------------------------|---------|-------------------| | Primary Predicate Device | | | | QLAB Advanced Quantification Software 11.0 | K181264 | June 7, 2018 | | Reference Devices | | | | TomTec-Arena TTA2 | K150122 | February 13, 2015 | Philips Ultrasound believes that the QLAB 13.0 modifications which are the subject of this 510(k) are substantially equivalent to QLAB 11.0 cleared under K181264. #### 4) Device Description Philips QLAB Advanced Quantification software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' {4}------------------------------------------------ ultrasound systems. It can be used for the off-line review and quantification of ultrasound studies. QLAB software provides basic and advanced quantification capabilities across a family of PC and cart based platforms. OLAB software functions through O-App modules, each of which provides specific capabilities. QLAB builds upon a simple and thoroughly modular design to provide smaller and more easily leveraged products. The primary modification to QLAB 13.0 includes the addition of the following applications: - Philips acquired TOMTEC Imaging Systems GmbH in 2017, and the modified OLAB 13.0 release integrates the currently marketed TomTec-Arena TTA2 AutoSTRAIN application (cleared under K150122 for the Left Ventricle) within the Philips QLAB portfolio as AutoStrain LV (Left Ventricle) with some workflow improvements. - . AutoStrain LA (Left Atrium) application combines the functionality of the cleared TomTec-Arena 2D Cardiac Performance Analysis (2D CPA cleared under K150122) and the technology of the cleared TomTec-Arena AutoSTRAIN (cleared under K150122) and provides an easy LA strain solution for user convenience. - . AutoStrain RV (Right Ventricle) application combines the functionality of the cleared TomTec-Arena 2D Cardiac Performance Analysis (2D CPA cleared under K150122) and the technology of the cleared TomTec-Arena AutoSTRAIN (cleared under K150122) and provides an easy RV strain solution for user convenience. 5) Indications for Use QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems. ## 6) Technological comparison to predicate devices The QLAB Advanced Quantification software with the modified Q-Apps has the same intended use and technological characteristics as the legally marketed predicate device. A comparison of the proposed QLAB applications (AutoStrain LV, AutoStrain LA, AutoStrain RV) to the currently marketed predicate device (QLAB) and reference device (TomTec-Arena TTA2) are provided in the tables below: {5}------------------------------------------------ Philips Ultrasound, Inc. ## Traditional 510(k) QLAB Advanced Quantification Software Modifications | Feature | Currently Marketed<br>Predicate QLAB<br>(Predicate Device -<br>K181264) | Currently<br>Marketed<br>Reference TomTec-<br>Arena TTA2<br>(Reference Device -<br>K150122) | Proposed QLAB<br>AutoStrain LV,<br>LA, RV<br>(Modified<br>Device) | Explanation of<br>Differences | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------| | Indication for<br>Use | QLAB Quantification<br>software is a software<br>application package. It<br>is designed to view and<br>quantify image data<br>acquired on Philips<br>ultrasound systems. | Indications for use of<br>TomTec-Arena<br>TTA2 software are<br>quantification and<br>reporting of<br>cardiovascular, fetal,<br>abdominal structures<br>and function of<br>patients with<br>suspected disease to<br>support the<br>physicians in the<br>diagnosis | Same as QLAB<br>(K181264) | Not applicable | ## AutoStrain LV | Feature | Currently Marketed<br>Predicate QLAB<br>Auto Cardiac Motion<br>Quantification<br>(aCMQ)<br>(K181264) | Currently<br>Marketed<br>Reference TomTec-<br>Arena TTA2<br>AutoSTRAIN<br>(Reference Device -<br>K150122) | Proposed QLAB<br>AutoStrain LV<br>(Modified<br>Device) | Explanation of<br>Differences | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Application<br>description | aCMQ provides an<br>angle-independent<br>analysis of regional<br>myocardial-tissue<br>velocity, displacement,<br>strain, and strain rate,<br>using the speckle<br>tracking technology. It<br>generates<br>measurements of the<br>global and regional<br>functions of the left<br>ventricle. | AutoSTRAIN is a<br>quantification tool of<br>global and regional<br>function based on<br>contour detection and<br>tracking. The tool<br>automatically<br>quantifies global and<br>regional strain based<br>on apical 4-chamber,<br>3-chamber and 2-<br>chamber views of the<br>left ventricle. | Same as<br>AutoSTRAIN on<br>TOMTEC-<br>ARENA | Reason for change:<br>AutoStrain LV<br>functionality enables<br>a simplified<br>workflow when<br>compared to QLAB<br>aCMQ (originally<br>cleared under<br>K132165) | {6}------------------------------------------------ | | Philips Ultrasound, Inc. | | |--|--------------------------|--| |--|--------------------------|--| ## Traditional 510(k) QLAB Advanced Quantification Software Modifications | Speckle Tracking<br>of the ROI per<br>frame | Comparable feature<br>available | Automatically tracks<br>the ROI of the wall<br>motion per frame<br>using speckle<br>tracking technology.<br>User is able to edit<br>the ROI after<br>tracking. | Same as AutoSTRAIN on TomTec-Arena. | | |-----------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | Automatic view<br>recognition to<br>detect chamber<br>views | Manual view selection<br>to detect chamber<br>view. | Manual view<br>selection to detect<br>chamber view. | The application<br>uses view<br>recognition to<br>automatically<br>assign labels. The<br>user is able to<br>overwrite the<br>automatic<br>assignation of<br>labels. | Workflow simplified<br>on QLAB for user<br>convenience | | Calculation of<br>GLS from three<br>views (global<br>strain analysis) | Same calculation<br>available | GLS is calculated<br>based on the Tracked<br>contours per view<br>and as average<br>according to the<br>length-of-line<br>method | Same as AutoSTRAIN on TomTec-Arena. | | ## AutoStrain LA | Feature | Currently Marketed<br>Predicate QLAB<br>(K181264) | Currently<br>Marketed<br>Reference TomTec-<br>Arena TTA2<br>2D Cardiac<br>Performance<br>Analysis - 2D CPA<br>(Reference Device -<br>K150122) | Proposed QLAB<br>AutoStrain LA<br>(Modified<br>Device) | Explanation of<br>Differences | |----------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Application<br>description | Strain quantification of<br>LA chamber is not<br>available on QLAB | 2D CPA speckle<br>tracking algorithm<br>supports the<br>calculation of 2D -<br>contour models of<br>the endocardial of the<br>LA. Corresponding | The AutoStrain<br>LA provides left<br>atrial strain<br>measurements<br>from apical four-<br>chamber (A4C). | AutoStrain LA<br>combines the<br>functionality of 2D<br>CPA and the<br>technology of<br>AutoSTRAIN (for<br>LV) cleared under | {7}------------------------------------------------ | | Philips Ultrasound, Inc. | | |--|--------------------------|--| |--|--------------------------|--| # Traditional 510(k) QLAB Advanced Quantification Software | Speckle Tracking<br>of the ROI per<br>frame | Option not available<br>for LA chamber | velocities,<br>displacements,<br>strains, strain rates<br>and functional<br>parameters can be<br>derived | A Speckle tracking<br>algorithm tracks the<br>ROI of the wall<br>motion per frame.<br>User is able to edit<br>the ROI after<br>tracking. | K150122 to provide<br>an easy LA strain<br>solution for user<br>convenience. | Speckle tracking<br>technology used for<br>TomTec-Arena 2D<br>CPA and<br>AutoSTRAIN (for<br>LV) has been<br>adapted for the left<br>atrial chamber for<br>AutoStrain LA | |--------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Calculation of<br>global strain<br>analysis from<br>one view | Option not available<br>for LA chamber | Left Atrial Strain is<br>calculated based on<br>the tracked contour | Same as 2D CPA. Additionally, conduit<br>and contraction Strain is calculated. | | | ## AutoStrain RV | Feature | Currently Marketed<br>Predicate QLAB<br>(K181264) | Currently<br>Marketed<br>Reference TomTec-<br>Arena TTA2<br>2D Cardiac<br>Performance<br>Analysis - 2D CPA<br>(Reference Device -<br>K150122) | Proposed QLAB<br>AutoStrain RV<br>(Modified<br>Device) | Explanation of<br>Differences | |----------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Application<br>description | Strain quantification of<br>RV chamber is not<br>available on QLAB | 2D CPA speckle<br>tracking algorithm<br>supports the<br>calculation of 2D -<br>contour models of<br>the endocardial<br>border of the RV.<br>Corresponding<br>velocities,<br>displacements. | The AutoStrain<br>RV provides right<br>ventricle strain<br>measurements<br>from apical four-<br>chamber (A4C)<br>views. | AutoStrain RV<br>combines the<br>functionality of 2D<br>CPA and the<br>technology of<br>AutoSTRAIN (for<br>LV) cleared under<br>K150122 to provide<br>an easy RV strain | {8}------------------------------------------------ | | Philips Ultrasound, Inc. | | |--|--------------------------|--| |--|--------------------------|--| ## Traditional 510(k) QLAB Advanced Quantification Software Modifications | | | strains, strain rates<br>are derived. | | solution for user<br>convenience. | |--------------------------------------------------------------|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Speckle Tracking<br>of the ROI per<br>frame | Option not available<br>for RV chamber | A Speckle tracking<br>algorithm tracks the<br>ROI of the wall<br>motion per frame.<br>User is able to edit<br>the ROI after<br>tracking. | Similar speckle<br>tracking algorithm<br>tracks the ROI of<br>the wall motion<br>per frame. User is<br>able to edit the<br>ROI after<br>tracking. | Speckle tracking<br>technology used for<br>TomTec-Arena 2D<br>CPA and<br>AutoSTRAIN (for<br>LV) has been<br>adapted for the right<br>ventricular chamber<br>for AutoStrain RV | | Calculation of<br>global strain<br>analysis from<br>one view | Option not available<br>for RV chamber | RV global Strain and<br>Freewall strain is<br>calculated based on<br>the tracked contour | Same as 2D CPA on TomTec-Arena | | ### Summary of changes documented via Letter to File since QLAB 11.0 release (K181264) | Feature/<br>Modification<br>incorporated in QLAB<br>software since QLAB<br>11.0 release | Feature / Modification | |-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | QLAB 12.0 | Integrate the currently marketed TomTec-Arena AutoSTRAIN (for Left Ventricle)<br>application (cleared under K150122) on the Philips QLAB platform.<br><br>Application description:<br>AutoSTRAIN is a quantification tool of global and regional function based on<br>contour detection and tracking. The tool automatically quantifies global and<br>regional strain based on apical 4-chamber, 3-chamber and 2-chamber views of the<br>left ventricle | | QLAB 13.0 | Integrate the currently marketed TomTec-Arena Mitral Valve Assessment (4D<br>MVA) application (cleared under K150122) on the Philips QLAB platform.<br><br>Application description:<br>The 4D MVA provides a morphological and functional analysis of mitral valves for<br>3D loops. The application generates models of anatomical structures such as MV<br>annulus, leaflets, and the<br>closure line. | QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems. The modifications to the currently marketed QLAB do not affect the safety and efficacy of the proposed QLAB {9}------------------------------------------------ 13.0 Advanced Quantification Software with AutoStrain LV, AutoStrain LA, AutoStrain RV clinical applications. #### 7) Determination of Substantial Equivalence #### Non-clinical performance data No performance standards for PACS systems or components have been issued under the authority of Section 514. The QLAB 13.0 modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB 13.0 software relative to the currently marketed unmodified QLAB software. Design Control activities to assure the safe and effective performance of the modified Q-Apps included but not limited to the following: - Requirements Review ● - . Design Review - . Risk Management - . Software Verification and Validation Software Verification and Validation testing were used to support substantial equivalence of the modified QLAB 13.0 to the predicate device. #### Summary of Clinical Tests QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing. #### 8) Conclusions Software Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of the modified QLAB software with respect to the predicate were performed. Testing performed demonstrated that the proposed QLAB 13.0 Advanced Quantification Software meets defined requirements. #### 514 Performance Standards There are no Sec. 514 performance standards for this device. #### Prescription Status This is a prescription device. The prescription device statement appears in the labeling. #### Sterilization Site(s) Not applicable. QLAB Advanced Quantification is a software only device.