QLAB Advanced Quantification Software

{0}------------------------------------------------ June 3, 2020 Image /page/0/Picture/1 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 text on the right. The symbol is a stylized depiction of a human figure, and the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The logo is simple and professional, and it is easily recognizable. Philips Healthcare % Travis Catania Senior Regulatory Affairs Specialist 22100 Bothell Everett Highway BOTHELL WA 98021 Re: K200974 Trade/Device Name: OLAB Advanced Ouantification Software System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH Dated: April 10, 2020 Received: April 13, 2020 Dear Travis Catania: 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/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 medical devices and radiation-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, Michael D. O'Hara 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) K200974 Device Name QLAB Advanced Quantification Software System 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) | | |------------------------------------------------------------------------------|----------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON SEPARATE PAGE/ME # 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}------------------------------------------------ Philips Ultrasound, Inc. Traditional 510(k) QLAB Advanced Quantification Software System Modifications Page 1 of 8 # Section 8: 510(k) Summary {4}------------------------------------------------ Philips Ultrasound, Inc. Traditional 510(k) QLAB Advanced Quantification Software System Modifications # Philips QLAB Advanced Quantification Software System This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92 #### Submitter's name, address, telephone number, contact person 1. | Sponsor: | Philips Ultrasound, Inc.<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Travis Catania<br>Senior Regulatory Affairs Specialist<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431<br>Phone: (908) 227-9423<br>Fax: 425-402-3481 | | Secondary Contact: | Hebe Sun<br>Senior Manager, Regulatory Affairs | | Date Prepared: | April 10, 2020 | | Proprietary Name: | QLAB Advanced Quantification Software System | |-------------------|--------------------------------------------------------------------------------------------------| | Common Name: | QLAB Advanced Quantification Software System<br>Automated Radiological Image Processing Software | ### Regulation Description: | Classification Description | 21 CFR Section | Product Code | |--------------------------------------------------|----------------|--------------| | Automated Radiological Image Processing Software | 892.2050 | QIH | As stated in 21 CFR, part 892.2050, each of the generic types of devices that meet this classification description have been classified as Class II. #### Device Class: Class II #### Indications for Use ന് {5}------------------------------------------------ Philips Ultrasound, Inc. Traditional 510(k) QLAB Advanced Quantification Software System Modifications QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound system. #### 4. Device Description The Philips QLAB Advanced Quantification Software System (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' ultrasound systems. The purpose of this Traditional 510(K) Pre-market Notification is to introduce a new to introduce the new 3D Auto MV cardiac quantification application to the Philips QLAB Advanced Quantification Software, which was most recently cleared under K191647. The latest QLAB software version (launching at version 15.0) will include the new Q-App 3D Auto MV, which integrates the segmentation engine of the cleared QLAB HeartModel Q-App (K181264) and the TomTec-Arena 4D MV Assessment application (K150122) thereby providing a dynamic Mitral Valve clinical quantification tool. #### ம் Substantially Equivalent Devices # Primary Predicate Device Philips QLAB Advanced Quantification Software System K191647 December 20, 2019 Reference Predicate Device TomTec Imaging Systems, GmbH TOMTEC-Arena TTA2 K150122 February 13, 2015 #### 6. Technological Comparison to Predicate Devices The QLAB Advanced Quantification Software System with the addition of the new Q-App entitled 3D Auto MV application has the same intended use and similar technological characteristics as the legally marketed primary QLAB System predicate device. A comparison of the proposed QLAB System (including 3D Auto MV application) to the currently marketed predicate OLAB System device and the reference predicate TomTec Imaging System TTA2 (4D MV Assessment application) are provided in the table below: {6}------------------------------------------------ | 7 | | |------|--| | L | | | | | | 009. | | | | | | | | | K2 | | | | | | | | | | | LAB Advanced Quantification Softwar LAB Advanced Quantification Software System Modifications ilips Ultrasound, In Page 4 of 8 # Table 1 Comparison of the proposed Philips QLAB System to the currently marketed and predicate devices: Philips QLAB System and TomTec Imaging Systems TTA2 System | | Subject Device | Predicate Device | Reference Predicate Device | Explanation of Differences | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Philips Ultrasound, Inc. | Philips Ultrasound, Inc. | TOMTEC Imaging Systems, GmbH | None | | Trade Name | QLAB System | QLAB System | Arena TTA2 | None | | Feature | 3D Auto MV | HeartModel | 4D MV-Assessment | None | | 510(k) Number | Pending | K191647 | K150122 | None | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Regulation Number,<br>Regulation Name,<br>Classification, and Product<br>Code are identical between<br>subject device and primary<br>predicate device. | | Regulation Name | Automated Radiological Image<br>Processing Software | Automated Radiological Image<br>Processing Software | System, Image processing,<br>Radiological - Picture Archiving and<br>Communications System (PACS) | | | Classification | Class II | Class II | Class II | | | Product Code(s) | QIH | QIH | LLZ | | | Indications for Use | QLAB Quantification software is a<br>software application package. It is<br>designed to view and quantify image<br>data acquired on Philips ultrasound<br>systems. | QLAB Quantification software is a<br>software application package. It is<br>designed to view and quantify<br>image data acquired on Philips<br>ultrasound systems. | Indications for use of TOMTEC-Arena<br>software are quantification and<br>reporting of cardiovascular, fetal, and<br>abdominal structures and function of<br>patients with suspected disease to<br>support the physicians in the<br>diagnosis. | The Indications for Use of<br>the subject QLAB System<br>and the primary predicate<br>QLAB System are identical<br>and have not been changed<br>from the previous clearance<br>of this system. The Philips<br>QLAB and TOMTEC Arena<br>TTA2 Systems are similar in<br>regards to image display<br>and quantification purposes<br>to the end user. | | System Components | Software only system | Software only system | Software only system | The System Components of<br>the subject QLAB System<br>and predicate devices<br>identified are identical as all<br>devices are software only | ಳ {7}------------------------------------------------ # ilips Ultrasound, In LAB Advanced Quantification Software LAB Advanced Quantification Software System Modifications Page 5 of 8 | Software<br>Design | Application<br>Description | Quantification<br>Technology of<br>the MV | Contour<br>Generation | systems. | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The 3D Auto MV Q-App is a semi-automatic tool that essentially is an integration of the machine-learning derived segmentation engine of the QLAB HeartModel and the TOMTEC-Arena TTA2 4D MV-Assessment application thereby providing a dynamic Mitral Valve clinical quantification tool. | Integrates the Heartmodel auto-segmentation technology with TOMTEC Arena TTA2 4D MV-Assessment algorithm for initial landmark identification and MV quantification. | 3D surface model is created semi-automatically using machine learning algorithm without user interaction. User is able to edit, accept, or reject the initial landmark proposals of the mitral valve anatomical locations. | The subject 3D Auto MV Q-App combines the HeartModel auto-segmentation technology with TOMTEC Arena TTA2 4D MV-Assessment application in order to provide initial mitral valve landmark proposals to the end user followed by reporting mitral valve measurements to the user. | | | The HeartModel Q-App provides a semi-automatic 3D anatomical border detection and identification of the heart chambers for the end-diastole (ED) and end-systole (ES) cardiac phases. | Semi-automatic border detection and identification of heart chambers. | 3D surface model is created semi-automatically without user interaction. User is required to edit, accept, or reject the contours before proceeding with the workflow. | The subject 3D Auto MV application integrates the semi-automatic border detection functionality of HeartModel and the functional mitral valve assessment measures of 4D MV-Assessment to provide a comprehensive MV assessment tool. | | | The TOMTEC Arena TTA2 4D MV-Assessment application provides a morphological and functional assessment of the mitral valve based on a surface model of the mitral valve anatomy. | Functional assessment of the mitral valve based on an MV surface model. | 3D surface model is created based on user defined anatomical landmarks. User is able to edit the contour of the surface model before proceeding with the workflow. | Workflow improvements for user convenience in initial model display and landmark proposal. Algorithm Training procedures is the same between the subject 3D Auto MV and the predicate HeartModel, with the exception being that the algorithm is being applied to the LV in Heartmodel, while | ம {8}------------------------------------------------ # nilips Ultrasound, Inc LAB Advanced Quantification Software LAB Advanced Quantification Software System Modifications Page 6 of 8 {9}------------------------------------------------ ilips Ultrasound, In Page 7 of 8 | | 3D MV<br>Parameters | No 3D mitral valve (MV) quantification parameters included as part of this application. | Assessment application.<br>The 3D Auto MV application introduces the Total Open Area measurement as an additional measure to further define the mitral valve anatomy. All other measurements are identical to the predicate 4D MV-Assessment application. | |--|------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | *Saddle Shaped Annulus Area<br>(cm²) | *Saddle Shaped Annulus Area<br>(cm²) | | | | *Saddle Shaped Annulus Perimeter<br>(cm) | *Saddle Shaped Annulus Perimeter<br>(cm) | | | | *Total Open Coaptation Area (cm²) | | | | | *Anterior Closure Line Length (cm) | *Anterior Closure Line Length (cm) | | | | *Posterior Closure Line Length<br>(cm) | *Posterior Closure Line Length<br>(cm) | | {10}------------------------------------------------ Philips Ultrasound, Inc. Traditional 510(k) QLAB Advanced Quantification Software System Modifications # 7. Non-Clinical Testing The proposed modifications (the introduction of the 3D Auto MV application) to the subject Philips QLAB Advanced Quantification Software System were tested in accordance with Philips internal processes. Verification and software validation test data are provided to support the latest QLAB software release (QLAB 15.0) relative to the currently marketed unmodified OLAB software. Design Control activities to assure the safe and effective performance of the modified QLAB System Q-App include but are not limited to the following: - O Requirements Review - Risk Analysis and Management O - Product Specifications O - Design Reviews O - O Software Verification and Validation Non-clinical V&V testing also included the 3D Auto MV Algorithm Training and the subsequent Validation Study performed for the proposed 3D Auto MV clinical application. Software Verification and Validation testing were used to support substantial equivalence of the modified QLAB software release version 15.0 (specifically the 3D Auto MV application) to the predicate QLAB software release version 13.0 device. #### 8. Clinical Testing The subject Philips QLAB Advanced Quantification Software System did not require clinical data in order to make a determination for substantial equivalence when compared to the predicate device(s). #### 9. Conclusion Based on the conformance to standards, development under Philips Ultrasound's Quality Management System, the successful verification and validation testing, Philips Ultrasound believes that the proposed Philips QLAB Advanced Quantification Software System is substantially equivalent to the predicate device Philips QLAB System (K191647) and TomTec Imaging Systems TTA2 (150122). Testing performed demonstrated that the proposed QLAB System with the 3D Auto MV application meets the defined requirements and performance claims.