Who is the manufacturer of QLAB Advanced Quantification Software?

Philips Health Care filed the 510(k) submission for QLAB Advanced Quantification Software (K191647).

What is the FDA product code for QLAB Advanced Quantification Software?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for QLAB Advanced Quantification Software?

510(k) clearance (submission type: Traditional).

Does QLAB Advanced Quantification Software use AI or machine learning?

Yes. QLAB Advanced Quantification Software (K191647) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like QLAB Advanced Quantification Software?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like QLAB Advanced Quantification Software get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

QLAB Advanced Quantification Software

Q: What are the predicate devices for QLAB Advanced Quantification Software?

QLAB Advanced Quantification Software (K181264).

K191647 · Philips Health Care · QIH · Dec 20, 2019 · Radiology

Device Facts

Record ID	K191647
Device Name	QLAB Advanced Quantification Software
Applicant	Philips Health Care
Product Code	QIH · Radiology
Decision Date	Dec 20, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

Device Story

QLAB Advanced Quantification Software 13.0 is a software application for viewing and quantifying ultrasound image data. It operates on standard PCs, dedicated workstations, or on-board Philips ultrasound systems. The device features a '3D Auto RV' application that integrates the segmentation engine from the QLAB HeartModel with the TomTec-Arena 4D RV-function algorithm. It uses machine learning to automatically identify endocardial contours of the right ventricle (RV) to generate 3D surface models. Clinicians review, edit, or accept these contours via a tracking revision screen. The output includes RV distance measurements, fractional area change, volumes (EDV, ESV), and ejection fraction. By automating RV border placement, the device assists physicians in assessing cardiac function, potentially improving workflow efficiency and reproducibility in diagnosing right ventricular conditions.

Clinical Evidence

No clinical testing conducted. Performance supported by bench testing and a validation study comparing 3D Auto RV to the predicate 4D RV and cross-modality CMR. Validation results showed RV end-diastolic volume error rates <15%. RMSE analysis: 8.3 ml for end-diastolic volume, 2.7 ml for end-systolic volume, and 2.7% for RV ejection fraction. External study published in the Journal of the American Society of Echocardiography confirmed accurate, reproducible quantification with <15% difference from CMR measurements.

Technological Characteristics

Software-only application. Utilizes machine learning algorithms for automated segmentation of cardiac structures. Operates on standard PC, workstation, or ultrasound system hardware. Connectivity via integration with Philips ultrasound systems. No sterilization required.

Indications for Use

Indicated for patients with suspected cardiovascular disease requiring quantification and reporting of cardiovascular structures and function to support physician diagnosis.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

QLAB Advanced Quantification Software (K181264)

Reference Devices

TomTec-Arena TTA2 (K150122)

Related Devices

K130159 — QLAB QUANTIFICATION SOFTWARE HEART MODEL · Philips Health Care · May 13, 2013
K200974 — QLAB Advanced Quantification Software · Philips Health Care · Jun 3, 2020
K223322 — Argus Cognitive ReVISION Software · Argus Cognitive, Inc. · Jul 24, 2023
K190913 — QLAB Advanced Quantification Software 13 · Philips Health Care · Jun 18, 2019
K171314 — QLAB Advanced Quantification Software · Philips Health Care · May 30, 2017

Submission Summary (Full Text)

{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: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. Philips Healthcare Eri Gremi Philips Ultrasound Inc. 3000 Minuteman Road Andover, MA 01810-6302 Re: K191647 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: QIH Dated: November 22, 2019 Received: November 25, 2019 Dear Eri Gremi: 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. 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 December 20, 2019 {1}------------------------------------------------ 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 (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 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) K191647 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) |--|--| 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 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: | Eri Gremi | |------------------|--------------------------------| | | Philips Ultrasound, Inc. | | | 3000 Minuteman Road | | | Andover, MA 01810-6302 | | | Email: erdit.gremi@philips.com | | | Tel: (978) 659-2980 | | | Fax: (978) 975-7324 | Date prepared: November 22 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: | QIH, Class II | 3) Substantially Equivalent Devices | Primary Predicate Device | | | |---------------------------------------|---------|-------------------| | QLAB Advanced Quantification Software | K181264 | June 7, 2018 | | Reference Device | | | | 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 K181264. 4) Device Description {4}------------------------------------------------ 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' ultrasound systems. The subject QLAB 3D Auto RV application integrates the segmentation engine of the cleared QLAB HeartModel (K181264) and the TomTec-Arena 4D RV-function (cleared under K150122) thereby providing a dynamic Right Ventricle clinical functionality. The proposed 3D Auto RV application is based on the automatic segmentation technology of HeartModel applied to the Right Ventricle, and uses machine learning algorithms to identify the endocardial contours of the Right Ventricle. 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 devices. A comparison of the proposed OLAB 3D Auto RV application to the currently marketed predicate device (QLAB) and reference device (TomTec-Arena TTA2) are provided in the tables below: | Feature | Currently Marketed Predicate QLAB (Predicate Device - K181264) | Currently Marketed Reference TomTec-Arena TTA2 (Reference Device - K150122) | Proposed QLAB 3D Auto RV (Modified Device) | Explanation of Differences | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------| | Indication for Use | QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems. | Indications for use of TomTec-Arena TTA2 software are quantification and reporting of cardiovascular, fetal, abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis | Same as QLAB (K181264) | Not applicable | {5}------------------------------------------------ | | Philips Ultrasound, Inc. | | |--|--------------------------|--| |--|--------------------------|--| # Traditional 510(k) QLAB Advanced Quantification Software | Feature | Currently Marketed Predicate QLAB HeartModel (K181264) | Currently Marketed Reference TomTec- Arena TTA2 4D RV (Reference Device - K150122) | Proposed QLAB 3D Auto RV (Modified Device) | Explanation of Differences | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Application description | The HeartModel provides semi-automatic 3D anatomical border detection and identification of the heart chambers for the end- diastole (ED) and end- systole (ES) cardiac phases. | The TOMTEC ARENA 4D RV- Function provides a morphological and functional assessment of the right ventricle based on a surface model of the RV. | The 3D Auto RV Q-App is an integration of the segmentation engine of the QLAB HeartModel and the TomTec-Arena 4D RV-Function thereby providing a dynamic Right Ventricle clinical functionality. | Integrates HeartModel auto-segmentation technology with TomTec Arena's 4D- RV algorithm for RV border placement. | | Quantification Technology of RV | Semi-automatic border detection and identification of LV and LA chambers | Functional assessment of RV based on a RV surface model. | Integrates HeartModel auto-segmentation technology with TomTec Arena's 4D-RV algorithm for RV border placement | Anatomical enhancement by Right Ventricle | | 2D RV measurement parameters | No RV parameters | ■ RVDd base (RVD1): Right Ventricle Distance base (mm) ■ RVDd mid (RVD2): Right Ventricle Distance medial (mm) ■ RVLd (RVD3): Right Ventricle Distance Longitudinal (mm) ■ TAPSE: Tricuspid annular plane systolic excursion (mm) ■ FAC: Fractional area change (%) ■ RVLS (free wall): right ventricular longitudinal strain (free wall) (%) ■ RVLS (Septum): right ventricular longitudinal strain (septum) (%) | ■ RVDd base (RVD1): Right Ventricle Distance base (mm) ■ RVDd mid (RVD2): Right Ventricle Distance medial (mm) ■ RVLd (RVD3): Right Ventricle Distance Longitudinal (mm) ■ TAPSE: Tricuspid annular plane systolic excursion (mm) ■ FAC: Fractional area change (%) ■ RVLS (free wall): right ventricular longitudinal strain (free wall) (%) ■ RVLS (Septum): right ventricular longitudinal strain (septum) (%) | Identical to 4D RV predicate | | 2D RV calculated parameters | No RV parameters | ■ Global strain ■ TAPSE: MMode measurement for movement of TV | ■ Global strain ■ TAPSE: MMode measurement for movement of TV | Identical to 4D RV predicate | | | | | | | | 3D RV measurement parameters | No RV parameters | ■ RV distance measurements: 3 distance measurements in the RV A4C in ED. ■ RVD1: maximal short-axis dimension in the basal one third of the right ventricle ■ RVD2: distance is measured on 50% of RVLd (RVD3) and parallel to the RVD1 ■ RVD3: base-apex length ■ Fractional area change (FAC) | ■ RV distance measurements: 3 distance measurements in the RV A4C in ED. ■ RVD1: maximal short- axis dimension in the basal one third of the right ventricle ■ RVD2: distance is measured on 50% of RVLd (RVD3) and parallel to the RVD1 ■ RVD3: base-apex length ■ Fractional area change (FAC) | EDV measurement includes semi- automatic function introduced in 3DAutoRV. All other measurements identical to 4D RV predicate. | | 3D RV measurement parameters | No RV parameters | ■ EDV: End-diastolic Volume ■ EDVI: End-diastolic Volume Index ■ ESV: End-systolic Volume ■ ESVI: End-systolic Volume Index ■ SV: Stroke Volume ■ EF: Ejection Fraction | ■ EDV: End-diastolic Volume ■ EDVI: End-diastolic Volume Index ■ ESV: End-systolic Volume ■ ESVI: End-systolic Volume Index ■ SV: Stroke Volume ■ EF: Ejection Fraction | EDV measurement includes semi- automatic function introduced in 3DAutoRV. All other measurements identical to 4D RV predicate. | | 3D RV calculated parameters | No RV parameters | ■ EF: Ejection Fraction ■ SV: Stroke Volume | ■ EF: Ejection Fraction ■ SV: Stroke Volume | Identical to 4D RV predicate | | Contour Generation | 3D surface model is created semi- automatically without user interaction. User is required to edit, accept or reject the contours | 3D surface model is created based on user defined anatomical landmarks. User is able to edit the contour of the surface model. | 3D surface model is created semi- automatically using machine learning algorithms without user interaction. User is able to edit, accept or reject the contours or the anatomical landmarks. | Workflow improvements for user convenience. Algorithm Training procedure is same between the subject and the predicate HeartModel, except that the algorithm is applied to LV in HeartModel, while to RV in subject 3D auto RV. | {6}------------------------------------------------ | | Philips Ultrasound, Inc. | | |--|--------------------------|--| |--|--------------------------|--| {7}------------------------------------------------ #### 7) Determination of Substantial Equivalence #### Non-clinical performance data 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 Non-clinical V&V testing also included the Machine Learning Algorithm Training and the subsequent Validation Study performed for the proposed 3D Auto RV clinical applications. Software Verification and Validation testing were used to support substantial equivalence of the modified QLAB 13.0 to the predicate device. The results of a validation study show that the overall performance of the 3D Auto RV software generates RV end diastolic volume error rates below 15% for every data set tested compared to the predicate 4D RV. A root mean square error (RMSE) analysis showed that in comparison to the predicate 4D RV, 3D Auto RV measured end diastolic RV volumes with 8.3 ml RMSE, end systolic RV volumes with 2.7 ml RMSE, and RV ejection fraction with 2.7% RMSE. Test datasets were segregated from training data sets. The results of the validation show that when used as intended, the healthcare professional was able to successfully determine which contours required revision and was capable of revising in the "tracking revision" screen prior to accepting the measurements for a report to create accurate measurements of the RV volume. An external study published in the Journal of the American Society of Echocardiography which concludes that 3D Auto RV provides an accurate and highly reproducible quantification not needing any revision in one-third of patients and needing only minor revisions in the rest of patients. The users were able to discern the patients images which needed manual editing on all cases. Ground truth in this study was considered to be the crossmodality CMR. 3D Auto RV results all showed less than 15% difference from the CMR measurements of RV volume. #### Summary of Clinical Tests No clinical testing conducted in support of substantial equivalence. #### 514 Performance Standards There are no Sec. 514 performance standards for this device. {8}------------------------------------------------ #### Prescription Status This is a prescription device. The prescription device statement appears in the labeling. #### Sterilization Not applicable. QLAB Advanced Quantification is a software only device. #### 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 and performance claims. Therefore, Philips concludes that the subject device is substantially equivalent to the predicate in terms of safety and effectiveness.