(71 days)
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems
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. 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 provided document describes the FDA 510(k) clearance for Philips Healthcare's QLAB Advanced Quantification Software 13.0, primarily focusing on its substantial equivalence to previously cleared predicate devices. The modifications in QLAB 13.0 involve integrating existing TomTec-Arena applications (AutoSTRAIN LV, AutoSTRAIN LA, AutoSTRAIN RV) into the Philips QLAB platform.
However, the document does not contain specific details about acceptance criteria or a dedicated study design that proves the device meets specific performance criteria. Instead, it relies on the concept of substantial equivalence to predicate devices that have already undergone prior clearance.
Based on the information provided, here's what can be extracted and what is missing:
Key Takeaways from the Document:
- Device: QLAB Advanced Quantification Software 13.0
- Purpose: To view and quantify image data acquired on Philips ultrasound systems.
- Modifications: Integration of AutoStrain LV, LA, and RV modules from TomTec-Arena (previously cleared under K150122) with "workflow improvements."
- Regulatory Pathway: 510(k) premarket notification, based on substantial equivalence.
- Clinical Testing: "QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing." This explicitly states that no new clinical study was performed for this specific 510(k) submission.
- Performance Data: Relies on "Verification and software validation data" and "Design Control activities" (Requirements Review, Design Review, Risk Management, Software Verification and Validation) to support substantial equivalence.
Therefore, it's not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study (with the specified details) was explicitly stated as not required and not performed for this 510(k) submission.
The document justifies its clearance based on the following:
- The new functionalities (AutoStrain LV, LA, RV) are derived from applications (TomTec-Arena AutoSTRAIN and 2D CPA) that were already cleared under K150122.
- The current modifications primarily focus on integrating these existing functionalities into the QLAB platform and making "workflow improvements."
- The intended use remains the same as the predicate device.
- The manufacturer performed non-clinical performance testing including software verification and validation, design control activities, and risk management to ensure the modified software performs safely and effectively relative to the predicate device and meets defined requirements.
If a hypothetical scenario were to involve a new device or a significant change requiring a de novo clearance or a more involved 510(k) where clinical performance needed to be demonstrated, the requested information would be crucial. However, for this specific 510(k) for QLAB 13.0, the provided document indicates that the performance evaluation was based on demonstrating equivalence, not on new clinical performance studies with acceptance criteria for the new features.
To answer your prompt directly, given the provided text, the answer to most of your questions is that this information is not present because a new comparative effectiveness study or standalone performance study with new ground truth establishment was explicitly deemed unnecessary due to the nature of the submission (integration of already cleared components and "workflow improvements").
Here's a breakdown of the requested information, indicating what is not available from this document due to the nature of the 510(k) submission:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided document. The submission relies on substantial equivalence to predicate devices, not on demonstrating new performance against defined acceptance criteria for the integrated features. The document states: "QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided document. No specific clinical test set data is described for QLAB 13.0. The "Verification and software validation data" mentioned are non-clinical, likely internal testing using synthetic data, simulated data, or existing clinical data from the development of the predicate/reference devices, but details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in the provided document. No new ground truth establishment process is described for QLAB 13.0 as no new clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided document. No new clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not available in the provided document, and explicitly stated as not required/done. The document explicitly states: "QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing." Therefore, no MRMC study was performed as part of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available in the provided document. Similarly, no new standalone performance study for the integrated algorithms is described beyond the assertion that the underlying algorithms (from K150122) were previously cleared.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in the provided document. As no new clinical study requiring ground truth was conducted for QLAB 13.0, this information is not provided. The ground truth for the original cleared components (TomTec-Arena AutoSTRAIN and 2D CPA) would have been established at their time of clearance (K150122), but those details are not in this document.
8. The sample size for the training set
- Not available in the provided document. This document describes a 510(k) clearance for a software update integrating existing, cleared algorithms. It doesn't detail the training data for the original development of those algorithms.
9. How the ground truth for the training set was established
- Not available in the provided document. (See point 8).
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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. 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
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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□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
- 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
- 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'
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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.
- 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:
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Philips Ultrasound, Inc.
Traditional 510(k) QLAB Advanced Quantification Software Modifications
| Feature | Currently MarketedPredicate QLAB(Predicate Device -K181264) | CurrentlyMarketedReference TomTec-Arena TTA2(Reference Device -K150122) | Proposed QLABAutoStrain LV,LA, RV(ModifiedDevice) | Explanation ofDifferences |
|---|---|---|---|---|
| Indication forUse | QLAB Quantificationsoftware is a softwareapplication package. Itis designed to view andquantify image dataacquired on Philipsultrasound systems. | Indications for use ofTomTec-ArenaTTA2 software arequantification andreporting ofcardiovascular, fetal,abdominal structuresand function ofpatients withsuspected disease tosupport thephysicians in thediagnosis | Same as QLAB(K181264) | Not applicable |
AutoStrain LV
| Feature | Currently MarketedPredicate QLABAuto Cardiac MotionQuantification(aCMQ)(K181264) | CurrentlyMarketedReference TomTec-Arena TTA2AutoSTRAIN(Reference Device -K150122) | Proposed QLABAutoStrain LV(ModifiedDevice) | Explanation ofDifferences |
|---|---|---|---|---|
| Applicationdescription | aCMQ provides anangle-independentanalysis of regionalmyocardial-tissuevelocity, displacement,strain, and strain rate,using the speckletracking technology. Itgeneratesmeasurements of theglobal and regionalfunctions of the leftventricle. | AutoSTRAIN is aquantification tool ofglobal and regionalfunction based oncontour detection andtracking. The toolautomaticallyquantifies global andregional strain basedon apical 4-chamber,3-chamber and 2-chamber views of theleft ventricle. | Same asAutoSTRAIN onTOMTEC-ARENA | Reason for change:AutoStrain LVfunctionality enablesa simplifiedworkflow whencompared to QLABaCMQ (originallycleared underK132165) |
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| Philips Ultrasound, Inc. | ||
|---|---|---|
| -- | -------------------------- | -- |
Traditional 510(k) QLAB Advanced Quantification Software Modifications
| Speckle Trackingof the ROI perframe | Comparable featureavailable | Automatically tracksthe ROI of the wallmotion per frameusing speckletracking technology.User is able to editthe ROI aftertracking. | Same as AutoSTRAIN on TomTec-Arena. | |
|---|---|---|---|---|
| Automatic viewrecognition todetect chamberviews | Manual view selectionto detect chamberview. | Manual viewselection to detectchamber view. | The applicationuses viewrecognition toautomaticallyassign labels. Theuser is able tooverwrite theautomaticassignation oflabels. | Workflow simplifiedon QLAB for userconvenience |
| Calculation ofGLS from threeviews (globalstrain analysis) | Same calculationavailable | GLS is calculatedbased on the Trackedcontours per viewand as averageaccording to thelength-of-linemethod | Same as AutoSTRAIN on TomTec-Arena. |
AutoStrain LA
| Feature | Currently MarketedPredicate QLAB(K181264) | CurrentlyMarketedReference TomTec-Arena TTA22D CardiacPerformanceAnalysis - 2D CPA(Reference Device -K150122) | Proposed QLABAutoStrain LA(ModifiedDevice) | Explanation ofDifferences |
|---|---|---|---|---|
| Applicationdescription | Strain quantification ofLA chamber is notavailable on QLAB | 2D CPA speckletracking algorithmsupports thecalculation of 2D -contour models ofthe endocardial of theLA. Corresponding | The AutoStrainLA provides leftatrial strainmeasurementsfrom apical four-chamber (A4C). | AutoStrain LAcombines thefunctionality of 2DCPA and thetechnology ofAutoSTRAIN (forLV) cleared under |
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| Philips Ultrasound, Inc. | ||
|---|---|---|
| -- | -------------------------- | -- |
Traditional 510(k) QLAB Advanced Quantification Software
| Speckle Trackingof the ROI perframe | Option not availablefor LA chamber | velocities,displacements,strains, strain ratesand functionalparameters can bederived | A Speckle trackingalgorithm tracks theROI of the wallmotion per frame.User is able to editthe ROI aftertracking. | K150122 to providean easy LA strainsolution for userconvenience. | Speckle trackingtechnology used forTomTec-Arena 2DCPA andAutoSTRAIN (forLV) has beenadapted for the leftatrial chamber forAutoStrain LA |
|---|---|---|---|---|---|
| Calculation ofglobal strainanalysis fromone view | Option not availablefor LA chamber | Left Atrial Strain iscalculated based onthe tracked contour | Same as 2D CPA. Additionally, conduitand contraction Strain is calculated. |
AutoStrain RV
| Feature | Currently MarketedPredicate QLAB(K181264) | CurrentlyMarketedReference TomTec-Arena TTA22D CardiacPerformanceAnalysis - 2D CPA(Reference Device -K150122) | Proposed QLABAutoStrain RV(ModifiedDevice) | Explanation ofDifferences |
|---|---|---|---|---|
| Applicationdescription | Strain quantification ofRV chamber is notavailable on QLAB | 2D CPA speckletracking algorithmsupports thecalculation of 2D -contour models ofthe endocardialborder of the RV.Correspondingvelocities,displacements. | The AutoStrainRV provides rightventricle strainmeasurementsfrom apical four-chamber (A4C)views. | AutoStrain RVcombines thefunctionality of 2DCPA and thetechnology ofAutoSTRAIN (forLV) cleared underK150122 to providean easy RV strain |
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| Philips Ultrasound, Inc. | ||
|---|---|---|
| -- | -------------------------- | -- |
Traditional 510(k) QLAB Advanced Quantification Software Modifications
| strains, strain ratesare derived. | solution for userconvenience. | |||
|---|---|---|---|---|
| Speckle Trackingof the ROI perframe | Option not availablefor RV chamber | A Speckle trackingalgorithm tracks theROI of the wallmotion per frame.User is able to editthe ROI aftertracking. | Similar speckletracking algorithmtracks the ROI ofthe wall motionper frame. User isable to edit theROI aftertracking. | Speckle trackingtechnology used forTomTec-Arena 2DCPA andAutoSTRAIN (forLV) has beenadapted for the rightventricular chamberfor AutoStrain RV |
| Calculation ofglobal strainanalysis fromone view | Option not availablefor RV chamber | RV global Strain andFreewall strain iscalculated based onthe tracked contour | Same as 2D CPA on TomTec-Arena |
Summary of changes documented via Letter to File since QLAB 11.0 release (K181264)
| Feature/Modificationincorporated in QLABsoftware since QLAB11.0 release | Feature / Modification |
|---|---|
| QLAB 12.0 | Integrate the currently marketed TomTec-Arena AutoSTRAIN (for Left Ventricle)application (cleared under K150122) on the Philips QLAB platform.Application description:AutoSTRAIN is a quantification tool of global and regional function based oncontour detection and tracking. The tool automatically quantifies global andregional strain based on apical 4-chamber, 3-chamber and 2-chamber views of theleft ventricle |
| QLAB 13.0 | Integrate the currently marketed TomTec-Arena Mitral Valve Assessment (4DMVA) application (cleared under K150122) on the Philips QLAB platform.Application description:The 4D MVA provides a morphological and functional analysis of mitral valves for3D loops. The application generates models of anatomical structures such as MVannulus, leaflets, and theclosure 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
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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.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).