(183 days)
Yes
The device description explicitly states that the proposed 3D Auto RV application "uses machine learning algorithms to identify the endocardial contours of the Right Ventricle."
No.
The device is a software for viewing and quantifying image data, described as an "Advanced Quantification Software." It does not directly treat or prevent a disease, but rather provides information for diagnosis and monitoring.
Yes.
Explanation: The device is designed to view and quantify image data acquired from ultrasound systems, specifically applying machine learning algorithms to identify endocardial contours of the Right Ventricle, and providing quantitative results like volume error rates and RMSE, which are used to assess the state of the heart.
Yes
The device is described as a "software application package" and "software" that functions on standard PCs, workstations, and on-board ultrasound systems. While it processes data from ultrasound systems, the device itself is the software component for viewing and quantifying that data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "view and quantify image data acquired on Philips ultrasound systems." This is focused on analyzing medical images, not on testing samples taken from the human body (like blood, urine, tissue, etc.) to diagnose or monitor a condition.
- Device Description: The description reinforces that it's a software application for viewing and quantifying image data.
- Input Imaging Modality: The input is Ultrasound, which is an imaging technique, not a method for analyzing biological samples.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This software operates on medical images, which falls under the category of medical imaging software or image analysis software, not IVD.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / 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.
Product codes
QIH
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' 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
ultrasound
Anatomical Site
Right Ventricle, cardiovascular, heart chambers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Test datasets were segregated from training data sets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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. 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 cross-modality CMR. 3D Auto RV results all showed less than 15% difference from the CMR measurements of RV volume.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
RV end diastolic volume error rates below 15%
8.3 ml RMSE (end diastolic RV volumes)
2.7 ml RMSE (end systolic RV volumes)
2.7% RMSE (RV ejection fraction)
Less than 15% difference from the CMR measurements of RV volume.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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: | 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
- 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 |
- 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.
- 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.
- 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.
- 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.