(71 days)
No
The document describes image processing and quantification software but does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development.
No.
The device is described as software for viewing and quantifying image data from ultrasound systems, used for off-line review and quantification, not for treating or diagnosing a condition.
Yes
The device is designed to "view and quantify image data" from ultrasound systems, and "quantification" of medical images is a common step in diagnostic processes to extract meaningful clinical information for diagnosis.
Yes
The device is described as a "software application package" and "software" that functions on standard PCs, dedicated workstations, and on-board ultrasound systems, with no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "view and quantify image data acquired on Philips ultrasound systems." This describes a tool for analyzing medical images, not for performing tests on biological samples (like blood, urine, or tissue) to diagnose or monitor a disease.
- Device Description: The description reinforces that it's a software application for reviewing and quantifying ultrasound studies. It doesn't mention any interaction with biological specimens or reagents.
- Input Imaging Modality: The input is ultrasound images, which are generated by a medical imaging device, not from a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on the analysis of biological materials.
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's function is centered around the analysis of medical images.
N/A
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 (comma separated list FDA assigned to the subject device)
LLZ
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Left Ventricle, Left Atrium, Right Ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190913
Device Name
QLAB Advanced Quantification Software 13.0
Indications for Use (Describe)
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
- 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'
4
ultrasound systems. It can be used for the off-line review and quantification of ultrasound studies.
QLAB software provides basic and advanced quantification capabilities across a family of PC and cart based platforms. OLAB software functions through O-App modules, each of which provides specific capabilities. QLAB builds upon a simple and thoroughly modular design to provide smaller and more easily leveraged products.
The primary modification to QLAB 13.0 includes the addition of the following applications:
- Philips acquired TOMTEC Imaging Systems GmbH in 2017, and the modified OLAB 13.0 release integrates the currently marketed TomTec-Arena TTA2 AutoSTRAIN application (cleared under K150122 for the Left Ventricle) within the Philips QLAB portfolio as AutoStrain LV (Left Ventricle) with some workflow improvements.
- . AutoStrain LA (Left Atrium) application combines the functionality of the cleared TomTec-Arena 2D Cardiac Performance Analysis (2D CPA cleared under K150122) and the technology of the cleared TomTec-Arena AutoSTRAIN (cleared under K150122) and provides an easy LA strain solution for user convenience.
- . AutoStrain RV (Right Ventricle) application combines the functionality of the cleared TomTec-Arena 2D Cardiac Performance Analysis (2D CPA cleared under K150122) and the technology of the cleared TomTec-Arena AutoSTRAIN (cleared under K150122) and provides an easy RV strain solution for user convenience.
- Indications for Use
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.
6) Technological comparison to predicate devices
The QLAB Advanced Quantification software with the modified Q-Apps has the same intended use and technological characteristics as the legally marketed predicate device. A comparison of the proposed QLAB applications (AutoStrain LV, AutoStrain LA, AutoStrain RV) to the currently marketed predicate device (QLAB) and reference device (TomTec-Arena TTA2) are provided in the tables below:
5
Philips Ultrasound, Inc.
Traditional 510(k) QLAB Advanced Quantification Software Modifications
| Feature | Currently Marketed
Predicate QLAB
(Predicate Device -
K181264) | Currently
Marketed
Reference TomTec-
Arena TTA2
(Reference Device -
K150122) | Proposed QLAB
AutoStrain LV,
LA, 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 |
AutoStrain LV
| Feature | Currently Marketed
Predicate QLAB
Auto Cardiac Motion
Quantification
(aCMQ)
(K181264) | Currently
Marketed
Reference TomTec-
Arena TTA2
AutoSTRAIN
(Reference Device -
K150122) | Proposed QLAB
AutoStrain LV
(Modified
Device) | Explanation of
Differences |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application
description | aCMQ provides an
angle-independent
analysis of regional
myocardial-tissue
velocity, displacement,
strain, and strain rate,
using the speckle
tracking technology. It
generates
measurements of the
global and regional
functions of the left
ventricle. | AutoSTRAIN is a
quantification tool of
global and regional
function based on
contour detection and
tracking. The tool
automatically
quantifies global and
regional strain based
on apical 4-chamber,
3-chamber and 2-
chamber views of the
left ventricle. | Same as
AutoSTRAIN on
TOMTEC-
ARENA | Reason for change:
AutoStrain LV
functionality enables
a simplified
workflow when
compared to QLAB
aCMQ (originally
cleared under
K132165) |
6
| Philips Ultrasound, Inc. | ||
|---|---|---|
| -- | -------------------------- | -- |
Traditional 510(k) QLAB Advanced Quantification Software Modifications
| Speckle Tracking
of the ROI per
frame | Comparable feature
available | Automatically tracks
the ROI of the wall
motion per frame
using speckle
tracking technology.
User is able to edit
the ROI after
tracking. | Same as AutoSTRAIN on TomTec-Arena. | |
|-----------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Automatic view
recognition to
detect chamber
views | Manual view selection
to detect chamber
view. | Manual view
selection to detect
chamber view. | The application
uses view
recognition to
automatically
assign labels. The
user is able to
overwrite the
automatic
assignation of
labels. | Workflow simplified
on QLAB for user
convenience |
| Calculation of
GLS from three
views (global
strain analysis) | Same calculation
available | GLS is calculated
based on the Tracked
contours per view
and as average
according to the
length-of-line
method | Same as AutoSTRAIN on TomTec-Arena. | |
AutoStrain LA
| Feature | Currently Marketed
Predicate QLAB
(K181264) | Currently
Marketed
Reference TomTec-
Arena TTA2
2D Cardiac
Performance
Analysis - 2D CPA
(Reference Device -
K150122) | Proposed QLAB
AutoStrain LA
(Modified
Device) | Explanation of
Differences |
|----------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Application
description | Strain quantification of
LA chamber is not
available on QLAB | 2D CPA speckle
tracking algorithm
supports the
calculation of 2D -
contour models of
the endocardial of the
LA. Corresponding | The AutoStrain
LA provides left
atrial strain
measurements
from apical four-
chamber (A4C). | AutoStrain LA
combines the
functionality of 2D
CPA and the
technology of
AutoSTRAIN (for
LV) cleared under |
7
| Philips Ultrasound, Inc. | ||
|---|---|---|
| -- | -------------------------- | -- |
Traditional 510(k) QLAB Advanced Quantification Software
| Speckle Tracking
of the ROI per
frame | Option not available
for LA chamber | velocities,
displacements,
strains, strain rates
and functional
parameters can be
derived | A Speckle tracking
algorithm tracks the
ROI of the wall
motion per frame.
User is able to edit
the ROI after
tracking. | K150122 to provide
an easy LA strain
solution for user
convenience. | Speckle tracking
technology used for
TomTec-Arena 2D
CPA and
AutoSTRAIN (for
LV) has been
adapted for the left
atrial chamber for
AutoStrain LA |
|--------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calculation of
global strain
analysis from
one view | Option not available
for LA chamber | Left Atrial Strain is
calculated based on
the tracked contour | Same as 2D CPA. Additionally, conduit
and contraction Strain is calculated. | | |
AutoStrain RV
| Feature | Currently Marketed
Predicate QLAB
(K181264) | Currently
Marketed
Reference TomTec-
Arena TTA2
2D Cardiac
Performance
Analysis - 2D CPA
(Reference Device -
K150122) | Proposed QLAB
AutoStrain RV
(Modified
Device) | Explanation of
Differences |
|----------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application
description | Strain quantification of
RV chamber is not
available on QLAB | 2D CPA speckle
tracking algorithm
supports the
calculation of 2D -
contour models of
the endocardial
border of the RV.
Corresponding
velocities,
displacements. | The AutoStrain
RV provides right
ventricle strain
measurements
from apical four-
chamber (A4C)
views. | AutoStrain RV
combines the
functionality of 2D
CPA and the
technology of
AutoSTRAIN (for
LV) cleared under
K150122 to provide
an easy RV strain |
8
| Philips Ultrasound, Inc. | ||
|---|---|---|
| -- | -------------------------- | -- |
Traditional 510(k) QLAB Advanced Quantification Software Modifications
| | | strains, strain rates
are derived. | | solution for user
convenience. |
|--------------------------------------------------------------|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Speckle Tracking
of the ROI per
frame | Option not available
for RV chamber | A Speckle tracking
algorithm tracks the
ROI of the wall
motion per frame.
User is able to edit
the ROI after
tracking. | Similar speckle
tracking algorithm
tracks the ROI of
the wall motion
per frame. User is
able to edit the
ROI after
tracking. | Speckle tracking
technology used for
TomTec-Arena 2D
CPA and
AutoSTRAIN (for
LV) has been
adapted for the right
ventricular chamber
for AutoStrain RV |
| Calculation of
global strain
analysis from
one view | Option not available
for RV chamber | RV global Strain and
Freewall strain is
calculated based on
the tracked contour | Same as 2D CPA on TomTec-Arena | |
Summary of changes documented via Letter to File since QLAB 11.0 release (K181264)
| Feature/
Modification
incorporated in QLAB
software since QLAB
| 11.0 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 on
contour detection and tracking. The tool automatically quantifies global and
regional strain based on apical 4-chamber, 3-chamber and 2-chamber views of the
left ventricle |
| QLAB 13.0 | Integrate the currently marketed TomTec-Arena Mitral Valve Assessment (4D
MVA) application (cleared under K150122) on the Philips QLAB platform.
Application description:
The 4D MVA provides a morphological and functional analysis of mitral valves for
3D loops. The application generates models of anatomical structures such as MV
annulus, leaflets, and the
closure line. |
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems. The modifications to the currently marketed QLAB do not affect the safety and efficacy of the proposed QLAB
9
13.0 Advanced Quantification Software with AutoStrain LV, AutoStrain LA, AutoStrain RV clinical applications.
7) Determination of Substantial Equivalence
Non-clinical performance data
No performance standards for PACS systems or components have been issued under the authority of Section 514. The QLAB 13.0 modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB 13.0 software relative to the currently marketed unmodified QLAB software.
Design Control activities to assure the safe and effective performance of the modified Q-Apps included but not limited to the following:
- Requirements Review ●
- . Design Review
- . Risk Management
- . Software Verification and Validation
Software Verification and Validation testing were used to support substantial equivalence of the modified QLAB 13.0 to the predicate device.
Summary of Clinical Tests
QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing.
8) Conclusions
Software Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of the modified QLAB software with respect to the predicate were performed. Testing performed demonstrated that the proposed QLAB 13.0 Advanced Quantification Software meets defined requirements.
514 Performance Standards
There are no Sec. 514 performance standards for this device.
Prescription Status
This is a prescription device. The prescription device statement appears in the labeling.
Sterilization Site(s)
Not applicable. QLAB Advanced Quantification is a software only device.