(26 days)
No
The summary describes software for viewing and quantifying ultrasound images with various "Q-App modules" for specific capabilities. There is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies. The testing focuses on verifying and validating modifications against a predicate device, not on evaluating AI/ML performance metrics.
No.
The device is a software application for viewing and quantifying image data from ultrasound systems, and its primary purpose is diagnostic image analysis rather than direct therapy.
No
This device is software designed to view and quantify existing image data from ultrasound systems. It does not acquire the image data itself, which is the direct diagnostic step. Its function is to process and analyze data that has already been acquired for diagnostic purposes.
Yes
The device is explicitly described as a "software application package" and "software" that functions on standard PCs, dedicated workstations, and on-board ultrasound systems. It is used for off-line review and quantification of image data, indicating its primary function is data processing and analysis through software. While it processes data from ultrasound systems, the device itself is the software component.
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 Healthcare 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.
- Lack of Mention of Biological Samples: There is no mention of the software interacting with or analyzing biological samples.
- Input Imaging Modality: The input is "image data acquired on Philips ultrasound systems," which are used for non-invasive imaging, not 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's function is centered around the analysis of medical images, which falls outside the scope of an IVD.
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 Healthcare Ultrasound systems.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Philips QLAB Advanced Quantification software (OLAB) is designed to view and quantify image data acquired on Philips ultrasound products. 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. QLAB software functions through Q-App modules, each of which provides specific capabilities.
Mentions image processing
system image processing, radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
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 a2DQ/aCMQ modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB a2DQ/aCMQ/CMQ Stress 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 were not limited to:
- Requirements Review
- Design Review
- Risk Management
- Software Verification and Validation
Software Verification and Validation testing concluded that the modifications to the QLAB a2DQ and aCMQ/CMQ Stress Q-Apps are safe and effective and introduce no new risks.
QLAB introduces no new indications for use, modes, features, or technologies relative to the predicate device (QLAB) that require clinical testing.
Software Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of the modified QLAB Q-Apps with respect to the predicate were performed. Testing performed demonstrated that the proposed OLAB Advanced Quantification Software, with modified Q-Apps, meets defined requirements and performance claims.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2017
Philips Healthcare % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K171314
Trade/Device Name: OLAB Advanced Ouantification Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 3, 2017 Received: May 3, 2017
Dear Mr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K171314 Device Name QLAB Advanced Quantification Software
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 Healthcare 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
Penny Greco Philips Healthcare, Inc. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810-6302 Tel: (508) 843-0282 Fax (978) 975-7324
Date prepared: April 3, 2017
- 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 |
| Classification Name: | 21 CFR 892.2050, system image processing, radiological, |
| Product code LLZ, Class II |
- Substantially Equivalent Devices
| Primary Predicate Device | ||
|---|---|---|
| QLAB Modifications | K132165 | 08/09/2013 |
| Reference Device | ||
| QLAB Quantification Software with Heart Model | K130159 | 05/13/2013 |
Philips Ultrasound believes that the QLAB Q-App modifications which are the subject of this 510(k) are substantially equivalent to other OLAB applications.
4) Device Description
Philips QLAB Advanced Quantification software (OLAB) is designed to view and quantify image data acquired on Philips ultrasound products. 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. QLAB software functions through Q-App modules, each of which provides specific capabilities.
4
| Philips Ultrasound, Inc. | Traditional 510(k)
QLAB Advanced Quantification Software
Modifications | Page 2 of 3 |
| -------------------------- | ------------------------------------------------------------------------------ | ------------- |
|---|
QLAB builds upon a simple and thoroughly modular design to provide smaller, lower cost, and more easily leveraged products.
Philips Ultrasound is submitting this 510(k) to address modifications to the a2DQ and aCMO which include:
- . a2DQ and aCMQ (including CMQ Stress) enhancements
- o Flexible screen layout options within a2DO and aCMO
- O The addition of LA volume calculation to a2DQ as a licensed option
5) 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.
6) Technological comparison to predicate devices
The QLAB Advanced Quantification software with the modified Q-Apps has the same technological characteristics as the legally marketed device.
| Proposed QLAB a2DQ/aCMQ | Currently Marketed Predicate
QLAB 10.0 Modifications
(a2DQ/aCMQ) K132165 | Explanation of Differences |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The proposed a2DQ/aCMQ/CMQ
Stress includes:
• 6-segment ROI
• Enhanced contour and
speckle tracking
• New selections GLS and
Reginal Strain
measurement | Current a2DQ/aCMQ/CMQ Stress
include:
• 7-segment ROI
• Contour and speckle
tracking
• Gives users peak strain or
peak systolic strain without
measurement label
differentiation. | Reason for modified QLAB
a2DQ/aCMQ/CMQ Stress
applications is to better comply with
the recommendations of
ASE/EACVI. |
| The proposed a2DQ Q-App
includes the licensed LA option for
LA volume measurements. | The current a2DQ Q-App does not
have the LA option | Reason for modified QLAB a2DQ
Application: Measurement of LA
function has been shown to provide
valuable clinical
information. QLAB Heart Model
(K130159/K132165) provides the
measurement of LA volume in
addition to LV volumes for 3D
images. Adding LA volume
measurements to a2DQ provides
this valuable information to the
large percentage of customers who
only do 2D imaging. |
| 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 aCMQ (including CMQ Stress) and a2DQ do not affect the safety and efficacy of the proposed QLAB Advanced Quantification with the modified the aCMQ/CMQ Stress and a2DQ applications.
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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 a2DQ/aCMQ modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB a2DQ/aCMQ/CMQ Stress 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 were not limited to:
- · Requirements Review
- Design Review
- · Risk Management
- · Software Verification and Validation
Software Verification and Validation testing concluded that the modifications to the QLAB a2DQ and aCMQ/CMQ Stress Q-Apps are safe and effective and introduce no new risks.
Summary of Clinical Tests
QLAB introduces no new indications for use, modes, features, or technologies relative to the predicate device (QLAB) that require clinical testing.
8) Conclusions
Software Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of the modified QLAB Q-Apps with respect to the predicate were performed. Testing performed demonstrated that the proposed OLAB Advanced Quantification Software, with modified Q-Apps, meets defined requirements and performance claims.
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.