(28 days)
Not Found
No
The document describes image processing and quantification software for ultrasound data but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No.
The device is designed for viewing and quantifying image data, which is a diagnostic function, not a therapeutic one.
No.
The device is designed for the review and quantification of image data, which is a post-acquisition process. While quantification can aid in diagnosis, the device itself does not acquire the images or provide a diagnostic output or interpretation. It solely processes existing ultrasound data.
Yes
The device is described as a "software application package" and is available as a "stand-alone product that can function on a standard PC" or "on board a dedicated workstation, or on-board Philips' ultrasound systems." While it can be integrated with hardware (workstations or ultrasound systems), its core function and description point to it being a software-only device that processes data from external sources. The verification and validation testing focuses on the software's performance and reliability, not on integrated hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device's function: The QLAB Quantification Software processes and quantifies image data acquired from ultrasound of the human body. It does not analyze biological specimens.
- Intended Use: The intended use is for viewing and quantifying ultrasound image data, not for analyzing biological samples.
Therefore, while it is a medical device used in healthcare, it falls under the category of imaging software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
QLAB Quantification software is available either as a stand-alone product that can function on a standard PC, on board a dedicated workstation, or on-board Philips' ultrasound systems. It can be used by trained healthcare professionals for the on-line and off-line review and quantification of ultrasound studies in healthcare facilities/hospitals.
The QLAB Quantification software application package is designed to view and quantify image data acquired on Philips ultrasound products. The four modified plug-ins, a2DO, aCMQ , MVN, and Heart Model are applications within Philips QLAB Quantification software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac chambers, vessel cavities (a2DQ), Myocardial tissue (aCMQ), Mitral valve (MVN), Left ventricle, left atrium (Heart Model)
Indicated Patient Age Range
Adult hearts (Heart Model)
Intended User / Care Setting
Trained healthcare professionals in healthcare facilities/hospitals.
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, MVN, and Heart Model modifications were tested in accordance with Philips verification and validation processes. Verification and validation data support the modified QLAB software for the a2DQ, aCMQ, MVN, and Heart Model software relative to the unmodified QLAB software.
Design Control activities to assure the safe and effective performance of the modified plug-ins included, but were not limited to:
- Requirements Review .
- Design Review .
- Risk Management .
- Verification and Validation Testing .
Verification and Validation testing concluded that the modified QLAB O-Apps are safe and effective and introduced no new risks.
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.
K042540, K070792, K120525, K130159
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.
Not Found
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
Special 510(k) Premarket Notification
QLAB Quantification Modifications
510(k) Summary
This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21 CFR. Part 807.92.
1 ) Submitter's name, address, telephone number, contact person
Philips Ultrasound, Inc. 3000 Minuteman Road Andover, MA 01810-6302 Penny Greco, Regulatory Affairs Specialist Tel: (978) 659-4615 Fax (978) 975-7324 E-mail: penny.greco@philips.com
AUG
09 2013
Date prepared: June 12, 2013
- 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 Systems Workstation
QLAB Quantification Software Proprietary Name: Classification Name: CFR 892.2050, system, image processing, radiological, 90 LLZ, Class II
3) Substantially Equivalent Devices
Philips Ultrasound believes that the modified QLAB a2DQ, aCMQ, MVN, and Heart Model Q-Apps are substantially equivalent to the previously cleared iU22 with 2DO (K042540), QLAB with MVQ (K070792), QLAB CMQ (K120525), and QLAB Heart Model (130159).
4) Device Description
QLAB Quantification software is available either as a stand-alone product that can function on a standard PC, on board a dedicated workstation, or on-board Philips' ultrasound systems. It can be used by trained healthcare professionals for the on-line and off-line review and quantification of ultrasound studies in healthcare facilities/hospitals.
The QLAB Quantification software application package is designed to view and quantify image data acquired on Philips ultrasound products. The four modified plug-ins, a2DO, aCMQ , MVN, and Heart Model are applications within Philips QLAB Quantification software.
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Automated 2D Quantification (a2DQ)
The 2DQ O-App for the display of 2D ultrasound images was originally submitted with Philips iU22 Ultrasound system (K042540). 2DQ has been renamed a2DQ. It computes areas, volumes and advanced parameters for LV systolic and diastolic function including: LV Ejection Fraction (EF), Peak Ejection Rate (PER), Peak Rapid Filling Rate (PRFR) and Atrial Filling Fraction (AFF). It also computes End Systolic Volume (ESV) and End Diastolic Volume (EDV). The Color Kinesis (CK) tool provides color-coded visualization of global and regional wall motion. a2DQ has been modified to improve workflows including semi-automated border detection for cardiac chambers and vessel cavities.
Automated Cardiac Motion Quantification (aCMQ)
CMQ modifications were last addressed in QLAB 510(k) K120525. CMQ has been renamed aCMQ aCMQ provides an angle-independent analysis of regional myocardialtissue velocity, displacement, strain, and strain rate, using the speckle-tracking technology. It generates measurements of the global and regional functions and reports them in a table, a 17-segment bull's eye, and a variety of waveform displays. It additionally computes LV Ejection Fraction (EF), End Systolic Volume (ESV) and End Diastolic Volume (EDV). aCMQ has been modified to automatically draw a region of interest based on the selected anatomical view, (user can edit the ROI if desired).
Mitral Valve Navigator (MVN)
The MVQ plug-in was submitted in QLAB 510(k) K070792. The application, renamed Mitral Valve Navigator (MVN), was originally designed as a manual segmentation interface that would allow for detailed segmentation of the mitral valve annulus, leaflets, and papillary muscle. However, as segmentation using the interface is entirely manual, the approximate time to complete the segmentation ranges from 5-15 minutes, depending on the user's familiarity with the interface, the quality of the image, and the user's knowledge of the mitral valve and experience in interpreting 3D echo images. The modification to MVN (MVQ) updates the application with improved task guidance and semi-automation for greater efficiency and ease of use. The modification focused primarily on decreasing the required workflow time by identifying bottlenecks in the workflow.
Heart Model Quantification (HM)
The Heart Model O-App (K130159) provides one-click visualization of all four cardiac chambers, and quantifies the left ventricle (LV) and left atrium (LA) using a 3D Volume image from an apical four-chamber view. It provides the LV and LA volume, stroke volume, and LV ejection fraction (EF) at end-systole and end-diastole (ED) for adult hearts. It easily delivers the routine 2D views from the 3D volume. Measurements are closely correlated to cardiac MR and are exported to the report. The modified Heart Model application allows users to override border placement. The user may edit the border by clicking and dragging the border to the desired location. Numeric quantification will be updated based upon user placement of borders.
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Special 510(k) Premarket Notification
QLAB Quantification Modifications
The OLAB modifications described in this Special 510(k) submission do not alter the intended use of the QLAB Quantification software with the modified a2DQ, aCMQ, MVN, and Heart Model Q-Apps.
5) Indications for Use
QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
6) Technological characteristics
The QLAB Quantification software with the modified Q-Apps has the same technological characteristics as the legally marketed device.
7) Non-clinical performance data
No performance standards for PACS systems or components have been issued under the authority of Section 514. The a2DQ, aCMQ, MVN, and Heart Model modifications were tested in accordance with Philips verification and validation processes. Verification and validation data support the modified QLAB software for the a2DQ, aCMQ, MVN, and Heart Model software relative to the unmodified QLAB software.
Design Control activities to assure the safe and effective performance of the modified plug-ins included, but were not limited to:
- Requirements Review .
- Design Review .
- Risk Management .
- Verification and Validation Testing .
Verification and Validation testing concluded that the modified QLAB O-Apps are safe and effective and introduced no new risks.
8) General Safety and Effectiveness Concerns
The device labeling contains operating instructions for the safe and effective use of the QLAB Quantification software with the modified Q-Apps.
9) Conclusions
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 involved system level tests, performance tests, and safety testing from hazard analysis. Testing performed demonstrated that the QLAB Quantification software with modified Q-Apps meets all defined reliability requirements and performance claims.
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Image /page/3/Picture/12 description: The image shows a partial view of a logo. The logo includes the words "HEALTH & HUMAN SERVICES USA" arranged in a circular pattern. To the right of the text is a stylized graphic consisting of three curved lines.
Public Health Service
Food and Onig Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MD 20993-002
August 9, 2013
Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25" Street NW BUFFALO MN 55313
Re: K132165
Trade/Device Name: QLAB Quantification Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 10, 2013 Received: July 12. 2013
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
4
Page 2 - Mr. Job
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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,
Sm.h.7)
for
Janine M. Morris 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): K132165
QLAB Quantification Software Device Name:
Indications for Use:
QLAB Quantification Software is a software application package. It is designed to view QCAD Quantify image data acquired on Philips Healthcare ultrasound products.
Prescription Use X (Part 2) CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Rediological Health
510(k)_K132165
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