(127 days)
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No
The document describes standard image processing and quantification tools for ultrasound data, with no mention of AI, ML, or related concepts.
No
The device is described as software for viewing and quantifying image data, and it is explicitly stated that there are no performance standards for PACS systems or components, suggesting a diagnostic rather than therapeutic function.
Yes
The device is described as "QLAB Quantification Software," which "is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products." It also mentions "Elastography Analysis (EA)" which "displays 2D images and clastograms acquired with the elastography imaging mode feature on an ultrasound system. EA provides a tool for comparing the size of a lesion on the 2D image and on the elastogram and enables the user to determine the ratio of two regions of interest (ROI), referred to as Size Compare." The ability to quantify image data, compare lesion sizes, and determine ratios of regions of interest for medical images points to its use in identifying or analyzing diseases or conditions, which falls under the definition of a diagnostic device. The predicate device, K093563 Philips iU22 Ultrasound System, is also a diagnostic imaging system.
Yes
The device is explicitly described as a "software application package" and a "software application" that can function on various computing platforms, including a standard PC, dedicated workstation, and on-board ultrasound systems. While it processes data from ultrasound systems, the device itself is presented as a software product.
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 Medical Systems ultrasound products." This describes a system for processing and analyzing medical images, not for performing tests on biological samples (like blood, urine, or tissue) to diagnose or monitor a disease or condition.
- Device Description: The description focuses on software for reviewing and quantifying ultrasound studies and introducing a new plug-in for Elastography Analysis. This is consistent with image processing and analysis, not in vitro testing.
- Regulatory Information: The mention of CFR 892.2050, "system, image processing, radiological," and Product code LLZ (which typically relates to Picture Archiving and Communications Systems - PACS) further supports its classification as a radiological image processing device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the QLAB Quantification Software is designed to process and analyze medical images obtained from ultrasound systems, which falls under the category of medical image processing devices, not in vitro diagnostics.
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 Medical Systems ultrasound products.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
QLAB 8.1 is a software application that is available cither 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 on-line and off-line review and quantification of ultrasound studies.
QLAB 8.1 introduces a new plug-in into the stand-alone version of the product: Elastography Analysis (EA).
Elastography Analysis (EA) displays 2D images and clastograms acquired with the elastography imaging mode feature on an ultrasound system. EA provides a tool for comparing the size of a lesion on the 2D image and on the elastogram and enables the user to determine the ratio of two regions of interest (ROI), referred to as Size Compare.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized caduceus with three intertwined snakes and a staff, representing health and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2015
Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K110414
Trade/Device Name: QLAB 8.1 Quantification Software with additional EA Plug-in Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: June 3, 2011 Received: June 6, 2011
Dear Mr. Job:
This letter corrects our substantially equivalent letter of June 21, 2011.
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. Isting 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
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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.
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" (21CFR 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,
Jeff Rogers
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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510(k) Premarket Notification
QLAB Quantification Software
4. Indications for Use Statement
510(k) Number (if known): K110414
Device Name: QLAB 8.1 Quantification Software with additional EA plug-in.
Indications for Use:
QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Prescription Use_X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K110414 510(k)
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5. 510(k) Summary
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
Philips Ultrasound, Inc. P.O. Box 3003 Bothell, WA 98021-3003 Mike Willingham, Sr. Director, Quality & Regulatory Telephone: (425) 482-8466 Facsimile: (425) 487-8666 E-mail: mike.willingham(@philips.com
Date prepared: April 18, 2011
- 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 |
|---|---|
| Proprietary Name: | QLAB Quantification Software 8.1 |
| Classification Name: | CFR 892.2050, system, image processing, radiological, Product code LLZ, Class II |
3) Substantially Equivalent Devices
Philips Ultrasound believes that the QLAB 8.1 software with the EA plug-in is substantially equivalent to other commercially available products, specifically the Size Compare feature cleared on the Philips iU22 Ultrasound System in K093563.
4) Device Description
QLAB 8.1 is a software application that is available cither 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 on-line and off-line review and quantification of ultrasound studies.
QLAB 8.1 introduces a new plug-in into the stand-alone version of the product: Elastography Analysis (EA).
11111 ,
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Elastography Analysis (EA) displays 2D images and clastograms acquired with the elastography imaging mode feature on an ultrasound system. EA provides a tool for comparing the size of a lesion on the 2D image and on the elastogram and enables the user to determine the ratio of two regions of interest (ROI), referred to as Size Compare.
5) Intended Use
QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
6) Technological comparison to predicate devices
Philips QLAB EA and the Size Compare feature on the Philips Ultrasound iU22 Ultrasound system are software tools for ultrasound image analysis. The Size Compare feature on the Ultrasound cart allows analysis during the Ultrasound exam while QLAB can be used as a standalone program for post-exam analysis and patient report preparation.
7) Non-clinical performance data
No performance standards for PACS systems or components have been issued under the authority of Section 514.
8) General Safety and Effectiveness Concerns
The device labeling contains operating instructions for the safe and effective use of the QLAB software.
9) Conclusions
The QLAB Quantification Software 8.1 is designed to incorporate components common to all image viewing systems for the display, manipulation and quantification tasks within a clinical setting. Software development for the OLAB software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image display and quantification product. The OLAB 8.1 software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.
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