(127 days)
QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
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.
This document describes the QLAB 8.1 Quantification Software with an additional EA plug-in.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K110414) is a 510(k) premarket notification for a Class II medical device. It primarily demonstrates substantial equivalence to a predicate device rather than providing a detailed performance study with specific acceptance criteria and outcome metrics for a novel technology.
The document states:
- "No performance standards for PACS systems or components have been issued under the authority of Section 514."
- "Software development for the QLAB 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."
Given the nature of a 510(k) submission for a post-processing software that views and quantifies existing image data, the "acceptance criteria" are typically related to the software's functional correctness, accuracy of measurements compared to ground truth or predicate devices, robustness, and usability. However, specific quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) and detailed performance results based on a clinical trial are not explicitly provided in the excerpt.
The reported device performance is implicitly stated by asserting substantial equivalence to the Size Compare feature on the Philips iU22 Ultrasound System (K093563). This implies that the EA plug-in's "Size Compare" functionality for comparing lesion sizes on 2D images and elastograms performs similarly to the predicate device.
Example of how a table might look if specific acceptance criteria were provided (hypothetical, as not explicitly stated in the document):
| Performance Metric (Hypothetical) | Acceptance Criteria (Hypothetical) | Reported Device Performance (Implied) |
|---|---|---|
| Measurement Accuracy of ROI (Size Compare) | ≤ 5% deviation from reference measurements on a phantom/dataset | Substantially equivalent to predicate device (Philips iU22 Ultrasound System's Size Compare feature, K093563). |
| Software Functionality | All specified features (e.g., 2D image display, elastogram display, ROI selection, ratio calculation) operate as intended without critical errors. | Verified through documented software design, verification, and validation testing. |
| Software Robustness | Handles various image formats and user inputs without crashing or producing incorrect outputs. | Verified through documented software design, verification, and validation testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for any specific test set related to the performance of the QLAB 8.1 EA plug-in, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The 510(k) focuses on substantial equivalence through comparison of technological characteristics and intended use, and internal software verification/validation rather than a separate clinical performance study with a defined test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the establishment of ground truth for a test set, nor does it mention the number or qualifications of experts involved. This information would typically be found in a clinical study report, which is not part of this 510(k) summary. Given the device's function as a quantification software, ground truth for measurements might involve phantom studies, established geometric measurements, or expert consensus on clinical images, but these specifics are absent.
4. Adjudication Method for the Test Set
Since a specific test set with expert-established ground truth is not detailed in the document, an adjudication method (such as 2+1, 3+1, or none) for such a test set is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on the software's standalone functionality and its substantial equivalence to a predicate device, not on assessing how human readers improve with AI assistance. Therefore, no effect size for human reader improvement with AI assistance is reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, the QLAB 8.1 Quantification Software (including the EA plug-in) is primarily described as a standalone product. It is a "software application package" designed to "view and quantify image data" and "can be used for the on-line and off-line review and quantification of ultrasound studies." The EA plug-in "enables the user to determine the ratio of two regions of interest (ROI), referred to as Size Compare." This implies a standalone algorithm providing measurements, which a user then interprets or utilizes. The performance assessment, as implicitly described, is of the software's ability to provide these measurements accurately.
7. Type of Ground Truth Used
The specific type of ground truth used for verifying the QLAB 8.1 EA plug-in is not explicitly stated in the document. For quantification software, ground truth could involve:
- Phantom measurements: Using objects of known dimensions imaged by ultrasound.
- Manual measurements by experts: A consensus or single expert measurement on images, cross-referenced with other modalities like pathology or MRI if available for the specific application.
- Pathology: For lesion characterization, but the document primarily discusses size comparison.
The excerpt only states that "Software development for the QLAB software follows documented processes for software design, verification and validation testing," which would involve some form of ground truth or reference data.
8. Sample Size for the Training Set
The document does not provide information about a specific training set or its sample size. This is common for predicate-based 510(k) submissions, especially for software performing quantification rather than complex AI inference requiring large training datasets. If the software uses machine learning techniques, the training data details would typically be included, but given the 2011 submission date and description, it appears to be a rule-based or conventional image processing application.
9. How Ground Truth for the Training Set Was Established
Since no specific training set is mentioned, the method for establishing its ground truth is also not described in the provided text.
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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).
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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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§ 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).