(24 days)
No
The document describes software for viewing and quantifying ultrasound images with enhancements to existing quantification methods (Dynamic Heart Model) and platform upgrades. There is no mention of AI, ML, or related concepts like training or test sets for algorithmic performance evaluation.
No
The device is a software application for viewing and quantifying image data from ultrasound systems and does not state any therapeutic function.
Yes
The device quantifies image data from ultrasound systems and provides advanced quantification capabilities which are generally used to assist in diagnosis, especially given the mention of a "Dynamic Heart Model" for cardiac analysis.
Yes
The device is explicitly described as a "software application package" and "software" throughout the summary. While it processes data from Philips ultrasound systems, the device itself is the software for viewing and quantifying that data, not the ultrasound hardware. It can function on standard PCs, dedicated workstations, and on-board ultrasound systems, indicating its nature as a software layer independent of the underlying hardware platform.
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 ultrasound systems." This describes a device that processes and analyzes medical images obtained from a patient's body, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces that it works with "image data acquired on Philips ultrasound systems" and is used for "off-line review and quantification of ultrasound studies." This is consistent with medical imaging software.
- Input Imaging Modality: The input is "ultrasound," which is a medical imaging technique performed on a patient.
- Anatomical Site: The mention of "cardiac" indicates it's used for imaging the heart, which is an organ within the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This software works with images of the body itself, not samples taken from it.
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
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. QLAB software functions through Q-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.
Philips Ultrasound is submitting this 510(k) to address QLAB 11.0 modifications which include:
- Dynamic Heart Model (DHM) an enhancement to the Heart Model Quantification application that provides tracking of the entire cardiac cycle
- QLAB functionality upgraded to the HSDP Platform 2 from the HSDP Platform 1
- O-Store Shared central database supporting multiple clients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
cardiac
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
No performance standards for PACS systems or components have been issued under the authority of Section 514. The QLAB 11.0 modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB 11.0 software relative to the currently marketed unmodified QLAB software.
Design Control activities to assure the safe and effective performance of the modified O-Apps included, but were not limited to:
- 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 11.0 to the predicate device.
QLAB 11.0 introduces no new indications for use, modes, features, or technologies relative to the predicate device (OLAB 10.8 K171314) that require clinical testing.
Software Verification and Validation activities required established the performance, functionality, and reliability characteristics of the modified QLAB software with respect to the predicate were performed. Testing performed demonstrated that the proposed OLAB 11.0 Advanced Quantification Software meets defined requirements and performance claims.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
June 7th, 2018
Re: K181264
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: May 11, 2018 Received: May 14, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jeff Rygoz
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
2
Indications for Use
510(k) Number (if known) K181264
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 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
Traditional 510(k) QLAB Advanced Quantification Software Modifications
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
| Philips Ultrasound, Inc. |
|---|
| 3000 Minuteman Road |
| Andover, MA 01810-6302 |
| Email: penny.greco@philips.com |
| Tel: (508) 843-0282 |
| Fax (978) 975-7324 |
Secondary Contact: Zhengbin Xu Philips Ultrasound, Inc. Email: Zhengbin.xu@philips.com
Date prepared: March 21, 2018
- 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 | K171314 | 05/30/2017 |
| Reference Devices | ||
| QLAB Quantification Software with Heart Model | K130159 | 05/13/2013 |
| QLAB Quantification 10.0 Modifications | K132165 | 08/09/2013 |
Philips Ultrasound believes that the QLAB 11.0 modifications which are the subject of this 510(k) are substantially equivalent to QLAB K171314.
4
Traditional 510(k) QLAB Advanced Quantification Software Modifications
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' 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.
QLAB builds upon a simple and thoroughly modular design to provide smaller and more easily leveraged products.
Philips Ultrasound is submitting this 510(k) to address QLAB 11.0 modifications which include:
- Dynamic Heart Model (DHM) an enhancement to the Heart Model Quantification ● application that provides tracking of the entire cardiac cycle
- QLAB functionality upgraded to the HSDP Platform 2 from the HSDP Platform 1 ●
- O-Store Shared central database supporting multiple clients. .
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 Dynamic
Heart Model (DHM) | Currently Marketed
Predicate QLAB Heart
Model (K171314) | Explanation of Differences |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The DHM Q-App is
an application within
QLAB intended to
provide quantification
of 3D cardiac images | Heart Model | Dynamic Heart Model is an enhancement to
the current Heart Model (K171314/
K132165/K130159) application that
provides tracking of the entire cardiac
cycle and expands the measurements |
| HSDP Platform 2 | HSDP
Platform 1 | The HSDP platform has been upgraded to
platform 2 to provide customers with:
Better installation support. Ease
of use and support of non SQL
database (SQLite) Support for Remote database and
storage feature Support for advanced database
operations like rebuild, relocate
and recreate without having to
reinstall |
5
Traditional 510(k)
QLAB Advanced Quantification Software
Modifications
| Proposed QLAB Dynamic
Heart Model (DHM) | Currently Marketed
Predicate QLAB Heart
Model (K171314) | Explanation of Differences |
|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Better support for HTML5 reporting feature to make it seamless with on cart reporting Off the shelf integration with PSC (latest service tool platform) Philips identity UI support |
| Q-Store Shared central
database that supports multiple
clients. | No central database | Q-Store is a central database and storage solution. |
| QLAB Advanced Quantification Software is a software application package. It is designed to view and | | |
quantify image data acquired on Philips ultrasound systems. The currently marketed QLAB do not affect the safety and efficacy of the proposed QLAB 11.0 Advanced Quantification with Dynamic Heart Model application, the HSDP platform2 or Q-Store.
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 11.0 modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB 11.0 software relative to the currently marketed unmodified QLAB software.
Design Control activities to assure the safe and effective performance of the modified O-Apps included, but were not limited to:
- · 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 11.0 to the predicate device.
Summary of Clinical Tests
QLAB 11.0 introduces no new indications for use, modes, features, or technologies relative to the predicate device (OLAB 10.8 K171314) that require clinical testing.
8) Conclusions
Software Verification and Validation activities required established the performance, functionality, and reliability characteristics of the modified QLAB software with respect to the predicate were performed. Testing performed demonstrated that the proposed OLAB 11.0 Advanced Quantification Software meets defined requirements and performance claims.
6
Traditional 510(k) QLAB Advanced Quantification Software Modifications
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.