(24 days)
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.
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. .
The document provided is a 510(k) premarket notification for the Philips QLAB Advanced Quantification Software. It states that the submission is for modifications to an existing device (QLAB 10.8 K171314) and does not introduce new indications, modes, features, or technologies that require clinical testing. Therefore, there is no detailed study described that definitively calculates specific acceptance criteria and device performance metrics in the traditional sense of a clinical trial for a novel device.
However, based on the information provided, we can infer the approach to acceptance criteria and "performance" from the perspective of software verification and validation for modifications to an already cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for modifications to an existing cleared device, the "acceptance criteria" revolve around ensuring the modified software functions as intended and does not negatively impact the safety and effectiveness of the previously cleared predicate device. Performance is demonstrated through software verification and validation against internal requirements.
| Acceptance Criterion (Inferred from V&V) | Reported Device Performance |
|---|---|
| Functional Requirements Met: Enhanced features (e.g., Dynamic Heart Model tracking, HSDP Platform 2, Q-Store) perform as specified. | Software Verification and Validation confirmed that the proposed QLAB 11.0 Advanced Quantification Software meets defined requirements and performance claims. |
| Safety and Effectiveness Maintained: No adverse impact on existing functionalities or overall device safety/effectiveness. | The modifications do not affect the safety and efficacy of the proposed QLAB 11.0 Advanced Quantification with Dynamic Heart Model application, the HSDP platform 2, or Q-Store. |
| Reliability: The modified software operates reliably. | Software Verification and Validation activities established the performance, functionality, and reliability characteristics of the modified QLAB software. |
| System Compatibility: Integration of new platforms (HSDP Platform 2, Q-Store) is successful. | QLAB functionality upgraded to HSDP Platform 2 from HSDP Platform 1; Q-Store Shared central database supporting multiple clients. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images for evaluating the diagnostic performance of the algorithms. Instead, the testing described is focused on software verification and validation. This typically involves:
- Test Cases: Software testing would involve a suite of test cases designed to cover all functionalities, new and existing, and boundary conditions. The number of these test cases is not specified.
- Data Provenance: The document does not mention the use of patient data for performance evaluation in terms of diagnostic accuracy. The testing is focused on the software's functional and technical aspects. Since this is an upgrade to an existing quantification software, it is likely that existing image data (possibly de-identified, potentially from various sources including internal datasets or public datasets for software testing purposes) would have been used to validate the functions of the application, but this is not explicitly stated. The document strongly emphasizes that no new indications or technologies requiring clinical testing are introduced.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that no clinical testing requiring a "ground truth" established by external experts is detailed, this information is not provided. The "ground truth" for software verification and validation is defined by the product's functional and technical requirements.
4. Adjudication Method for the Test Set
Not applicable, as no external expert adjudication for a "test set" (in the clinical sense) is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "QLAB 11.0 introduces no new indications for use, modes, features, or technologies relative to the predicate device (QLAB 10.8 K171314) that require clinical testing." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The QLAB Advanced Quantification Software is described as a "software application package" designed to "view and quantify image data." It functions as an "off-line review and quantification" tool. While its primary function is quantification, the context implies it's a tool used by a human to assist in diagnosis or assessment. The mention of "tracking of the entire cardiac cycle" and "expanding the measurements" for the Dynamic Heart Model suggests algorithmic quantification, but it is not presented as a standalone diagnostic AI system that operates without human review or interaction. The performance data focuses on the software fulfilling its functional requirements within the existing framework of the predicate device.
7. The Type of Ground Truth Used
The "ground truth" for the software verification and validation activities is based on the defined software requirements and specifications. This is a functional "ground truth" rather than a clinical ground truth (like pathology, expert consensus on patient outcomes). The goal was to demonstrate that the software modifications (Dynamic Heart Model, HSDP Platform 2, Q-Store) work as designed.
8. The Sample Size for the Training Set
No training set is mentioned. This submission is for modifications to quantification software, not a de novo AI model that requires training on a dataset. The "Dynamic Heart Model" is described as an "enhancement" to an existing application providing "tracking" and "expanding measurements," suggesting algorithmic improvements rather than a new discriminative AI model requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a de novo AI model is mentioned.
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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.
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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
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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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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, radiologicalProduct 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.
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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 DynamicHeart Model (DHM) | Currently MarketedPredicate QLAB HeartModel (K171314) | Explanation of Differences |
|---|---|---|
| The DHM Q-App isan application withinQLAB intended toprovide quantificationof 3D cardiac images | Heart Model | Dynamic Heart Model is an enhancement tothe current Heart Model (K171314/K132165/K130159) application thatprovides tracking of the entire cardiaccycle and expands the measurements |
| HSDP Platform 2 | HSDPPlatform 1 | The HSDP platform has been upgraded toplatform 2 to provide customers with:Better installation support. Easeof use and support of non SQLdatabase (SQLite) Support for Remote database andstorage feature Support for advanced databaseoperations like rebuild, relocateand recreate without having toreinstall |
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Traditional 510(k)
QLAB Advanced Quantification Software
Modifications
| Proposed QLAB DynamicHeart Model (DHM) | Currently MarketedPredicate QLAB HeartModel (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 centraldatabase that supports multipleclients. | 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.
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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.
§ 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).