QLAB Advanced Quantification Software

K181264 · Philips Ultrasound, Inc. · LLZ · Jun 7, 2018 · Radiology

Device Facts

• Record ID: K181264
• Device Name: QLAB Advanced Quantification Software
• Applicant: Philips Ultrasound, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
3D cardiac image quantification	—	—	—	—	—	—	—

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.

Device Story

QLAB Advanced Quantification Software is a modular software application for viewing and quantifying ultrasound image data. It operates on standard PCs, dedicated workstations, or integrated into Philips ultrasound systems. The device utilizes Q-App modules to perform specific quantification tasks, including the Dynamic Heart Model (DHM) for tracking the entire cardiac cycle in 3D cardiac images. It features the HSDP Platform 2 for improved database management and Q-Store for shared central database access across multiple clients. Clinicians use the software for off-line review and analysis of ultrasound studies. The output provides quantitative measurements that assist healthcare providers in clinical decision-making and patient assessment. The system supports HTML5 reporting and remote database storage, facilitating workflow efficiency in clinical environments.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation activities were performed to establish performance, functionality, and reliability, demonstrating that the modified QLAB 11.0 software meets defined requirements and performance claims.

Technological Characteristics

Software-only application. Modular design using Q-App modules. HSDP Platform 2 architecture. Supports SQLite databases, HTML5 reporting, and remote storage. Connectivity includes networked shared database (Q-Store) and integration with Philips ultrasound systems. No physical materials or sterilization required.

Indications for Use

Indicated for clinicians requiring viewing and quantification of image data acquired on Philips ultrasound systems. Prescription use only.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• QLAB Modifications (K171314)

Reference Devices

• QLAB Quantification Software with Heart Model (K130159)
• QLAB Quantification 10.0 Modifications (K132165)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------|------------------------------------------------------|
| <span style="text-decoration: underline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | <div> <input checked="true" type="checkbox"/> </div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <input type="checkbox"/> </div> |

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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

1) Submitter's name, address, telephone number, contact person

| Philips Ultrasound, Inc. |
|--------------------------------|
| 3000 Minuteman Road |
| Andover, MA 01810-6302 |
| Email: [e-mail] |
| Tel: [phone] |
| Fax [phone] |

Secondary Contact: Zhengbin Xu Philips Ultrasound, Inc. Email: [e-mail]

Date prepared: March 21, 2018

2) 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<br>Product code LLZ. Class II |

3) 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 Dynamic<br>Heart Model (DHM) | Currently Marketed<br>Predicate QLAB Heart<br>Model (K171314) | Explanation of Differences |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The DHM Q-App is<br>an application within<br>QLAB intended to<br>provide quantification<br>of 3D cardiac images | Heart Model | Dynamic Heart Model is an enhancement to<br>the current Heart Model (K171314/<br>K132165/K130159) application that<br>provides tracking of the entire cardiac<br>cycle and expands the measurements |
| HSDP Platform 2 | HSDP<br>Platform 1 | The HSDP platform has been upgraded to<br>platform 2 to provide customers with:<br>Better installation support. Ease<br>of use and support of non SQL<br>database (SQLite) Support for Remote database and<br>storage feature Support for advanced database<br>operations like rebuild, relocate<br>and recreate without having to<br>reinstall |

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# Traditional 510(k)

# QLAB Advanced Quantification Software

#### Modifications

| Proposed QLAB Dynamic<br>Heart Model (DHM) | Currently Marketed<br>Predicate QLAB Heart<br>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<br>database that supports multiple<br>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.

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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.