QLAB Advanced Quantification Software

K171314 · Philips Health Care · LLZ · May 30, 2017 · Radiology

Device Facts

• Record ID: K171314
• Device Name: QLAB Advanced Quantification Software
• Applicant: Philips Health Care
• Product Code: LLZ · Radiology
• Decision Date: May 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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.

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 software utilizes specific Q-App modules (a2DQ, aCMQ, CMQ Stress) to perform image analysis, including speckle tracking, contouring, and strain measurements (GLS, Regional Strain). It also provides LA volume calculations. Clinicians use the software for off-line review or real-time quantification to assist in diagnostic decision-making. The device benefits patients by providing standardized, quantitative cardiac measurements, such as strain and volume, to assess cardiac function.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation were performed to confirm performance, functionality, and reliability against defined requirements.

Technological Characteristics

Software-only application; modular architecture (Q-Apps). Functions on standard PCs, workstations, or embedded in ultrasound systems. Utilizes speckle tracking and contouring algorithms for image quantification. No hardware components; no sterilization required.

Indications for Use

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

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 (K132165)

Reference Devices

• QLAB Quantification Software with Heart Model (K130159)

Submission Summary (Full 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 30, 2017

Philips Healthcare % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K171314

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: April 3, 2017 Received: May 3, 2017

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 (reporting of medical 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.

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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 [phone] or [phone] 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" (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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
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)

K171314 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 Healthcare Ultrasound systems.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.25 3.34315L5.75 10.8431L2.75 7.84315" stroke="black" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 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

Penny Greco Philips Healthcare, Inc. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810-6302 Tel: [phone] Fax [phone]

Date prepared: April 3, 2017

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 | K132165 | 08/09/2013 |
| Reference Device | | |
| QLAB Quantification Software with Heart Model | K130159 | 05/13/2013 |

Philips Ultrasound believes that the QLAB Q-App modifications which are the subject of this 510(k) are substantially equivalent to other OLAB applications.

#### 4) Device Description

Philips QLAB Advanced Quantification software (OLAB) is designed to view and quantify image data acquired on Philips ultrasound products. 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.

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| Philips Ultrasound, Inc. | Traditional 510(k)<br>QLAB Advanced Quantification Software<br>Modifications | Page 2 of 3 |
|--------------------------|------------------------------------------------------------------------------|-------------|
|--------------------------|------------------------------------------------------------------------------|-------------|

QLAB builds upon a simple and thoroughly modular design to provide smaller, lower cost, and more easily leveraged products.

Philips Ultrasound is submitting this 510(k) to address modifications to the a2DQ and aCMO which include:

- . a2DQ and aCMQ (including CMQ Stress) enhancements
- o Flexible screen layout options within a2DO and aCMO
- O The addition of LA volume calculation to a2DQ as a licensed option

## 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 a2DQ/aCMQ | Currently Marketed Predicate<br>QLAB 10.0 Modifications<br>(a2DQ/aCMQ) K132165 | Explanation of Differences |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The proposed a2DQ/aCMQ/CMQ<br>Stress includes:<br>• 6-segment ROI<br>• Enhanced contour and<br>speckle tracking<br>• New selections GLS and<br>Reginal Strain<br>measurement | Current a2DQ/aCMQ/CMQ Stress<br>include:<br>• 7-segment ROI<br>• Contour and speckle<br>tracking<br>• Gives users peak strain or<br>peak systolic strain without<br>measurement label<br>differentiation. | Reason for modified QLAB<br>a2DQ/aCMQ/CMQ Stress<br>applications is to better comply with<br>the recommendations of<br>ASE/EACVI. |
| The proposed a2DQ Q-App<br>includes the licensed LA option for<br>LA volume measurements. | The current a2DQ Q-App does not<br>have the LA option | Reason for modified QLAB a2DQ<br>Application: Measurement of LA<br>function has been shown to provide<br>valuable clinical<br>information. QLAB Heart Model<br>(K130159/K132165) provides the<br>measurement of LA volume in<br>addition to LV volumes for 3D<br>images. Adding LA volume<br>measurements to a2DQ provides<br>this valuable information to the<br>large percentage of customers who<br>only do 2D imaging. |
| QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify | | |

image data acquired on Philips ultrasound systems. The modifications to the currently marketed QLAB aCMQ (including CMQ Stress) and a2DQ do not affect the safety and efficacy of the proposed QLAB Advanced Quantification with the modified the aCMQ/CMQ Stress and a2DQ applications.

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### 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 a2DQ/aCMQ modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB a2DQ/aCMQ/CMQ Stress software relative to the currently marketed unmodified QLAB software.

Design Control activities to assure the safe and effective performance of the modified Q-Apps included, but were not limited to:

- · Requirements Review
- Design Review
- · Risk Management
- · Software Verification and Validation

Software Verification and Validation testing concluded that the modifications to the QLAB a2DQ and aCMQ/CMQ Stress Q-Apps are safe and effective and introduce no new risks.

#### Summary of Clinical Tests

QLAB introduces no new indications for use, modes, features, or technologies relative to the predicate device (QLAB) that require clinical testing.

#### 8) Conclusions

Software Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of the modified QLAB Q-Apps with respect to the predicate were performed. Testing performed demonstrated that the proposed OLAB Advanced Quantification Software, with modified Q-Apps, meets defined requirements and performance claims.

#### 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.