QLAB WITH FHN AND VPQ PLUG-IN

K121223 · Philips Ultrasound, Inc. · LLZ · May 15, 2012 · Radiology

Device Facts

• Record ID: K121223
• Device Name: QLAB WITH FHN AND VPQ PLUG-IN
• Applicant: Philips Ultrasound, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

Device Story

QLAB Quantification Software is a software package for viewing and quantifying ultrasound image data, operating on standard PCs, dedicated workstations, or on-board Philips ultrasound systems. It includes two plug-ins: Fetal Heart Navigator (FHN) and Vascular Plaque Quantification (VPQ). FHN uses 4D ultrasound acquisitions to provide semi-automated alignment of the fetal heart, guiding users through standard views (4-Chamber, LVOT, RVOT) for visualization of anomalies; it does not produce quantitative measurements. VPQ provides protocol-driven, semi-automated analysis of carotid artery plaques, outputting maximum reduction site location, percentage of stenosis, and plaque volume. Clinicians use these outputs to assist in fetal heart assessment and vascular plaque characterization. The software facilitates clinical decision-making by providing standardized views and automated quantification metrics.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including risk analysis, product specifications, design reviews, and verification and validation processes.

Technological Characteristics

Software-based image processing application. Operates on standard PCs, dedicated workstations, or integrated into Philips ultrasound systems. Utilizes semi-automated algorithms for image alignment (FHN) and plaque analysis (VPQ). Complies with AIUM, ACOG, ACR, and ISOUG standards for fetal heart screening. No specific hardware materials or energy sources; software-only device.

Indications for Use

Indicated for the viewing and quantification of ultrasound image data acquired on Philips Healthcare ultrasound systems. Intended for prescription use by clinicians.

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

• Philips QLAB MVQ (K070792)
• GE's Voluson Expert 8 VCAD (K113758)
• Philips QLAB ROI (K021966)
• IMT's M'Ath® Std (K040686)

Submission Summary (Full Text)

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QLAB Quantification Software

4121223

#### 5. 510(k) Summary

# MAY 1 5 2012

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 Penny Greco, Regulatory Affairs Specialist Telephone: [phone] Facsimile: [phone] E-mail: [e-mail]

Date prepared: April 4, 2012

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 Systems<br>Workstation |
|----------------------|-------------------------------------------------------------------------------------|
| Proprietary Name: | QLAB Quantification Software with FHN & VPQ |
| Classification Name: | CFR 892.2050, system, image processing, radiological.<br>Product code LLZ, Class II |

3) Substantially Equivalent Devices

Philips Ultrasound believes that the QLAB software with

- · Fetal Heart Navigator (FHN) plug-in is substantially equivalent to other commercially available products, including Philips QLAB MVQ (K070792) and GE's Voluson Expert 8 VCAD (K113758).
- · Vascular Plaque Quantification (VPO) plug-in is substantially equivalent to other commercially available products, including Philips QLAB ROI (K021966) and IMT's M'Ath® Std (K040686).

### 4) Device Description

The QLAB software application is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound

Philips Ultrasound

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#### 510(k) Premarket Notification

systems. It can be used for the on-line and off-line review and quantification of ultrasound studies.

QLAB Quantification software now includes two new plug-in applications: Fetal Heart Navigator (FHN) and Vascular Plaque Quantification (VPO).

### Fetal Heart Navigator

The Fetal Heart Navigator (FHN) plug-in provides a semi-automated alignment of the fetal heart from a 4D acquisition and a protocol that steps users through the standard views. The objective of the protocol is to obtain the standard set of views that best reveal the most common fetal heart anomalies. The purpose of the FHN plug-in is for visualization The Fetal Heart Navigator tools do not produce quantitative data or measurements.

### Vascular Plaque Quantification

The Vascular Plaque Quantification (VPQ) plug-in provides protocol-driven tools for performing a semi-automated analysis of plaques in the carotid artery. The clinical results include the location of the maximum reduction site, the percentage of stenosis. and the plaque volume in the entire image.

### 5) Intended Use

QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

### 6) Technological comparison to predicate devices

QLAB's FHN is similar to the QLAB MVQ in that users are able to rotate an image to a desired view. While MVQ requires the user to place reference points to finish a trace, FHN finds the center of the heart and ductal arch and then displays the ductal arch view. Similar to GE's VCAD, the QLAB Fetal Heart Navigator (FHN) feature is a tool that helps guide the user through the process of obtaining standard views used for fetal heart assessment: 4-Chamber, LVOT, and RVOT. Both FHN and VCAD comply with the recommended standard screening exam of the fetal heart as outlined by AIUM, ACOG, ACR and ISOUG.

Similar to the QLAB ROI plug-in, VPQ creates ROIs and can then measure the area of arbitrarily sized/shaped ROIs. Both the QLAB VPQ plug-in and the IMT M' Ath software automate plaque visualization and characterization. Both process Ultrasound images.

### 7) Non-clinical performance data

No performance standards for PACS systems or components have been issued under the authority of Section 514. The FHN and VPQ plug-ins were tested in accordance with Philips verification and validation processes. Quality assurance measures were applied to the system design and development, including:

## Philips Ultrasound

8

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- . Risk Analysis
- . Product Specifications
- . Design Reviews
- Verification & Validation .

### Summary of Clinical Tests:

The subject of this premarket submission, OLAB Quantification software with VPO and FHN did not require clinical studies to support substantial equivalence.

#### Conclusion:

Verification and validation testing concluded that the Fetal Heart Navigator and Vascular Plaque Quantification plug-ins are safe and effective and introduced no new risks.

#### 8) General Safety and Effectiveness Concerns

The device labeling contains operating instructions for the safe and effective use of the QLAB software with the Fetal Heart Navigator and Vascular Plaque Quantification plugins.

### 9) Conclusions

The QLAB Quantification Software with Fetal Heart Navigator and Vascular Plaque Quantification incorporate components common to all image viewing systems for the display, manipulation and quantification tasks within a clinical setting. Software development for the QLAB software follows documented processes for software design, verification and validation testing. A risk assessment was 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. Verification and validation testing of the QLAB Quantification software with Fetal Heart Navigator and Vascular Plaque Quantification indicate no new issues of safety and effectiveness.

#### Philips Ultrasound

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Philips Ultrasound, Inc. % Mr. Mark Job Third Party Consultant Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

MAY 1 5 2012

Re: K121223

Trade/Device Name: QLAB Quantification Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 10, 2012 Received: May 14, 2012

### 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):

Device Name: QLAB Quantification Software

Indications for Use:

QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare 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

510(k) Kla1223