QLAB QUANTIFICATION SOFTWARE

K061396 · Philips Ultrasound, Inc. · LLZ · May 30, 2006 · Radiology

Device Facts

• Record ID: K061396
• Device Name: QLAB QUANTIFICATION SOFTWARE
• Applicant: Philips Ultrasound, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 30, 2006
• 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 Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

Device Story

QLAB Quantification software is a PACS workstation application for viewing and quantifying ultrasound image data. The Parametric Imaging feature, an addition to the Cardiac 3DQ Advanced plug-in, processes ultrasound data to generate color-coded representations of regional left-ventricular (LV) segmental timing and excursion parameters. These are displayed on a standard AHA/ASE 17-segment Bull's-eye plot. Used in clinical settings by healthcare providers, the software assists clinicians in visualizing regional LV function. The output provides quantitative and visual data to support clinical decision-making regarding cardiac function. The device benefits patients by providing standardized, user-friendly analysis of cardiac ultrasound images.

Clinical Evidence

Bench testing only. The software underwent verification and validation testing, including risk assessment to identify potential design hazards related to quantification results.

Technological Characteristics

Software-based PACS workstation application. Complies with JPEG image compression standards. Operates on Philips ultrasound systems. Features include color-coded parametric imaging for LV segmental analysis using AHA/ASE 17-segment Bull's-eye display.

Indications for Use

Indicated for clinicians requiring visualization and quantification of ultrasound image data acquired on Philips Medical Systems ultrasound products. 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

• TomTec Image-Arena and Research-Arena applications with 4D LV-Analysis 2.x module (K040546)

Reference Devices

• iE33 (K042540)

Submission Summary (Full Text)

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# B - Administrative Information

#### SERER Summer of Statery and BRECOVERSS

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

Lynn Harmer, Regulatory Submissions Manager Philips Ultrasound, Inc. P.O. Box 3003 Bothell, WA 98041-3003 Telephone: [phone] Facsimile: [phone] E-mail: Lynn.Harmer(@philips.com

MAY 3 0 2006

Date prepared: 9 May 2006

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 Workstation

Proprietary Name: QLAB Quantification

Classification Name: Picture Archiving and Communications System, Class II

## 3) Device Description

The Parametric Imaging feature is an addition to the existing Cardiac 3DQ Advanced Plug-in already described on the iE33 510(k) submission K042540. The QLAB 5.0 3DQA plug-in Parametric Imaging provides the user with easy-to-use color-coded representations of regional left-ventricular (LV) segmental Timing and Excursion parameters displayed on the standard AHA/ASE 17-segment Bull's-eye display. The Parametric display may be used in assisting the clinician to visualize directly LV regional function in a user-friendly format.

4) Performance Standards

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No performance standards for PACS systems or components have been issued under the authority of Section 514. The QLAB software has been designed to comply with the following voluntary standards:

- MSDN Microsoft Developer's Network October 2001 .
- ISO Joint Photographic Experts Group (JPEG) Image Compression Standard ●

# 5) General Safety and Effectiveness Concerns

The device labeling contains operating instructions for the safe and effective use of the QLAB software.

## 6) Substantially Equivalent Devices

Philips Ultrasound believes that the QLAB 5.0 software with 3DQA plug-in is substantially equivalent to other commercially available products, specifically TomTec Image-Arena and Research-Arena applications with 4D LV-Analysis 2.x module (K040546).

# 7) Software

Software development for the QLAB software follows documented processes for software design, verification and validation testing. A risk assessment has been 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.

## 8) Conclusions

The QLAB software is designed and manufactured to meet United States and international standards for the display and quantification of images acquired on Phillips Ultrasound devices. The system is designed to incorporate components common to all image viewing systems for the display, manipulation and quantification tasks within a clinical setting. The QLAB software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, resembling an eagle or a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the abstract design.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 3 0 2006

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

Re: K061396

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 17, 2006 Received: May 19, 2006

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in bold, black font. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by text that reads "Dedicated to Consumer Protection & Public Health Since 1906".

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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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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,

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KI)A fudhatton for 163 Pornic

510(k) Number:

K041396

Device Name: QLAB 5.0 Quantification Software with Cardiac 3DQ Advanced plug-in including Parametric Imaging.

Indications for Use: QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

OR Over-The-Counter Use: Prescription Use: X_ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Lyman
(Division Sign-Off)

Division of Reproductive, and Radiological Devices 510(k) Number