Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN

K023877 · Philips Ultrasound, Inc. · LLZ · Dec 23, 2002 · Radiology

Device Facts

• Record ID: K023877
• Device Name: Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
• Applicant: Philips Ultrasound, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

Device Story

Q LAB software operates on Windows 2000/XP platforms to display and quantify ultrasound image data from Philips systems. The Strain Rate quantification plug-in allows users to define an 'M-Line' of interest over image data. The software analyzes image content within this line to calculate velocity, strain-rate, and strain data. Outputs are presented as XY graphics and virtual M-Mode formats; data can be exported as AVI or BMP files. Used in clinical settings by healthcare professionals to assist in image analysis and quantification. Benefits include objective assessment of myocardial deformation/strain parameters to support clinical decision-making.

Clinical Evidence

No clinical data provided. The submission relies on bench testing, software verification, and validation processes to demonstrate safety and effectiveness.

Technological Characteristics

Software-based PACS workstation application. Operates on Windows 2000/XP. Complies with MSDN (October 2001) and ISO JPEG image compression standards. Features include image display, M-Line definition for region-of-interest analysis, and data export (AVI/BMP).

Indications for Use

Indicated for viewing and quantifying ultrasound image data acquired on Philips Medical Systems ultrasound products. Intended for prescription use.

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

• GE's Strain-Rate software

Submission Summary (Full Text)

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K023877

# 510(k) Summary of Safety and Effectiv

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, Manager, Regulatory Submissions Philips Ultrasound, a Philips Medical System Company 22100 Bothell Everett Highway Bothell, WA 98021-8431 Telephone: [phone] Facsimile: [phone] E-mail: [e-mail]

Date prepared: 19 November 2002

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: | Q LAB Quantification Software with Strain Rate Quantification Plug-in |
| Classification Name: | Picture Archiving and Communications System, Class II |

## 3) Device Description

The Q LAB software provides a means of opening and displaying image files, creating AVI and BMP files from the image data displayed by the software. The Strain Rate quantification plug-in module is designed to operate within the QLAB software by creating a "line of interest" (called "M-Line") that is overlaid on the image data displayed by the software. The plug-in analyzes the content of the image data contained within the M-Line figure, presenting the velocity, strain-rate and strain data in XY graphic and virtual M-Mode format. The software provides a means of exporting the data generated by the plugin module in a form accessible to the end user.

- 4) Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514. The Q LAB 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 Q LAB software.

### 6) Substantially Equivalent Devices

Philips Ultrasound believes that the Strain-Rate Imaging quantification capabilities of the Q LAB software make it substantially equivalent to other commercially available products, specifically GE's Strain-Rate software.

## 7) Software

Software development for the Q LAB 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.

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## 8) Conclusions

The Q LAB 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 Q LAB software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynn Harmer Manager, Regulatory Submissions Philins Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431

Re: K023877

Trade/Device Name: O LAB Quantification Software with Strain Rate Ouantification Plug-in Regulation Number: 21 CFR 892.2050 · Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 19, 2002

Received: November 21, 2002

Dear Ms. Harmer:

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 (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); 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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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdin

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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Q LAB Strain Rate Quantification Software

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# Appendix A - Indications for Use

Device Name: Q LAB Quantification Software with Strain Rate Quantification Plug-in

Indications for Use:

The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

877

Prescription Use

David A. Peterson

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _