Q-STATION

K140808 · Philips Ultrasound, Inc. · LLZ · Apr 17, 2014 · Radiology

Device Facts

• Record ID: K140808
• Device Name: Q-STATION
• Applicant: Philips Ultrasound, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric, 3rd-Party Reviewed

Intended Use

Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT, and X-Ray modalities for reference viewing. It supports connectivity to ultrasound systems, PACS and other DICOM storage repositories.

Device Story

Q-Station is PC-based application software for post-acquisition management of ultrasound data; integrates with QLAB for advanced analysis. Inputs include ultrasound images/measurements from acquisition devices and non-ultrasound DICOM images (CT, MR, etc.) for reference. Clinicians use software to review exams, perform manual cardiac wall motion scoring, create/edit measurements, and generate reports. Supports import/export of exams and anonymization. Facilitates clinical decision-making by providing tools for quantitative/qualitative assessment of cardiac and vascular data. Used in clinical settings by healthcare professionals; enables sharing of interpretive findings and reports across clinical teams.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including system-level performance tests, risk analysis, and verification and validation of software functionality.

Technological Characteristics

Application software for PC; DICOM compatible. Features multi-modality viewing (1-up/n-up) and integrated analysis packages (Adult/Pediatric Echo, Vascular). Connectivity via DICOM to ultrasound systems and PACS. Manual measurement tools for labels, groups, and collections. Software-based; no specific hardware requirements listed beyond PC platform.

Indications for Use

Indicated for clinicians requiring management, viewing, analysis, and reporting of qualitative and quantitative ultrasound image data. Supports adult echo, pediatric echo, and vascular applications. Used for reference viewing of non-ultrasound DICOM images (CT, MR, NM, CR, MG, XA, PET, RT, X-Ray). 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

• Philips Q-Station (K103815)
• Philips Xcelera (K061995)
• Philips EPIQ (K132304)

Reference Devices

• QLAB Q-Apps (K132165)

Submission Summary (Full Text)

{0}------------------------------------------------

# K140808 APR 1 7 2014

# 5. 510(k) Summary

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, Regulatory Affairs Specialist Philips Healthcare, Ultrasound 3000 Minuteman Road Andover, MA Telephone: [phone] Facsimile: [phone] E-mail: [e-mail]

Date prepared: March 14, 2014

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-Station

CFR 892.2050, system, image processing, radiological, Product Classification Name: code LLZ, Class II

#### 3) Substantially Equivalent Devices

Philips Ultrasound believes that modifications introduced with Q-Station 3.0 are substantially equivalent to other commercially available devices including Philips Xcelera (K061995) and Philips EPIQ (K132304). The Q-Station analysis packages and multi-modality viewing are the same as those found on Philips ultrasound systems, including EPIQ.

#### 4) Device Description

Q-Station is designed to manage post-acquisition ultrasound images and other data, for the purposes of diagnosing the patient's condition. This includes using Q-Station on a PC to review

{1}------------------------------------------------

images and measurements sent from an ultrasound acquisition device, analyze 3D and other data with QLAB. Q-Station is used to review various ultrasound exam types, including Adult echo, General Imaging, Stress echo, Vascular, and TEE. In addition, Q-Station can be used for reference viewing of non-ultrasound DICOM images. Q-Station can be used to add interpretive findings, key images, measurements and calculations and other comments that create reports that can be shared with other clinicians. During this review, users may also use Q-Station to import and export exams, print reports, and anonymize images for export. Q-Station supports QLAB Q-Apps for advanced analysis (K132165).

#### 5) Intended Use

O-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT, and X-Ray modalities for reference viewing. It supports connectivity to ultrasound systems, PACS and other DICOM storage repositories.

#### 6) Technological comparison to predicate devices

Philips Q-Station 3.0 is application software similar to Q-Station as submitted in K103815. It is designed to manage, view and report image data acquired by Ultrasound systems, but with Q-Station 3.0 now includes analysis packages and multi-modality viewing similar to Philips Xcelera and Philips EPIQ.

Both Q-Station and Xcelera are software applications for off-cart image analysis and patient report preparation. Both are DICOM compatible.

The integrated analysis packages included in Q-Station 3.0 are essentially the same as those included with the EPIQ ultrasound system (K132304), except that the Q-Station analysis packages are limited to Adult Echo, Pediatric Echo and Vascular applications. The Analysis packages are also similar to Philips Xcelera analysis packages (K061995).

The Q-Station 3.0 multi-modality viewing allows users to view non ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT, and X-Ray modalities for reference viewing. These images can be viewed in 1-up or in n-up for comparison. In cases where the images are present in stack format, O-Station viewer will allow the user to navigate the frames/slices of these stacks and analyze them one by one. No modification is allowed on multi-modality images/studies, nor is reporting allowed on such studies. The Q-Station Multi-modality viewing is similar to that of both EPIQ and Xcelera.

{2}------------------------------------------------

| Model | Philips<br>Q-Station | Philips<br>Q-Station 3.0 | Philips<br>Xcelera | Philips<br>EPIQ<br>Ultrasound System |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Reference | K103815 | Subject submission | K061995 | K132304 |
| Product Code | LLZ | LLZ | LLZ | IYN, IYO, ITX |
| Intended Use | Q-Station software is<br>a software<br>application package.<br>It is designed to<br>manage, view and<br>report image data<br>acquired by<br>Ultrasound systems<br>and cardiac<br>waveformn data<br>from Philips<br>StressVue<br>EGG systems. Q-<br>Station offers<br>support for QLAB<br>plug-ins for analysis,<br>quantification and<br>reporting of data<br>from ultrasound<br>systems. | Q-Station is application<br>software intended to manage,<br>view, analyze, and report<br>qualitative and quantitative<br>image data from ultrasound<br>exams. It is designed to host<br>optional advanced analysis<br>applications via QLAB<br>integration and provides<br>integrated tools that allow<br>users to manually assess and<br>score cardiac wall motion<br>and export images and/or<br>exams and reports. Q-<br>Station can view DICOM<br>images of non-ultrasound<br>images such as CT, MR, NM,<br>CR, MG, XA, PET, RT, and<br>X-Ray modalities for<br>reference viewing. It supports<br>connectivity to ultrasound<br>systems, PACS and other<br>DICOM storage repositories. | An integrated<br>multimodality image and<br>information system,<br>designed to perform the<br>necessary functions<br>required for<br>import/export/storage/<br>archiving/review/<br>analysis/quantification/<br>reporting and database<br>management of digital<br>cardiovascular images.<br>waveforms and data related<br>to cardiology. | The EPIQ Diagnostic<br>Ultrasound System is a<br>general purpose,<br>software controlled<br>diagnostic ultrasound<br>system. Its function is<br>to acquire ultrasound<br>data and to display the<br>data in a various modes<br>of operation. |
| Analysis<br>Packages | No | Adult Echo<br>Pediatric Echo<br>Vascular | Xcelera packages include:<br>Adult Echo<br>Pediatric Echo<br>Vascular | EPIQ packages include:<br>Adult Echo<br>Pediatric Echo<br>Vascular |
| Measurement<br>Tool | No | View, copy, and edit system-<br>defined measurement labels,<br>groups, and collections.<br>Create, edit, and delete<br>customized measurement<br>labels, groups, and<br>collections. | Create, edit, delete<br>measurements &<br>calculations and re-label<br>existing measurements &<br>calculations | Same as Q-Station 3.0 |
| Viewer for<br>other<br>Modalities | No | CT, MR, NM, CR, MG, XA,<br>PET, RT, and X-Ray images | Same + US | Same as Q-Station 3.0 |

.

{3}------------------------------------------------

#### 7) Non-clinical performance data

No performance standards for PACS systems or components have been issued under the authority of Section 514. O-Station 3.0 was tested in accordance with Philips verification and validation processes. Quality assurance measures were applied to the system design and development, including:

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

#### Summary of Clinical Tests:

The subject of this premarket submission, Q-Station 3.0 software did not require clinical studies to support substantial equivalence.

#### Conclusion:

Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of Q-Station 3.0 were performed. Testing involved system level tests, performance tests, and safety testing from risk analysis. Testing performed demonstrated that the O-Station 3.0 meets all defined reliability requirements and performance claims.

#### 8) General Safety and Effectiveness Concerns

The device labeling contains operating instructions for the safe and effective use of the Q-Station 3.0 software.

#### 9) Conclusions

The Q-Station software is designed and manufactured to meet United States and international standards for the display and reporting of qualitative and quantitative image data 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-Station software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that represents the department's mission related to health and human services. The symbol is composed of three curved lines that form a stylized human figure.

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

April 17, 2014

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313

Re: K140808

Trade/Device Name: Q-station Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 31, 2014 Received: April 1, 2014

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.

{5}------------------------------------------------

Page 2-Mr. Job

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Sm.h.D

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known)

#### K140808

Device Name

# Q-Station

Indications for Use (Describe)

Q-Station is application software intended to manage, view, and report qualitative and quantitative image data from ultrasound < rans. It is designed to host optional advanced analysis applications via QLAB integration and provides integrated tools that allow users to manually assess and score cardiae wall motion and export images and/or exams and reports. Q-Station can view DICOM images of nonwhansound images such as CT, MR, NM, XA, PET, RT, and X-Ray modalities for reference viewing. It supports connectivity to ultrasound systems, PACS and other DICOM storage repositories.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Page 1 of 1

EF PSC Publishing Services [phone]