(16 days)
No
The document does not mention AI, ML, deep learning, or any related terms, and the description focuses on standard image management and analysis tools.
No.
This device is an image management and analysis software for post-acquisition medical images, primarily for diagnostic purposes, and does not directly provide therapy.
Yes
The "Device Description" explicitly states, "Q-Station is designed to manage post-acquisition ultrasound images and other data, for the purposes of diagnosing the patient's condition."
Yes
The device is described as "application software" and its function is to manage, view, analyze, and report image data. While it interacts with hardware (ultrasound systems, PACS, PCs), the device itself is presented as a software application for post-acquisition image processing and analysis. The description focuses on software functionalities and does not mention any proprietary hardware components included with the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary function described is managing, viewing, analyzing, and reporting image data from ultrasound and other imaging modalities. This is focused on interpreting images of the patient's anatomy and physiology, not on analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces the focus on post-acquisition image management and analysis for diagnosing the patient's condition based on imaging data.
- Lack of Mention of In Vitro Activities: There is no mention of analyzing biological samples, reagents, or any processes that would be performed outside of the living body.
- Product Classification: The provided classification code LLZ is for "System, Image Processing, Radiological". This classification is for devices used in medical imaging, not for in vitro diagnostics.
- Predicate Devices: The predicate devices listed (Philips Xcelera, Philips EPIQ) are also imaging systems or image management systems, not IVDs.
In vitro diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes. This device deals with images of the body itself, not with samples taken from the body.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
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 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, CT, MR, NM, CR, MG, XA, PET, RT, X-Ray
Anatomical Site
Cardiac (Adult Echo, Pediatric Echo), Vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The subject of this premarket submission, Q-Station 3.0 software did not require clinical studies to support substantial equivalence. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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
- Submitter's name, address, telephone number, contact person Penny Greco, Regulatory Affairs Specialist Philips Healthcare, Ultrasound 3000 Minuteman Road Andover, MA Telephone: (978) 659-4615 Facsimile: (978) 975-7324 E-mail: penny.greco@philips.com
Date prepared: March 14, 2014
- 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.
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| Model | Philips
Q-Station | Philips
Q-Station 3.0 | Philips
Xcelera | Philips
EPIQ
Ultrasound System |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Reference | K103815 | Subject submission | K061995 | K132304 |
| Product Code | LLZ | LLZ | LLZ | IYN, IYO, ITX |
| Intended Use | Q-Station software is
a software
application package.
It is designed to
manage, view and
report image data
acquired by
Ultrasound systems
and cardiac
waveformn data
from Philips
StressVue
EGG systems. Q-
Station offers
support for QLAB
plug-ins for analysis,
quantification and
reporting of data
from ultrasound
systems. | 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. | An integrated
multimodality image and
information system,
designed to perform the
necessary functions
required for
import/export/storage/
archiving/review/
analysis/quantification/
reporting and database
management of digital
cardiovascular images.
waveforms and data related
to cardiology. | The EPIQ Diagnostic
Ultrasound System is a
general purpose,
software controlled
diagnostic ultrasound
system. Its function is
to acquire ultrasound
data and to display the
data in a various modes
of operation. |
| Analysis
Packages | No | Adult Echo
Pediatric Echo
Vascular | Xcelera packages include:
Adult Echo
Pediatric Echo
Vascular | EPIQ packages include:
Adult Echo
Pediatric Echo
Vascular |
| Measurement
Tool | No | View, copy, and edit system-
defined measurement labels,
groups, and collections.
Create, edit, and delete
customized measurement
labels, groups, and
collections. | Create, edit, delete
measurements &
calculations and re-label
existing measurements &
calculations | Same as Q-Station 3.0 |
| Viewer for
other
Modalities | No | CT, MR, NM, CR, MG, XA,
PET, RT, and X-Ray images | Same + US | Same as Q-Station 3.0 |
.
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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.
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
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| 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