(27 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard image management, viewing, and manual analysis tools.
No
This device is workstation software designed for managing, viewing, reporting, and analyzing image and waveform data to aid clinicians in diagnostic activity. It does not directly provide therapy or affect the structure or function of the body.
Yes
The device is described as aiding clinicians in "diagnostic activity" and providing tools for users to "manually assess and score cardiac wall motion", which are diagnostic functions.
Yes
The device is explicitly described as "workstation software" and "a software application package" designed to manage, view, and report data from other medical devices (Ultrasound and ECG systems). There is no mention of accompanying hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device function: The Q-Station software manages, views, and reports image data acquired by Ultrasound systems and cardiac waveform data from ECG systems. It processes and analyzes in vivo (within the living body) data, not in vitro (outside the living body) specimens.
- Intended Use: The intended use describes managing, viewing, and reporting image and waveform data from medical imaging and physiological monitoring devices. This aligns with medical imaging and data management, not IVD testing.
- Device Description: The description reinforces its function as a workstation for managing and analyzing image and waveform data from ultrasound and ECG systems.
- Lack of IVD characteristics: There is no mention of handling biological specimens, performing laboratory tests, or providing diagnostic information based on the analysis of bodily fluids or tissues.
Therefore, the Q-Station software falls under the category of medical imaging software or medical data management software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 waveform data from Philips Stress Vue ECG systems. Q-Station offers support for QLAB plug-ins for analysis, quantification and reporting of data from ultrasound systems.
Product codes
LLZ
Device Description
O-Station is workstation software designed for managing, viewing and reporting qualitative and quantitative image data from ultrasound exams. It includes advanced analysis via QLAB integration (QLAB 8.0) and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. It supports connectivity to ultrasound systems, PACS, other DICOM storage repositories, and Philips Stress Vue ECG systems to aid clinicians in diagnostic activity. Q-Station supports QLAB Plug-ins.
Mentions image processing
CFR 892.2050, system, image processing, radiological, Product code LLZ, Class II
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound systems, cardiac waveform data from Philips StressVue ECG systems
Anatomical Site
Not Found
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. The Q-Station software has been designed to comply with the following voluntary standards:
- NEMA PS 3.1 - 3.18 (2008), Digital Imaging and Communications in Medicine (DICOM) Set
- t IEC/ISO 10918-1:1994 Technical Corrigendum 1:2005, Information technology - Digital compression and coding of continuous-tone still images
Software development for the Q-Station 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
510(k) Premarket Notification
... ... ...
Q-Station 1.0
5. 510(k) Summary
This summary of safety and effectiveness is provided as part of the Premarket JAN 2 2011
Notification in compliance with 21CER Part 807 Submat E Section 807 92 Notification in compliance with 21CFR. Part 807, Subpart E. Section 807.92
- Submitter's name, address, telephone number, contact person
Philips Ultrasound. Inc. P.O. Box 3003 Bothell, WA 98021-3003 Nancy Burke, Regulatory Affairs Specialist Telephone: (425) 487-7371 Facsimile: (425) 487-8666 E-mail: Nancy. Burke@philips.com
Date prepared: December 15, 2010
- 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 |
| Classification Name: | CFR 892.2050, system, image processing, radiological, Product code LLZ, Class II |
3) Substantially Equivalent Devices
Philips Ultrasound believes that the Q-Station 1.0 software is substantially equivalent to other commercially available products, specifically Xcelera (K061995).
3) Device Description
O-Station is workstation software designed for managing, viewing and reporting qualitative and quantitative image data from ultrasound exams. It includes advanced analysis via QLAB integration (QLAB 8.0) and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. It supports connectivity to ultrasound systems, PACS, other DICOM storage repositories, and Philips Stress Vue ECG systems to aid clinicians in diagnostic activity. Q-Station supports QLAB Plug-ins.
1
4) 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 waveform data from Philips StressVue ECG systems.
5) Technological comparison to predicate devices
Both Philips Q-Station and Philips Xcelera are software applications for medical image and data review and patient report preparation. Both are DICOM compatible and allow for the storage and save/retrieve of image data and reports. Both are workstation software applications intended to be used with medical DICOM images and waveforms acquired from other modalities.
6) Non-clinical performance data
No performance standards for PACS systems or components have been issued under the authority of Section 514. The Q-Station software has been designed to comply with the following voluntary standards:
- NEMA PS 3.1 - 3.18 (2008), Digital Imaging and Communications in Medicine (DICOM) Set
- t IEC/ISO 10918-1:1994 Technical Corrigendum 1:2005, Information technology - Digital compression and coding of continuous-tone still images
Software development for the Q-Station 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.
7) General Safety and Effectiveness Concerns
The device labeling contains operating instructions for the safe and effective use of the Q-Station software.
8) Conclusions
The O-Station software is designed and manufactured to meet United States and international standards for the display and quantification of images acquired on 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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three lines representing the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird 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 Medical Systems Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
JAN 2 5 2011
Re: K103815
Trade/Device Name: Q-Station Software 1.0 Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 28, 2010 Received: December 29, 2010
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 of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
1. Indications for Use Statement
510(k) Number (if known):
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
Device Name: Q-Station software 1.0
Indication for 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 waveform data from Philips Stress Vue ECG systems. Q-Station offers support for QLAB plug-ins for analysis, quantification and reporting of data from ultrasound systems.
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)
Richard O'Brien
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103815