(23 days)
Not Found
No
The summary describes a client/server software architecture for image display and analysis, but does not mention any AI or ML capabilities.
No
The device is used to aid in detecting, localizing, diagnosing, and staging diseases through imaging, and for assessment and quantification of pathologies, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders". The software also aims "to aid the clinician in the assessment and quantification of pathologies".
Yes
The device is described as a software application provided on a server with clients running on personal computers or Macs, and the description focuses solely on the software's functionality for display and analysis of medical images, without mentioning any proprietary or integrated hardware components.
Based on the provided information, the Siemens Symbia series is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function" using imaging modalities like SPECT, PET, and CT. This involves analyzing images of the patient's body, not analyzing samples taken from the patient (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The description focuses on the software and hardware for processing and displaying medical images. It doesn't mention any components or processes related to analyzing biological samples.
- Input Imaging Modality: The input modalities are imaging techniques (SPECT, PET, CT), which capture images of the body, not laboratory tests on biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. The Siemens Symbia series is a medical imaging system used for diagnostic imaging, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Symbia.net introduces client/server functionality allowing the MI Applications product to be deployed on any compatible hardware (including desktops, laptops and workstations) that meet minimal hardware requirements. Symbia.net is a solution for SPECT. SPECT-CT. PET. and PET-CT systems.
The software application is provided on a server. Clients running on any personal computer or Mac, meeting minimum requirements, can have access to the system. The rendered images on the client and server side are clinically equivalent with each other. No image quality deqradation on any of the images shown in the clients compared to the images shown on the server related to resolution, color and timing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT, SPECT-CT, PET, PET-CT and other imaging modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 110844
APR 2 0 2011
Symbia.net VA10B Special 510(k) Premarket Notification
Strictly Confidential
510(k) Summary as required by 21 CFR Part 807.87(h) Elaine Chang Submitter: Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road · Hoffman Estates, IL 60192 .. USA Telephone Number: (847) 304-7516 Fax Number: (865) 218-3019 Siemens Medical Solutions USA, Inc Name / Address of Molecular Imaging Manufacturer 2501 N. Barrington Road Hoffman Estates, IL 60192 USA Date of Submission: March 25, 2011 ldentification of the product Device Proprietary Name: Symbia.net VA10B Common Name: Picture Archiving and Communication System Classification Name: Picture Archiving and Communication System per 21 CFR 892.2050 Product Code: LLZ Classification Panel: Radiology Device Class: Class II
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Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| Symbia.net (2009A) | Siemens Medical Solutions USA, | |
| Inc | K100619 | |
| Symbia 4.0 (MI | ||
| Applications 2009A) | Siemens Medical Solutions USA, | |
| Inc | K082506 |
Device Description:
Symbia.net introduces client/server functionality allowing the MI Applications product to be deployed on any compatible hardware (including desktops, laptops and workstations) that meet minimal hardware requirements. Symbia.net is a solution for SPECT. SPECT-CT. PET. and PET-CT systems.
The software application is provided on a server. Clients running on any personal computer or Mac, meeting minimum requirements, can have access to the system. The rendered images on the client and server side are clinically equivalent with each other. No image quality deqradation on any of the images shown in the clients compared to the images shown on the server related to resolution, color and timing.
Safety and Effectiveness:
Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cvcle and continuing throughout the development of the product. Siemens considers that the proposed device does not introduce new safety concerns, and is substantially the same in indications for use, design, materials, energy sources and technology as the predicate devices. Siemens believes that Symbia.net is substantially equivalent to the predicate devices.
Indications for Use:
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT. PET. CT and other imaging modalities.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
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
Ms. Elaine Chang Regulatory Technical Specialist Siemens Medical Solutions USA. Inc. 2501 N Barrington Road HOFFMAN ESTATES IL 60192
APR 2 0 2011
Re: K110844
Trade/Device Name: Symbia.net VA10B Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 25, 2011 Received: March 28, 2011
Dear Ms. Chang:
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 (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 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 Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K11 U 8-4 Y
Device Name: Symbia.net VA10B
Indications for Use:
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
Prescription Use × (Part 21 CFR 801 Subpart D) OR
Over the Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
Mary S. Patel
510K K110 844
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