(90 days)
No
The document describes image viewing, manipulation, 3D visualization, comparison, and analytical tools, but does not mention AI or ML. The description of the modification explicitly states it "does not change the technological characteristics of the device" and is based on "current commercially available software features."
No
The device is described as a "medical diagnostic application" and provides "analytical tools to help user assess, and document changes... at diagnostic and therapy follow-up examinations." It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "syngo.via MI Workflows are medical diagnostic applications".
Yes
The device description explicitly states that "The syngo. via MI Workflows are software only medical devices".
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The syngo.via MI Workflows are described as software applications for viewing, manipulating, and analyzing medical images (PET, SPECT, CT, MR). They process image data acquired from imaging modalities, not biological samples.
- Intended Use: The intended use focuses on aiding in the interpretation and evaluation of medical images for diagnostic and follow-up purposes. It does not involve the analysis of in vitro samples.
Therefore, the syngo.via MI Workflows fall under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via M1 Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV(PET) across different PET systems or different reconstruction methods.
syngo.via MI Workflows support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo. via MI Workflows are a complement to these standard procedures.
Product codes
LLZ
Device Description
The syngo. via MI Workflows are software only medical devices which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.
syngo. via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.
The modifications to the syngo.via MI Workflows (K123577) is adding a new feature allowing the physician to harmonize SUV data based on a standard reference value, allowing comparison of scans acquired over multiple timepoints or using different scan parameters or equipment. This change is based on current commercially available software features and does not change the technological characteristics of the device.
syngo via MI Workflows are intended to be run on the Siemens syngo.via software platform (K123375) either alone or with other advanced commercially cleared applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET or SPECT, CT or MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.
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)
Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed and that all hazard mitigations have been fully implemented.
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).
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K133644
Page 1 of 3
. ..
510(k) Summary
as required by 21 CFR Part 807.87(h)
FEB 2 5 2014
- « «
Identification of the Submitter
| Submitter: | M. Alaine Medio, RAC
PET and PCS Regulatory Projects Manager
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | (865)218-2703 |
| Fax Number: | (865)218-3019 |
| Name / Address of Manufacturer | Siemens Medical Solutions USA, Inc
Molecular Imaging
2501 N. Barrington Road
Hoffman Estates, IL 60192
USA |
| Date of Submission: | November 25, 2013 |
| Identification of the product | |
| Device Proprietary Name: | syngo.via MI Workflows |
| Common Name: | Image Processing Software |
| Classification Name: | Picture Archiving and Communication System per 21 CFR
892.2050 |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | Class II |
1
Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| syngo.via MI | ||
| Workflows | Siemens Medical Solutions USA, Inc | K123577 (January 22, 2013) |
Device Description:
The syngo. via MI Workflows are software only medical devices which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.
syngo. via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.
The modifications to the syngo.via MI Workflows (K123577) is adding a new feature allowing the physician to harmonize SUV data based on a standard reference value, allowing comparison of scans acquired over multiple timepoints or using different scan parameters or equipment. This change is based on current commercially available software features and does not change the technological characteristics of the device.
syngo via MI Workflows are intended to be run on the Siemens syngo.via software platform (K123375) either alone or with other advanced commercially cleared applications.
Safety and Effectiveness:
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk Management has been ensured via risk analyses in compliance with ISO 14971:2012 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards for development including ISO 13485 and IEC 62304.
Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed and that all hazard mitigations have been fully implemented.
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K133644
Page 3 of 3
Indications for Use:
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via M1 Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV(PET) across different PET systems or different reconstruction methods.
syngo.via MI Workflows support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo. via MI Workflows are a complement to these standard procedures.
Conclusions:
There are no differences in the Fundamental Technological Characteristics of the syngo.via MI Workflows as compared to the currently commercially available software (K123577). Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device. Based on this information, as well as the documentation in support of the modifications, it is Siemens opinion that the syngo via MI Workflows software with the modifications outlined in this application is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
Siemens Medical Solutions USA, Inc. % Alaine Medio, RAC PET and PCS Regulatory Projects Manager 810 Innovation Drive KNOXVILLE TN 37932-2571
Re: K133644
Trade/Device Name: syngo.via MI Workflows Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: 1.L.Z Dated: November 26, 2013 Received: November 27. 2013
Dear Ms. Medio:
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. Iisting 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 (2) CFR Part 820); and if applicable, the electronic form in and quinn control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
4
Page 2-Ms. Medio
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
hup://www.fda.gov/MedicalDevices/Resources/or You/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/deliault.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/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Michael D. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K133644
Device Name: syngo.via MI Workflows
Indications for Use:
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports functional data, such as PET or SPECT as well as anatomical data sets. such as CT or MR.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo via MI Workflows provide analytical tools to help user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.
syngo via MI Workflows support the interpretation and evaluation of examinations and followup documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.
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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Richard D. O'Hara
(Division Sign-Off Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
રે । O(k) K133644
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