(63 days)
No
The document describes standard image viewing, manipulation, and analysis tools without mentioning AI, ML, or related concepts. The description of modifications explicitly states they are based on current commercially available software features and do not change the technological characteristics.
No
Explanation: The device is described as a "medical diagnostic application" and "diagnostic applications" used for viewing, manipulating, and comparing medical images to help users assess and document changes for diagnostic and therapy follow-up examinations. It explicitly states it is a "complement to these standard procedures" where the clinician retains "the ultimate responsibility for making the pertinent diagnosis," which indicates it is an aid for diagnosis rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that "syngo.via MI Workflows are medical diagnostic applications." They also mention that the application provides analytical tools to help the user "assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations."
Yes
The device description explicitly states, "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 images 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. This is distinct from analyzing biological 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 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.
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 (comma separated list FDA assigned to the subject device)
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.
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 morpholoqical 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 synqo.via MI Workflows (K113029) are adding enhanced functionality to the commercially available Oncology workflow in this software. All changes are based on current commercially available software features and do not change the technological characteristics of the device.
syngo.via MI Workflows are intended to be run on the Siemens synqo.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, SPECT, CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiology, Nuclear Medicine, 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 mitigators have been fully implemented.
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.
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
Siemens syngo.via MI Workflows
510(k) Premarket Notification
510(k) Summary
1235
as required by 21 CFR Part 807.87(h)
JAN 2 2 2013
Identification of the Submitter
M. Alaine Medio, RAC Submitter: 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 Siemens Medical Solutions USA, Inc Name / Address of Molecular Imaqing Manufacturer 2501 N. Barrington Road Hoffman Estates, IL 60192 USA Date of Submission: November 19, 2012 Identification of the product Device Proprietary Name: syngo.via MI Workflows Common Name: Image Processing Software Picture Archiving and Communication System per 21 Classification Name: CFR 892.2050 Product Code: LLZ
Radiology
Class II
Classification Panel:
Device Class:
1
Siemens syngo.via MI Workflows 510(k) Premarket Notification
Marketed Devices to which Equivalence is claimed
Device
Manufacturer
510(k) Number
synqo.via Ml Workflows (syngo.via MI Taskflows)
Siemens Medical Solutions USA, Inc
K113029 (November 18, 2011)
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 morpholoqical 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 synqo.via MI Workflows (K113029) are adding enhanced functionality to the commercially available Oncology workflow in this software. All changes are based on current commercially available software features and do not change the technological characteristics of the device.
syngo.via MI Workflows are intended to be run on the Siemens synqo.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 14971:2007 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 mitigators have been fully implemented.
2
Indications for Use:
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaginq 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 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.
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 Indications for Use or Fundamental Technological Characteristics of the syngo via MI Workflows as compared to the currently commercially available software (K113029). 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.
Page 33 of 2835
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure with three arms or extensions, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
January 22, 2013
Ms. Alaine Medio, RAC PET and PCS Regulatory Projects Manager Molecular Imaging 810 Innovation Drive KNOXVILLE TN 37934
Re: K123577
Trade/Device Name: syngo.via MI Workstaion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 19, 2012 Received: November 20, 2012
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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Ms. Medio, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Industry/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):
syngo.via MI Workflows Device Name:
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 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.
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.
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 ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
OR
Division/Sign Off
Page 1 of
Division of Radiological Hea
Office of In Vitro Diagnostics and
Office of In Vitro Diag.
510(k) K123577.