(79 days)
Not Found
No
The summary describes post-processing software for viewing and evaluating MR images, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on image manipulation and structured evaluation.
No
This device is described as post-processing software used for viewing, manipulating, and evaluating diagnostic MR images, not for providing therapy.
No
The device is described as "post-processing software" for viewing, manipulating, and evaluating images provided by a magnetic resonance diagnostic device, indicating it processes data from a diagnostic device rather than being one itself.
Yes
The device is explicitly described as "post-processing software / applications" and "syngo.via-based post-processing software / applications" for viewing, manipulating, and evaluating MR images. There is no mention of accompanying hardware components.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this software is for post-processing and evaluating images provided by a magnetic resonance diagnostic device. It works with images generated by a medical imaging device, not with samples taken from the body.
- Lack of Biological Sample Processing: There is no mention of processing biological samples, reagents, or any of the typical components associated with IVD devices.
- Focus on Image Analysis: The entire description revolves around viewing, manipulating, and evaluating MR images.
Therefore, this device falls under the category of medical image processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The software comprising the syngo.MR post-processing applications are post-processing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating MR neurological images.
syngo.MR Oncology is a syngo based post-processing software for viewing, manipulating, and evaluating MR oncological images.
Product codes
LLZ, LNH
Device Description
syngo.MR Neurology and syngo.MR Oncology are syngo.via-based post-processing software / applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.
syngo.MR Neurology and syngo.MR Oncology comprise of the following:
syngo.MR Neuro Perfusion
syngo.MR Neuro Perfusion Mismatch
syngo.MR Neuro fMRI
syngo.MR Tractography
syngo.MR Neuro Dynamics (NEW)
syngo.MR Neuro Perfusion Engine
syngo.MR Neuro Perfusion Engine Pro (NEW Marketing Bundle)
syngo.MR Neuro 3D Engine
syngo.MR Onco
syngo.MR 3D Lesion Segmentation
syngo.MR Tissue4D
syngo.MR OncoCare (NEW)
syngo.MR Onco Engine
syngo.MR Onco Engine Pro (NEW)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance diagnostic device / MR images
Anatomical Site
Neurological, Oncological
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare 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)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the symbol. The logo is simple and clean, with a focus on the caduceus symbol and the department's name.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Siemens Medical Solutions USA, Inc. % Cordell Fields, Esq. Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K151353
Trade/Device Name: syngo.MR Neurology and syngo.MR Oncologv Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and LNH Dated: May 1, 2015 Received: May 21, 2015
Dear Mr. Fields:
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. 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
1
Page 2-Cordell Fields, Esq.
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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,
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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 below.
510(k) Number (if known) K151353
Device Name syngo.MR Neurology and syngo.MR Oncology
Indications for Use (Describe)
The software comprising the syngo.MR post-processing applications are post-processing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating MR neurological images.
syngo.MR Oncology is a syngo based post-processing software for viewing, manipulating, and evaluating MR oncological images.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
3
510(k) Summary: syngo.MR Post-Processing Software (syngo.MR Neurology & syngo.MR Oncology)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
Date of Summary Preparation: April 28, 2015
- I. General Information
| Importer / Distributor: | Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 2240869 |
| Manufacturer: | Siemens AG
Medical Solutions
Henkestrasse 127
D-91052 Erlangen, Germany |
| Registration Number: | 3002808157 |
| Contact Person: | Cordell Fields
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy
Mail Code D02
Malvern, PA 19355, USA
Phone: (610) 219-8518 |
Fax: (610) 427-3465
Email: cordell.fields@siemens.com
4
| Data | Details |
|---|---|
| Trade name / | |
| Device Proprietary | |
| Name: | syngo.MR Neurology |
syngo.MR Neurology covers single and engine applications:
• syngo.MR Neuro Perfusion
• syngo.MR Neuro Perfusion Mismatch
• syngo.MR Neuro fMRI
• syngo.MR Tractography
• syngo.MR Neuro Perfusion Engine
• syngo.MR Neuro Perfusion Engine Pro (NEW)
• syngo.MR Neuro 3D Engine
• syngo.MR Neuro Dynamics (NEW) |
| | syngo.MR Oncology
syngo.MR Oncology covers single and engine applications:
syngo.MR Onco
syngo.MR 3D Lesion Segmentation
syngo.MR Tissue4D
syngo.MR Onco Engine
syngo.MR Onco Engine Pro (NEW)
syngo.MR OncoCare (NEW) |
| Classification
Name: | Regulation Description:
Picture Archiving and Communication System (PACS) |
| Classification
Panel: | Radiology |
| Device
Classification: | Class II devices |
| Regulation number: | 21 CFR § 892.2050 |
| Product Code: | Primary: LLZ, Secondary: LNH |
Device Name and Classification
5
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The software comprising the syngo.MR post-processing applications are postprocessing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.
syngo.MR Oncology is a syngo based post-processing software for viewing, manipulating, and evaluating MR oncological images.
Device Description
syngo.MR Neurology and syngo.MR Oncology are syngo.via-based post-processing software / applications to be used for viewing and evaluating2 MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.
syngo.MR Neurology and syngo.MR Oncology comprise of the following:
² While viewing (i.e. assessing) of images from other vendors is always possible; for advanced post-processing applications, some of the post-processing steps may depend on information contained in private DICOM tags, therefore evaluation and processing of images can't be guaranteed for other vendors.
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| Table 1: syngo.MR Neurology and syngo.MR Oncology and their content; new applications for
| this submission are denoted (NEW); all other applications are currently cleared. | |
|---|---|
| Medical device / | |
| post-processing | |
| application | covered single and engines applications |
| syngo.MR | |
| Neurology | syngo.MR Neuro Perfusion |
| allows the visualization of temporal variations in the dynamic | |
| susceptibility time series of MR datasets. |
syngo.MR Neuro Perfusion Mismatch
calculates the difference between the DWI lesion (diffusion
ROI) and the PWI lesion (perfusion ROI) areas.
syngo.MR Neuro fMRI
is a workflow-oriented visualization package for BOLD3 fMRI.
It enables the visualization of task-related areas of activation
overlaid onto 2D or 3D anatomical datasets, providing the
spatial correspondence of BOLD results.
syngo.MR Tractography
allows assessment of central nervous system structures
through utilitzing 3D tractographic data derived from Diffusion
Tensor Imaging.
syngo.MR Neuro Dynamics (NEW)
allows the assessment and evaluation of various spots of
cerebral lesions.
syngo.MR Neuro Perfusion Engine
contains:
syngo.MR Neuro Perfusion syngo.MR Neuro Perfusion Mismatch
syngo.MR Neuro Perfusion Engine Pro (NEW Marketing
Bundle)
contains:
syngo.MR Neuro Perfusion Engine syngo.MR Neuro Dynamics
syngo.MR Neuro 3D Engine
contains:
syngo.MR Neuro fMRI syngo.MR Tractography |
| Medical device /
post-processing
application | covered single and engines applications |
| syngo.MR
Oncology | syngo.MR Onco is an image viewing, processing and reading software that allows for oncological MR image evaluation in a structured way.
syngo.MR 3D Lesion Segmentation provides convenient volumetric evaluation of lesions and/or other structure of interest as well as particularly useful tools for oncology applications.
syngo.MR Tissue4D is post-processing workflow which supports the physician in reading of dynamic contrast-enhanced MR data sets.
syngo.MR OncoCare (NEW) enables the physician to evaluate signal intensities in segmented regions of interest with the help of histograms and color maps as well as evaluation the change of time in typical lesion parameters like diameter or volume (trending).
syngo.MR Onco Engine contains: syngo.MR Onco syngo.MR 3D Lesion Segmentation syngo.MR Onco Engine Pro (NEW) contains: syngo.MR Onco Engine syngo.MR OncoCare (new, see below) |
Table 1: syngo.MR Neurology and syngo.MR Oncology and their content; new applications for
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General Safety and Effectiveness Concerns
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 is ensured via a Risk Analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a Risk Analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development. SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluating and postprocessing of MR images.
8
syngo.MR Neurology and syngo.MR Oncology conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.
Substantial Equivalence
syngo.MR Neurology and syngo.MR Oncology running with the herein described version VB10 has the same Intended Use as the predicate device (see Table 2). The conclusions from the non-clinical data suggest that the additional features bear an equivalent safety and performance profile as that of the predicate device and also does not affect the Indications for use of it.. Therefore syngo.MR Neurology and syngo.MR Oncology are considered to be substantially equivalent to the following current legally marketed device:
| Predicate Device Name | FDA
Clearance
Number | FDA Clearance
Date | Product Code |
|-------------------------------------------------------|----------------------------|-----------------------|--------------|
| syngo.MR Post-Processing
Software Version SMRVA16B | K133401 | March 11, 2014 | LLZ, LNH |
Table 2: Predicate device for syngo.MR Neurology and syngo.MR Oncology
Conclusion as to Substantial Equivalence
The syngo.MR post-processing applications syngo.MR Neurology and syngo.MR Oncology are intended for similar indications as cleared in the predicate device.
In summary, Siemens is of the opinion that the syngo.MR post-processing applications syngo.MR Neurology and syngo.MR Oncology do not raise new questions of safety or effectiveness and are substantially equivalent to the currently marketed device syngo.MR post-processing software version SMRVA16B (K133401 - cleared on March 11, 2014).
There is new added functionality for syngo.MR Neurology (syngo.MR Neuro Dynamics) and syngo.MR Oncology (syngo.MR OncoCare). The differences give the device greater capabilities than the predicate, but the Intended Use, the basic technological characteristics and functionalities remain the same.
Therefore, Siemens believes that the subject device, the syngo.MR post-processing applications syngo.MR Neurology and syngo.MR Oncology, is substantially equivalent to the predicate device listed above in Table 2.