(79 days)
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 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.
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 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 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)
The provided text is a 510(k) summary for the syngo.MR Neurology and syngo.MR Oncology post-processing software. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone study proving the device meets those criteria.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study results, sample sizes, ground truth establishment for a test set, and multi-reader multi-case studies is not present in this document.
However, based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
This document does not provide specific quantitative acceptance criteria or a table of reported device performance metrics like sensitivity, specificity, or accuracy. The clearance is based on substantial equivalence to a predicate device (syngo.MR Post-Processing Software Version SMRVA16B, K133401) under the regulation for Picture Archiving and Communication Systems (PACS) (21 CFR 892.2050), which typically involves functional equivalence and safety rather than a diagnostic performance study against a clinical gold standard for the post-processing applications themselves.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical data" suggesting an equivalent safety and performance profile, but it does not detail a specific test set, its size, or provenance for a clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Since no specific clinical performance study is detailed, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The document focuses on the capabilities of the post-processing software for viewing, manipulating, and evaluating images, and it does not describe a comparative effectiveness study involving human readers with and without AI assistance for improved diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study against a clinical ground truth for diagnostic parameters (like sensitivity/specificity) is not detailed in this document. The description of the device is as "post-processing software / applications to be used for viewing and evaluating," implying human interpretation of the processed images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
Given that this is a 510(k) for a PACS-related software and not a de novo AI diagnostic device, there is no mention of a training set in the context of machine learning model development. The "syngo.MR Neurology" and "syngo.MR Oncology" applications and their sub-components are described as post-processing software that perform tasks like visualization of temporal variations, calculation of differences between lesions, workflow-oriented visualization of fMRI, and 3D tractographic data utilization. While these involve algorithms, the document doesn't frame them as AI models requiring a training set in the typical sense for a diagnostic claim.
9. How the ground truth for the training set was established
Since there is no mention of a training set or machine learning model development, this information is not applicable/provided in the document.
Summary of what the document indicates regarding "acceptance criteria" and "study":
The "acceptance criteria" for this 510(k) appear to be based on the general safety and effectiveness of the device, primarily by demonstrating substantial equivalence to an already cleared predicate device (syngo.MR Post-Processing Software Version SMRVA16B, K133401). The "study" that proves the device meets these criteria is an internal assessment against recognized standards and the predicate device.
- General Safety and Effectiveness Concerns: The document states that the device labeling contains instructions for use and warnings, and that risk management is ensured via a Risk Analysis compliant with ISO 14971:2007. Risks are controlled via measures in software development, SW testing, and product labeling.
- Conformance to Standards: The device conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards.
- Substantial Equivalence: The primary "proof" is the comparison to the predicate device. The new functionalities (syngo.MR Neuro Dynamics and syngo.MR OncoCare) are stated to give the device "greater capabilities than the predicate" but that "the Intended Use, the basic technological characteristics and functionalities remain the same."
- Conclusion: Siemens believes the device "do[es] not raise new questions of safety or effectiveness and are substantially equivalent to the currently marketed device."
In essence, this 510(k) submission relies on the established safety and performance profile of a predicate device and adherence to general device safety and quality standards, rather than presenting a de novo clinical performance study with defined acceptance criteria for diagnostic accuracy.
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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
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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
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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
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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 ParkwayMail Code D02Malvern, PA 19355, USA |
|---|---|
| Registration Number: | 2240869 |
| Manufacturer: | Siemens AGMedical SolutionsHenkestrasse 127D-91052 Erlangen, Germany |
| Registration Number: | 3002808157 |
| Contact Person: | Cordell FieldsRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.51 Valley Stream PkwyMail Code D02Malvern, PA 19355, USAPhone: (610) 219-8518 |
Fax: (610) 427-3465
Email: cordell.fields@siemens.com
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| Data | Details |
|---|---|
| Trade name /Device ProprietaryName: | syngo.MR Neurologysyngo.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 Oncologysyngo.MR Oncology covers single and engine applications:syngo.MR Oncosyngo.MR 3D Lesion Segmentationsyngo.MR Tissue4Dsyngo.MR Onco Enginesyngo.MR Onco Engine Pro (NEW)syngo.MR OncoCare (NEW) | |
| ClassificationName: | Regulation Description:Picture Archiving and Communication System (PACS) |
| ClassificationPanel: | Radiology |
| DeviceClassification: | Class II devices |
| Regulation number: | 21 CFR § 892.2050 |
| Product Code: | Primary: LLZ, Secondary: LNH |
Device Name and Classification
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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 forthis submission are denoted (NEW); all other applications are currently cleared. | |
|---|---|
| Medical device /post-processingapplication | covered single and engines applications |
| syngo.MRNeurology | syngo.MR Neuro Perfusionallows the visualization of temporal variations in the dynamicsusceptibility time series of MR datasets.syngo.MR Neuro Perfusion Mismatchcalculates the difference between the DWI lesion (diffusionROI) and the PWI lesion (perfusion ROI) areas.syngo.MR Neuro fMRIis a workflow-oriented visualization package for BOLD3 fMRI.It enables the visualization of task-related areas of activationoverlaid onto 2D or 3D anatomical datasets, providing thespatial correspondence of BOLD results.syngo.MR Tractographyallows assessment of central nervous system structuresthrough utilitzing 3D tractographic data derived from DiffusionTensor Imaging.syngo.MR Neuro Dynamics (NEW)allows the assessment and evaluation of various spots ofcerebral lesions.syngo.MR Neuro Perfusion Enginecontains:syngo.MR Neuro Perfusion syngo.MR Neuro Perfusion Mismatchsyngo.MR Neuro Perfusion Engine Pro (NEW MarketingBundle)contains:syngo.MR Neuro Perfusion Engine syngo.MR Neuro Dynamicssyngo.MR Neuro 3D Enginecontains:syngo.MR Neuro fMRI syngo.MR Tractography |
| Medical device /post-processingapplication | covered single and engines applications |
| syngo.MROncology | 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.
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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 | FDAClearanceNumber | FDA ClearanceDate | Product Code |
|---|---|---|---|
| syngo.MR Post-ProcessingSoftware 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.
§ 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).