It is a syngo via based software option with dedicated MR specific workflows and basic MR specific evaluation tools and thus supports interpretation and evaluation of examinations within healthcare institutions, for example in Radiology, Neuroradiology and Neurosurgery environments.

Device Description

syngo.MR Neurology is a post-processing software/application to be used for viewing and evaluating neurological MR images provided by a magnetic resonance diagnostic device. syngo.MR Neurology is a syngo.via-based software that enables structured evaluation of MR neurological images.

The medical device syngo.MR Neurology comprises syngo.MR Neuro fMRI (Neuro functional evaluation) and syngo.MR Neuro Perfusion Engine. syngo.MR Neuro Perfusion Engine comprises syngo.MR Neuro Perfusion (Perfusion and Local as well as Global AIF (Arterial Input Function)) and syngo.MR Neuro Perfusion Mismatch (Perfusion-Diffusion Mismatch Evaluation). This bundling is done for purchase purposes. Each application can also be purchased separately.

syngo.MR Neuro Perfusion enables: processing of brain perfusion datasets acquired with DSC imaging. It provides color display and calculation of perfusion maps based on Arterial Input Function (AIF) (relative Mean Transit Time (relMTT), relative Cerebral Blood Volume (relCBV), and relative Cerebral Blood Flow (relCBF)).
syngo.MR Neuro Perfusion Mismatch performs a calculation of the area differences between perfusion-diffusion datasets.
syngo.MR Neuro fMRI is a workflow-oriented visualization package for BOLD fMRI.

AI/ML Overview

The provided text is a 510(k) summary for the syngo.MR Neurology device. It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. The document claims substantial equivalence based on similar intended use and technical characteristics, and lists standards followed, but does not provide a table of acceptance criteria vs. device performance or details of a performance study in the manner requested.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria or provide a table of device performance metrics against such criteria. It states that the device "does not introduce any new issues of safety or effectiveness" and that "risk management is ensured via a risk analysis in compliance with ISO 14971:2007."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No information regarding a test set or data provenance is present in the document.

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)

Cannot be provided. No information about ground truth establishment or experts is present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No information about adjudication methods is present.

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

Cannot be provided. The document does not describe an MRMC study or any comparison of human readers with vs. without AI assistance. The device is described as "post-processing software" and "evaluation tools" for physicians, but not explicitly as an AI-assisted diagnostic tool in the sense of a comparative effectiveness study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. No information about a standalone performance study is present.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No information about ground truth is present.

8. The sample size for the training set

Cannot be provided. No information about a training set for algorithm development is present.

9. How the ground truth for the training set was established

Cannot be provided. No information about training set ground truth establishment is present.

Summary

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SIEMENS

Traditional 510(k) Submission: syngo.MR Neurolo

JUN 2 2 2012

510(k) Summary: syngo.MR Neuroloqy

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: May 15, 2012

l. General Information

Importer/Distributor	Siemens Medical Solutions USA, Inc.
	51 Valley Stream Pkwy
	Mail Code D02
	Malvern, PA 19355, USA
Registration Number:	2240869

Manufacturer

Siemens AG Sector Healthcare Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany 8010024

Registration Number:

Contact Person

Michelle Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwv Mail Code D02 Malvern, PA 19355, USA Phone: (610) 448-4293 Fax: (610) 448-1787 Email: Michelle.L.Byrne@siemens.com

Device Name and Classification

Data	Details
Trade name /DeviceProprietaryName:	syngo.MR Neurology
	syngo.MR Neurology includes syngo.MR Neuro PerfusionEngine and syngo.MR Neuro fMRI. syngo.MR NeuroPerfusion Engine bundles the applications syngo.MRNeuro Perfusion and syngo.MR Neuro Perfusion Mismatch.
	Each application is also sold separately.

Traditional 510(k) for syngo.MR Neurology

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Traditional 510(k) Submission: syngo.MR Neurology

Data	Details
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:	LLZ, LNH

II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

SIEMENS

syngo.MR Neurology is a software solution to be used for viewing and evaluation of Neuroperfusion MR images for the routine use in MR image viewing.

Device Description

and Local as well as Global AIF (Arterial Input Function)) and syngo.MR Neuro Perfusion Mismatch (Perfusion-Diffusion Mismatch Evaluation). This bundling is done for purchase purposes. Each application can also be purchased separately.

syngo.MR Neuro Perfusion enables: processing of brain perfusion datasets acquired with DSC imaging. It provides color display and calculation of perfusion maps based on Arterial Input Function (AIF) (relative Mean Transit Time (relMTT), relative Cerebral Blood Volume (relCBV), and relative Cerebral Blood Flow (relCBF)).
syngo.MR Neuro Perfusion Mismatch performs a calculation of the area differences between perfusion-diffusion datasets.

Traditional 510(k) for syngo.MR Neurology

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SIEMENS

Traditional 510(k) Submission: syngo.MR Neurology

syngo.MR Neuro fMRI is a workflow-oriented visualization package for BOLD fMRI.

General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Risk management is ensured via a risk analysis 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. These potential hazards are controlled via software development, verification and validation testing. To minimize hazards, Siemens adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluating and post processing of magnetic resonance images.

syngo.MR Neurology conforms 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 is substantially equivalent to the following predicate devices (see Table 1):

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
syngo MR D11D for MAGNETOMAera & MAGNETOM Skyra	K111242	November 23, 2011
syngo.x®3	K092519	August 27, 2009

Predicate devices for syngo.MR Neurology Table 1:

Conclusion as to Substantial Equivalence

syngo.MR Neurology has a similar intended use and the same basic technical characteristics as the predecessor devices syngo MR D11D (on MAGNETOM Aera and MAGNETOM Skyra) and syngo.x, in regards to the specific neurological functionalities. syngo.MR Neurology will be used for post-processing neurological images (viewing, processing and reading). The predicate device, MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D11D, is also capable of postprocessing neurological images (viewing, processing and reading), in addition to acquiring the MR images. syngo.x is used as the basic software platform and is intended for post-processing, for example, viewing, manipulating, communicating and

3 syngo.x is a registered trademark of Siemens AG. Traditional 510(k) for syngo.MR Neurology

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SIEMENS

Traditional 510(k) Submission: syngo.MR Neurology

storing medical images. The differences between the subject device and the predicate devices, which include the aforementioned new software applications, give the subject device greater capabilities than the predicate devices, but have the same technological characteristics as the predicate devices, are similar to the functionalities of the predicate devices, and do not introduce any new issues of safety or effectiveness.

Traditional 510(k) for syngo.MR Neurology

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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

JUN 2 2 2012

Ms. Michelle L. Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355

Re: K121459

Trade/Device Name: syngo.MR Neurology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 15. 2012 Received: May 17, 2012

Dear Mr. Ms. Byrne:

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 r 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 or any I vith 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 pactice mourements 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,

Janine M. Morris

Acting 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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K121459

SIEMENS

Traditional 510(k) Submission: syngo.MR Neurology

Indications for Use Statement

510(k) Number (if known)

syngo.MR Neurology Device Name:

Indications for Use:

syngo.MR Neurology is a software solution to be used for viewing and evaluation of Neuroperfusion MR images for the routine use in MR image viewing.

Prescription Use × (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 Diagnostic Devices (OIVD)

Aalund D. O'R

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Kla1459

Page 1 of 1

Traditional 510(k) for syngo.MR Neurology

Regulation Number and Section

§ 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).