Who is the manufacturer of syngo.MR Neurology, syngo.MR Oncology?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for syngo.MR Neurology, syngo.MR Oncology (K151353).

What is the FDA product code for syngo.MR Neurology, syngo.MR Oncology?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for syngo.MR Neurology, syngo.MR Oncology?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like syngo.MR Neurology, syngo.MR Oncology?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

syngo.MR Neurology, syngo.MR Oncology

K151353 · Siemens Medical Solutions USA, Inc. · LLZ · Aug 7, 2015 · Radiology

Device Facts

Record ID	K151353
Device Name	syngo.MR Neurology, syngo.MR Oncology
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	LLZ · Radiology
Decision Date	Aug 7, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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 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 Story

syngo.MR Neurology and syngo.MR Oncology are syngo.via-based post-processing software applications. Input consists of MR images from magnetic resonance diagnostic devices. Software performs image viewing, manipulation, and structured evaluation. Specific modules include neuro perfusion visualization, mismatch calculation, fMRI BOLD activation overlay, 3D tractography, and oncological lesion segmentation, volumetric evaluation, and trending of signal intensities/diameters. Used in clinical settings by healthcare professionals to assist in diagnostic evaluation. Output is displayed on workstation monitors for physician review. Clinical benefit includes structured assessment of neurological and oncological MR data to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Risk management performed per ISO 14971:2007.

Technological Characteristics

Post-processing software platform (syngo.via). Operates on MR image datasets (DICOM). Conforms to applicable IEC, ISO, and NEMA standards. Software-based processing; no hardware components. Deployment is workstation-based.

Indications for Use

Indicated for viewing, manipulating, and evaluating MR neurological and oncological images provided by a magnetic resonance diagnostic device. Intended for use by healthcare professionals.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

syngo.MR Post-Processing Software Version SMRVA16B (K133401)

Related Devices

K121459 — SYNGO.MR NEUROLOGY · Siemens Medical Solutions USA, Inc. · Jun 22, 2012
K182904 — syngo.MR Applications · Siemens Medical Solutions USA, Inc. · Jul 5, 2019
K180336 — syngo.MR Applications · Siemens Medical Solutions USA, Inc. · Apr 19, 2018
K130749 — SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR · Siemens Medical Solutions USA, Inc. · Aug 20, 2013
K133401 — SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL · Siemens Medical Solutions USA, Inc. · Mar 11, 2014

Submission Summary (Full Text)

{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. {6}------------------------------------------------ | 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 {7}------------------------------------------------ ## 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.