(148 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on new sequences, features, and modifications of existing software.
No
The device is described as a "magnetic resonance diagnostic device (MRDD)" and its "Intended Use / Indications for Use" explicitly state it is for "diagnostic devices" that "yield information that may assist in diagnosis," not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The MAGNETOM systems are indicated for use as magnetic resonance diagnostic devices (MRDD)".
No
The device is described as "syngo MR E11C system software" which is made available for specific MAGNETOM MR Systems. While it is software, it is explicitly stated to be part of and operate on existing hardware (MAGNETOM MR Systems), indicating it is not a standalone software-only medical device. The performance studies also include nonclinical tests related to acoustic noise and image quality assessments, which are tied to the performance of the overall MR system, not just the software in isolation.
Based on the provided information, 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 or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MAGNETOM systems are described as magnetic resonance diagnostic devices (MRDD) that produce images and/or spectra of the internal structure and/or function of the body. This is an in vivo diagnostic method, meaning it is performed on a living organism, not on a sample taken from the body.
- Intended Use: The intended use clearly states that the systems produce images and spectra of the head, body, or extremities, and that these images are interpreted by a trained physician to assist in diagnosis. This aligns with the function of an imaging device, not an IVD.
- Device Description: The device description focuses on the software for MR systems, which are imaging devices.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the MAGNETOM systems and the syngo MR E11C system software are imaging devices used for in vivo diagnosis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MAGNETOM systems are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Product codes
LNH, LNI, MOS
Device Description
The subject device, syngo MR E11C system software, is being made available for the following MAGNETOM MR Systems:
- MAGNETOM Aera,
- MAGNETOM Skyra, ●
- MAGNETOM Prisma and
- MAGNETOM Prisma™ ●
The syngo MR E11C SW includes new sequences. new features and minor modifications of already existing features. A high level summary of the new sequences and features is included below. Further, modified and migrated sequences and features are also listed.
New Sequences
-
qDWI a new Quiet Diffusion Sequence for Brain Imaging .
A noise reduced sequence for diffusion weighted imaging (called "qDWI") is provided with syngo MR E11C. The sequence is technically based on a readout segmented EPI sequence (RESOLVE, currently available on the predicate device software). Gradients have been stretched to minimize the slew rate in order to reduce acoustic noise. -
Improvements in BLADE Imaging (fast TSE) .
With this software version, an optimized variant of the TSE for abdominal imaging is released and is called FAST_TSE. The main characteristics of FAST TSE are the same as for TSE which is one of the most basic sequences available on all MAGNETOM Systems.
New Features
- SMS EPI a new feature for Brain Diffusion and BOLD Imaging . In Simultaneous Multi Slice imaging several slices are excited simultaneously and separated during image reconstruction. The feature is intended for EPI diffusion and EPI BOLD brain imaging.
- . GOBrain – a new feature which supports brain examination in short acquisition time for MAGNETOM Aera/Skyra
With syngo MR E11C a complete brain examination in short acquisition time is provided for MAGNETOM Aera and MAGNETOM Skyra systems with a 20, 32, or 64 channel head coil. The examination consists of a localizer, T1w, T2w, dark fluid (FLAIR), DWI, and T2*w protocol.
- New features for Breast Dot Engine Dynamic Breast Evaluation and . Auto Bolus Detection
With synqo MR VD13A (clearance K133435) the feature 'Breast Dot Engine', a workflow solution for breast MRI, was cleared. Following the FDA clearance of the contrast agent Gadavist® for breast MRI, this software version adds the Automatic Bolus Detection feature for support of contrast exams.
Modified Sequences or Features
- । SPAIR fat sat improvements (applicable for 3T MR Systems addressed by syngo MR E11C)
- । Improvements in Liver Seqmentation
- Improvement in Multi Echo Dixon for Fat Iron Quantification
- A flow compensated SE sequence for 3T systems (Skyra and । Prisma/Prisma™) only
- । Improvements in Inline Ventricular function
- Improvements in VIBE ।
Migrated Features
- QISS, MyoMaps and LiverLab for MAGNETOM Skyra 24 only
- The Body 18 and Body 18 long coil will be made available for MAGNETOM Skyra (24-channel configuration only ("Skyra-24")). These coils are cleared on other Skyra systems with the primary predicate device with exception of Skyra-24.
Other Modifications
- Front cover panel refresh for MAGNETOM Aera and MAGNETOM Skyra
- Provide secure MR scanner setup for DoD (Department of Defense) Information Assurance compliance.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
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)
Nonclinical Tests
The following performance testing was conducted on the subject device
- Sample clinical images were taken for particular new and modified sequences. ●
- . Acoustic noise measurements were performed for quiet sequences
- . Image quality assessments of all new/modified sequences and algorithms, were completed.
- Software verification and validation testing was completed in accordance with the ● FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.
Clinical Tests
No clinical tests were conducted to support the subject device and the substantial equivalence argument; however, clinical images were provided to support the new coils as well as the new software features of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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 the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
Siemens Medical Solutions, Inc. % Mr. John Urtz Regulatory Affairs Specialist 40 Liberty Boulevard Mail Code 65-1A MALVERN PA 19355
Re: K153343
Trade/Device Name: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prismafit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 14, 2016 Received: March 14, 2016
Dear Mr. Urtz:
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.
1
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 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. O'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma/Prismafit
Indications for Use (Describe)
The MAGNETOM systems are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 84 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
|× Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented.
510(k) Summary
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.
- I. General Information
| Establishment | Siemens Medical Solutions USA. Inc.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 13, 2016 |
| Manufacturer | Siemens AG / Siemens Healthcare GmbH
Henkestrasse 127
Erlangen Bayern, Germany 91052
Registration Number: 3002808157
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
Siemens MRI Center
Hi-Tech Industrial park (middle)
Gaoxin C. Ave., 2nd
Shenzhen 518057, P.R. CHINA
Registration Number: 3004754211 |
| Contact Person | Mr. John Urtz
Regulatory Affairs Specialist
Siemens Healthcare
Siemens Medical Solutions USA, Inc.
Customer Solutions Group
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Phone: (610) 448-6002
Fax: (610) 640-4481 |
| Device Name | syngo MR E11C software for MAGNETOM Aera,
MAGNETOM Skyra and MAGNETOM Prisma/Prismafit MR
Systems |
Siemens 510(k) Traditional Premarket Notification
April 13, 2016
syngo MR E11C Software for Siemens MR Systems: MAGNETOM Aera (1.5T), MAGNETOM Skyra (3T) and MAGNETOM Prisma/ Prismafit (3T)
4
Trade Names: MAGNETOM Aera MAGNETOM Skyra MAGNETOM Prisma MAGNETOM Prisma™
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
|---|---|
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH, Secondary: LNI, MOS |
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The indications for use for the subject device are the same as the predicate device and are as follows:
The MAGNETOM systems [MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma and MAGNETOM Prisma™] are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Device Description
The subject device, syngo MR E11C system software, is being made available for the following MAGNETOM MR Systems:
- MAGNETOM Aera,
- MAGNETOM Skyra, ●
- MAGNETOM Prisma and
- MAGNETOM Prisma™ ●
Siemens 510(k) Traditional Premarket Notification
April 13, 2016
syngo MR E11C Software for Siemens MR Systems: MAGNETOM Aera (1.5T), MAGNETOM Skyra (3T) and MAGNETOM Prisma/ Prismafit (3T)
5
SIEMENS
The syngo MR E11C SW includes new sequences. new features and minor modifications of already existing features. A high level summary of the new sequences and features is included below. Further, modified and migrated sequences and features are also listed.
New Sequences
-
qDWI a new Quiet Diffusion Sequence for Brain Imaging .
A noise reduced sequence for diffusion weighted imaging (called "qDWI") is provided with syngo MR E11C. The sequence is technically based on a readout segmented EPI sequence (RESOLVE, currently available on the predicate device software). Gradients have been stretched to minimize the slew rate in order to reduce acoustic noise. -
Improvements in BLADE Imaging (fast TSE) .
With this software version, an optimized variant of the TSE for abdominal imaging is released and is called FAST_TSE. The main characteristics of FAST TSE are the same as for TSE which is one of the most basic sequences available on all MAGNETOM Systems.
New Features
- SMS EPI a new feature for Brain Diffusion and BOLD Imaging . In Simultaneous Multi Slice imaging several slices are excited simultaneously and separated during image reconstruction. The feature is intended for EPI diffusion and EPI BOLD brain imaging.
- . GOBrain – a new feature which supports brain examination in short acquisition time for MAGNETOM Aera/Skyra
With syngo MR E11C a complete brain examination in short acquisition time is provided for MAGNETOM Aera and MAGNETOM Skyra systems with a 20, 32, or 64 channel head coil. The examination consists of a localizer, T1w, T2w, dark fluid (FLAIR), DWI, and T2*w protocol.
- New features for Breast Dot Engine Dynamic Breast Evaluation and . Auto Bolus Detection
With synqo MR VD13A (clearance K133435) the feature 'Breast Dot Engine', a workflow solution for breast MRI, was cleared. Following the FDA clearance of the contrast agent Gadavist® for breast MRI, this software version adds the Automatic Bolus Detection feature for support of contrast exams.
Modified Sequences or Features
- । SPAIR fat sat improvements (applicable for 3T MR Systems addressed by syngo MR E11C)
- । Improvements in Liver Seqmentation
- Improvement in Multi Echo Dixon for Fat Iron Quantification
April 13, 2016
syngo MR E11C Software for Systems: MAGNETOM Aera (1.5T), MAGNETOM Skyra (3T) and MAGNETOM Prisma/ Prismafit (3T)
6
SIEMENS
- A flow compensated SE sequence for 3T systems (Skyra and । Prisma/Prisma™) only
- । Improvements in Inline Ventricular function
- Improvements in VIBE ।
Migrated Features
- QISS, MyoMaps and LiverLab for MAGNETOM Skyra 24 only
- The Body 18 and Body 18 long coil will be made available for MAGNETOM Skyra (24-channel configuration only ("Skyra-24")). These coils are cleared on other Skyra systems with the primary predicate device with exception of Skyra-24.
Other Modifications
- Front cover panel refresh for MAGNETOM Aera and MAGNETOM Skyra
- Provide secure MR scanner setup for DoD (Department of Defense) Information Assurance compliance.
Technological Characteristics
syngo MR E11C for MAGNETOM Aera MAGNETOM Skyra, Software MAGNETOM Prisma and MAGNETOM Prismall systems ("syngo MR E11C") has the same technological characteristics as the predicate devices MR systems (K151579; cleared September 29, 2015 and K141977, cleared November 19, 2014).
The subject device is substantially equivalent to the predicate devices with regard to the operational environment, programming language, operating system and performance.
syngo MR E11C SW conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
While syngo MR E11C SW offers new and modified SW features, modified SW features with respect to the predicate device systems, the syngo MR E11C software on the subject device MR Systems has the same technological characteristics as the predicate device systems. Further, this submission includes hardware modifications including new coils for the Skyra-24 system (already cleared with other Skyra systems) and a cosmetic modification to the front cover panel for Aera and Skyra systems. These do not represent a change in technological characteristics.
Nonclinical Tests
The following performance testing was conducted on the subject device
- Sample clinical images were taken for particular new and modified sequences. ●
- . Acoustic noise measurements were performed for quiet sequences
syngo MR E11C Software for Systems: MAGNETOM Aera (1.5T), MAGNETOM Skyra (3T) and MAGNETOM Prisma/ Prismafit (3T)
7
- . Image quality assessments of all new/modified sequences and algorithms, were completed.
- Software verification and validation testing was completed in accordance with the ● FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.
Clinical Tests
No clinical tests were conducted to support the subject device and the substantial equivalence argument; however, clinical images were provided to support the new coils as well as the new software features of the subject device.
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 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, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
The syngo MR E11C software for the MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma and MAGNETOM Prismall systems, 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
E11C SW for the MAGNETOM Aera, MAGNETOM Skyra, svnao MR MAGNETOM Prisma and MAGNETOM Prisma™ Systems, includes all of the features of the primary predicate device and additional sequences and features as noted above.
syngo MR E11C Software for Siemens MR Systems: MAGNETOM Aera (1.5T), MAGNETOM Skyra (3T) and MAGNETOM Prisma/ Prismafit (3T)
8
Predicate Device Information
| Primary Predicate Device | FDA Clearance
Number and Date | Product
code | Manufacturer |
|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------|-----------------------------------------------|
| syngo MR E11B for MAGNETOM
Aera (24) (1.5T), MAGNETOM
Avantofit (1.5T), MAGNETOM
Skyrafit (3T) and MAGNETOM
Prisma/ Prismafit (3T) | K151597, cleared
September 29,
2015 | LNH
LNI,MOS | Siemens AG /
Siemens
Healthcare
GmbH |
| Secondary Predicate Device | FDA Clearance
Number and Date | Product
code | Manufacturer |
| Software syngo MR E11A for the
MAGNETOM systems
Aera/Skyra | K141977 cleared
November 19,
2014 | LNH
LNI,MOS | Siemens AG /
Siemens
Healthcare
GmbH |
Conclusion as to Substantial Equivalence
syngo MR E11C software for the MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma and MAGNETOM Prismal" Systems has the same intended use and the same basic technological characteristics as the predicate device systems, MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma and MAGNETOM Prismat" Systems with syngo MR E11B, with respect to the magnetic resonance features and functionalities. While there are some minor technical features that vary with respect to the predicate device MR Systems, the conclusions from the non-clinical data suggest that the features with different technological characteristics from the predicate devices bear an equivalent safety and performance profile as that of the predicate and secondary predicate devices. Therefore the subject device is substantially equivalent to the predicate device.
syngo MR E11C Software for Siemens MR Systems: MAGNETOM Aera (1.5T), MAGNETOM Skyra (3T) and MAGNETOM Prisma/ Prismafit (3T)