Siemens Medical Solutions USA Inc.
Siemens Medical Solutions USA, Inc. February 28, 2020
℅ Cordell L. Fields, Esq.
Regulatory Affairs Professional
40 Liberty Blvd., Mail Code 65-1A
MALVERN PA 19355
Re: K192496
Trade/Device Name: MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic Resonance Diagnostic Device
Regulatory Class: Class II
Product Code: LNH, LNI, MOS
Dated: January 23, 2020
Received: January 28, 2020
Dear Cordell 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. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. 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
K192496 - Cordell Fields Page 2
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, PhD.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Section 4: Indications for Use Statement
K192496
Traditional Premarket Notification 510(k) September 10, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
K192496
510(k) Summary
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted
in accordance with the requirements of the Safe Medical Devices Act 1990 and
21 CFR § 807.92.
1. General Information
Establishment: Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869
Date Prepared: September 9, 2019
Manufacturer: Siemens Healthcare GmbH
Henkestrasse 127
91052 Erlangen
Germany
Registration Number: 3002808157
For MAGNETOM Sola and
MAGNETOM Altea:
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
2. Contact Information
Cordell L. Fields, Esq.
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Phone: (610) 448-6469
Fax: (610) 448-1787
E-mail: cordell.fields@siemens-
healthineers.com
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
510(k) Summary
3. Device Name and Classification
Device name: MAGNETOM Sola, MAGNETOM Altea
and MAGNETOM Sola Fit
Trade name: MAGNETOM Sola, MAGNETOM Altea
and MAGNETOM Sola Fit
Classification Name: Magnetic Resonance Diagnostic Device
(MRDD)
Classification Panel: Radiology
CFR Code: 21 CFR § 892.1000
Classification: II
Product Code: Primary: LNH
Secondary: LNI, MOS
4. Legally Marketed Predicate Device
Trade name: MAGNETOM Sola
510(k) Number: MAGNETOM Sola
Clearance Date: K181322, K182129, cleared October 5,
2018 (K181322), October 12, 2018
(K182129)
Classification Name: Magnetic Resonance Diagnostic Device
(MRDD)
Classification Panel: Radiology
CFR Code: 21 CFR § 892.1000
Classification: II
Product Code: Primary: LNH
Secondary: LNI, MOS
5. Intended Use
The indications for use for the subject devices is the same as the predicate
device:
Your MAGNETOM system is 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
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
510(k) Summary
images and/or spectra when interpreted by a trained physician yield information
that may assist in diagnosis.
Your MAGNETOM system may also be used for imaging during interventional
procedures when performed with MR compatible devices such as in-room
displays and MR Safe biopsy needles.
6. Device Description
MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software
syngo MR XA20A includes new and modified hardware and software compared
to the predicate device, MAGNETOM Sola with software syngo MR XA11A. A
high level summary of the hardware and software is provided below:
Hardware
Hardware
- Computer
- Nose Marker for Inline Motion Correction
Coils
- BM Body 18: The new BM Body 18 coil is a receive coil with 18 elements and
is based on the Body 18 coil, (cleared with K101347). It is a general purpose
coil.
The BM Body 18 coil can be used with two different cables of different length;
this capability was introduced with the BM Body 12 coil.
Software
Features and Applications
- SMS for TSE_DIXON: Simultaneous excitation and acquisition of multiple
slices with the Simultaneous multi-slice (SMS) technique for TSE Dixon
imaging.
- GOLiver is a set of optimized pulse sequence for fast and efficient imaging of
the abdomen / liver. It is designed to provide consistent exam slots and to
reduce the workload for the user in abdominal / liver MRI.
- Angio TOF with Compressed Sensing (CS): The Compressed Sensing (CS)
functionality is now available for TOF MRA within the BEAT pulse sequence
type for the 1.5 T MR systems. Scan time can be reduced by an incoherent
undersampling of k-space data. The usage of CS as well as the acceleration
factor and further options can be freely selected by the user.
- RT Respiratory self-gating for FL3D_VIBE: Non-contrast abdominal and
thoracic examination in free breathing with reduced blur induced by respiratory
motion.
- SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of
multiple slices with the Simultaneous multi-slice (SMS) technique for readout-
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
510(k) Summary
segmented echo planar imaging (RESOLVE) and quiet diffusion weighted
imaging (QDWI).
- SPACE with Compressed Sensing (CS): The Compressed Sensing (CS)
functionality is now available for the SPACE pulse sequence type. Scan time
can be reduced by the incoherent under-sampling of the k-space data. The
usage of CS as well as the acceleration factor and other options can be freely
selected by the user.
- SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of
patients with whole joint replacement. Using Compressed Sensing the
acquisition can be accelerated.
- TSE_MDME: A special variant of the TSE pulse sequence type which
acquires several contrasts (with different TI and TE, i.e. Multi Delay Multi
Echo) within a single sequence.
- TFL (3D MPRAGE), TSE and GRE with Inline Motion Correction: 3D
MPRAGE, TSE and GRE with Inline Motion Correction: Tracking of motion of
the head during head scans with a nose marker and a camera system. The
MR system uses the tracking information to compensate for the detected
motion.
- EP_SEG_PHS: pulse sequence type EP_SEG_PHS, based on BEAT_EPI
and modified with a silent period that can be used by external
devices/applications for synchronization with the MR imaging
- GRE_PHS: pulse sequence type GRE_PHS, is a GRE pulse sequence type,
modified to provide a silent period that can be used by external
devices/applications for synchronization with the MR imaging.
- GRE_Proj: The GRE projection pulse sequence type ““ allows the acquisition
of 1-D projection data for different orientations.
- GOKnee2D: GOKnee2D is a set of multi-band pulse sequence types with
Simultaneous Multislice TSE for fast and efficient imaging of the knee. It is
designed to provide consistent exam slots and to reduce the workload for the
user in Knee MRI.
- BEAT_interactive: The BEAT_Interactive pulse sequence type is a
modification of the BEAT_IRTTT pulse sequence type in order to interactively
increase the slice thickness and switch on and off a magnetization pulse that
the user can select prior to the measurement start.
- EP2D_SE_MRE: As an alternative of greMRE, EP2D_SE_MRE pulse
sequence type is based on single-shot EP2D_SE_MRE sequence. It offers
acquisition of multiple slices in a single, short breath-hold, and it is more
robust against signal dephasing effects while providing comparable relative
stiffness values.
- ZOOMit DWI: syngo ZOOMit based on EPI diffusion allows diffusion weighted
imaging (DWI) while avoiding signal and artifacts from surrounding tissue. The
feature is now available for 1-ch-systems and enables improved robustness to
infolding artifacts from tissue from outside the excited region.
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
510(k) Summary
- SPACE Flair Improvements: SPACE pulse sequence type offers a
magnetization preparation mode for brain imaging with FLAIR contrast (FLuid
Attenuated Inversion Recovery); improving the image quality of FLAIR
images.
- External Phase Correction Scan for EPI Diffusion: Separate N/2 Nyquist ghost
correction acquisition method for diffusion imaging in the presence of fat.
- MR Breast Biopsy Workflow improvements: The changes made to MR Breast
Biopsy application target two areas: the improved readability of planning
results and the ability to handle the planning of multiple biopsy targets.
- GOBrain / GOBrain+: GOBrain (brain examination in short acquisition time)
GOBrain+ (adaptation of GOBrain pulse sequences)
Software / Platform
- Dot Cockpit: MR Protocol Manager as part of a scanner fleet with connection
via a share.
- Access-i: The interface Access-i allows 3rd party devices to establish a bi-
directional communication with the MR scanner via a secure local network
connection, supporting data transfer to and triggering of data acquisition from
the 3rd party device. It enables the 3rd party client to control and edit a
measurement program on the MR.
- Table positioning mode: A new table positioning mode “FIX” is introduced
which complements the existing table positioning modes ISO and LOC to
support workflows in which the user needs to be in control of a defined Z-
position at which measurements get executed.
Other Modifications and / or Minor Changes
- MAGNETOM Sola Fit: The MAGNETOM Sola Fit is a new MRI System which
is the result of an upgrade from a MAGNETOM Aera.
- BM Body 12: For MR examinations of head and neck in situations where a
rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic
masks used for radiotherapy planning, aiming at higher signal-to-noise and
spatial resolution as what can be achieved with 4-channel Flex rf coils
- Body 18: For MR examinations of head and neck in situations, where a rigid rf
head coil cannot be used, e.g. with patients positioned in thermoplastic masks
used for radiotherapy planning, aiming at higher signal-to-noise and spatial
resolution than what can be achieved with 4-channel Flex rf coils
- UltraFlex Large 18, UltraFlex Small 18: For MR examinations of head and
neck in situations, where a rigid rf head coil cannot be used, e.g. with patients
positioned in thermoplastic masks used for radiotherapy planning, aiming at
higher signal-to-noise and spatial resolution than what can be achieved with 4-
channel Flex rf coils
- Broad band / narrow band online supervision: The broadband/narrowband
supervision checks the correctness of the measurement values used for the
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
510(k) Summary
SAR calculation. With syngo MR XA20A, the supervision cycle is reduced
significantly.
- LiverLab Dot Engine - debundling: LiverLab is now offered separately as
standalone workflow and is also still available as part of the Abdomen Dot
Engine.
- The 1.5T system MAGNETOM Altea is made available to the marked with
software syngo MR XA20A.
7. Substantial Equivalence
MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software
syngo MR XA20A are substantially equivalent to the following predicate device:
Predicate Device FDA Clearance Number Product Manufacturer
and Date Code
MAGNETOM Sola with K181322, K182129, LNH Siemens Healthcare
syngo MR XA11A cleared October 5, 2018 LNI, MOS GmbH
(K181322), October 12,
2018 (K182129)
MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software
syngo MR XA20A includes hardware and software already cleared on the
following reference devices:
Reference Devices FDA Clearance Number Product Manufacturer
and Date Code
MAGNETOM Aera with K182299 LNH Siemens Healthcare
software syngo MR E11C- cleared October 26, 2018 LNI, MOS GmbH
AP01
MAGNETOM Aera with K163312 LNH, LNI, Siemens AG / Siemens
syngo MR E11C-AP02 cleared January 27, 2017 MOS Healthcare GmbH
MAGNETOM Aera with K153343 LNH Siemens AG / Siemens
syngo MR E11C cleared April 15, 2016 Healthcare GmbH
MAGNETOM Vida with K183254 LNH Siemens Healthcare
software syngo MR XA11B cleared January 18, 2019 LNI, MOS GmbH
MAGNETOM Skyra with K123510 LNH Siemens AG
syngo MR D13C cleared May 17, 2013
MAGNETOM Lumina with K183244 LNH Siemens Healthcare
syngo MR XA11B cleared January 24, 2019 LNI, MOS GmbH
8. Technological Characteristics
The subject devices, MAGNETOM Sola, MAGNETOM Altea and MAGNETOM
Sola Fit with software syngo MR XA20A, are substantially equivalent to the
predicate device with regard to the operational environment, programming
language, operating system and performance.
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
510(k) Summary
The subject devices conform to the standard for medical device software
(IEC 62304) and other relevant IEC and NEMA standards.
While there are some differences in technological characteristics between the
subject devices and predicate device, including new and modified hardware and
software, these differences have been tested and the conclusions from the non-
clinical data suggests that the features bear an equivalent safety and
performance profile to that of the predicate device.
9. Nonclinical Tests
The following performance testing was conducted on the subject devices.
Performance Test Tested Hardware or Software Source/Rationale for test
Sample clinical images coils, new and modified Guidance for Submission of
software features Premarket Notifications for
Image quality assessments by - new / modified pulse Magnetic Resonance
sample clinical images. In sequence types. Diagnostic Devices
some cases a comparison of - comparison images between
the image quality / quantitative the new / modified features
data was made. and the predicate device
features
Performance bench test mainly new and modified
hardware
Software verification and mainly new and modified Guidance for the Content of
validation software features Premarket Submissions for
Software Contained in Medical
Devices
Biocompatibility surface of applied parts ISO 10993-1
Electrical, mechanical, complete system - AAMI / ANSI ES60601-1
structural, and related system - IEC 60601-2-33
safety test
Electrical safety and complete system IEC 60601-1-2
electromagnetic compatibility
(EMC)
The results from each set of tests demonstrate that the devices perform as
intended and are therefore substantially equivalent to the predicate device to
which it has been compared.
10. Clinical Tests
No additional clinical tests were conducted to support substantial equivalence for
the subject devices; however, as stated above, sample clinical images were
provided. Clinical publications were referenced to provide information on the use
of some features and functions.
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
510(k) Summary
11. Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and
warnings to ensure safe and effective use of the device.
Risk Management is ensured via a risk analysis in compliance with ISO 14971,
to identify and provide mitigation of potential hazards early in the design cycle
and continuously throughout the development of the product. Siemens
Healthcare GmbH adheres to recognized and established industry standards,
such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.
Furthermore, the device is intended for healthcare professionals familiar with and
responsible for the acquisition and post processing of magnetic resonance
images.
MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software
syngo MR XA20A conform to the following FDA recognized and international
IEC, ISO and NEMA standards:
Standards
Recognition Product Reference
Title of Standard Development
Number Area Number and date
Organization
19-4 General Medical electrical equipment - ES60601- AAMI / ANSI
Part 1: general requirements for 1:2005/(R) 2012
basic safety and essential and A1:2012
performance
19-8 General Medical electrical equipment - 60601-1-2, Ed. IEC
Part 1-2: General requirements 4.0:2014-02
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests
12-295 Radiology Medical electrical equipment - 60601-2-33, Ed. IEC
Part 2-33: Particular 3.2:2015
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for
medical diagnosis
5-40 General Medical devices - Application of 14971, Ed. 2:2007- ISO
risk management to medical 10
devices
5-114 General Medical devices – Application of 62366, Ed. AAMI
usability engineering to medical 1.0:2015 ANSI
devices IEC
13-79 Software Medical device software - 62304:2015-06 AAMI
Software life cycle processes ANSI
IEC
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
510(k) Summary
12-232 Radiology Acoustic Noise Measurement MS 4:2010 NEMA
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices
12-288 Radiology Characterization of Phased MS 9:2008 NEMA
Array Coils for Diagnostic
Magnetic Resonance Images
(MRI)
12-300 Radiology Digital Imaging and PS 3.1 - 3.20:2016 NEMA
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology
2-220 Biocompati Biological evaluation of medical 10993-1:2009 AAMI
bility devices - Part 1: evaluation and ANSI
testing within a risk ISO
management process
(Biocompatibility)
12. Conclusion as to Substantial Equivalence
MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software
syngo MR XA20A have the same intended use and same basic technological
characteristics than the predicate device system, MAGNETOM Sola with syngo
MR XA11A. While there are some differences in technilogical
characteristics/features compared to the predicate device, the differences have
been tested and the conclusions from all verification and validation data suggest
that the features bear an equivalent safety and performance profile to that of the
predicate device and reference devices.
Siemens believes that MAGNETOM Sola, MAGNETOM Altea and MAGNETOM
Sola Fit with software syngo MR XA20A are substantially equivalent to the
currently marketed predicate device MAGNETOM Sola with software syngo MR
XA11A (K181322, K182129, cleared on October 5, 2018 (K181322), October 12,
2018 (K182129)).
Traditional Premarket Notification 510(k) September 9, 2019
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo
MR XA20A
