Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
Device Facts
| Record ID | K192496 |
|---|---|
| Device Name | Magnetom Sola, Magnetom Altea and Magnetom Sola Fit |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | LNH · Radiology |
| Decision Date | Feb 28, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
Indications for Use
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 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 display and MR-Safe biopsy needles.
Device Story
MAGNETOM Sola, Altea, and Sola Fit are 1.5T MRI systems using syngo MR XA20A software. Systems acquire MR signals to produce cross-sectional images, spectra, and derived physical parameters for diagnostic interpretation by physicians. Hardware includes computer systems, BM Body 18 receive coils, and nose markers for inline motion correction. Software features include Compressed Sensing (CS) for scan acceleration, Simultaneous Multi-Slice (SMS) techniques, respiratory self-gating, and various pulse sequences (e.g., GOLiver, GOKnee2D, SEMAC for metal artifact correction). Systems support interventional workflows with MR-compatible devices. Data is processed to compensate for motion, reduce scan times, and improve image quality. Used in clinical settings by trained healthcare professionals. Output assists in diagnosis of internal structures and functions. Benefits include faster exams, reduced motion artifacts, and consistent image quality.
Clinical Evidence
No clinical trials were conducted. Substantial equivalence is supported by bench testing, software verification and validation, and sample clinical images comparing new/modified features to the predicate. Biocompatibility testing per ISO 10993-1 and electrical/mechanical safety testing per IEC 60601 series were performed.
Technological Characteristics
1.5T MRI system; includes BM Body 18 receive coils (18-element). Features include Compressed Sensing, Simultaneous Multi-Slice (SMS) acquisition, and inline motion correction via nose marker/camera. Connectivity via DICOM. Software conforms to IEC 62304. System safety complies with IEC 60601-1, IEC 60601-2-33, and IEC 60601-1-2. Biocompatibility per ISO 10993-1.
Indications for Use
Indicated for patients requiring diagnostic MR imaging of head, body, or extremities; includes interventional procedures using MR-compatible devices. No specific age or gender contraindications stated beyond standard MR safety requirements.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
Reference Devices
- MAGNETOM Aera (K182299)
- MAGNETOM Aera (K163312)
- MAGNETOM Aera (K153343)
- MAGNETOM Vida (K183254)
- MAGNETOM Skyra (K123510)
- MAGNETOM Lumina (K183244)
Submission Summary (Full Text)
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February 28, 2020
Siemens Medical Solutions USA, Inc. % 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
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801); medical device 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-reportingcombination-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) 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
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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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192496
Device Name
MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit
#### Indications for Use (Describe)
Your MAGNETOM system is indicated for use as a magnetic 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, vield 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 display and MR-Safe biopsy needles.
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 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
#### Traditional Premarket Notification 510(k)
September 10, 2019
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# 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.<br>40 Liberty Boulevard<br>Mail Code 65-1A<br>Malvern, PA 19355, USA<br>Registration Number: 2240869 |
| Date Prepared: | September 9, 2019 |
| Manufacturer: | Siemens Healthcare GmbH<br>Henkestrasse 127<br>91052 Erlangen<br>Germany<br>Registration Number: 3002808157<br>For MAGNETOM Sola and<br>MAGNETOM Altea:<br>Siemens Shenzhen Magnetic<br>Resonance LTD.<br>Siemens MRI Center<br>Hi-Tech Industrial park (middle)<br>Gaoxin C. Ave., 2nd<br>Shenzhen 518057, P.R. CHINA<br>Registration Number: 3004754211 |
| 2. Contact Information | |
| | Cordell L. Fields, Esq.<br>Regulatory Affairs Technical Specialist<br>Siemens Medical Solutions USA, Inc.<br>40 Liberty Boulevard<br>Mail Code 65-1A<br>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
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# 3. Device Name and Classification
Device name:
Trade name:
Classification Name:
Classification Panel: CFR Code: Classification: Product Code:
MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 . Primary: LNH Secondary: LNI, MOS
## 4. Legally Marketed Predicate Device
Trade name: 510(k) Number: Clearance Date:
Classification Name:
Classification Panel: CFR Code: Classification: Product Code:
MAGNETOM Sola MAGNETOM Sola K181322, K182129, cleared October 5, 2018 (K181322), October 12, 2018 (K182129) Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 = 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
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Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
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.
- i 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
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Image /page/6/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots.
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 i 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 i 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, i 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 i 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 i 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 reqion.
Traditional Premarket Notification 510(k)
September 9, 2019
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Image /page/7/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a pattern of orange dots.
- SPACE Flair Improvements: SPACE pulse sequence type offers a maqnetization 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 i 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 i via a share.
- Access-i: The interface Access-i allows 3rd party devices to establish a bidirectional 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 Zposition at which measurements get executed.
#### Other Modifications and / or Minor Changes
- MAGNETOM Sola Fit: The MAGNETOM Sola Fit is a new MRI System which i 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 4channel 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
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Image /page/8/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
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<br>and Date | Product<br>Code | Manufacturer |
|--------------------------------------|------------------------------------------------------------------------------------------|-----------------|----------------------------|
| MAGNETOM Sola with<br>syngo MR XA11A | K181322, K182129,<br>cleared October 5, 2018<br>(K181322), October 12,<br>2018 (K182129) | LNH<br>LNI, MOS | Siemens Healthcare<br>GmbH |
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<br>and Date | Product<br>Code | Manufacturer |
|-------------------------------------------------------|-------------------------------------|------------------|-----------------------------------------|
| MAGNETOM Aera with<br>software syngo MR E11C-<br>AP01 | K182299<br>cleared October 26, 2018 | LNH,<br>LNI, MOS | Siemens Healthcare<br>GmbH |
| MAGNETOM Aera with<br>syngo MR E11C-AP02 | K163312<br>cleared January 27, 2017 | LNH, LNI,<br>MOS | Siemens AG / Siemens<br>Healthcare GmbH |
| MAGNETOM Aera with<br>syngo MR E11C | K153343<br>cleared April 15, 2016 | LNH | Siemens AG / Siemens<br>Healthcare GmbH |
| MAGNETOM Vida with<br>software syngo MR XA11B | K183254<br>cleared January 18, 2019 | LNH,<br>LNI, MOS | Siemens Healthcare<br>GmbH |
| MAGNETOM Skyra with<br>syngo MR D13C | K123510<br>cleared May 17, 2013 | LNH | Siemens AG |
| MAGNETOM Lumina with<br>syngo MR XA11B | K183244<br>cleared January 24, 2019 | LNH,<br>LNI, MOS | Siemens Healthcare<br>GmbH |
#### Technoloqical Characteristics 8.
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)
Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo MR XA20A
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September 9, 2019
Image /page/9/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
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 nonclinical 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<br>software features | Guidance for Submission of<br>Premarket Notifications for<br>Magnetic Resonance<br>Diagnostic Devices |
| Image quality assessments by<br>sample clinical images. In<br>some cases a comparison of<br>the image quality / quantitative<br>data was made. | - new / modified pulse<br>sequence types.<br>- comparison images between<br>the new / modified features<br>and the predicate device<br>features | |
| Performance bench test | mainly new and modified<br>hardware | |
| Software verification and<br>validation | mainly new and modified<br>software features | Guidance for the Content of<br>Premarket Submissions for<br>Software Contained in Medical<br>Devices |
| Biocompatibility | surface of applied parts | ISO 10993-1 |
| Electrical, mechanical,<br>structural, and related system<br>safety test | complete system | - AAMI / ANSI ES60601-1<br>- IEC 60601-2-33 |
| Electrical safety and<br>electromagnetic compatibility<br>(EMC) | complete system | IEC 60601-1-2 |
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
MR XA20A
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)
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Image /page/10/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
# 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:
| Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and date | Standards<br>Development<br>Organization |
|-----------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| 19-4 | General | Medical electrical equipment -<br>Part 1: general requirements for<br>basic safety and essential<br>performance | ES60601-<br>1:2005/(R) 2012<br>and A1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment -<br>Part 1-2: General requirements<br>for basic safety and essential<br>performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements<br>and tests | 60601-1-2, Ed.<br>4.0:2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment -<br>Part 2-33: Particular<br>requirements for the basic<br>safety and essential<br>performance of magnetic<br>resonance equipment for<br>medical diagnosis | 60601-2-33, Ed.<br>3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application of<br>risk management to medical<br>devices | 14971, Ed. 2:2007-<br>10 | ISO |
| 5-114 | General | Medical devices - Application of<br>usability engineering to medical<br>devices | 62366, Ed.<br>1.0:2015 | AAMI<br>ANSI<br>IEC |
| 13-79 | Software | Medical device software -<br>Software life cycle processes | 62304:2015-06 | AAMI<br>ANSI<br>IEC |
#### Traditional Premarket Notification 510(k)
September 9, 2019
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Image /page/11/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
| 12-232 | Radiology | Acoustic Noise Measurement<br>Procedure for Diagnosing<br>Magnetic Resonance Imaging<br>Devices | MS 4:2010 | NEMA |
|--------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------|
| 12-288 | Radiology | Characterization of Phased<br>Array Coils for Diagnostic<br>Magnetic Resonance Images<br>(MRI) | MS 9:2008 | NEMA |
| 12-300 | Radiology | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set 03/16/2012<br>Radiology | PS 3.1 - 3.20:2016 | NEMA |
| 2-220 | Biocompatibility | Biological evaluation of medical<br>devices - Part 1: evaluation and<br>testing within a risk<br>management process<br>(Biocompatibility) | 10993-1:2009 | AAMI<br>ANSI<br>ISO |
## 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
