(125 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of performance studies and key metrics does not indicate the use of AI/ML algorithms.
No
The device is described as a "magnetic resonance diagnostic device (MRDD)" that produces images to "assist in diagnosis," not to treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the images/spectra, when interpreted by a trained physician, "yield information that may assist in diagnosis."
No
The device description explicitly states that the device includes "new and modified hardware and software" and is a "magnetic resonance diagnostic device (MRDD)," which is a hardware-based imaging system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the internal structure and/or function of the body. It assists in diagnosis when interpreted by a trained physician. This describes an in vivo diagnostic imaging system, not a device that performs tests on samples taken from the body (which is the definition of an IVD).
- Device Description: The description confirms it's a MAGNETOM system, which is a type of MRI scanner. MRI is an in vivo imaging modality.
- Input Imaging Modality: It explicitly states "Magnetic Resonance (MR)", which is an in vivo imaging technique.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates by scanning the patient directly.
N/A
Intended Use / 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 that displays the internal structure and/or function of the head, body, or extremittes. 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 mages 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 displays and MR Safe biopsy needles.
Product codes
LNH, LNI, MOS
Device Description
MAGNETOM Vida with software syngo MR XA10A is similar to the previous cleared predicate device MAGNETOM Skyra with syngo MR E11C (K153343) but includes new and modified hardware and software compared to MAGNETOM Skyra. A high level summary of the hardware and software changes is included below.
Hardware:
New Hardware
- main components such as:
- magnet
- gradient coil
- patient table (fixed and mobile)
- new coils:
- Body Coil -
- BioMatrix Head/Neck 20 TCS -
- BioMatrix Head/Neck 64 CS -
- BioMatrix Spine 72 RS -
- BioMatrix Spine 32 RS -
- UltraFlex Large 18 -
- UltraFlex Small 18 -
- Shoulder Shape 16 -
- -Tx/Rx Knee 18
- other components such as:
- helium compressor
- cover incl. new touch displays with extended functionalty and redesigned control island
- computers and monitor
- respiratory sensor (respiratory sensor loops integrated into BioMatrix Spine 32 RS and BioMatrix Spine 72 RS)
Modified Hardware - main components such as gradient power amplifier and patient communication unit
- other components such as RF power amplifier, magnet supervision, electronic cabinet and measurement control components
Software:
New Features and Applications
- SliceAdjust (framework for pulse sequence types which allows applying adjustment settings dynamically to measured sub-volumes during the measurement.)
- Whole-Body Dot Engine (supports multi-region examinations with consistent settings for spatial resolution, image contrast, and breath-hold capacity covering the regions chest, abdomen, pelvis and also extensions towards head and legs.)
- CoilShim (reduce patient induced strongly localized B0 inhomogeneities by generating the respective anatomy-specific B0 field with local shim coil elements integrated in the local Rx coils BioMatrix Head/Neck 20 TCS and BioMatrix Head/Neck 64 CS.)
- Left/Right Balancing (method for balancing the signal in the left and right brain hemispheres to reduce the signal asymmetry between the left and right brain hemispheres.)
New Software / Platform
- Software platform (new software version syngo MR XA10A based on the new Numaris/X software which combines the software of the predicate device and the reference device with modifications and extensions as well as changed structure and design of the user interface and changed post processing integration.)
- General workflow (left-hand side (LHS) and right-hand side (RHS) concept with dual monitor workflow where patient handling and scanning is separated from post-processing and data handling. The "LHS" contains scan-related elements such as the Patient Browser (Scheduler) and scan UI and displays the inline processed images. On the "RHS" additional results are generated in the form of basic and advanced post-processing including data handling and result distribution.)
- User role concept (five user roles with different rights)
- Distribution step (allows the selection of data sets for archiving and DICOM transfer within MR View&GO)
- 4D Viewing (allows the visualization of 4D data such as different phases, bvalues or echos of one DICOM series within MR View&GO and allows temporal (phase navigation in 4D data sets) and spatial scrolling.)
- Launcher Step (starts an advanced application on the RHS)
- Multiframe DICOM format (now available in addition with improvements in performance, application support, navigation and data interchange.)
- Touch positioning (Select&GO) (to position the patient to the isocenter by using the touch displays integrated in the system cover)
Modified Features and Applications
- Compressed Sensing Cardiac Cine: An option to enable Compressed Sensing Cardiac Cine is integrated into the BEAT pulse sequence type. The total acceleration factor is a user-interface parameter that controls the degree of k-space under-sampling. Compressed Sensing Cardiac Cine can be performed in single-shot and in multi-shot mode.
- Dixon fat/water separation: improvement for a more robust assignment of local fat and water regions to the respective image.
- Pre-Scan-Normalize: Improvements with the qoal to correct MRI images for local coil sensitivity variations and to generate homogenous MRI images. Three different matrix sizes are available now.
- iPAT: Improvements in the VIBE and in the HASTE pulse sequence types to improve the image quality. Changes in the VIBE pulse sequence type concern the k-space reordering, the external GRE reference scan and the minimal slice oversampling. Changes in the HASTE sequence includes the possibility to use a reference scan "TSE/Separate" for GRAPPA acquisition and reconstruction.
- HeartFreeze: extended to support multiple repeats and averaging of the same slice acquired at the same phase of the cardiac cycle in combination with non-selective inversion recovery imaging.
Modified (general) Software / Platform
- Patient Browser (Scheduler): two components (Patient Registration and Scheduler) consolidated.
- Table Positioning Mode: Automated movement of table provided on examination level so that the scan is performed in the magnet isocenter. Additionally the "LocalRange" positioning mode can be used for smaller regions like e.g. the heart or the brain.
- Spectroscopy Add-in: enables planning on non-distortion corrected images for spectroscopy.
- MR View&GO: For quality assurance, image viewing, basic post-processing, printing and result distribution. The functionality is provided in workflow steps which provide guidance, allow independent work and do not require any reloading of data.
- Prior Handling: for the display of available priors.
- System Start and Shutdown: improvements with a System Start Timer and shutdown unattended by the user.
Other Modifications and / or Minor Changes
- SAR: software for the simulation of local SAR.
- SAR Assistant: two additional options for selection.
- Noise masking: to remove the noise floor in outer regions.
- MAGNETOM RT Pro Edition Marketing bundle: extension of the bundle.
- Siemens "Healthineers": new Siemens brand.
- Improved Adiustments: transmitter adjustment to avoid any signal-manipulating dephasing, frequency adjustment optimized for more reliable water peak detection, and FastView adjustments extended to be available for all kind of data selectable in the user interface.
- Cooling Cabinet: increased cooling capacity and improvements.
- BEAT IRTT: extends BEAT IRT sequence with a multi-slice functionality and introduces some parameters. "TTT" stands for the extension of BEAT IRT to three dimensions.
- Vacuum pump: automatic switching mechanism.
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 / Not Found
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:
- Sample clinical images were taken in particular for the coils, as well as for new and modified software features and modified features in the pulse sequence types.
- Image quality assessments of all new/modified pulse sequence types and algorithms were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.
- 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"
- Performance tests were completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016
Results: The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
Clinical Tests:
- A clinical study of 33 individuals was conducted to determine the nerve stimulation thresholds used to limit the gradient system output. The observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level which is required in IEC 60601-2-33.
- No additional clinical tests were conducted to support the subject device and the substantial equivalence argument; however, sample clinical images were provided to support the new coils as well as the new and modified hardware and software features of the subject device per the MR guidance document. Clinical publications were referenced to provide information on the use of some features and functions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K153343, K141977, K163312, K150843, K162102, K123510, K121434
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 & Human Services. The logo features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three human profiles facing right, representing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2017
SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL FIELDS, ESQ. REGULATORY TECHNICAL SPECIALIST 65 VALLEY STREAM PARKWAY, MAILCODE 65-1A MALVERN, PA 19355
Re: K170396
Trade/Device Name: MAGNETOM Vida Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: May 17, 2017 Received: May 19, 2017
Dear Cordell Fields, Esq:
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
For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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Indications for Use Section 4 Statement
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)
Device Name
MAGNETOM Vida
Indications for Use (Describe)
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 that displays the internal structure and/or function of the head, body, or extremittes. 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 mages 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 displays 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.
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|---|---|
| ----------------------------------------------------------------------------------- | -- |
*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
"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) 443-674) 4 EF
Siemens 510(k) Traditional Premarket Notification
Siemens MR System MAGNETOM Vida (3T) with syngo MR XA10A Software
3
Section 5 510(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.
- l. General Information
| Establishment | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | February 08, 2017 |
| Manufacturer | Siemens Healthcare GmbH
Henkestrasse 127
Erlangen, Bayern, Germany 91052
Registration Number: 3002808157 |
| Contact Person | Cordell L. Fields, Esq
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc. |
| Device Name | MAGNETOM Vida |
| Trade Name | MAGNETOM Vida |
| 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:
4
Image /page/4/Picture/1 description: The image shows the word "SIEMENS" in a large, sans-serif font. The text is a teal color, and the background is white. The word is the logo for the Siemens company, a German conglomerate and the largest industrial manufacturing company in Europe.
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 displays and MR Safe biopsy needles.
Device Description
MAGNETOM Vida with software syngo MR XA10A is similar to the previous cleared predicate device MAGNETOM Skyra with syngo MR E11C (K153343) but includes new and modified hardware and software compared to MAGNETOM Skyra. A high level summary of the hardware and software changes is included below.
Hardware
New Hardware
- । main components such as:
- magnet
- gradient coil |
- patient table (fixed and mobile)
- new coils:
- Body Coil -
- BioMatrix Head/Neck 20 TCS -
- BioMatrix Head/Neck 64 CS -
- BioMatrix Spine 72 RS -
- BioMatrix Spine 32 RS -
- UltraFlex Large 18 -
- UltraFlex Small 18 -
- Shoulder Shape 16 -
- -Tx/Rx Knee 18
- other components such as: ।
- helium compressor
- cover incl. new touch displays with extended functionalty and redesigned control island
- computers and monitor
5
-
respiratory sensor (respiratory sensor loops integrated into BioMatrix Spine 32 RS and BioMatrix Spine 72 RS)
Modified Hardware -
main components such as gradient power amplifier and patient communication unit
-
other components such as RF power amplifier, magnet supervision, electronic cabinet and measurement control components
Software
New Features and Applications
- | SliceAdjust (framework for pulse sequence types which allows applying adjustment settings dynamically to measured sub-volumes during the measurement.)
- । Whole-Body Dot Engine (supports multi-region examinations with consistent settings for spatial resolution, image contrast, and breath-hold capacity covering the regions chest, abdomen, pelvis and also extensions towards head and legs.)
- । CoilShim (reduce patient induced strongly localized B0 inhomogeneities by generating the respective anatomy-specific B0 field with local shim coil elements integrated in the local Rx coils BioMatrix Head/Neck 20 TCS and BioMatrix Head/Neck 64 CS.)
- Left/Right Balancing (method for balancing the signal in the left and right brain hemispheres to reduce the signal asymmetry between the left and right brain hemispheres.)
New Software / Platform
- Software platform (new software version syngo MR XA10A based on the | new Numaris/X software which combines the software of the predicate device and the reference device with modifications and extensions as well as changed structure and design of the user interface and changed post processing integration.)
- General workflow (left-hand side (LHS) and right-hand side (RHS) concept । with dual monitor workflow where patient handling and scanning is separated from post-processing and data handling. The "LHS" contains scan-related elements such as the Patient Browser (Scheduler) and scan UI and displays the inline processed images. On the "RHS" additional results are generated in the form of basic and advanced post-processing including data handling and result distribution.)
- | User role concept (five user roles with different rights)
6
SIEMENS
- । Distribution step (allows the selection of data sets for archiving and DICOM transfer within MR View&GO)
- 4D Viewing (allows the visualization of 4D data such as different phases, bvalues or echos of one DICOM series within MR View&GO and allows temporal (phase navigation in 4D data sets) and spatial scrolling.)
- । Launcher Step (starts an advanced application on the RHS)
- Multiframe DICOM format (now available in addition with improvements in performance, application support, navigation and data interchange.)
- Touch positioning (Select&GO) (to position the patient to the isocenter by using the touch displays integrated in the system cover)
Modified Features and Applications
- Compressed Sensing Cardiac Cine: An option to enable Compressed — Sensing Cardiac Cine is integrated into the BEAT pulse sequence type. The total acceleration factor is a user-interface parameter that controls the degree of k-space under-sampling. Compressed Sensing Cardiac Cine can be performed in single-shot and in multi-shot mode.
- Dixon fat/water separation: improvement for a more robust assignment of । local fat and water regions to the respective image.
- । Pre-Scan-Normalize: Improvements with the qoal to correct MRI images for local coil sensitivity variations and to generate homogenous MRI images. Three different matrix sizes are available now.
- । iPAT: Improvements in the VIBE and in the HASTE pulse sequence types to improve the image quality. Changes in the VIBE pulse sequence type concern the k-space reordering, the external GRE reference scan and the minimal slice oversampling. Changes in the HASTE sequence includes the possibility to use a reference scan "TSE/Separate" for GRAPPA acquisition and reconstruction.
- HeartFreeze: extended to support multiple repeats and averaging of the । same slice acquired at the same phase of the cardiac cycle in combination with non-selective inversion recovery imaging.
Modified (general) Software / Platform
- Patient Browser (Scheduler): two components (Patient Registration and — Scheduler) consolidated.
- Table Positioning Mode: Automated movement of table provided on examination level so that the scan is performed in the magnet isocenter. Additionally the "LocalRange" positioning mode can be used for smaller regions like e.g. the heart or the brain.
- Spectroscopy Add-in: enables planning on non-distortion corrected images for spectroscopy.
7
SIEMENS
- MR View&GO: For quality assurance, image viewing, basic post- । processing, printing and result distribution. The functionality is provided in workflow steps which provide guidance, allow independent work and do not require any reloading of data.
- । Prior Handling: for the display of available priors.
- System Start and Shutdown: improvements with a System Start Timer and | shutdown unattended by the user.
Other Modifications and / or Minor Changes
- SAR: software for the simulation of local SAR.
- SAR Assistant: two additional options for selection.
- Noise masking: to remove the noise floor in outer regions. —
- MAGNETOM RT Pro Edition Marketing bundle: extension of the bundle.
- Siemens "Healthineers": new Siemens brand.
- Improved Adiustments: transmitter adjustment to avoid any signal- | manipulating dephasing, frequency adjustment optimized for more reliable water peak detection, and FastView adjustments extended to be available for all kind of data selectable in the user interface.
- Cooling Cabinet: increased cooling capacity and improvements. l
- BEAT IRTT: extends BEAT IRT sequence with a multi-slice functionality | and introduces some parameters. "TTT" stands for the extension of BEAT IRT to three dimensions.
-Vacuum pump: automatic switching
mechanism.
Technological Characteristics
MAGNETOM Vida with software syngo MR XA10A has different technological characteristics as the predicate device MAGNETOM Skyra (K153343; cleared April 15, 2016).
The subject device is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.
MAGNETOM Vida conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
While MAGNETOM Vida offers new and modified software with respect to the predicate device systems, MAGNETOM Vida has different technological characteristics as the predicate device systems. Additionally, this submission includes new and modified hardware including new coils.
8
SIEMENS
Nonclinical Tests
The following performance testing was conducted on the subject device
- Sample clinical images were taken in particular for the coils, as well as for new and modified software features and modified features in the pulse sequence types.
- lmage quality assessments of all new/modified pulse sequence types and l algorithms were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.
- 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"
- Performance tests were completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
Clinical Tests
A clinical study of 33 individuals was conducted to determine the nerve stimulation thresholds used to limit the gradient system output. The observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level which is required in IEC 60601-2-33.
No additional clinical tests were conducted to support the subject device and the substantial equivalence argument; however, sample clinical images were provided to support the new coils as well as the new and modified hardware and software features of the subject device per the MR guidance document. Clinical publications were referenced to provide information on the use of some features and functions.
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 of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as
9
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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.
MAGNETOM Vida with software syngo MR XA10A 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 as stated in the following table.
| Recognition
Number | Product
Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
|-----------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| 19-4 | General | Medical electrical equipment -
part 1: general requirements for
basic safety and essential
performance | ES60601-
1:2005/(R) 2012
and A1:2012 | AAMI / ANSI |
| 19-1 | General | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements and
tests | 60601-1-2 Edition
3:2007-03 | IEC |
| 12-271 | Radiology | Medical electrical equipment -
Part 2-33: Particular
requirements for the basic safety
and essential performance of
magnetic resonance equipment
for medical diagnosis | 60601-2-33 Ed.
3.1:2013 | IEC |
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971 Second
edition 2007-10 | ISO |
| 5-96 | General | Medical devices - Application of
usability engineering to medical
devices | 62366 Edition 1.0
2015 | AAMI
ANSI
IEC |
| 13-32 | Software | Medical device software -
Software life cycle processes | 62304:2006 | AAMI
ANSI
IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4-2010 | NEMA |
| 12-288 | Radiology | Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images
(MRI) | MS 9-2008 | NEMA |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012 | PS 3.1 - 3.20
(2016) | NEMA |
| Recognition
Number | Product
Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
| 2-156 | Biocompatibility | biological evaluation of medical
devices -- part 1: evaluation and
testing within a risk management
process. (Biocompatibility) | 10993-1:2009/(R)
2013 | AAMI
ANSI
ISO |
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Substantial Equivalence
MAGNETOM Vida with software syngo MR XA10A includes most of the features of the predicate device and additional new and modified hardware and software as noted above.
Predicate Device & Reference Device Information
| Predicate Device | FDA Clearance
Number and Date | Product
code | Manufacturer |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------|--------------------------------------------|
| syngo MR E11C for MAGNETOM
Skyra | K153343,
cleared April 15,
2016 | LNH
LNI,MOS | Siemens AG /
Siemens Healthcare
GmbH |
| Reference Devices | FDA Clearance
Number and Date | Product
code | Manufacturer |
| syngo MR E11C for MAGNETOM
Aera | | | |
| Please note: Gradient Power Amplifier
GPA 90/22/F (XQ gradient engine), as
part of MAGNETOM Aera with syngo MR
E11C, is the reference device related to
Gradient Power Amplifier GPA 90/22/DG
(XQ gradient engine) | K153343,
cleared April 15,
2016 | LNH
LNI,MOS | Siemens AG /
Siemens Healthcare
GmbH |
| syngo MR E11A for MAGNETOM
Skyra | K141977,
cleared November
19, 2014 | LNH
LNI,MOS | Siemens AG |
| syngo MR E11C-AP02 for
MAGNETOM Skyra | K163312,
cleared January
27, 2017 | LNH
LNI,MOS | Siemens Healthcare
GmbH |
| syngo.via VB10A
Please note: reference device related to
Numaris/X | K150843,
cleared April 24,
2015 | LLZ | Siemens AG |
| MAGNETOM Avantotm
Please note: reference device related to
the cover (manufacturing procedure and
material) | K162102,
cleared November
22, 2016 | LNH
LNI,MOS | Siemens AG /
Siemens Healthcare
GmbH |
| syngo MR D13C for MAGNETOM
Skyra | K123510,
cleared May
17, 2013 | LNH | Siemens AG |
Siemens 510(k) Traditional Premarket Notification
February 08, 2017
Siemens MR System MAGNETOM Vida (3T) with syngo MR XA10A Software
11
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| Predicate Device & Reference Device Information | |||
|---|---|---|---|
| syngo MR D13A for MAGNETOM | |||
| Verio | K121434, | ||
| cleared November | |||
| 5, 2012 | LNH | ||
| LNI,MOS | Siemens AG |
Conclusion as to Substantial Equivalence
MAGNETOM Vida with software syngo MR XA10A has the same intended use and different technological characteristics as the predicate device system, MAGNETOM Skyra with synqo MR E11C. with respect to the magnetic resonance features and functionalities. While there are some technical features that vary with respect to the predicate device MR System, the conclusions from all verification and validation data suggest that the features with different technological characteristics from the predicate device bear an equivalent safety and performance profile as that of the predicate device and the reference devices.
Therefore the subject device is substantially equivalent to the predicate device.
In summary, MAGNETOM Vida has similar functionalities of the predicate device and based on the aforementioned information, does not introduce any new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Vida with software syngo MR XA10A does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device MAGNETOM Skyra with software syngo MR E11C (K153343 cleared on April 15, 2016).