(140 days)
No
The document lists new and modified software features, but none of the descriptions explicitly mention or imply the use of AI or ML technologies. The focus is on pulse sequences, image acquisition techniques, and workflow improvements.
No
Explanation: The device is indicated for use as a magnetic device for creating images and spectra to assist in diagnosis, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the images and/or spectra and derived physical parameters, when interpreted by a trained physician, "yield information that may assist in diagnosis." This directly implies its role in the diagnostic process.
No
The device description explicitly lists new and modified hardware components, including coils, a camera, a computer, and a multi-channel interface. This indicates it is a system with both hardware and software, not a software-only device.
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 produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. These images and parameters are then interpreted by a trained physician to assist in diagnosis. This describes an in vivo diagnostic imaging device, not an in vitro diagnostic device.
- Device Description: The description details hardware and software components related to magnetic resonance imaging (MRI), such as coils, computers, RF channels, and various pulse sequences and applications for imaging different anatomical regions and functions. This aligns with an MRI system, which is an in vivo imaging modality.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
Therefore, the MAGNETOM system described is a Magnetic Resonance Diagnostic Device (MRDD), which is a type of medical device used for in vivo imaging, not an IVD.
N/A
Intended Use / Indications for Use
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 inages 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 XA11A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA10A. A high level summary of the new and modified features is provided below:
Hardware
New Hardware
- New coils:
- BM Body 12
- BM Spine 24
- Head/Neck 16
- Head 32 MR Coil 3T
- Other components:
- camera
- computer
- Multi-Channel Interface
Modified Hardware
- Main components such as 32 independent RF channels
- Other components such as Tx-Box / RF filter plate / transmit system
Software
New Features and Applications
- GOKnee3D (examination comprising the AutoAlign knee localizer and two SPACE with CAIPIRINHA sequences to support fast high-resolution 3D exams of the knee)
- SPACE with CAIPIRINHA (3D SPACE pulse sequence type with the iPAT mode CAIPIRINHA)
- GOBrain (brain examination in short acquisition time)
- GOBrain+ (adaptation of GOBrain pulse sequences)
- MR Breast Biopsy (supports planning and execution of MR guided breast biopsies and wire localizations)
- MRSim / Synthetic CT (provides MR pulse sequences for the creation of Synthetic CT images based on the MR image input)
- Cardiac Dot Flow Add-In (extension of Cardiac Dot Engine to support blood flow measurements)
- PCASL mode (extension of ASL pulse sequence types by a new blood labeling mode)
- SMS in TSE (Simultaneous Multi Slice (SMS) support for TSE)
Modified Features and Applications
- SliceAdjust (the framework support was extended to include additional pulse sequence types)
- RetroGating (Compressed Sensing Cardiac Cine acquisitions which split the data acquisition over multiple heartbeats can now be configured to perform complete sampling of the cardiac cycle without prior definition of an acquisition window. Combination with arrhythmia rejection is possible.)
- iPAT / TSE Reference Scan (Changes in the TSE, FAST TSE and TSE DIXON pulse sequence types includes the possibility to use a reference scan "TSE/Separate" for GRAPPA acquisition and reconstruction)
- Care Bolus in Angio Dot Engine (workflow support for bolus administration (bolus detection))
- MRCP in SPACE (improvement of the image quality for MR Cholangiopancreatography (MRCP) acquisitions based on the SPACE pulse sequence type)
- MR Elastography:
- Replacement of existing masking by masking performed on the prescan images used within the prescan/normalize (PSN) functionality.
- Optimization of pulse sequence type timing.
- Changes in MEG time period (no longer fixed to the wavelength of the MEG and also implementation of a reduced MEG period)
- Respiratory Sensor Support (additional support for respiratory triggered measurements is provided in several SE-, GRE- and EPI-based pulse sequence types)
Modified (general) Software / Platform
- Single and dual monitor workflow (In the single monitor setup the features of the LHS monitor and RHS monitor are provided on separate tab-cards)
- Touch positioning (Select&GO 2.0) (extension to additional body area positions when dedicated coils are plugged in)
- Dot Cockpit (additional features for handling of scan pulse sequences and offline Dot Cockpit)
- MR View&GO (Addition of Mosaic View (view mode to scroll through dimensions instead of space) and 4D Movie Toolbar (movie toolbar to navigate the 4th dimension))
Other Modifications and / or Minor Changes
- teamplay Protocols Interface (interface to support external pulse sequences management systems)
- Unilateral Hip (added in Large Joint Dot Engine) (user workflow optimized, since information/settings are taken from the patient registration)
- GRE RefScan (external GRE RefScan has been extended to multiple pulse sequence types)
- Asymmetric saturation pulses (support for regional saturation with an asymmetric shape has been added for BOLD imaging)
- CP Mode modification ("RF Transmit Mode" is provided as part of the patient registration based on IEC 60601-2-33)
- SPAIR FatSat (new "SPAIR Breast" mode in several pulse sequence types and extension of "Abdomen&Pelvis" and "Thorax" modes)
- Compressed Sensing GRASP-VIBE (improvement of SPAIR fat saturation performance)
- MAGNETOM RT Pro Edition marketing bundle (extension of the bundle)
- Siemens "BioMatrix" (extension with additional components)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
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
Sample clinical images were taken for the new coils and new and modified software features.
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 device 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", dated May 11, 2005.
Performance tests were completed in accordance with the FDA quidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical tests were conducted to support substantial equivalence for the subject device: however, sample clinical images were provided to support the new coils and new/modified hardware and software features per the FDA quidance document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016. 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)
K173592, K153343, K163312, K173617, K150843
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and is stacked in two lines.
October 19, 2018
Siemens Medical Solutions USA, Inc. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Boulevard Mail Code 65-1A MALVERN, PA 19355
Re: K181433
Trade/Device Name: MAGNETOM Vida Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: September 26, 2018 Received: September 27, 2018
Dear Martin Rajchel:
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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hol 2. nils
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
Indications for Use
510(k) Number (if known)
K181433 Device Name
MAGNETOM Vida
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 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 inages 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
May 31, 2018 Date Prepared
Manufacturer Siemens Healthcare GmbH Henkestrasse 127 Erlangen, Bayern, Germany 91052 Registration Number: 3002808157
2. Contact Information
Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 640-4481 E-mail: martin.raichel@siemens-healthineers.com
3. Device Name and Classification
| 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 |
4
4. Legally Marketed Predicate Device
| Trade Name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K170396, cleared June 14, 2017 |
| 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 |
5. Intended Use
The indications for use for the subject device 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 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 Vida with software syngo MR XA11A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA10A. A high level summary of the new and modified features is provided below:
Hardware
New Hardware
- -New coils:
- BM Body 12 ।
- BM Spine 24 |
- | Head/Neck 16
- -Head 32 MR Coil 3T
- Other components:
- camera —
- computer
- Multi-Channel Interface —
5
Modified Hardware
- Main components such as 32 independent RF channels -
- -Other components such as Tx-Box / RF filter plate / transmit system
Software
New Features and Applications
- GOKnee3D (examination comprising the AutoAlign knee localizer and two SPACE with CAIPIRINHA sequences to support fast high-resolution 3D exams of the knee)
- SPACE with CAIPIRINHA (3D SPACE pulse sequence type with the iPAT mode CAIPIRINHA)
- GOBrain (brain examination in short acquisition time)
- GOBrain+ (adaptation of GOBrain pulse sequences)
- । MR Breast Biopsy (supports planning and execution of MR guided breast biopsies and wire localizations)
- । MRSim / Synthetic CT (provides MR pulse sequences for the creation of Synthetic CT images based on the MR image input)
- Cardiac Dot Flow Add-In (extension of Cardiac Dot Engine to support blood flow measurements)
- PCASL mode (extension of ASL pulse sequence types by a new blood labeling mode)
- SMS in TSE (Simultaneous Multi Slice (SMS) support for TSE)
Modified Features and Applications
- । SliceAdjust (the framework support was extended to include additional pulse sequence types)
- RetroGating (Compressed Sensing Cardiac Cine acquisitions which split the data acquisition over multiple heartbeats can now be configured to perform complete sampling of the cardiac cycle without prior definition of an acquisition window. Combination with arrhythmia rejection is possible.)
- iPAT / TSE Reference Scan (Changes in the TSE, FAST TSE and TSE DIXON pulse sequence types includes the possibility to use a reference scan "TSE/Separate" for GRAPPA acquisition and reconstruction)
- Care Bolus in Angio Dot Engine (workflow support for bolus administration (bolus detection))
6
- MRCP in SPACE (improvement of the image quality for MR Cholangiopancreatography (MRCP) acquisitions based on the SPACE pulse sequence type)
- MR Elastography:
- Replacement of existing masking by masking performed on the prescan images used within the prescan/normalize (PSN) functionality.
- Optimization of pulse sequence type timing. |
- Changes in MEG time period (no longer fixed to the wavelength of the | MEG and also implementation of a reduced MEG period)
- Respiratory Sensor Support (additional support for respiratory triggered measurements is provided in several SE-, GRE- and EPI-based pulse sequence types)
Modified (general) Software / Platform
- ー Single and dual monitor workflow (In the single monitor setup the features of the LHS monitor and RHS monitor are provided on separate tab-cards)
- Touch positioning (Select&GO 2.0) (extension to additional body area positions when dedicated coils are plugged in)
- Dot Cockpit (additional features for handling of scan pulse sequences and offline Dot Cockpit)
- MR View&GO (Addition of Mosaic View (view mode to scroll through dimensions । instead of space) and 4D Movie Toolbar (movie toolbar to navigate the 4th dimension))
Other Modifications and / or Minor Changes
- teamplay Protocols Interface (interface to support external pulse sequences । management systems)
- Unilateral Hip (added in Large Joint Dot Engine) (user workflow optimized, since information/settings are taken from the patient registration)
- GRE RefScan (external GRE RefScan has been extended to multiple pulse sequence types)
- Asymmetric saturation pulses (support for regional saturation with an asymmetric shape has been added for BOLD imaging)
- CP Mode modification ("RF Transmit Mode" is provided as part of the patient registration based on IEC 60601-2-33)
7
- SPAIR FatSat (new "SPAIR Breast" mode in several pulse sequence types and extension of "Abdomen&Pelvis" and "Thorax" modes)
- Compressed Sensing GRASP-VIBE (improvement of SPAIR fat saturation performance)
- MAGNETOM RT Pro Edition marketing bundle (extension of the bundle)
- Siemens "BioMatrix" (extension with additional components)
7. Technological Characteristics
The subject device, MAGNETOM Vida with software syngo MR XA11A, is substantially equivalent to the predicate device with reqard to the operational environment, programming language, operating system, and performance.
MAGNETOM Vida with software syngo MR XA11A conforms to the standard for medical device software (IEC 62304:2006) and other relevant IEC and NEMA standards.
While there are some differences in technological characteristics between the subject device and predicate device, including new and modified software applications and hardware additions, 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.
8. Nonclinical Tests
The following performance testing was conducted on the subject device:
- Sample clinical images were taken for the new coils and new and modified software features.
- 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 device 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", dated May 11, 2005.
- । Performance tests were completed in accordance with the FDA quidance 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.
8
9. Clinical Tests
No clinical tests were conducted to support substantial equivalence for the subject device: however, sample clinical images were provided to support the new coils and new/modified hardware and software features per the FDA quidance document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016. Clinical publications were referenced to provide information on the use of some features and functions.
10. 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 ISO 14971:2007 compliance 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 the IEC 60601-1 series, to minimize electrical and mechanical risks. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
MAGNETOM Vida with software syngo MR XA11A conforms to the following FDA recognized and international IEC, ISO and NEMA standards:
| 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 |
| 19-8 | General | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests | 60601-1-2 Edition
4.0:2014-02 | IEC |
Siemens MR System MAGNETOM Vida (3T) with new syngo MR XA11A Software
9
| Recognition
Number | Product
Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
|-----------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------------------------|
| 12-295 | 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.
3.2:2015 | 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
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
| 2-156 | Biocompati
bility | biological evaluation of medical
devices - part 1: evaluation and
testing within a risk management
process. (Biocompatibility) | 10993-1:2009/(R)
2013 | AAMI
ANSI
ISO |
11. Substantial Equivalence
MAGNETOM Vida with software syngo MR XA11A is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance
Number and Date | Product code | Manufacturer |
|--------------------------------------|-----------------------------------|----------------|----------------------------|
| MAGNETOM Vida with syngo MR
XA10A | K170396,
cleared June 14, 2017 | LNH
LNI,MOS | Siemens Healthcare
GmbH |
10
MAGNETOM Vida with syngo MR XA11A includes features already cleared on the following reference devices:
| Reference Devices | FDA Clearance
Number and Date | Product code | Manufacturer |
|----------------------------------------------------------------------------|-----------------------------------------------------------|----------------|--------------------------------------------|
| MAGNETOM Skyra with syngo
MR E11C-AP04 | K173592,
cleared February
13, 2018 | LNH
LNI,MOS | Siemens Healthcare
GmbH |
| MAGNETOM Skyra with syngo
MR E11C | K153343,
cleared April 15,
2016 | LNH
LNI,MOS | Siemens AG /
Siemens Healthcare
GmbH |
| MAGNETOM Skyra with syngo
MR E11C-AP02 | K163312,
cleared January
27, 2017 | LNH
LNI,MOS | Siemens Healthcare
GmbH |
| Compressed Sensing GRASP-
VIBE for MAGNETOM Vida with
syngo MR XA10A | K173617,
cleared March 30,
2018 | LNH
LNI,MOS | Siemens Healthcare
GmbH |
| syngo.via VB30A
based on syngo.via VB10A | syngo.via VB10A:
K150843,
cleared April 24,
2015 | LLZ | Siemens Healthcare
GmbH |
12. Conclusion as to Substantial Equivalence
MAGNETOM Vida with software syngo MR XA11A has the same intended use and same technological characteristics as the predicate device system, MAGNETOM Vida with syngo MR XA10A, with respect to the magnetic resonance features and functionalities. While there are some differences in technical 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 Vida with software syngo MR XA11A is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA10A (K170396, cleared on June 14, 2017).