(94 days)
Not Found
Yes
The device description explicitly mentions "deep learning-based image reconstruction" for "Deep Resolve Swift Brain" and "Deep Resolve Boost".
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectra that assist in diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MAGNETOM system is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the information derived from it "may assist in diagnosis."
No
The device description explicitly states "A high-level summary of the new and modified hardware and software is provided below," and then lists both software and hardware changes. The intended use also describes a "magnetic resonance diagnostic device (MRDD)," which is a hardware 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 MAGNETOM system is a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the internal structure and/or function of the body. It is used to assist in diagnosis when interpreted by a trained physician. This describes an in-vivo imaging device, not a device that performs tests on samples taken from the body.
- Device Description: The description focuses on hardware and software features related to image acquisition, reconstruction, and processing for MRI scans. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Input: The input is the patient's body within the magnetic field, not a biological sample.
- Output: The output is images, spectra, and derived physical parameters, not results from a laboratory test on a sample.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The MAGNETOM system operates by imaging the body directly using magnetic resonance technology.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The 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.
The 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 XA50A includes new and modified software compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A. A high-level summary of the new and modified hardware and software is provided below:
Software
New Features and Applications
- Deep Resolve Swift Brain is a protocol for fast routine brain imaging primarily based on echo planar imaging (EPI) pulse sequences. Its main enablers are multi-shot (ms) EPI pulse sequence types and a deep learning-based image reconstruction.
- Deep Resolve Boost is a novel deep learning-based image reconstruction algorithm for 2D TSE data, which reconstructs images from k-space raw-data.
- BLADE diffusion is a multi-shot imaging method based on TSE or TGSE (when EPI factor > 1) readout and a BLADE trajectory with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity and reduced T2 decay caused image blurring.
- HASTE diffusion (HASTE DIFF) is a single-shot imaging method based on TSE readout with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity.
Modified Features and Applications
- Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
- Static Field Correction is a reconstruction option reducing susceptibility-induced distortions and intensity variations.
- Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned images. The functionality has been extended to pulse sequence types SE and TSE DIXON.
- Deep Resolve Sharp is an interpolation algorithm which increases the perceived sharpness of the interpolated images. The functionality has been extended to pulse sequence types SE and TSE DIXON.
- The myExam Angio Advanced Assist provides an assisted and quided workflow for peripheral angiography examination using care bolus. The main advantage of this new workflow is a simplified and improved planning procedure of multi-station peripherical angiography measurements.
Other Modifications and / or Minor Changes
- TSE MoCo is an image-based motion correction in the average-dimension for the TSE pulse sequence type.
- MR Breast Biopsy is improved with an automatic fiducial detection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests were conducted. Sample clinical images, new and modified software features, new / modified pulse sequence types and algorithms, comparison images between the new / modified features and the predicate device features were tested for image quality assessments. Software verification and validation was performed on new and modified software features. The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared.
No additional clinical tests were conducted to support substantial equivalence for the subject devices; however, sample clinical images were provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
February 25, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Karthik Pillai, Ph.D. Senior Regulatory Affairs Professional 40 Liberty Boulevard Mail Code 65-1A MALVERN PA 19355
Re: K213693
Trade/Device Name: MAGNETOM Vida with syngo MR XA50A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI and MOS Dated: February 1, 2022 Received: February 2, 2022
Dear Karthik Pillai:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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, Ph.D. 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
2
Indications for Use
Submission Number (if known)
Device Name
MAGNETOM Vida with syngo MR XA50A
Indications for Use (Describe)
The 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.
The 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)
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3
K213693 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 ട്ട 807.92.
-
- General Information
| Establishment: | Siemens Medical Solutions USA, Inc. |
|---|---|
| 40 Liberty Boulevard | |
| Mail Code 65-1A | |
| Malvern, PA 19355, USA | |
| Registration Number: 2240869 |
- Date Prepared: November 22, 2021
- Siemens Healthcare GmbH Manufacturer: Henkestr. 127 91052 Erlangen Germany Registration Number: 3002808157
Siemens Shenzhen Magnetic Resonance LTD. Siemens MRI Center Hi-Tech Industrial park (middle) Gaoxin C. Ave., 2nd Shenzhen 518057 P.R. CHINA Registration Number: 3004754211
2. Contact Information
Karthik Pillai, PhD Senior Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355, USA +1(317)371-8593 Phone: Fax: (610) 448-1787 E-mail: karthik.pillai@siemens-healthineers.com
3. Device Name and Classification
| Device/ Trade name: | MAGNETOM Vida with syngo MR XA50A |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
4
Image /page/4/Picture/0 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 words is a graphic of orange dots arranged in a circular pattern.
| Product Code: | Primary: LNH | |
|---|---|---|
| Secondary: LNI. MOS |
4. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K203443 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
5. Intended Use
The indications for use for the subject devices are the same as the predicate device:
The 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.
The 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 XA50A includes new and modified software compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A. A high-level summary of the new and modified hardware and software is provided below:
Software
New Features and Applications
- Deep Resolve Swift Brain is a protocol for fast routine brain imaging primarily based on echo planar imaging (EPI) pulse sequences. Its main enablers are multi-shot (ms) EPI pulse sequence types and a deep learning-based image reconstruction.
- Deep Resolve Boost is a novel deep learning-based image reconstruction algorithm for 2D TSE data, which reconstructs images from k-space raw-data.
- BLADE diffusion is a multi-shot imaging method based on TSE or TGSE (when EPI factor > 1) readout and a BLADE trajectory with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity and reduced T2 decay caused image blurring.
5
Image /page/5/Picture/0 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 graphic of orange dots.
- HASTE diffusion (HASTE DIFF) is a single-shot imaging method based on TSE readout with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity.
Modified Features and Applications
- Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
- Static Field Correction is a reconstruction option reducing susceptibilityinduced distortions and intensity variations.
- Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned images. The functionality has been extended to pulse sequence types SE and TSE DIXON.
- Deep Resolve Sharp is an interpolation algorithm which increases the perceived sharpness of the interpolated images. The functionality has been extended to pulse sequence types SE and TSE DIXON.
- The myExam Angio Advanced Assist provides an assisted and quided workflow for peripheral angiography examination using care bolus. The main advantage of this new workflow is a simplified and improved planning procedure of multi-station peripherical angiography measurements.
Other Modifications and / or Minor Changes
- TSE MoCo is an image-based motion correction in the average-dimension for the TSE pulse sequence type.
- MR Breast Biopsy is improved with an automatic fiducial detection.
7. Substantial Equivalence
MAGNETOM Vida with software syngo MR XA50A is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------------------------|------------------------------------|-----------------|----------------------------|
| MAGNETOM Vida with
syngo MR XA31A | K203443, cleared March
31, 2021 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
8. Comparison of technological characteristics with the predicate device
The subject device, MAGNETOM Vida with software syngo MR XA50A, is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.
The subject devices conform to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards.
There are some differences in technological characteristics between the subject device and predicate device, including modified software. These differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device.
9. Nonclinical Tests
The following performance testing was conducted on the subject devices.
6
Image /page/6/Picture/0 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.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Sample clinical images | new and modified software features | Guidance for Submission of |
| Premarket Notifications for | ||
| Image quality assessments by | ||
| sample clinical images. In | ||
| some cases a comparison of | ||
| the image quality / quantitative | ||
| data was made. | - new / modified pulse sequence | |
| types and algorithms. |
- comparison images between
the new / modified features
and the predicate device
features | Magnetic Resonance
Diagnostic Devices |
| Software verification and
validation | mainly new and modified
software features | Guidance for the Content of
Premarket Submissions for
Software Contained in Medical
Devices |
The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared.
10.Clinical Tests / Publications
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 the following features and functions.
| Feature / Function | Clinical Publication |
|---|---|
| Deep Resolve Swift | |
| Brain | [1] Pruessmann KP, Weiger M, Scheidegger MB, Boesiger P. SENSE: |
| Sensitivity encoding for fast MRI. Magn Reson Med. 1999;42:952-962. | |
| [2] Hyun CM, Kim HP, Lee SM, Lee S, Seo JK. Deep learning for | |
| undersampled MRI reconstruction. Phys Med Biol. 2018;63(13):135007. | |
| doi:10.1088/1361-6560/aac71a | |
| [3] Wang S, Su Z, Ying L, et al. Accelerating magnetic resonance imaging | |
| via deep learning. In: 2016 IEEE 13th International Symposium on | |
| Biomedical Imaging (ISBI). Prague, Czech Republic: IEEE; 2016:514-517. | |
| doi:10.1109/ISBI.2016.7493320 | |
| [4] Yu S, Park B, Jeong J. Deep iterative down-up CNN for image | |
| denoising. In: Proc. IEEE Conf. Comput. Vis. Pattern Recognit.; 2019:9. | |
| [5] Hammernik K, Schlemper J, Qin C, Duan J, Summers RM, Rueckert D. | |
| Σ-net: Systematic evaluation of iterative deep neural networks for fast | |
| parallel MR image reconstruction. ArXiv191209278 Cs Eess. December |
- http://arxiv.org/abs/1912.09278. Accessed January 9, 2020. |
| | [6] Hammernik K, Schlemper J, Qin C, Duan J, Summers RM, Rueckert D.
Systematic evaluation of iterative deep neural networks for fast parallel
MRI reconstruction with sensitivity-weighted coil combination. Magn.
Reson. Med. 2021;86(4):1859-1872. doi:10.1002/mrm.28827 |
| [7] Wang Z, Bovik AC, Sheikh HR, Simoncelli EP. Image quality
assessment: From error visibility to structural similarity. IEEE Trans Image
Process. 2004;13(4):600-612. doi:10.1109/TIP.2003.819861 | |
| [8] Schlemper J, Caballero J, Hajnal JV, Price AN, Rueckert D. A deep
cascade of convolutional neural networks for dynamic MR image
reconstruction," IEEE Trans. Med. Imag. 2018;37:491-503 | |
| [9] Zbontar J, Knoll F, Sriram A, et al. fastMRI: An open dataset and
benchmarks for accelerated MRI. arXiv:181108839 [physics, stat].
December 2019. http://arxiv.org/abs/1811.08839. Accessed March 5, -
| |
| [10] Demir et al., Optimization of Magnetization Transfer Contrast for EPI
FLAIR Brain Imaging, Proceedings of the ISMRM 2021, abstract 4179 | |
| [11] Clifford et al., Clinical evaluation of an Al-accelerated two-minute
multi-shot EPI protocol for comprehensive high-quality brain imaging,
Proceedings of the ISMRM 2021, abstract 300 | |
| [12] Filho et al., Clinical Evaluation of An Al-Accelerated Two-Minute
Multi-Shot EPI Protocol For Comprehensive High-Quality Brain MRI In An
Emergency And Inpatient Setting, Proceedings of the RSNA 2021,
accepted, abstract 16890 | |
| [13] Pistocchi et al., Al-enhanced multi-shot multi-contrast EPI protocol:
Preliminary clinical experience, Proceedings of the ECR 2022, submitted | |
| [14] Gassenmaier S et al., Deep learning-accelerated T2-weighted
imaging of the prostate: Reduction of acquisition time and improvement
of image quality, European Journal of Radiology, 137 (2021) | |
| [15] Herrmann J et al., Diagnostic Confidence and Feasibility of a Deep
Learning Accelerated HASTE Sequence of the Abdomen in a Single
Breath-Hold, Investigative Radiology, Volume 56, Number 5, May 2021 | |
| [16] Shanbhogue K et al. Accelerated single-shot T2-weighted fat-
suppressed (FS) MRI of the liver with deep learning-based image
reconstruction: qualitative and quantitative comparison of image quality
with conventional T2-weighted FS sequence. Eur Radiol. 2021 May 7. | |
| Deep Resolve Boost | |
| [17] Herrmann J et al., Development and Evaluation of Deep Learning-
Accelerated Single-Breath-Hold Abdominal HASTE at 3 T Using Variable
Refocusing Flip Angles. Invest Radiol. 2021 Apr 22. | |
| [18] Gassenmaier S et al., Accelerated T2-Weighted TSE Imaging of the
Prostate Using Deep Learning Image Reconstruction: A Prospective
Comparison with Standard T2-Weighted TSE Imaging, Cancers, 13,
3593 (2021) | |
7
8
| | [19] Herrmann J et al., Feasibility and implementation of a Deep Learning
MR reconstruction for TSE sequences in musculoskeletal imaging,
Diagnostics, 11, 1484 (2021) | | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Publications under review: | | |
| | [20] Judith Herrmann et al., Feasibility and diagnostic confidence of deep
learning reconstructed TSE imaging of the knee at 1.5 and 3 T. A
prospective study. | | |
| | [21] Alsop, D. C. (1997). Phase insensitive preparation of single
shot RARE: application to diffusion imaging in humans. Magnetic
resonance in medicine, 527-533. | | |
| BLADE_Diffusion | [22] Fu, Q., Kong, X.-c., Liu, D.-x., Guo, Y.-h., Zhou, K., Lei, Z.-q., &
Zheng, C.-s. (2021). Clinical utility of turbo gradient and spin echo
BLADE-DWI (TGSE-BLADE-DWI) for orbital tumors compared
with readout-segmented echo-planar DWI. Proc. Intl. Soc. Mag.
Reson. Med., (p. 3933). | | |
| | [23] Fu, Q., Kong, X.-c., Liu, D.-x., Guo, Y.-h., Zhou, K., Lei, Z.-q., &
Zheng, C.-s. (2021). The efficacy 2D turbo gradient- and spin-echo
diffusion-weighted imaging for cerebellopontine angle tumors.
Proc. Intl. Soc. Mag. Reson. Med., (p. 3934). | | |
| | [24] Hu, H. H., McAllister, A. S., Jin, N., Lubeley, L. J., Selvaraj, B., Smith,
M., ... Zhou, K. (2019). Comparison of 2D BLADE turbo gradient-and
spin-Echo and 2D spin-Echo Echo-planar diffusion-weighted brain MRI at
3 T: preliminary experience in children. Academic radiology, 1597-1604. | | |
| | [25] Pipe, J. G., Farthing, V. G., & Forbes, K. P. (2002). Multishot
Diffusion-Weighted FSE UsingPROPELLER MRI. Magnetic Resonance
in Medicine, 42-52. | | |
| | [26] Sheng, Y., Hong, R., Sha, Y., Zhang, Z., Zhou, K., & Fu, C. (2020).
Performance of TGSE BLADE DWI compared with RESOLVE DWI in the
diagnosis of cholesteatoma. BMC medical imaging, 1-9. | | |
| | [27] Srinivasan, G., Rangwala, N., & Zhou, X. J. (2018). Steer-PROP: a
GRASE-PROPELLER sequence with interecho steering gradient pulses.
Magnetic resonance in medicine, 2533-2541. | | |
| | [28] Yuan, T., Sha, Y., Zhang, Z., Liu, X., Ye, X., Sheng, Y., ... Fu, C.
(2020). TGSE diffusion-weighted pulse sequence in the evaluation of
optic neuritis: Acomprehensive comparison of image quality with
RESOLVE DWI. Proc. Intl. Soc. Mag. Reson. Med., (p. 4137). | | |
| | [29] Zhou, K., Liu, W., & Cheng, S. (2018). Non-CPMG PROPELLER
diffusion imaging: comparison of phase insensitive preparation with split
acquisition. Proc. Intl. Soc. Mag. Reson. Med., (p. 5320). | | |
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
9
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 Vida with software syngo MR XA50A 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 II
(ES/
EMC) | C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated
Text) Medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance (IEC
60601-1:2005, MOD) | ES60601-
1:2005/(R)2012
and A1:2012 | ANSI AAMI |
| 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 IEC
b:2015 | IEC |
| 5-40 | General I
(QS/
RM) | Medical devices - Application of
risk management to medical
devices | 14971 Second
edition 2007-03-01 | ISO |
| 5-114 | General I
(QS/
RM) | Medical devices - Part 1:
Application of usability
engineering to medical devices | 62366-1:2015 | ANSI AAMI
IEC |
| 13-79 | Software/
Informatics | Medical device software -
Software life cycle processes
[Including Amendment 1 (2016)] | 62304:2006/A1:201
6 | ANSI AAMI
IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4-2010 | NEMA |
| 12-288 | Radiology | Standards Publication
Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images | MS 9-2008 (R2014) | NEMA |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
| 12-331 | Radiology | Characterization of
Radiofrequency (RF) Coil
Heating in Magnetic Resonance
Imaging Systems | Standards
Publication MS 14-
2019 | NEMA |
12.Conclusion as to Substantial Equivalence
MAGNETOM Vida with software syngo MR XA50A has the same intended use and same basic technological characteristics than the predicate device system,
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MAGNETOM Vida with syngo MR XA31A, 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.
Siemens believes that MAGNETOM Vida with software syngo MR XA50A is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA31A (K203443, cleared on March 31, 2021).