(128 days)
Yes
The "Mentions AI, DNN, or ML" section explicitly states that "Deep Resolve Sharp is an interpolation algorithm based on trained convolutional neuronal networks," which is a type of deep learning, a subset of machine learning and AI.
No
The "Intended Use / Indications for Use" section explicitly states that the system is a "magnetic resonance diagnostic device (MRDD)" used to produce images that assist in diagnosis, not provide therapy.
Yes
Explanation: 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 images and spectra "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states that the system includes "new and modified hardware and software," indicating it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description 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 head, body, or extremities. This is an in vivo diagnostic method, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use is to assist in diagnosis by interpreting images and spectra of the internal body. This aligns with in vivo imaging, not in vitro testing of specimens.
Therefore, based on the provided information, the MAGNETOM system is an in vivo diagnostic device, not an in vitro diagnostic device.
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
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.
Product codes
LNH, LNI, MOS
Device Description
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with software syngo MR XA31A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA20A.
Hardware
- New Hardware
- The Nexaris Dockable Table is a new variant of the MR patient table which is used for intraoperative or interventional imaging. It enables the patient transfer between OR tables and the MR system without repositioning on the MR patient table and vice versa during interventional procedures and surgeries. Additionally, it can be used for diagnostic imaging.
- The Nexaris Head Frame holds up to two Ultra Flex Large 18 coils. It can be used for head imaging in combination with the Nexaris Dockable Table when the patient is positioned on the transfer board but not pinned in a head clamp.
- New Computer
- New Coils
- The Nexaris Spine 36 is used in combination with and without transfer board for body imaging on the Nexaris Dockable Table.
- The Flex Loop Large local coil is a 1Ch receive only multipurpose coil.
- Modified Hardware
- The Beat Sensor is a contact less method for generating cardiac triggers as an alternative to the already existing ECG or pulse triggers. It is based on a measurement of the modulation of a weak magnetic Pilot Tone, caused by conformation changes in conductive tissues.
Software
- New Features and Applications
- SVS EDIT is a special variant of the SVS SE pulse sequence type, which acquires two different spectra (one with editing pulses on resonance, one with editing pulses off resonance) within a single sequence.
- BEAT FQ nav allows the user to make use of navigator echo based respiratory gating for flow imaging to acquire 4D flow data. Both navigator echo based respiratory gating as well as flow imaging are part of the predicate device already. New is merely the combination of both.
- The HASTE interactive pulse sequence type extends the existing HASTE pulse sequence type by offering the possibility to interactively change imaging parameters.
- GRE_WAVE is a special variant of the GRE pulse sequence type which allows larger acceleration factors, measuring one or two contrasts. GRE Wave results in higher signal-to-noise ratio for larger acceleration factors which can be leveraged to allow fast high-resolution 3D susceptibility-weighted imaging.
- The Prostate Dot Engine provides an assisted and guided workflow for prostate imaging. This automated workflow leads to higher reproducibility of slice angulation and coverage; this may support exams not having to be repeated.
- Injector coupling is a software application that allows the connection of certain contrast agent injectors to the MR system for simplified, synchronized contrast injection and examination start.
- Modified Features and Applications
- An optimized high bandwidth inversion recovery pulse is combined with gradient echo readout to improve diagnostic image quality when imaging myocardial tissue.
- The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.
- Deep Resolve Sharp is an interpolation algorithm based on trained convolutional neuronal networks which increases the perceived sharpness of the interpolated images.
- Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned images
- The 3D ASL sequence (tgse_asl) now provides relCBF maps, by implementing an additional M0 scan and performing the corresponding reconstruction method. It also provides BAT maps in multiple inversion time(multi-TI) imaging.
- Other Modifications and / or Minor Changes
- Elastography-AddIn synchronizes settings between the Elastography sequence and the active driver.
- HASTE MoCo is an image-based motion correction in the average-dimension for the HASTE pulse sequence type.
- The Needle Intervention AddIn provides a user interface for workflow improvement of MR-guided needle interventions under real-time imaging conditions. It supports planning a needle trajectory, laser-based localization of the entry point as well as automatic slice positioning.
- The PhaseRev Dot Addin/Component supports the measurement workflow of the user by automatically flipping the direction of the phase encoding gradient.
- Coil independent pulse sequences remove the coil information from the pulse sequences and generate this information during run-time from automatic coil detection and localization.
- The adjustment mode "offcenter" triggers a transmitter adjustment method that is specialized for offcenter imaging. The transmitter adjustment determines the RF voltage that is required to excite a certain B1 field.
Mentions image processing
Yes, "Deep Resolve Sharp is an interpolation algorithm based on trained convolutional neuronal networks which increases the perceived sharpness of the interpolated images." and "Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned images". Also, "HASTE MoCo is an image-based motion correction in the average-dimension for the HASTE pulse sequence type."
Mentions AI, DNN, or ML
Mentions DNN: "Deep Resolve Sharp is an interpolation algorithm based on trained convolutional neuronal networks which increases the perceived sharpness of the interpolated images."
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD)
Anatomical Site
Head, body, or extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Performance Test: Sample clinical images, Image quality assessments by sample clinical images. In some cases a comparison of the image quality / quantitative data was made.
Tested Hardware or Software: coils, new and modified software features; new / modified pulse sequence types and algorithms. comparison images between the new / modified features and the predicate device features
Source/Rationale for test: Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
Performance Test: Performance bench test
Tested Hardware or Software: mainly new and modified hardware
Performance Test: Software verification and validation
Tested Hardware or Software: mainly new and modified software features
Source/Rationale for test: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Performance Test: Biocompatibility
Tested Hardware or Software: surface of applied parts
Source/Rationale for test: ISO 10993-1
Performance Test: Electrical safety and electromagnetic compatibility (EMC)
Tested Hardware or Software: Only separate testing for Nexaris Dockable Table
Source/Rationale for test: IEC 60601-1-2
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K192496, K192924, K192496, K202014
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.
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March 31, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Mr. Andrew Turner Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A MALVERN PA 19355
Re: K203443
Trade/Device Name: MAGNETOM Vida. MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with syngo MR XA31A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: February 26, 2021 Received: March 1, 2021
Dear Mr. Turner:
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K203443
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with syngo MR XA31A
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/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.
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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Image /page/3/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 triangular shape.
March 29, 2021
Section 5 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21 CFR § 807.92.
1. General Information
| Establishment: | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869 |
| ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Date Prepared: March 29, 2021
- Manufacturer: Siemens Healthcare GmbH 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
Andrew Turner Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 40 Libertv Boulevard Mail Code 65-1A Malvern, PA 19355, USA Phone: (610) 850-5627 Fax: (610) 448-1787 E-mail: andrew.turner@siemens-healthineers.com
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Image /page/4/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of several orange circles of varying sizes arranged in a cluster.
3. Device Name and Classification
| Device/ Trade name: | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with syngo MR XA31A |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
4. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K192924 |
| 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:
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 vield information that may assist in diagnosis.
Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
6. Device Description
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with software syngo MR XA31A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software
Traditional Premarket Notification 510(k)
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Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots.
syngo MR XA20A. A high-level summary of the new and modified hardware and software is provided below:
Hardware
New Hardware
- The Nexaris Dockable Table is a new variant of the MR patient table which is used for intraoperative or interventional imaging. It enables the patient transfer between OR tables and the MR system without repositioning on the MR patient table and vice versa during interventional procedures and surgeries. Additionally, it can be used for diagnostic imaging.
- The Nexaris Head Frame holds up to two Ultra Flex Larqe 18 coils. It can be used for head imaging in combination with the Nexaris Dockable Table when the patient is positioned on the transfer board but not pinned in a head clamp.
- New Computer
New Coils
-
The Nexaris Spine 36 is used in combination with and without transfer board ı for body imaging on the Nexaris Dockable Table.
The Flex Loop Large local coil is a 1Ch receive only multipurpose coil. - Modified Hardware -
The Beat Sensor is a contact less method for generating cardiac triggers as an alternative to the already existing ECG or pulse triggers. It is based on a measurement of the modulation of a weak magnetic Pilot Tone, caused by conformation changes in conductive tissues.
Software
New Features and Applications
- SVS EDIT is a special variant of the SVS SE pulse sequence type, which i acquires two different spectra (one with editing pulses on resonance, one with editing pulses off resonance) within a single sequence.
- BEAT FQ nav allows the user to make use of navigator echo based respiratory gating for flow imaging to acquire 4D flow data. Both navigator echo based respiratory gating as well as flow imaging are part of the predicate device already. New is merely the combination of both.
- The HASTE interactive pulse sequence type extends the existing HASTE pulse sequence type by offering the possibility to interactively change imaging parameters.
- GRE_WAVE is a special variant of the GRE pulse sequence type which allows larger acceleration factors, measuring one or two contrasts. GRE Wave results in higher signal-to-noise ratio for larger acceleration factors which can be leveraged to allow fast high-resolution 3D susceptibilityweighted imaging.
- The Prostate Dot Engine provides an assisted and quided workflow for prostate imaging. This automated workflow leads to higher reproducibility of
6
Image /page/6/Picture/1 description: The image displays 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 text is a graphic of orange dots arranged in a circular pattern.
slice angulation and coverage; this may support exams not having to be repeated.
-
Injector coupling is a software application that allows the connection of certain contrast agent injectors to the MR system for simplified, synchronized contrast injection and examination start.
Modified Features and Applications -
An optimized high bandwidth inversion recovery pulse is combined with ı gradient echo readout to improve diagnostic image quality when imaging myocardial tissue.
-
The AbsoluteShim mode is a shimming procedure based on a 3-echo qradient echo protocol.
-
Deep Resolve Sharp is an interpolation algorithm based on trained convolutional neuronal networks which increases the perceived sharpness of the interpolated images.
-
Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned images
-
The 3D ASL sequence (tgse_asl) now provides relCBF maps, by implementing an additional M0 scan and performing the corresponding reconstruction method. It also provides BAT maps in multiple inversion time(multi-TI) imaging.
Other Modifications and / or Minor Changes
- Elastography-AddIn synchronizes settings between the Elastography i sequence and the active driver.
- HASTE MoCo is an image-based motion correction in the average-dimension for the HASTE pulse sequence type.
- The Needle Intervention AddIn provides a user interface for workflow improvement of MR-quided needle interventions under real-time imaging conditions. It supports planning a needle trajectory, laser-based localization of the entry point as well as automatic slice positioning.
- The PhaseRev Dot Addin/Component supports the measurement workflow of the user by automatically flipping the direction of the phase encoding gradient.
- Coil independent pulse sequences remove the coil information from the pulse sequences and generate this information during run-time from automatic coil detection and localization.
- The adjustment mode "offcenter" triggers a transmitter adjustment method that is specialized for offcenter imaging. The transmitter adjustment determines the RF voltage that is required to excite a certain B1 field.
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Image /page/7/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
7. Substantial Equivalence
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with software syngo MR XA31A are substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------------------------|------------------------------------|-----------------|----------------------------|
| MAGNETOM Vida with
syngo MR XA20A | K192924, cleared March
11, 2020 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with software syngo MR XA31A include hardware and software already cleared on the following reference devices:
| Reference Devices | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|------------------------------------------------------------------------------------------|----------------------------------------|-----------------|----------------------------|
| MAGNETOM Sola with
syngo MR XA20A | K192496, cleared February
28, 2020 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
| MAGNETOM Lumina with
syngo MR XA20A | K192924, cleared March
11, 2020 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
| MAGNETOM Altea with
syngo MR XA20A | K192496, cleared February
28, 2020 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
| MAGNETOM Area,
MAGNETOM Skyra,
MAGNETOM
Prisma/Prismafit with syngo
MR XA30A | K202014, cleared
September 08, 2020 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
8. Technological Characteristics
The subiect devices. MAGNETOM Vida. MAGNETOM Sola. MAGNETOM Lumina, MAGNETOM Altea with software syngo MR XA31A, are 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.
As seen above there are some differences in technological characteristics between the subject devices and predicate device, including different hardware and 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.
8
March 29, 2021
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Sample clinical images | coils, 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 |
| Performance bench test | mainly new and modified
hardware | |
| Software verification and
validation | mainly new and modified
software features | Guidance for the Content of
Premarket Submissions for
Software Contained in Medical
Devices |
| Biocompatibility | surface of applied parts | ISO 10993-1 |
| Electrical safety and
electromagnetic compatibility
(EMC) | Only separate testing for
Nexaris Dockable Table | IEC 60601-1-2 |
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 |
|---|---|
| SVS_EDIT | [1] Mescher et al, NMR Biomed 11, 266-272 (1998) |
| [2] Mikkelsen et al, Neurolmage 159, 32-45 (2017) | |
| [3] Saleh et al, Neurolmage 189, 425-431 (2019) | |
| GRE_WAVE | [4] B. Bilgic et al., “Wave-CAIPI for Highly Accelerated 3D Imaging.” |
| MRM 73(6):2152-2162 (2015) | |
| [5] F. Breuer et al., Controlled aliasing in volumetric parallel imaging (2D | |
| CAIPIRINHA).” MRM 55(3):549-56 (2006) | |
| Prostate Dot Engine | [6] Essner M, Zinsser D, Kündel M, et. al. Performance of an Automated |
| Workflow for Magnetic Resonance Imaging of the Prostate: Comparison | |
| With a Manual Workflow. Invest Radiol. 2020 May;55(5):277-284. Doi: | |
| 10.1097. | |
| [7] Horger W, Thoermer G, Weiland E, et. al. Prostate Dot Engine – a | |
| system guided and assisted workflow to improve consistency in prostate | |
| MR exams. |
9
| [8] Yadong C, Siyuan H, Chunmei Li, et. al. Performance and | |||||
|---|---|---|---|---|---|
| Reproducibility of a Day Optimizing Throughput (Dot) Workflow Engine in | |||||
| Automated Prostate MRI Positioning. Abstract accepted for the 28th | |||||
| annual meeting of the International Society of Magnetic Resonance in | |||||
| Medicine (ISMRM). | |||||
| Deep Resolve Gain | [9] Kellman P. et al. Image Reconstruction in SNR Units: A General | ||||
| Method for SNR Measurement. MRM 2005; 54:1439. Erratum in MRM | |||||
| 2007; 58:311. | |||||
| [10] Blu T. et al. The SURE-LET approach to image denoising. IEEE | |||||
| Transactions on Image Processing 16(11):2778-86 | |||||
| [11] D C. Alsop, J A. Detre, et al. Recommended Implementation of | |||||
| Arterial Spin Labeled Perfusion MRI for Clinical Applications: A | |||||
| consensus of the ISMRM Perfusion Study Group and the European | |||||
| Consortium for ASL in Dementia. Magn Reson Med. 2015 Jan; 73(1): | |||||
| 102-116. | |||||
| [12] R B. Buxton, L R. Frank, et al. A general kinetic model for | |||||
| quantitative perfusion imaging with arterial spin labeling. Magn Reson | |||||
| Improvement of | |||||
| TGSE_ASL | Med. 1998 Sep; 40(3):383-96. | ||||
| [13] S. Yang, B. Zhao, et al. Improving the Grading Accuracy of | |||||
| Astrocytic Neoplasms Noninvasively by Combining Timing Information | |||||
| with Cerebral Blood Flow: A Multi-TI Arterial Spin-Labeling MR Imaging | |||||
| Study. Am. J. Neuroradiol. 2016 Dec; 37 (12) 2209-2216 | |||||
| [14] P G Qiao, C Han, et al. Clinical assessment of cerebral | |||||
| hemodynamics in Moyamoya disease via multiple inversion time arterial | |||||
| spin labeling and dynamic susceptibility contrast-magnetic resonance | |||||
| imaging: A comparative study. J Neuroradiol. 2017 Jul;44(4):273-280. | |||||
| [15] Y Shen, B Zhao, et al. Cerebral Hemodynamic and White Matter | |||||
| Changes of Type 2 Diabetes Revealed by Multi-TI Arterial Spin Labeling | |||||
| and Double Inversion Recovery Sequence. Front Neurol. 2017; 8: 717. |
11.Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.
Risk Management is ensured via a risk analysis in compliance with ISO 14971, to identify and provide mitigation of potential hazards early in the design cycle and continuously throughout the development of the product. Siemens Healthcare GmbH adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
MAGNETOM Vida. MAGNETOM Sola. MAGNETOM Lumina. MAGNETOM Altea with software syngo MR XA31A conform to the following FDA recognized and international IEC, ISO and NEMA standards:
Siemens MR Systems: MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea (1.5 / 3T) with new Software syngo MR XA31A
Traditional Premarket Notification 510(k)
10
| 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 |
| 19-8 | General II
(ES/
EMC) | 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 |
| 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
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/A1:2016 | 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 |
| 2-220 | Biocompati
bility | Biological evaluation of medical
devices - Part 1: Evaluation and
testing within a risk
management process | 10993-
1:2009/(R)2013 | ANSI AAMI
ISO |
Traditional Premarket Notification 510(k)
Confiderial
11
March 29, 2021
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12.Conclusion as to Substantial Equivalence
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with software syngo MR XA31A have the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA20A, 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, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with software syngo MR XA31A are substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA20A (K192924, cleared on March 11, 2020).