(128 days)
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.
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.
This document describes the Siemens MAGNETOM MR system (various models) with syngo MR XA31A software, and it does not describe an AI device. The information provided is a 510(k) summary for a Magnetic Resonance Diagnostic Device (MRDD). The "Deep Resolve Sharp" and "Deep Resolve Gain" features are mentioned as using "trained convolutional neuronal networks" but the document does not provide details on acceptance criteria or studies specific to the AI components as requested.
Therefore, many of the requested items (e.g., sample sizes for training/test sets for AI, expert consensus for ground truth, MRMC studies) cannot be extracted from this document because it is primarily focused on the substantial equivalence of the overall MR system and its general technological characteristics, not a specific AI algorithm requiring detailed performance studies against a clinical ground truth.
However, I can extract the available information, especially concerning the "Deep Resolve Sharp" and "Deep Resolve Gain" features, and note where the requested information is not present.
Here's the breakdown of available information, with specific answers to your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for the "Deep Resolve Sharp" or "Deep Resolve Gain" features, nor does it present a table of reported device performance metrics for these features in the context of clinical accuracy or diagnostic improvement specifically. The performance testing mentioned is general for the entire system ("Image quality assessments," "Performance bench test," "Software verification and validation"), concluding that devices "perform as intended and are thus substantially equivalent."
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated for specific features like "Deep Resolve Sharp" or "Deep Resolve Gain." The document broadly mentions "Sample clinical images" were used for "Image quality assessments."
- Data Provenance (Country/Retrospective/Prospective): Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not specified. The document states "Image quality assessments by sample clinical images" and that the "images...when interpreted by a trained physician yield information that may assist in diagnosis," but it does not detail the number or qualifications of experts involved in these assessments for specific software features or for establishing ground truth for any AI component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not described for the "Deep Resolve Sharp" or "Deep Resolve Gain" features or any other AI component. The document references clinical publications for some features (e.g., Prostate Dot Engine, GRE_WAVE, SVS_EDIT) but these are general publications related to the underlying clinical concepts or techniques, not comparative effectiveness studies of the system's AI features versus human performance. The statement "No additional clinical tests were conducted to support substantial equivalence for the subject devices" reinforces this.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While "Deep Resolve Sharp" and "Deep Resolve Gain" involve "trained convolutional neuronal networks," the document does not describe standalone performance studies for these algorithms. Their inclusion is framed as an enhancement to the overall MR system's image processing capabilities, rather than a separate diagnostic AI tool. The stated purpose of Deep Resolve Sharp is to "increases the perceived sharpness of the interpolated images" and Deep Resolve Gain "improves the SNR of the scanned images," both being image reconstruction/enhancement features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not specified for any AI-related features. For general image quality assessment, the "trained physician" is mentioned as interpreting images to assist in diagnosis, implying clinical interpretation, but no formal ground truth establishment process is detailed.
8. The sample size for the training set
Not specified for the "trained convolutional neuronal networks" used in "Deep Resolve Sharp" or "Deep Resolve Gain."
9. How the ground truth for the training set was established
Not specified.
{0}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
{3}------------------------------------------------
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 BoulevardMail Code 65-1AMalvern, PA 19355, USARegistration 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
{4}------------------------------------------------
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: LNHSecondary: 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: LNHSecondary: 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)
{5}------------------------------------------------
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.
{7}------------------------------------------------
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 Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Vida withsyngo MR XA20A | K192924, cleared March11, 2020 | LNHLNI, MOS | Siemens HealthcareGmbH |
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 Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Sola withsyngo MR XA20A | K192496, cleared February28, 2020 | LNHLNI, MOS | Siemens HealthcareGmbH |
| MAGNETOM Lumina withsyngo MR XA20A | K192924, cleared March11, 2020 | LNHLNI, MOS | Siemens HealthcareGmbH |
| MAGNETOM Altea withsyngo MR XA20A | K192496, cleared February28, 2020 | LNHLNI, MOS | Siemens HealthcareGmbH |
| MAGNETOM Area,MAGNETOM Skyra,MAGNETOMPrisma/Prismafit with syngoMR XA30A | K202014, clearedSeptember 08, 2020 | LNHLNI, MOS | Siemens HealthcareGmbH |
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 modifiedsoftware features | Guidance for Submission ofPremarket Notifications for |
| Image quality assessments bysample clinical images. Insome cases a comparison ofthe image quality / quantitativedata was made. | - new / modified pulse sequencetypes and algorithms.- comparison images betweenthe new / modified featuresand the predicate devicefeatures | Magnetic ResonanceDiagnostic Devices |
| Performance bench test | mainly new and modifiedhardware | |
| Software verification andvalidation | mainly new and modifiedsoftware features | Guidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices |
| Biocompatibility | surface of applied parts | ISO 10993-1 |
| Electrical safety andelectromagnetic compatibility(EMC) | Only separate testing forNexaris 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 (2DCAIPIRINHA).” MRM 55(3):549-56 (2006) | |
| Prostate Dot Engine | [6] Essner M, Zinsser D, Kündel M, et. al. Performance of an AutomatedWorkflow for Magnetic Resonance Imaging of the Prostate: ComparisonWith 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 – asystem guided and assisted workflow to improve consistency in prostateMR 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 ofTGSE_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}------------------------------------------------
| RecognitionNumber | ProductArea | Title of Standard | ReferenceNumber and date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General II(ES/EMC) | C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) Medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance (IEC60601-1:2005, MOD) | ES60601-1:2005/(R)2012and A1:2012 | ANSI AAMI |
| 19-8 | General II(ES/EMC) | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests | 60601-1-2 Edition4.0 2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment -Part 2-33: Particularrequirements for the basicsafety and essentialperformance of magneticresonance equipment formedical diagnosis | 60601-2-33 Ed. 3.2b:2015 | IEC |
| 5-40 | General I(QS/RM) | Medical devices - Application ofrisk management to medicaldevices | 14971 Secondedition 2007-03-01 | ISO |
| 5-114 | General I(QS/RM) | Medical devices - Part 1:Application of usabilityengineering to medical devices | 62366-1:2015 | ANSI AAMIIEC |
| 13-79 | Software/Informatics | Medical device software -Software life cycle processes[Including Amendment 1 (2016)] | 62304:2006/A1:2016 | ANSI AAMIIEC |
| 12-232 | Radiology | Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices | MS 4-2010 | NEMA |
| 12-288 | Radiology | Standards PublicationCharacterization of PhasedArray Coils for DiagnosticMagnetic Resonance Images | MS 9-2008 (R2014) | NEMA |
| 12-300 | Radiology | Digital Imaging andCommunications in Medicine(DICOM) Set 03/16/2012Radiology | PS 3.1 - 3.20(2016) | NEMA |
| 2-220 | Biocompatibility | Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a riskmanagement process | 10993-1:2009/(R)2013 | ANSI AAMIISO |
Traditional Premarket Notification 510(k)
Confiderial
{11}------------------------------------------------
March 29, 2021
Image /page/11/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
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).
§ 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.