(445 days)
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body, or 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 display and MR-Safe biopsy needles.
The subject devices, MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with syngo MR XA20A, with the new pulse sequence MR Fingerprinting (MRF) consists of slightly modified software that are similar to what is currently offered in the predicate devices, MAGNETOM Vida with syngo MR XA31A (K203443) and MAGNETOM Vida with syngo MR XA20A (K192924) respectively.
The subject devices MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with synqo MR XA20A includes features that were cleared under K203443 and K192924 respectively. In addition to these features, the subject devices include a new pulse sequence type called MR Fingerprinting (MRF), a method that permits the simultaneous non-invasive quantification mapping of MRF-derived T1 and T2 relaxation times of brain tissue. The MRF is not intended to yield the ground truth T1 and T2 relaxation times of brain tissue.
The document describes the Siemens MAGNETOM Vida MRI system with a new pulse sequence called MR Fingerprinting (MRF). The acceptance criteria for this device and the study proving it meets these criteria are outlined as follows:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Confirmation of successful MRF execution | MRF T1 and T2 maps from volunteers were acquired, confirming successful execution and absence of obvious artifacts or degradations. |
| Quantitative performance (precision): repeatability and reproducibility of MRF T1 and T2 values | Repeated MRF T1 and T2 maps acquired in phantom and healthy volunteers showed quantitative performance in terms of precision (repeatability and reproducibility). MRF T1 and T2 maps confirmed results were stable and parametric values reproducible across different systems within specified ranges. |
| Software verification and validation | Systematic testing according to MRF test specifications was performed, confirming stability and reproducibility of parametric values. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 3 healthy volunteers were scanned multiple times using multiple systems. Additionally, several clinical patient cases demonstrating a longitudinal use case scenario (repeated scans from the same subject over time) were provided.
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as it involved actively scanning volunteers and collecting clinical patient cases for demonstration.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth for the provided clinical patient cases or for interpreting the volunteer scans. It states that the device provides "information that may assist in diagnosis" when interpreted by a trained physician, but this is in the general "Indications for Use" and not directly about the ground truth establishment for the performance study.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned as being done to compare human readers with and without AI assistance. The study focuses on the technical performance of the MRF sequence itself.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation of the MRF sequence was performed. The "Performance bench test" and "Software verification and validation" involved quantitative evaluation of MRF-derived T1 and T2 values in phantoms and volunteers, and testing to confirm stable and reproducible parametric values across systems. This assessment of the algorithm's output without human interpretation is a standalone evaluation.
7. The Type of Ground Truth Used
The ground truth used for the quantitative evaluation of T1 and T2 values came from:
- Quantitative Phantom: For confirming stability and reproducibility of parametric values.
- Healthy Volunteers: For evaluating quantitative performance in terms of precision (repeatability and reproducibility) for T1 and T2 maps.
- The document implies that for the "Sample clinical images" and "clinical patient cases," the assessment was based on whether the sequence executed successfully and produced images free of artifacts, rather than comparing against an external, independent "ground truth" for diagnosis. The MRF itself is described as "not intended to yield the ground truth T1 and T2 relaxation times of brain tissue."
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set for the MRF pulse sequence.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as details about a training set are not included.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.
February 24, 2023
Siemens Medical Solutions USA, Inc. % Martin Rajchel Senior Regulatory Affairs Manager 40 Liberty Boulevard Mail Code 65-1A MALVERN PA 19355
Re: K213805
Trade/Device Name: MAGNETOM Vida Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH. LNI. MOS Dated: January 27, 2023 Received: January 27, 2023
Dear Martin Rajchel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 medical devices and radiation-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,
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K213805
Device Name MAGNETOM Vida
Indications for Use (Describe)
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross sectional images, spectroscopic images 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 display and MR-Safe biopsy needles.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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 | |
| Malvern, PA 19355, USA | |
| Registration Number: 2240869 |
Date Prepared: February 16, 2023
Manufacturer: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157
2. Contact Information
Martin Rajchel Sr. Manager, Requlatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: 484-473-4209 E-mail: martin.rajchel@siemens-healthineers.com
3. Device Name and Classification
| Device name: | MAGNETOM Vida |
|---|---|
| Trade name: | MAGNETOM Vida |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNHSecondary: LNI, MOS |
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SIEMENS Healthineers
4. Legally Marketed Predicate Devices
- i. Predicate for MAGNETOM Vida with software syngo XA31A and pulse sequence MR Fingerprinting
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K203443 |
| Clearance Date | March 31, 2021 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNHSecondary: LNI, MOS |
- ii. Predicate for MAGNETOM Vida with software syngo XA20A and pulse sequence MR Fingerprinting
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K192924 |
| Clearance Date: | March 11, 2020 |
| 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
Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
6. Device Description
The subject devices, MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with syngo MR XA20A, with the new pulse sequence MR Fingerprinting (MRF) consists of slightly modified software that are similar to
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SIEMENS Healthineers
510(k) Summary - K213805
what is currently offered in the predicate devices, MAGNETOM Vida with syngo MR XA31A (K203443) and MAGNETOM Vida with syngo MR XA20A (K192924) respectively.
The subject devices MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with synqo MR XA20A includes features that were cleared under K203443 and K192924 respectively. In addition to these features, the subject devices include a new pulse sequence type called MR Fingerprinting (MRF), a method that permits the simultaneous non-invasive quantification mapping of MRF-derived T1 and T2 relaxation times of brain tissue. The MRF is not intended to yield the ground truth T1 and T2 relaxation times of brain tissue.
7. Substantial Equivalence
MAGNETOM Vida with software syngo MR XA31A and the pulse sequence MRF is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Vida withsyngo MR XA31A | K203443,cleared March 31, 2021 | LNHLNI, MOS | Siemens HealthcareGmbH |
MAGNETOM Vida with software syngo MR XA20A and the pulse sequence MRF is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Vida with | K192924,cleared March 11, 2020 | LNH | Siemens Healthcare |
| syngo MR XA20A | LNI, MOS | GmbH |
The software sequence for MRF is identical in the device software versions syngo MR XA31A and syngo MR XA20A.
8. Technological Characteristics
The MR Fingerprinting (MRF) is the one new function within software versions synqo MR XA20A and synqo MR XA31A for MAGNETOM Vida.
There are differences in technological characteristics between the subject devices and predicate devices. The underlying software (syngo MR XA20A and synqo MR XA31A) are identical to the predicate, and the inclusion of MRF is the only difference in terms of technological characteristics.
The subject device conforms to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards
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9. Nonclinical Tests
The following performance testing was conducted on the subject device.
| Performance Test | Tested Software | Source/Rationale |
|---|---|---|
| Sample clinical images | New feature "MR Fingerprinting"with the new 2D FISP MR-Fingerprinting pulse sequencetype as part of the softwareversion syngo MR XA20A andsyngo MR XA31A*. | Submission of PremarketNotifications for MagneticResonance Diagnostic Devices(November 2016) |
| Performance bench test | Phantom and volunteer testingfor quantitative evaluation ofMRF-derived T1 and T2 values | |
| Software verification andvalidation | New feature "MR Fingerprinting"with the new 2D FISP MR-Fingerprinting pulse sequencetype as part of the softwareversion syngo MR XA20A andsyngo MR XA31A. | Guidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices (May 2005) |
- The tests were performed with the MR Fingerprinting (MRF) software sequence implemented in syngo MR XA20A. As the MR Fingerprinting (MRF) software sequence is identical between syngo MR XA20A and syngo MR XA31A, the clinical results are also valid for syngo MR XA31A.
For the performance test 'Sample clinical images', MRF T1 and T2 maps from volunteers were acquired to confirm the MRF sequence was executed successfully, and the resulting images were free of any obvious artifacts or degradations.
For the 'Performance bench test' repeated MRF T1 and T2 maps were acquired as part of a controlled study setup in phantom and healthy volunteers to evaluate the quantitative performance in terms of precision (repeatability and reproducibility).
The process 'Software verification and validation' comprises systematic testing according to the MRF test specification. MRF T1 and T2 maps were retrieved using on a quantitative phantom to confirm that the results were stable and parametric values were reproducible across different systems within specified ranges.
The results from each set of tests demonstrate that the devices perform as intended and is thus substantially equivalent to the predicate devices to which they have been compared.
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10. Clinical Tests
A study was performed with 3 healthy volunteers who were scanned multiple times using multiple systems to show the repeatability and reproducibility of the T1 and T2 maps acquired on the subject device and other MAGNETOM 3T scanners. In addition, several clinical patient cases were provided which demonstrated a longitudinal use case scenario, i.e., repeated scans from the same subject to observe changes over time.
The tests were performed with the MR Fingerprinting (MRF) software sequence implemented in syngo MR XA20A. As the MR Fingerprinting (MRF) software sequence is identical between syngo MR XA20A and syngo MR XA31A, the clinical results are also valid for syngo MR XA31A.
Clinical publications were referenced to provide additional clinical information on the new MR Fingerprinting method.
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 devices.
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 Healthineers 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 synqo MR XA31A and MAGNETOM Vida with software syngo MR XA20A conforms to the following FDA recognized and international IEC, ISO and NEMA standards:
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510(k) Summary - K213805
| RecognitionNumber | ProductArea | Title of Standard | ReferenceNumber and date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General | Medical electrical equipment -part 1: general requirements forbasic safety and essentialperformance | ES60601-1:2005/(R) 2012and A1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests | 60601-1-2, Ed.4.0:2014 | 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.3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application ofrisk management to medicaldevices | 14971, Ed. 2:2007 | ISO |
| 5-114 | General | Medical devices – Application ofusability engineering to medicaldevices | 62366, Edition1.0:2015 | AAMIANSIIEC |
| 13-32 | Software | Medical device software -Software life cycle processes | 62304:2006 | AAMIANSIIEC |
| 12-232 | Radiology | Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices | MS 4:2010 | NEMA |
| 12-288 | Radiology | Characterization of PhasedArray Coils for DiagnosticMagnetic Resonance Images(MRI) | MS 9:2008 | NEMA |
| 12-300 | Radiology | Digital Imaging andCommunications in Medicine(DICOM) Set 03/16/2012Radiology | PS 3.1 - 3.20:2016 | NEMA |
12.Conclusion to Substantial Equivalence
MAGNETOM Vida with software syngo MR XA31A and the new pulse sequence MRF has the same intended use and similar technological characteristics compared to the predicate device, MAGNETOM Vida with syngo MR XA31A (K203443), with respect to the magnetic resonance features and functionalities. Similarly, MAGNETOM Vida with software syngo MR XA20A and the new pulse sequence MRF has the same intended use and similar technological
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SIEMENS Healthineers
characteristics compared to the predicate device MAGNETOM Vida with syngo MR XA20A (K192924).
The difference between the subject device and predicate device is the addition of the new pulse sequence "MRF". The difference has been tested and the conclusions from the non-clinical and clinical data suggests that the feature bears an equivalent safety and performance profile to that of the predicate device.
Siemens believes that the addition of the new pulse sequence "MRF" to MAGNETOM Vida with software syngo MR XA31A and MAGNETOM Vida with software syngo MR XA20A is substantially equivalent to the currently marketed devices MAGNETOM Vida with software syngo MR XA31A (K203443, cleared on March 31, 2021) and MAGNETOM Vida with software syngo MR XA20A (K192924, cleared on March 11, 2020) respectively.
§ 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.