(29 days)
Yes
The device description explicitly mentions "deep learning-based image reconstruction" and "deep learning-based image reconstruction algorithm".
No
The device is described as a magnetic device that produces images to assist in diagnosis, explicitly stating "when interpreted by a trained physician yield information that may assist in diagnosis." It is not described as providing treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the images and/or spectra and derived physical parameters, when interpreted by a trained physician, "yield information that may assist in diagnosis." This directly indicates its role in the diagnostic process.
No
The device description explicitly mentions the transfer of both software and hardware components, including a new patient table variant, a head frame, a computer, and a coil. This indicates it is not a software-only device.
Based on the provided information, the MAGNETOM system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- MAGNETOM System Function: The MAGNETOM system is a magnetic resonance imaging (MRI) device. It produces images and spectra of the internal structure and function of the body in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "magnetic device (MRDD)" that produces images and spectra of the head, body, or extremities. The information derived from these images assists in diagnosis when interpreted by a trained physician. This is consistent with an imaging device, not an IVD.
Therefore, the MAGNETOM system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
No
The provided text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found". This indicates that the letter does not confirm PCCN authorization.
Intended Use / Indications for Use
The MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/ or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A include new software compared to the predicate devices, MAGNETOM Vida Fit with software syngo MR XA20A (K192924) and MAGNETOM Lumina with syngo MR XA31A (K203443). This software and some hardware components are transferred from the reference device MAGNETOM Vida with software syngo MR XA50A (K213693) as well as an imaging feature from MAGNETOM Vida with software syngo MR XA11A (K181433). A high-level summary of the transferred hardware and software is provided below:
Hardware (Vida Fit only)
Transferred 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.
- Transferred MaRS Computer
Transferred Coil: - The Nexaris Spine 36 is used in combination with and without transfer board for body imaging on the Nexaris Dockable Table.
Transferred modifications for 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
Transferred Features and Applications: Vida Fit only: - 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 myExam Prostate Assist 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.
Lumina only:
- Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.
Lumina and Vida Fit:
- Deep Resolve Swift Brain is a protocol for fast routine brain imaging primarily based on echo planar imaging (EPI) pulse sequences. Its main enablers are multi-shot (ms) EPI pulse sequence types and a deep learning-based image reconstruction.
- Deep Resolve Boost is a novel deep learning-based image reconstruction algorithm for 2D TSE data, which reconstructs images from k-space raw-data.
- BLADE diffusion is a multi-shot imaging method based on TSE or TGSE (when EPI factor > 1) readout and a BLADE trajectory with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity and reduced T2 decay caused image blurring.
- HASTE diffusion (HASTE DIFF) is a single-shot imaging method based on TSE readout with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity.
Transferred Modifications for Features and Applications:
Vida Fit only:
- The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.
- 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.
Lumina and Vida Fit:
- Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
- Static Field Correction is a reconstruction option reducing susceptibilityinduced distortions and intensity variations.
- Deep Resolve Sharp is an interpolation algorithm which increases the perceived sharpness of the interpolated images. Functionality is available for different pulse sequence types. (Newly transferred to Vida Fit)
- Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned images. Functionality is available for different pulse sequence types. (Newly transferred to Vida Fit)
- The myExam Angio Advanced Assist provides an assisted and guided workflow for peripheral angiography examination using care bolus. The main advantage of this new workflow is a simplified and improved planning procedure of multi-station peripherical angiography measurements.
Other transferred Modifications and / or Minor Changes
Vida Fit only:
- 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.
- 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 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.
- 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.
Lumina and Vida Fit:
- TSE MoCo is an image-based motion correction in the average-dimension for the TSE pulse sequence type.
- MR Breast Biopsy is improved with an automatic fiducial detection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No additional clinical tests were conducted to support substantial equivalence for the subject devices.
The following performance testing was conducted on the subject devices:
Performance Test: Verification and validation
Tested Hardware or Software: Transferred hardware and software features
Source/Rationale for test: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices / 21 CFR §820.30
Results: The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate devices to which they have been compared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Siemens Medical Solutions USA, Inc. % Alina Goodman Regulatory Affairs Professional 40 Liberty Blvd. MALVERN PA 19355
Re: K220939
Trade/Device Name: MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: March 30, 2022 Received: March 31, 2022
Dear Alina Goodman:
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
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2
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,
for
CAPT Patrick Hintz, MSIH, CIH, USPHS Assistant Director Eletronic Products Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220939
Device Name MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Indications for Use (Describe)
The MAGNETOM system is indicated for use as a magnetic 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 inages 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.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 pattern of orange dots.
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: | March 30, 2022 |
| 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 |
2. Contact Information
Alina Goodman Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA +1(224)526-1404 Phone: E-mail: alina.goodman@siemens-healthineers.com
Registration Number: 3004754211
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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 word "Healthineers" is a graphic of orange dots.
3. Device Name and Classification
| Device/ Trade name: | MAGNETOM Lumina and MAGNETOM Vida Fit with
syngo MR XA50A |
|-----------------------|--------------------------------------------------------------|
| 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 Devices
| Trade name: | MAGNETOM Lumina with syngo MR XA31A |
|---|---|
| 510(k) Number: | K203443 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS | |
| Trade name: | MAGNETOM Vida Fit with syngo MR XA20A |
| Trade name: | MAGNETOM Vida Fit with syngo MR XA20A |
|---|---|
| 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. Indications for use
The indications for use for the subject devices are the same as the predicate device:
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional imaqes, 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.
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Image /page/5/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 word "Healthineers" is a graphic of orange dots in a circular pattern.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
6. Device Description
MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A include new software compared to the predicate devices, MAGNETOM Vida Fit with software syngo MR XA20A (K192924) and MAGNETOM Lumina with syngo MR XA31A (K203443). This software and some hardware components are transferred from the reference device MAGNETOM Vida with software syngo MR XA50A (K213693) as well as an imaging feature from MAGNETOM Vida with software syngo MR XA11A (K181433). A high-level summary of the transferred hardware and software is provided below:
Hardware (Vida Fit only)
Transferred 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.
- Transferred MaRS Computer
Transferred Coil:
- The Nexaris Spine 36 is used in combination with and without transfer board for body imaging on the Nexaris Dockable Table.
Transferred modifications for 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
Transferred Features and Applications: Vida Fit only:
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Image /page/6/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 arranged in a circular pattern.
- 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 myExam Prostate Assist provides an assisted and quided 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.
- Iniector 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.
Lumina onlv:
- Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.
Lumina and Vida Fit:
- Deep Resolve Swift Brain is a protocol for fast routine brain imaging primarily based on echo planar imaging (EPI) pulse sequences. Its main enablers are multi-shot (ms) EPI pulse sequence types and a deep learning-based image reconstruction.
- Deep Resolve Boost is a novel deep learning-based image reconstruction alqorithm for 2D TSE data, which reconstructs images from k-space raw-data.
- BLADE diffusion is a multi-shot imaging method based on TSE or TGSE (when EPI factor > 1) readout and a BLADE trajectory with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity and reduced T2 decay caused image blurring.
- HASTE diffusion (HASTE DIFF) is a single-shot imaging method based on TSE readout with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity.
Transferred Modifications for Features and Applications:
Vida Fit only:
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Image /page/7/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 orange dots arranged in a circular pattern.
- The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.
- 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.
Lumina and Vida Fit:
- Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
- Static Field Correction is a reconstruction option reducing susceptibilityinduced distortions and intensity variations.
- Deep Resolve Sharp is an interpolation algorithm which increases the perceived sharpness of the interpolated images. Functionality is available for different pulse sequence types. (Newly transferred to Vida Fit)
- Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned imaqes. Functionality is available for different pulse sequence types. (Newly transferred to Vida Fit)
- The myExam Angio Advanced Assist provides an assisted and quided workflow for peripheral angiography examination using care bolus. The main advantage of this new workflow is a simplified and improved planning procedure of multi-station peripherical angiography measurements.
Other transferred Modifications and / or Minor Changes
Vida Fit only:
- 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.
- 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 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.
- 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.
Lumina and Vida Fit:
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Image /page/8/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 cluster of orange dots.
- TSE MoCo is an image-based motion correction in the average-dimension for the TSE pulse sequence type.
- MR Breast Biopsy is improved with an automatic fiducial detection.
7. Substantial Equivalence
MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A are substantially equivalent to the following predicate devices:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Lumina with
syngo MR XA31A | K203443, cleared March
31, 2021 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
| MAGNETOM Vida Fit with
syngo MR XA20A | K192924, cleared on March
11, 2020 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A consist of hardware and software features previously cleared with the following reference device:
| Reference Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Vida with
syngo MR XA50A | K213693, cleared February
25, 2022 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
| MAGNETOM Vida with
syngo MR XA11A | K181433, cleared October
19, 2018 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
8. Comparison of technological characteristics with the predicate devices
The subject devices, MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A, are substantially equivalent to the predicate devices with regard to the operational environment, programming language, operating system and performance.
The subject devices conform to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards.
There are some differences in technological characteristics between the subject devices and predicate devices, including transferred hardware and software from the reference device. The transferred features and components have been tested and the conclusion from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate devices.
9. Nonclinical Tests
The following performance testing was conducted on the subject devices.
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Image /page/9/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.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Verification and validation | Transferred hardware and | |
| software features | Guidance for the Content of | |
| Premarket Submissions for | ||
| Software Contained in Medical | ||
| Devices / 21 CFR §820.30 |
The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate devices to which they have been compared.
10.Clinical Tests
No additional clinical tests were conducted to support substantial equivalence for the subject devices.
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 Lumina and MAGNETOM Vida Fit with software syngo MR XA50A conform to the following FDA recognized and international IEC, ISO and NEMA standards:
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and date | Standards
Development
Organization |
|-----------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/
EMC) | C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated
Text) Medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance (IEC
60601-1:2005, MOD) | ES60601-
1:2005/(R)2012
and A1:2012 | ANSI AAMI |
10
Image /page/10/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. To the right of the word "Healthineers" is a graphic of orange dots.
| 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 |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
| 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 |
| 12-331 | Radiology | Characterization of
Radiofrequency (RF) Coil
Heating in Magnetic Resonance
Imaging Systems | Standards
Publication MS 14-
2019 | NEMA |
| 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.Conclusion as to Substantial Equivalence
MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A have the same intended use and same basic technological characteristics than the predicate device systems, MAGNETOM Lumina with syngo MR XA31A and MAGNETOM Vita Fit with sygno XA20A, with respect to the magnetic resonance features and functionalities. While there are some differences in technical features compared to the predicate device, the transfer of software features has been tested and the conclusion from all verification and validation data suggest
11
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that the features bear an equivalent safety and performance profile to that of the predicate and reference devices.
Siemens believes that MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A are substantially equivalent to the currently marketed device MAGNETOM Lumina with syngo MR XA31A (K203443, cleared on March 31, 2021) and MAGNETOM Vida Fit with software syngo MR XA20A (K192924, cleared on March 11, 2020).