MAGNETOM Amira; MAGNETOM Sempra

K223343 · Siemens Medical Solutions USA, Inc. · LNH · Mar 28, 2023 · Radiology

Device Facts

• Record ID: K223343
• Device Name: MAGNETOM Amira; MAGNETOM Sempra
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Mar 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

Device Story

MAGNETOM Amira and Sempra are MRI systems using magnetic resonance to generate diagnostic images/spectra of human anatomy. Systems utilize RF coils, gradient systems, and computer processing to acquire and reconstruct data. New software (syngo MR XA50M) introduces AI-based reconstruction (Deep Resolve Boost/Sharp) to improve SNR and sharpness. Operated by healthcare professionals in clinical settings. Output is viewed by physicians to assist in diagnosis. AI features use deep learning to process raw k-space data, reducing scan time and enhancing image quality. Benefits include faster acquisition and improved diagnostic clarity. Hardware additions include new Flex coils for Sempra. System supports interventional procedures with MR-safe accessories.

Clinical Evidence

No clinical trials conducted. Evidence consists of bench testing, software verification/validation, and sample clinical images. AI features (Deep Resolve Boost/Sharp) validated using retrospective datasets (26,473 and 13,977 slices respectively) with PSNR, SSIM, and visual sharpness metrics. Peer-reviewed literature (7 publications, 427 patients) supported clinical utility for various body regions.

Technological Characteristics

MR diagnostic device; 1.5T/3T field strengths. Includes RF coils (Flex series), gradient systems, and syngo MR XA50M software. Connectivity via DICOM. Software includes AI-based reconstruction (Deep Resolve). Conforms to IEC 60601-1, 60601-2-33, 62304, 62366, and ISO 14971/10993 standards.

Indications for Use

Indicated for use as an MRDD to produce cross-sectional images, spectroscopic images, and spectra of the head, body, or extremities for diagnostic purposes. Applicable to patients requiring MR imaging, including interventional procedures using MR-compatible devices.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• MAGNETOM Amira (K183221)
• MAGNETOM Sempra (K183221)

Reference Devices

• MAGNETOM Sola (K221733)
• MAGNETOM Free.Max (K220575)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 28, 2023

Siemens Medical Solutions USA, Inc. % Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355

Re: K223343

Trade/Device Name: MAGNETOM Amira; MAGNETOM Sempra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS, LNI Dated: March 3, 2023 Received: March 3, 2023

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

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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 (OS) 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 ([e-mail]) or phone [phone] 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

Submission Number (if known)

#### K223343

Device Name

MAGNETOM Amira; MAGNETOM Sempra

Indications for Use (Describe)

The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician 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)

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.<br>40 Liberty Boulevard<br>Malvern, PA 19355, USA<br>Registration Number: 2240869 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | October 31, 2022 |
| Manufacturer: | Siemens Shenzhen Magnetic Resonance Ltd.<br>Siemens MRI Center, Gaoxin C. Ave., 2nd<br>Hi-Tech Industrial Park<br>518057 Shenzhen<br>PEOPLE'S REPUBLIC OF CHINA<br>Registration Number: 3004754211<br>Siemens Healthcare GmbH |

Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157

## 2. Contact Information

Alina Goodman Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: [phone] E-mail: [e-mail]

#### 3. Device Name and Classification

| Device/ Trade name: | MAGNETOM Amira<br>MAGNETOM Sempra |
|-----------------------|---------------------------------------------|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH<br>Secondary: LNI, MOS |
| 4.1 Predicate Device | |
| Trade name: | MAGNETOM Amira |
| 510(k) Number: | K183221 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH<br>Secondary: LNI, MOS |
| Trade name: | MAGNETOM Sempra |
| 510(k) Number: | K183221 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH<br>Secondary: LNI, MOS |
| 4.2 Reference Device | |
| Trade name: | MAGNETOM Sola |
| 510(k) Number: | K221733 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH<br>Secondary: LNI, MOS |
| Trade name: | MAGNETOM Free.Max |
| 510(k) Number: | K220575 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH<br>Secondary: MOS |

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#### 4. Legally Marketed Predicate Device

#### 5. Intended Use

The indications for use for the subject devices are the same as that of the predicate device:

The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the

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images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

# 6. Device Description

MAGNETOM Amira and MAGNETOM Sempra with syngo MR XA50M include new and modified features comparing to the predicate devices MAGNETOM Amira and MAGNETOM Sempra with syngo MR XA12M (K183221, cleared on February 14, 2019).

Below is a high-level summary of the new and modified hardware and software features comparing to the predicate devices MAGNETOM Amira and MAGNETOM Sempra with syngo MR XA12M:

# Hardware

Dedicated coils only for MAGNETOM Sempra with syngo MR XA50M:

- -Flex Large 8 Coil
- Flex Small 8 Coil -
- Flex 8 Coil Interface -

# Software

New Features and Applications:

- SMS TSE DIXON -
- SE EPI MRE (EP2D_SE_MRE) -
- ZOOMit PRO -
- High bandwidth inversion recovery -
- WAVE-CAIPI SWI (GRE) WAVE) -
- Deep Resolve Sharp -
- Deep Resolve Gain -
- -Deep Resolve Boost
- -Table positioning mode
- Coil independent pulse sequences -
- BLADE Diffusion -
- -TSE MoCo
- MR protocols module (new name for "MR Protocol Manager") -
- Automatic fiducial detection -
- Access-i -
- myExam Brain Autopilot
- SMS Averaging -

Modified Features and Applications:

- 3D ASL (TGSE_ASL) -
- myExam LiverLab Assist

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Below Table 1 shows an executive summary of training and validation dataset of Al features (Deep Resolve Boost and Deep Resolve Sharp) in subject devices:

| | Deep Resolve Boost | Deep Resolve Sharp |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample size | 26,473 2D slices | 13,977 2D slices |
| | Note: due to reasons of data privacy, we did not record how many<br>individuals the datasets belong to. Gender, age and ethnicity distribution<br>was also not recorded during data collection. Due to the network<br>architecture, attributes like gender, age and ethnicity are not relevant to<br>the training data. | |
| Sample source | in-house measurements<br>and collaboration partners | in-house measurements |
| Dataset slipt | Training: 24,599 slices<br>Validation: 1,874 slices | Training: 11,920 slices<br>Validation: 2,057 slices |
| | Note: Data split maintained similar data distribution (e.g. contrast,<br>orientation, field strength, ...) in both training and validation datasets. | |
| Equipments | 1.5T and 3T MRI scanners | |
| Protocols | Representative protocols (T1, T2 and PD with and without<br>fat saturation) which have been altered (e.g. to increase<br>SNR, increase resolution or reduced acceleration). | |
| Body regions | a broad range of different body regions | |
| Clinical<br>subgroups | No clinical subgroups have been defined for the datasets. | |
| Counfouders | The input and output variables of the network have been<br>derived from the same dataset so that no confounders exist<br>for the training methodology. | |
| Test statistics<br>and test<br>results | The impact of the network has<br>been characterized by several<br>quality metrics such as peak<br>signal-to-noise ratio (PSNR)<br>and structural similarity index<br>(SSIM). Additionally, images<br>were inspected visually to<br>ensure that potential artefacts<br>are detected that are not well<br>captured by the metrics listed<br>above.<br>After successful passing of the<br>quality metrics tests, work-in-<br>progress packages of the<br>network were delivered and<br>evaluated in clinical settings<br>with cooperation partners. In a<br>total of seven peer-reviewed<br>publications 427 patients were<br>successfully scanned on 1.5T<br>and 3T. The investigations<br>covered following body<br>regions: prostate, abdomen, | The impact of the network has<br>been characterized by several<br>quality metrics such as peak<br>signal-to-noise ratio (PSNR),<br>structural similarity index<br>(SSIM), and perceptual loss. In<br>addition, the feature has been<br>verified and validated by<br>inhouse tests. These tests<br>include visual rating and an<br>evaluation of image sharpness<br>by intensity profile comparisons<br>of reconstruction with and<br>without Deep Resolve Sharp.<br>Both tests show increased edge<br>sharpness. |
| | liver, knee, hip, ankle,<br>shoulder, hand and lumbar<br>spine. All publications have<br>concluded that the work-in-<br>progress package and the<br>reconstruction algorithm can<br>be beneficially used for clinical<br>routine imaging. No cases<br>have been reported where the<br>network led to a<br>misinterpretation of the images<br>or where anatomical<br>information has been altered,<br>suppressed, or introduced. In<br>most cases the new algorithm<br>has been used to acquire<br>images faster and significant<br>time savings are reported. | |
| Reference<br>standard | The acquired datasets<br>represent the ground truth for<br>the training and validation.<br>Input data was retrospectively<br>created from the ground truth<br>by data manipulation and<br>augmentation. This process<br>includes further under-<br>sampling of the data by<br>discarding k-space lines,<br>lowering of the SNR level by<br>addition of noise and mirroring<br>of k-space data. | The acquired datasets represent<br>the ground truth for the training<br>and validation. Input data was<br>retrospectively created from the<br>ground truth by data<br>manipulation. k-space data has<br>been cropped such that only the<br>center part of the data was used<br>as input. With this method<br>corresponding low-resolution<br>data as input and high-resolution<br>data as output / ground truth<br>were created for training and<br>validation. |

Table 1. Training and validation dataset of Al features

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# 7. Substantial Equivalence

MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA50M are substantially equivalent to the predicate devices list in Table 2:

| Predicate Device | FDA Clearance Number and Date | Product<br>Code | Manufacturer |
|------------------------------------------|----------------------------------------|---------------------|------------------------------------------------|
| MAGNETOM Amira with<br>syngo MR XA12M | K183221, cleared on February 14, 2019 | LNH,<br>LNI,<br>MOS | Siemens Shenzhen<br>Magnetic Resonance<br>Ltd. |
| MAGNETOM Sempra with<br>syngo MR XA12M | K183221, cleared on February 14, 2019 | LNH,<br>LNI,<br>MOS | Siemens Shenzhen<br>Magnetic Resonance<br>Ltd. |
| Reference Device | FDA Clearance Number and Date | Product<br>Code | Manufacturer |
| MAGNETOM Sola with<br>syngo MR XA51A | K221733, cleared on September 13, 2022 | LNH,<br>LNI,<br>MOS | Siemens Healthcare<br>GmbH |
| MAGNETOM Free.Max with<br>syngo MR XA50A | K220575, cleared on June 24, 2022 | LNH,<br>MOS | Siemens Shenzhen<br>Magnetic Resonance<br>Ltd. |

Table 2. Predicate devices and reference devices.

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## 8. Technological Characteristics

The subject devices, MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA50M, 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 new and modified hardware and software features. Please see below Table 3 and Table 4 for the comparison between subject devices and predicate/ reference devices.

| | Subject Device | Predicate Device | Subject Device | Predicate Device |
|---------------------------|------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------|
| Feature | MAGNETOM<br>Amira with<br>software syngo<br>MR XA50M | MAGNETOM<br>Amira with<br>software syngo<br>MR XA12M<br>(K183221) | MAGNETOM<br>Sempra with<br>software syngo<br>MR XA50M | MAGNETOM<br>Sempra with<br>software syngo<br>MR XA12M<br>(K183221) |
| Magnet<br>System | same | same | same | same |
| RF System | same | same | same | same |
| Transmission<br>Technique | same | same | same | same |
| Gradient<br>System | same | same | same | same |
| Patient Table | same | same | same | same |
| Computer | same | same | same | same |
| Coils | same | same | New coils:<br>-Flex Large 8,<br>-Flex Small 8,<br>-Flex 8 Coil<br>Interface | - |
| Other HW<br>components | same | same | same | same |

Table 3. Hardware Comparison

Comparison results: new local coils are introduced to MAGNETOM Sempra with syngo MR XA50M comparing to the predicate device. These differences have been tested and non-clinical data concluded no impact on safety and effectiveness of the device.

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| | Table 4. Software Features Comparison |
|--|---------------------------------------|
| | |

| | Subject Device | Subject Device | Reference<br>Device | Predicate<br>Device | Predicate<br>Device |
|-----------------------------------------|---------------------------------------------|----------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------|
| Feature | MAGNETOM<br>Amira with<br>syngo MR<br>XA50M | MAGNETOM<br>Sempra with<br>syngo MR<br>XA50M | MAGNETOM<br>Sola with<br>syngo MR<br>XA51A<br>(K221733) | MAGNETOM<br>Amira with<br>syngo MR<br>XA12M<br>(K183221) | MAGNETOM<br>Sempra with<br>syngo MR<br>XA12M<br>(K183221) |
| SMS for TSE<br>DIXON | | same | | No | No |
| SE EPI MRE | | same | | No | No |
| ZOOMit PRO | | same | | No | No |
| High bandwidth<br>inversion<br>recovery | | same | | No | No |
| WAVE-CAIPI SWI | | same | | No | No |
| Deep Resolve<br>Sharp | | same | | No | No |
| Deep Resolve<br>Gain | | same | | No | No |
| Deep Resolve<br>Boost | | same | | No | No |
| Table positioning<br>mode | | same | | No | No |
| Coil independent<br>pulse sequences | | same | | No | No |
| BLADE Diffusion | | same | | No | No |
| TSE MoCo | | same | | No | No |
| MR Protocols<br>Module | | same | | No | No |
| Automatic fiducial<br>detection | | same | | No | No |
| Access-i | | same | | No | No |
| myExam Brain<br>Autopilot | | same | | No | No |
| SMS Averaging [1] | | same | No | No | No |
| 3D ASL | | same, modified comparing to predicate device | | Yes | Yes |
| myExam LiverLab<br>Assist | | same, modified comparing to predicate device | | Yes | Yes |

[1] SMS Averaging for TSE was cleared in reference device MAGNETOM Free.Max with syngo MR XA50A (K220575). SMS Averaging is made available for both TSE and TSE DIXON pulse sequence in subject devices.

Comparison results: new and modified software features are introduced to subject devices comparing to the predicate devices. These differences have been tested and non-clinical data concluded no impact on safety and effectiveness of the devices.

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# 9. Nonclinical Tests

| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|-----------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Sample clinical images | New local coils, new and<br>modified software features,<br>pulse sequence types | Guidance for Submission of<br>Premarket Notifications for<br>Magnetic Resonance<br>Diagnostic Devices |
| Software verification and<br>validation | mainly new and modified<br>software features | Guidance for the Content of<br>Premarket Submissions for<br>Software Contained in Medical<br>Devices |

The following performance testing was conducted on the subject devices:

The following performance testing for local coils was conducted on the predicate devices and can be reused for the subject devices:

| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Performance bench test | - SNR and image uniformity<br>measurements for coils<br>- Heating measurements for<br>coils | Guidance for Submission of<br>Premarket Notifications for<br>Magnetic Resonance<br>Diagnostic Devices |

The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared.

## 10.Clinical Tests / Publications

No clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided.

## 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 adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards. Furthermore, the devices are intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA50M conform to the following FDA recognized and international IEC, ISO and NEMA standards:

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| Recogniti<br>on<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and date | Standards<br>Development<br>Organization |
|---------------------------|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| 19-4 | General | Medical electrical equipment - part<br>1: general requirements for basic<br>safety and essential performance | ES60601-<br>1:2005/(R) 2012<br>and A1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment - Part<br>1-2: General requirements for basic<br>safety and essential performance -<br>Collateral Standard:<br>Electromagnetic disturbances -<br>Requirements and tests | 60601-1-2 Edition<br>4.0:2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment - Part<br>2-33: Particular requirements for the<br>basic safety and essential<br>performance of magnetic resonance<br>equipment for medical diagnosis | 60601-2-33 Ed.<br>3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application of risk<br>management to medical devices | 14971:2019 | ISO |
| 5-96 | General | Medical devices - Application of<br>usability engineering to medical<br>devices | 62366 Edition 1.0<br>2015 | AAMI ANSI<br>IEC |
| 13-32 | Software | Medical device software - Software<br>life cycle processes | 62304 Edition 1.1<br>2015-06 | AAMI<br>ANSI<br>IEC |
| 12-195 | Radiology | NEMA MS 6-2008 (R2014)<br>Determination of Signal-to-Noise<br>Ratio and Image Uniformity for<br>Single-Channel Non-Volume Coils<br>in Diagnostic MR Imaging | MS 6-2008<br>(R2014) | NEMA |
| 12-300 | Radiology | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set 03/16/2012 Radiology | PS 3.1 - 3.20<br>(2016) | NEMA |
| 2-156 | Biocompati<br>bility | Biological evaluation of medical<br>devices - part 1: evaluation and<br>testing within a risk management<br>process. (Biocompatibility) | 10993-1:2018/(R)<br>2013 | AAMI<br>ANSI<br>ISO |

# 12.Conclusion as to Substantial Equivalence

MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA50M have the same intended use and same basic technological characteristics as the predicate devices system, MAGNETOM Amira and MAGNETOM Sempra with syngo MR XA12M (K183221, cleared on February 14, 2019), with respect to the magnetic resonance features and functionalities. While there are some differences in technical features compared to the predicate devices, the differences have been tested and the conclusions from all verification and

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validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device and reference device.

Siemens believes that MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA50M are substantially equivalent to the currently marketed devices MAGNETOM Amira and MAGNETOM Sempra with syngo MR XA12M.