Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The document explicitly mentions "Al features (Deep Resolve Boost and Deep Resolve Sharp)" and provides details about the training and testing of these features, including sample sizes, data sources, and performance metrics like PSNR and SSIM, which are commonly used in evaluating AI/ML models for image processing.

Therapeutic

No.
The device is described as a magnetic resonance diagnostic device that produces images to assist in diagnosis, not for therapeutic purposes.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states, "The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD)". It also mentions that the images and derived parameters, when interpreted by a physician, "yield information that may assist in diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states "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". The predicate devices are described as "magnetic resonance diagnostic device (MRDD)", which are hardware systems. The summary also mentions "Tested Hardware or Software: New local coils, new and modified software features, pulse sequence types" and "Tested Hardware or Software: - SNR and image uniformity measurements for coils - Heating measurements for coils" in the performance studies, indicating hardware components are part of the system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the MAGNETOM system is a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the internal structure and/or function of the body. It is used for imaging and assisting in diagnosis when interpreted by a trained physician. This describes an in vivo diagnostic imaging device, not an in vitro diagnostic device.
IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The MAGNETOM system does not perform tests on such samples.
Device Description: The description focuses on the hardware and software features of an MRI system.
Input Imaging Modality: The input is Magnetic Resonance, which is an imaging technique applied directly to the patient, not to a sample.
Anatomical Site: The device images the head, body, or extremities of the patient.
Intended User: The intended users are healthcare professionals responsible for acquiring and processing magnetic resonance images, which aligns with an imaging device.

While the device uses AI for image processing (Deep Resolve Boost and Deep Resolve Sharp), this processing is applied to the in vivo acquired MR images, not to in vitro samples.

Therefore, the MAGNETOM system is an in vivo diagnostic imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Overview

Intended Use / Indications for 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.

Product codes

LNH, MOS, LNI

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).

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

Software Modified Features and Applications:
-3D ASL (TGSE_ASL)
-myExam LiverLab Assist

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 / Clinical settings

Description of the training set, sample size, data source, and annotation protocol

Deep Resolve Boost:
Sample size: 26,473 2D slices. Note: due to reasons of data privacy, we did not record how many individuals the datasets belong to. Gender, age and ethnicity distribution was also not recorded during data collection. Due to the network architecture, attributes like gender, age and ethnicity are not relevant to the training data.
Sample source: in-house measurements and collaboration partners
Dataset split: Training: 24,599 slices. Note: Data split maintained similar data distribution (e.g. contrast, 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 fat saturation) which have been altered (e.g. to increase SNR, increase resolution or reduced acceleration).
Body regions: a broad range of different body regions
Clinical subgroups: No clinical subgroups have been defined for the datasets.
Confounders: The input and output variables of the network have been derived from the same dataset so that no confounders exist for the training methodology.
Reference standard: The acquired datasets represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation and augmentation. This process includes further under-sampling of the data by discarding k-space lines, lowering of the SNR level by addition of noise and mirroring of k-space data.

Deep Resolve Sharp:
Sample size: 13,977 2D slices. Note: due to reasons of data privacy, we did not record how many individuals the datasets belong to. Gender, age and ethnicity distribution was also not recorded during data collection. Due to the network architecture, attributes like gender, age and ethnicity are not relevant to the training data.
Sample source: in-house measurements
Dataset split: Training: 11,920 slices. Note: Data split maintained similar data distribution (e.g. contrast, 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 fat saturation) which have been altered (e.g. to increase SNR, increase resolution or reduced acceleration).
Body regions: a broad range of different body regions
Clinical subgroups: No clinical subgroups have been defined for the datasets.
Confounders: The input and output variables of the network have been derived from the same dataset so that no confounders exist for the training methodology.
Reference standard: The acquired datasets represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation. k-space data has been cropped such that only the center part of the data was used as input. With this method corresponding low-resolution data as input and high-resolution data as output / ground truth were created for training and validation.

Description of the test set, sample size, data source, and annotation protocol

Deep Resolve Boost:
Sample size:
Validation: 1,874 slices.
After successful passing of the quality metrics tests, work-in-progress packages of the network were delivered and evaluated in clinical settings with cooperation partners. In a total of seven peer-reviewed publications 427 patients were successfully scanned on 1.5T and 3T.
Body regions: prostate, abdomen, liver, knee, hip, ankle, shoulder, hand and lumbar spine.
Note: due to reasons of data privacy, we did not record how many individuals the datasets belong to. Gender, age and ethnicity distribution was also not recorded during data collection. Due to the network architecture, attributes like gender, age and ethnicity are not relevant to the training data.
Sample source: in-house measurements and collaboration partners for validation dataset; clinical settings with cooperation partners (data source for clinical evaluation).
Annotation protocol: Not explicitly stated, but implies qualitative visual inspection and quantitative metrics.

Deep Resolve Sharp:
Sample size:
Validation: 2,057 slices.
Note: due to reasons of data privacy, we did not record how many individuals the datasets belong to. Gender, age and ethnicity distribution was also not recorded during data collection. Due to the network architecture, attributes like gender, age and ethnicity are not relevant to the training data.
Sample source: in-house measurements for validation dataset; inhouse tests for verification and validation.
Annotation protocol: Not explicitly stated, but implies qualitative visual rating and quantitative evaluation of image sharpness by intensity profile comparisons.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Deep Resolve Boost:
Study type: Validation and clinical evaluation.
Sample size: Validation: 1,874 slices. Clinical evaluation: 427 patients across seven peer-reviewed publications.
Key results: The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM). Additionally, images were inspected visually to ensure that potential artefacts are detected that are not well captured by the metrics listed above. All publications have concluded that the work-in-progress package and the reconstruction algorithm can be beneficially used for clinical routine imaging. No cases have been reported where the network led to a misinterpretation of the images or where anatomical information has been altered, suppressed, or introduced. In most cases the new algorithm has been used to acquire images faster and significant time savings are reported.

Deep Resolve Sharp:
Study type: Validation and inhouse tests.
Sample size: Validation: 2,057 slices.
Key results: The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR), structural similarity index (SSIM), and perceptual loss. In addition, the feature has been verified and validated by inhouse tests. These tests include visual rating and an evaluation of image sharpness by intensity profile comparisons of reconstruction with and without Deep Resolve Sharp. Both tests show increased edge sharpness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Deep Resolve Boost: peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM).
Deep Resolve Sharp: peak signal-to-noise ratio (PSNR), structural similarity index (SSIM), and perceptual loss.

Predicate Device(s)

K183221

Reference Device(s)

K221733, K220575

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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

1

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 (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

2

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.
40 Liberty Boulevard
Malvern, PA 19355, USA
Registration Number: 2240869 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | October 31, 2022 |
| Manufacturer: | Siemens Shenzhen Magnetic Resonance Ltd.
Siemens MRI Center, Gaoxin C. Ave., 2nd
Hi-Tech Industrial Park
518057 Shenzhen
PEOPLE'S REPUBLIC OF CHINA
Registration Number: 3004754211
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: +1(224)526-1404 E-mail: alina.goodman@siemens-healthineers.com

3. Device Name and Classification

| Device/ Trade name: | MAGNETOM Amira
MAGNETOM Sempra |
|-----------------------|---------------------------------------------|
| 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 |
| 4.1 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
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
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
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
Secondary: MOS |

4

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

5

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

Table 1. Training and validation dataset of Al features

7

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
Code | Manufacturer |
|------------------------------------------|----------------------------------------|---------------------|------------------------------------------------|
| MAGNETOM Amira with
syngo MR XA12M | K183221, cleared on February 14, 2019 | LNH,
LNI,
MOS | Siemens Shenzhen
Magnetic Resonance
Ltd. |
| MAGNETOM Sempra with
syngo MR XA12M | K183221, cleared on February 14, 2019 | LNH,
LNI,
MOS | Siemens Shenzhen
Magnetic Resonance
Ltd. |
| Reference Device | FDA Clearance Number and Date | Product
Code | Manufacturer |
| MAGNETOM Sola with
syngo MR XA51A | K221733, cleared on September 13, 2022 | LNH,
LNI,
MOS | Siemens Healthcare
GmbH |
| MAGNETOM Free.Max with
syngo MR XA50A | K220575, cleared on June 24, 2022 | LNH,
MOS | Siemens Shenzhen
Magnetic Resonance
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
Amira with
software syngo
MR XA50M	MAGNETOM
Amira with
software syngo
MR XA12M
(K183221)	MAGNETOM
Sempra with
software syngo
MR XA50M	MAGNETOM
Sempra with
software syngo
MR XA12M
(K183221)
Magnet
System	same	same	same	same
RF System	same	same	same	same
Transmission
Technique	same	same	same	same
Gradient
System	same	same	same	same
Patient Table	same	same	same	same
Computer	same	same	same	same
Coils	same	same	New coils:
-Flex Large 8,
-Flex Small 8,
-Flex 8 Coil
Interface	-
Other HW
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
Device | Predicate
Device | Predicate
Device |
|-----------------------------------------|---------------------------------------------|----------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------|
| Feature | MAGNETOM
Amira with
syngo MR
XA50M | MAGNETOM
Sempra with
syngo MR
XA50M | MAGNETOM
Sola with
syngo MR
XA51A
(K221733) | MAGNETOM
Amira with
syngo MR
XA12M
(K183221) | MAGNETOM
Sempra with
syngo MR
XA12M
(K183221) |
| SMS for TSE
DIXON | | same | | No | No |
| SE EPI MRE | | same | | No | No |
| ZOOMit PRO | | same | | No | No |
| High bandwidth
inversion
recovery | | same | | No | No |
| WAVE-CAIPI SWI | | same | | No | No |
| Deep Resolve
Sharp | | same | | No | No |
| Deep Resolve
Gain | | same | | No | No |
| Deep Resolve
Boost | | same | | No | No |
| Table positioning
mode | | same | | No | No |
| Coil independent
pulse sequences | | same | | No | No |
| BLADE Diffusion | | same | | No | No |
| TSE MoCo | | same | | No | No |
| MR Protocols
Module | | same | | No | No |
| Automatic fiducial
detection | | same | | No | No |
| Access-i | | same | | No | No |
| myExam Brain
Autopilot | | same | | No | No |
| SMS Averaging [1] | | same | No | No | No |
| 3D ASL | | same, modified comparing to predicate device | | Yes | Yes |
| myExam LiverLab
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
modified software features,
pulse sequence types	Guidance for Submission of
Premarket Notifications for
Magnetic Resonance
Diagnostic Devices
Software verification and
validation	mainly new and modified
software features	Guidance for the Content of
Premarket Submissions for
Software Contained in Medical
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
measurements for coils

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

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.