MAGNETOM Free.Max, MAGNETOM Free.Star

K220575 · Siemens Medical Solutions USA, Inc. · LNH · Jun 24, 2022 · Radiology

Device Facts

• Record ID: K220575
• Device Name: MAGNETOM Free.Max, MAGNETOM Free.Star
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 24, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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

Device Story

MAGNETOM Free.Max and Free.Star are 0.55T MRI systems; Free.Max features 80cm bore, Free.Star features 60cm bore. Systems acquire MR signals to produce cross-sectional images of head, body, or extremities. Operated by healthcare professionals in clinical settings. Features include myExam Autopilot for shoulder exams, myExam 3D camera for patient positioning, and EP2D FID pulse sequences for brain perfusion imaging. Inline technology performs real-time calculation of parameter maps. Output consists of diagnostic images and derived physical parameters for physician interpretation to assist in clinical diagnosis. Access-i interface enables third-party workstation connectivity.

Clinical Evidence

No clinical trials conducted. Substantial equivalence supported by bench testing (SNR, image uniformity, heating measurements), software verification and validation, and sample clinical images.

Technological Characteristics

0.55T MRI system; 60cm (Free.Star) or 80cm (Free.Max) bore. Conforms to IEC 60601-1, IEC 60601-2-33, NEMA MS 4, NEMA MS 9, and ISO 10993-1. Software follows IEC 62304. Connectivity via DICOM and Access-i. Features myExam 3D camera for auto-registration and patient positioning.

Indications for Use

Indicated for patients requiring magnetic resonance imaging of the head, body, or extremities to assist in diagnosis. No specific age or gender restrictions; contraindications depend on standard MRI safety protocols.

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 Free.Max (K210611)

Reference Devices

• MAGNETOM Sola with syngo MR XA20A (K192496)

Submission Summary (Full Text)

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June 24, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

#### Re: K220575

Trade/Device Name: MAGNETOM Free.Max with syngo MR XA50A and MAGNETOM Free.Star with syngo MR XA50A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: May 25, 2022 Received: May 26, 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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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K220575

Device Name

MAGNETOM Free.Max with syngo MR XA50A and MAGNETOM Free.Star with syngo MR XA50A

Indications for Use (Describe)

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

These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 ട്ട 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: | June 22, 2022 | |
| Manufacturer: | Siemens Shenzhen Magnetic Resonance | |

td. 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 Reqistration 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 Free.Max with syngo MR XA50A<br>MAGNETOM Free.Star 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<br>Secondary: MOS |

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### 4. Legally Marketed Predicate Device

| Trade name: | MAGNETOM Free.Max |
|-----------------------|---------------------------------------------|
| 510(k) Number: | K210611 |
| 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 |

### 5. Intended Use

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

These images and the physical parameters derived from the images when interpreted by a trained physician vield information that may assist in diagnosis.

## 6. Device Description

The subject device software version, syngo MR XA50A, can support the following two MRI systems:

- -MAGNETOM Free.Max, which has been cleared with its initial software version syngo MR XA40A, through K210611 on July 1, 2021;
- MAGNETOM Free.Star, a new product. -

With the introduction of MAGNETOM Free.Star, we extend the Free. platform, which consists of two products with a field strength of 0.55 Tesla on our high-value MRI platform. The main difference between these two products is the bore size, MAGNETOM Free.Star is equipped with a 60 cm patient bore while the MAGNETOM Free.Max is equipped with an 80 cm patient bore. The Gradient system, body coil and the system cover for MAGNETOM Free.Star are modified based those of the predicate device MAGNETOM Free.Max with syngo MR XA40A (K210611) to accommodate the smaller bore diameter. The other main components for the new device MAGNETOM Free.Star are the same as those of MAGNETOM Free.Max as cleared with K210611.

Apart from the hardware adaption applied for MAGNETOM Free.Star for the smaller bore diameter, the new / modified hardware and software features for the subject devices comparing to the predicate device MAGNETOM Free.Max with software version syngo MR XA40A (K210611, cleared on July 1, 2021) are listed below:

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MAGNETOM Free.Max

#### software version syngo MR XA50A

#### New/Modified Hardware

Common for both subject devices:

- Scanner User Interface (SUI): introduce option to have two SUI set on both ● sides of the scanner, while there is only one set available on the left hand side as the standard configuration for the predicate device MAGNETOM Free.Max with software version syngo MR XA40A (K210611); Swap the orientation of patient pictogram on Select&GO is supported syngo MR XA50A.
- myExam 3D Camera: auto registration with detection of patient height. ● weight and orientation are supported in the subject device software version syngo MR XA50A. The hardware remains unchanged as cleared with K210611 on July 1, 2021.
- New Patient Video: A new patient video with 1920×1080 pixels is . introduced.

Applicable to the following subject device(s)

MAGNETOM Free.Max

MAGNETOM Free.Star

#### New Local Coils ●

| Contour M Coil | Contour M Coil |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| <b>New Patient table –</b><br><b>High-load patient table:</b> a new fixed patient table with vertical<br>movement for heavy load patient is introduced. | N/A |

Software Features

Common for both subject devices:

#### New Software Platform/Workflow

myExam Autopilot is extended the supporting body region to shoulder:

- myExam Shoulder Autopilot: it helps users to automate a shoulder ● examination.
### Migrated Software feature

- EP2D FID: Single-shot FID EPI pulse sequence type optimized for ● perfusion-imaging in the brain.
- Inline Perfusion: Automatic real-time calculation of parameter maps with . Inline technology based on image data acquired with the ep2d fid pulse sequence type.
- . Access-i: Provides an interface to enable the connection of a 3rd party workstation to the MR syngo Acquisition Workplace via a network router and secure local network connection.

### Modified Software Platform/Workflow

Modify in Scan assistance: Modified guidance of off-center imaging is provided to users who encounter the scan suspension by too off-centered shim volume.

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## 7. Substantial Equivalence

MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA50A are substantially equivalent to the predicate device and includes migrated features from the following reference devices:

| Predicate Device | FDA Clearance Number<br>and Date | Product<br>Code | Manufacturer |
|------------------------------------------|------------------------------------------|---------------------|---------------------------------------------|
| MAGNETOM Free.Max<br>with syngo MR XA40A | K210611, cleared on July 1, 2021 | LNH,<br>MOS | Siemens Shenzhen<br>Magnetic Resonance Ltd. |
| Reference Device | FDA Clearance Number<br>and Date | Product<br>Code | Manufacturer |
| MAGNETOM Sola with<br>syngo MR XA20A | K192496, cleared on<br>February 28, 2020 | LNH,<br>LNI,<br>MOS | Siemens Healthcare GmbH |

## 8. Technological Characteristics

The subject devices, MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA50A, are substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.

The subject devices conform to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards.

There are some differences in technological characteristics between the subject devices and predicate device, including modified hardware and software. These differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device.

## 9. Nonclinical Tests

| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|-----------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Sample clinical images | Coils, new and modified<br>software features, pulse<br>sequence types | Guidance for Submission of<br>Premarket Notifications for<br>Magnetic Resonance<br>Diagnostic Devices |
| 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 |
| 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 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.

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## 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 maqnetic resonance images.

MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA50A conform to the following FDA recognized and international IEC, ISO and NEMA standards:

| Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and date | Standards<br>Development<br>Organization |
|-----------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------|
| 19-4 | General II<br>(ES/<br>EMC) | C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text) Medical electrical<br>equipment - Part 1: General<br>requirements for basic safety<br>and essential performance (IEC<br>60601-1:2005, MOD) | ES60601-<br>1:2005/(R)2012<br>and A1:2012 | ANSI AAMI |
| 19-8 | General | Medical electrical equipment -<br>Part 1-2: General requirements<br>for basic safety and essential<br>performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements<br>and tests | 60601-1-2, Ed.<br>4.0:2014 | IEC |
| 12-295 | Radiology | Medical electrical equipment -<br>Part 2-33: Particular<br>requirements for the basic<br>safety and essential<br>performance of magnetic<br>resonance equipment for<br>medical diagnosis | 60601-2-33 Ed. 3.2<br>b:2015 | IEC |
| 5-125 | General I<br>(QS/<br>RM) | Medical devices - Application of<br>risk management to medical<br>devices | 14971 Third Edition<br>2019-12 | ISO |
| 5-114 | General I<br>(QS/<br>RM) | Medical devices - Part 1:<br>Application of usability<br>engineering to medical devices | 62366-1:2015 | ANSI AAMI<br>IEC |
| 13-79 | Software/<br>Informatics | Medical device software -<br>Software life cycle processes<br>[Including Amendment 1 (2016)] | 62304:2006/A1:201<br>6 | ANSI AAMI<br>IEC |
| 12-232 | Radiology | Acoustic Noise Measurement<br>Procedure for Diagnosing<br>Magnetic Resonance Imaging<br>Devices | MS 4-2010 | NEMA |

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| 12-288 | Radiology | Standards Publication<br>Characterization of Phased<br>Array Coils for Diagnostic<br>Magnetic Resonance Images | MS 9-2008 (R2014) | NEMA |
|--------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------|
| 12-300 | Radiology | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set 03/16/2012<br>Radiology | PS 3.1 - 3.20<br>(2016) | NEMA |
| 2-258 | Biocompatibility | biological evaluation of medical<br>devices - part 1: evaluation and<br>testing within a risk<br>management process<br>(Biocompatibility) | 10993-1:2018 | AAMI<br>ANSI<br>ISO |

## 12.Conclusion as to Substantial Equivalence

MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA50A have the same intended use and same basic technological characteristics as the predicate device system, MAGNETOM Free.Max with syngo MR XA40A (Cleared with K210611 on July 1, 2021), with respect to the magnetic resonance features and functionalities. While there are some differences in technical features compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device and reference device.

Siemens believes that MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA50A are substantially equivalent to the currently marketed device MAGNETOM Free.Max with syngo MR XA40A.