(116 days)
No
The summary describes software updates and hardware modifications to an existing MRI system. While it mentions features like "myExam Autopilot" and "auto registration," these are described in terms of automation and workflow assistance, not explicitly as AI/ML algorithms. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML-driven devices.
No.
The device is described as a "magnetic resonance diagnostic device" used to produce images for diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The MAGNETOM MR 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 trained physician yield information that may assist in diagnosis."
No
The device description explicitly details hardware components (MRI systems, coils, patient table) and modifications to them, indicating it is not solely software.
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 system is a "magnetic resonance diagnostic device (MRDD)" that produces images of the internal structure and/or function of the head, body, or extremities. It also mentions deriving physical parameters from these images. The interpretation of these images and parameters by a trained physician assists in diagnosis.
- Device Description: The description details the hardware and software of an MRI system.
- Input Imaging Modality: The input is Magnetic Resonance (MR) imaging.
- Anatomical Site: The device is used on the head, body, or extremities.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) by using magnetic fields and radio waves to create images.
The information provided consistently describes a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LNH, MOS
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:
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
New Patient table –
High-load patient table: a new fixed patient table with vertical
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Head, body, or extremities.
Intended Patient Age Range
Not Found.
Intended User / Care Setting
Trained physician / Not Found.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests were conducted. Sample clinical images were provided, SNR and image uniformity measurements for coils, heating measurements for coils, and software verification and validation. The results demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device. No clinical tests were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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.
40 Liberty Boulevard
Malvern, PA 19355, USA
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: +1(224)526-1404 E-mail: alina.goodman@siemens-healthineers.com
3. Device Name and Classification
| Device/ Trade name: | MAGNETOM Free.Max with syngo MR XA50A
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
Secondary: MOS |
4
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 |
| 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:
5
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 |
|---|---|
| New Patient table – | |
| High-load patient table: a new fixed patient table with vertical | |
| 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.
6
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
and Date | Product
Code | Manufacturer |
|------------------------------------------|------------------------------------------|---------------------|---------------------------------------------|
| MAGNETOM Free.Max
with syngo MR XA40A | K210611, cleared on July 1, 2021 | LNH,
MOS | Siemens Shenzhen
Magnetic Resonance Ltd. |
| Reference Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
| MAGNETOM Sola with
syngo MR XA20A | K192496, cleared on
February 28, 2020 | LNH,
LNI,
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 | |
| software features, pulse | ||
| sequence types | Guidance for Submission of | |
| Premarket Notifications for | ||
| Magnetic Resonance | ||
| Diagnostic Devices | ||
| 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 |
| 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 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.
7
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
Number | Product
Area | Title of Standard | Reference
Number and date | Standards
Development
Organization |
|-----------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/
EMC) | C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated
Text) Medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance (IEC
60601-1:2005, MOD) | ES60601-
1:2005/(R)2012
and A1:2012 | ANSI AAMI |
| 19-8 | General | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests | 60601-1-2, Ed.
4.0:2014 | IEC |
| 12-295 | Radiology | Medical electrical equipment -
Part 2-33: Particular
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for
medical diagnosis | 60601-2-33 Ed. 3.2
b:2015 | IEC |
| 5-125 | General I
(QS/
RM) | Medical devices - Application of
risk management to medical
devices | 14971 Third Edition
2019-12 | ISO |
| 5-114 | General I
(QS/
RM) | Medical devices - Part 1:
Application of usability
engineering to medical devices | 62366-1:2015 | ANSI AAMI
IEC |
| 13-79 | Software/
Informatics | Medical device software -
Software life cycle processes
[Including Amendment 1 (2016)] | 62304:2006/A1:201
6 | ANSI AAMI
IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4-2010 | NEMA |
8
| 12-288 | Radiology | Standards Publication
Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images | MS 9-2008 (R2014) | NEMA |
|--------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------|
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
| 2-258 | Biocompatibility | biological evaluation of medical
devices - part 1: evaluation and
testing within a risk
management process
(Biocompatibility) | 10993-1:2018 | AAMI
ANSI
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.