Who is the manufacturer of MAGNETOM Free.Max; MAGNETOM Free.Star?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for MAGNETOM Free.Max; MAGNETOM Free.Star (K231617).

What is the FDA product code for MAGNETOM Free.Max; MAGNETOM Free.Star?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MAGNETOM Free.Max; MAGNETOM Free.Star?

510(k) clearance (submission type: Traditional).

Does MAGNETOM Free.Max; MAGNETOM Free.Star use AI or machine learning?

Yes. MAGNETOM Free.Max; MAGNETOM Free.Star (K231617) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for MAGNETOM Free.Max; MAGNETOM Free.Star?

MAGNETOM Free.Max with syngo MR XA50A (K220575); MAGNETOM Free.Star with syngo MR XA50A (K220575).

Who can help prepare an FDA 510(k) submission like MAGNETOM Free.Max; MAGNETOM Free.Star?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like MAGNETOM Free.Max; MAGNETOM Free.Star get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

MAGNETOM Free.Max; MAGNETOM Free.Star

K231617 · Siemens Medical Solutions USA, Inc. · LNH · Nov 9, 2023 · Radiology

Device Facts

Record ID	K231617
Device Name	MAGNETOM Free.Max; MAGNETOM Free.Star
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	LNH · Radiology
Decision Date	Nov 9, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	AI/ML, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K231617 · Nov 9, 2023	MAGNETOM Free.Max; MAGNETOM Free.Star	Siemens Medical Solutions USA, Inc.	In-house measurements; Collaboration partner clinical datasets	Retrospective clinical datasets were used to train and validate the 'Deep Resolve Boost' AI feature. The data included 26,473 2D slices acquired from 1.5T and 3T MRI scanners in clinical settings.	AI/ML; Deep Resolve Boost; Retrospective data; Clinical settings

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Deep Resolve Boost Training and Validation Dataset; Retrospective training and validation of AI algorithm; Follow-up/Duration: Not applicable	Broad range of body regions; clinical patients (individual counts not recorded); Sample Size: 26,473 2D slices; Number of Sites: Not specified (in-house and collaboration partners)	Not applicable for this study	Peak signal-to-noise ratio (PSNR), structural similarity index (SSIM), and visual inspection for artifacts

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Image noise reduction	Deep learning neural network	—	—	Training: 24,599 slices; Validation: 1,874 slices	—	—	—

Indications for Use

MAGNETOM Free.Max system is indicated for use as a magnetic resonance diagnostic device (MRDD) that 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. MAGNETOM Free.Max may also be used for imaging during interventional procedures when performed with MR-compatible devices such as MR Safe biopsy needles. MAGNETOM Free.Star system is indicated for use as a magnetic resonance diagnostic device (MRDD) that 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

Magnetic resonance diagnostic devices (MRDD) producing cross-sectional images of head, body, or extremities; utilizes magnetic resonance imaging (MRI) technology. Inputs include RF signals and gradient magnetic fields; processed via syngo MR XA60A software to generate diagnostic images. Used in clinical settings by trained physicians/technicians. New features include Contour Knee coil, respiratory sensor, and various software applications (e.g., Deep Resolve Boost, myExam RT Assist, interventional needle support). Output images assist in clinical diagnosis and interventional guidance. Benefits include improved image quality, workflow efficiency, and expanded interventional capabilities.

Clinical Evidence

No clinical tests conducted. Evidence consists of bench testing, software verification and validation, and sample clinical images. AI feature 'Deep Resolve Boost' validated using 26,473 2D slices (in-house/collaboration data) with metrics including PSNR and SSIM.

Technological Characteristics

MR diagnostic system; 1.5T/3T field strengths. Hardware includes magnet, RF body coil, gradient system, patient table, host computer, MaRS, Contour Knee coil, and respiratory sensor. Software: syngo MR XA60A. Conforms to IEC 60601-1, IEC 60601-2-33, IEC 62304, ISO 14971, and NEMA standards. Connectivity via DICOM.

Indications for Use

Indicated for patients requiring MR imaging of the head, body, or extremities to assist in diagnosis. MAGNETOM Free.Max is also indicated for imaging during 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 Free.Max with syngo MR XA50A (K220575)
MAGNETOM Free.Star with syngo MR XA50A (K220575)

Reference Devices

MAGNETOM Sola (K221733)
MAGNETOM Amira (K223343)
MAGNETOM Vida (K213693)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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. Siemens Medical Solutions USA, Inc. Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19355 November 9, 2023 #### Re: K231617 Trade/Device Name: MAGNETOM Free.Max; MAGNETOM Free.Star Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: September 11, 2023 Received: September 11, 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Julie Sullivan -S Julie Sullivan, Ph.D. Director 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 {2}------------------------------------------------ #### Indications for Use Submission Number (if known) #### K231617 Device Name MAGNETOM Free.Max; MAGNETOM Free.Star Indications for Use (Describe) MAGNETOM Free.Max: MAGNETOM Free.Max system is indicated for use as a magnetic resonance diagnostic device (MRDD) that 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. MAGNETOM Free.Max may also be used for imaging during interventional procedures when performed with MR-compatible devices such as MR Safe biopsy needles. MAGNETOM Free.Star: MAGNETOM Free.Star system is indicated for use as a magnetic resonance diagnostic device (MRDD) that 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 క్త 807.92. | 1. General Information | | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment: | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Registration Number: 2240869 | | Date Prepared: | May 31, 2023 | | 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 Free.Max MAGNETOM Free.Star | | 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 4.1 Predicate Device Trade name: 510(k) Number: Classification Name: Classification Panel: CFR Code: Classification: Product Code: Trade name: 510(k) Number: Classification Name: Classification Panel: CFR Code: Classification: Product Code: 4.2 Reference Device Trade name: 510(k) Number: Classification Name: Classification Panel: CFR Code: Classification: Product Code: Trade name: 510(k) Number: Classification Name: Classification Panel: CFR Code: Classification: Product Code: Trade name: 510(k) Number: Classification Name: Classification Panel: CFR Code: Classification: MAGNETOM Free.Max K220575 Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 ll Primary: LNH Secondary: MOS MAGNETOM Free.Star K220575 Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 Primary: LNH Secondary: MOS MAGNETOM Sola K221733 Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 . Primary: LNH Secondary: LNI, MOS MAGNETOM Amira K223343 Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 ============================================================================================================================================================================== Primary: LNH Secondary: LNI, MOS MAGNETOM Vida K213693 Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 {5}------------------------------------------------ #### Product Code: Primary: LNH Secondary: LNI, MOS #### 5. Indications for Use #### MAGNETOM Free.Max: The indications for use for the subject device MAGNETOM Free.Max with syngo MR XA60A is extended to include MR imaging during interventional procedures compared to the predicate device MAGNETOM Free.Max with syngo MR XA50A: MAGNETOM Free.Max system is indicated for use as a magnetic resonance diagnostic device (MRDD) that 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. MAGNETOM Free.Max may also be used for imaging during interventional procedures when performed with MR-compatible devices such as MR Safe biopsy needles. #### MAGNETOM Free.Star: The indications for use for the subject device MAGNETOM Free.Star with syngo MR XA60A is the same as the predicate device MAGNETOM Free.Star with syngo MR XA50A: MAGNETOM Free.Star system is indicated for use as a magnetic resonance diagnostic device (MRDD) that 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. #### Indications for use modification rationale for MAGNETOM Free.Max: The product features that support MR imaging during interventional procedures are released in subject device MAGNETOM Free.Max with syngo MR XA60A. MR imaging during interventional procedures is already included in the reference device MAGNETOM Sola's indications for use and is 510(k) cleared (K221733, cleared on September 13, 2022). This difference in indications for use does not alter the functionality in assisting diagnosis of the subject device as a magnetic resonance diagnostic device. Therefore, this difference does not constitute a new intended use according to FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]". {6}------------------------------------------------ #### 6. Device Description MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA60A include new and modified features compared to the predicate devices MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA50A (K220575, cleared on June 24, 2022). Below is a high-level summary of the new and modified hardware and software features compared to the predicate devices MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA50A: #### Hardware New hardware features: - Contour Knee coil - - -Respiratory Sensor Modified hardware features: - myExam 3D Camera - - -Host computer - -MaRS #### Software New Features and Applications: - -Injector coupling - Respiratory Sensor Support - - myExam RT Assist (only for MAGNETOM Free.Max) - - myExam Autopilot Hip - - -Deep Resolve Boost - Complex Averaging - - HASTE_Interactive (only for MAGNETOM Free.Max) - - BEAT_Interactive (only for MAGNETOM Free.Max) - - -Needle Intervention AddIn (only for MAGNETOM Free.Max) Modified Features and Applications: - Deep Resolve Sharp - - Deep Resolve Gain - - -SMS Averaging #### Other Modifications: - -Indications for Use (only for MAGNETOM Free.Max) - MAGNETOM Free.Max RT Edition marketing bundle (only for MAGNETOM -Free.Max) Below Table 1 shows an executive summary of training and validation dataset of Al feature Deep Resolve Boost in subject devices: {7}------------------------------------------------ | | 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 slipt | Training: 24,599 slices | | | Validation: 1,874 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 [1] | | 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. | | 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. | Table 1. Training and validation dataset of Al feature [1] According to assessment, the network can be transferred to subject devices without the need of retraining with additional data sets. # 7. Substantial Equivalence MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA60A are substantially equivalent to the predicate devices listed in Table 2: {8}------------------------------------------------ | Predicate Device | FDA Clearance Number and Date | Product Code | Manufacturer | |-------------------------------------------|-------------------------------------------|---------------------|---------------------------------------------| | MAGNETOM Free.Max with syngo MR XA50A | K220575, cleared on June 24, 2022 | LNH, MOS | Siemens Shenzhen Magnetic Resonance Ltd. | | MAGNETOM Free.Star with syngo MR XA50A | K220575, cleared on June 24, 2022 | LNH, 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 Amira with syngo MR XA50M | K223343, cleared on March 23, 2023 | LNH, LNI, MOS | Siemens Shenzhen Magnetic Resonance Ltd. | | MAGNETOM Vida with syngo MR XA50A | K213693, cleared on Feburary 25, 2022 | LNH, LNI, MOS | Siemens Healthcare GmbH | Table 2. Predicate devices and reference devices #### 8. Technological Characteristics The subject devices, MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA60A, are substantially equivalent to the predicate devices with reqard 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, and extended indications for use for MAGNETOM Free.Max. These differences have been tested and the conclusion from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate devices. Please see below Table 3 and Table 4 for the comparison between subject devices and predicate/ reference devices. | | Subject Devices | | Predicate Devices | | |---------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Hardware | MAGNETOM Free.Max with software syngo MR XA60A | MAGNETOM Free.Star with software syngo MR XA60A | MAGNETOM Free.Max with Error! Reference source not found. (K220575) | MAGNETOM Free.Star with Error! Reference source not found. (K220575) | | Magnet System | Yes, same as predicate device | | Yes | | | RF System | Yes, same as predicate device | | Yes | | | Transmission technique - RF Body Coil | Yes, same as predicate device | | Yes | | | Gradient System | Yes, same as predicate device | | Yes | | Table 3. Hardware Comparison {9}------------------------------------------------ | Patient Table | Yes, same as predicate device | Yes | |------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----| | Computer | Yes, modified compared to predicate device: -new host computer hardware -new MaRS hardware | Yes | | Coils | Yes, new coil compared to predicate device: Contour Knee coil | Yes | | Other HW components | Yes, Modified compared to predicate device: -myExam 3D Camera New compared to predicate device: -Respiratory Sensor | Yes | # Table 4. Software Features Comparison | | Subject Devices | | Predicate Devices | | |-------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------| | Software | MAGNETOM Free.Max with software syngo MR XA60A | MAGNETOM Free.Star with software syngo MR XA60A | MAGNETOM Free.Max with software syngo MR XA50A (K220575) | MAGNETOM Free.Star with syngo MR XA50A (K220575) | | Injector coupling | Yes, new feature migrated from reference device MAGNETOM Sola with syngo MR XA51A (K221733) | | No | | | Respiratory Sensor Support | Yes, new feature migrated from reference device MAGNETOM Amira with syngo MR XA50M (K223343) | | No | | | myExam RT Assist | Yes, new feature migrated from reference device MAGNETOM Sola with syngo MR XA51A (K221733) | No | No | | | myExam AutoPilot Hip | Yes, new feature | | No | | | Deep Resolve Boost | Yes, new feature migrated from reference device MAGNETOM Vida with syngo MR XA50A (K213693) | | No | | | Complex Averaging | Yes, new feature | | No | | | HASTE_Interactive | Yes, new feature migrated from reference device MAGNETOM Sola with syngo MR XA51A (K221733) | No | No | | | BEAT_Interactive | Yes, new feature migrated from reference device MAGNETOM Sola with syngo MR XA51A (K221733) | No | No | | {10}------------------------------------------------ | Needle Intervention AddIn | Yes, new feature migrated from reference device MAGNETOM Sola with syngo MR XA51A (K221733) | No | No | |------------------------------|---------------------------------------------------------------------------------------------------------|----|-----| | Deep Resolve Sharp | Yes, modified compared to predicate device | | Yes | | Deep Resolve Gain | Yes, modified compared to predicate device | | Yes | | SMS Averaging | Yes, modified compared to predicate device | | Yes | # 9. Nonclinical Tests The following performance testing was conducted on the subject devices. | Performance Test | Tested Hardware or Software | Source/Rationale for test | |--------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------| | Sample clinical images | New and modified software features, pulse sequence types | Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices | | Software verification and validation | New and modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical 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 Manaqement 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 Free.Max and MAGNETOM Free.Star with software syngo MR XA60A conform to the following FDA recognized and international IEC, ISO and NEMA standards: {11}------------------------------------------------ | 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 | | 19-36 | General | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 60601-1-2:2014 + AMD1:2020 | 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 | | 5-129 | General I (QS/ RM) | Medical devices - Part 1: Application of usability engineering to medical devices | 62366-1: 2015 + AMD1:2020 | ANSI AAMI IEC | | 13-79 | Software/ Informatics | Medical device software - Software life cycle processes [Including Amendment 1 (2016)] | IEC 62304:2006 + AMD1:2015 | ANSI AAMI IEC | | 12-232 | Radiology | Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices | MS 4-2010 | NEMA | | 12-288 | Radiology | Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images | MS 9-2008 (R2014) | NEMA | | 12-342 | Radiology | Digital Imaging and Communications in Medicine (DICOM) Set 03/16/2012 Radiology | PS 3.1 - 3.20 (2021e) | NEMA | | 2-258 | Biocompati bility | 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 XA60A have the same basic technological characteristics as the predicate device systems, MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA50A (Cleared with K220575 on June 24, 2022), 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 {12}------------------------------------------------ all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate devices and reference devices. Siemens believes that MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA60A are substantially equivalent to the currently marketed device MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA50A.

MAGNETOM Free.Max; MAGNETOM Free.Star

Device Facts

Real-World Evidence

Clinical Evidence

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

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MAGNETOM Free.Max; MAGNETOM Free.Star

Device Facts

Real-World Evidence

Clinical Evidence

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

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