(201 days)
Yes
The device description explicitly mentions "Deep Resolve Boost HASTE" and "Deep Resolve Boost EPI Diffusion" as new software features, and the "Mentions AI, DNN, or ML" section is marked as "Yes". Furthermore, the "Description of the training set" and "Description of the test set" sections detail the training and validation data and methods for "Deep Resolve Boost" and "Deep Resolve Sharp", which are described as "AI Features/Applications".
No
The device is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces images and/or spectra to assist in diagnosis, rather than for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MAGNETOM system is indicated for use as a "magnetic resonance diagnostic device (MRDD)".
No
The device description explicitly states that the subject device consists of "new and modified software and hardware" and lists several hardware components.
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 explicitly states that these images and parameters, when interpreted by a trained physician, "yield information that may assist in diagnosis." This describes an imaging system used for clinical diagnosis based on visual and parametric data, not a device that performs tests on biological samples in vitro.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device that is intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MAGNETOM system does not perform tests on biological specimens in vitro.
- Device Description: The description details hardware and software components related to magnetic resonance imaging, not laboratory testing equipment.
- Performance Studies and Metrics: The performance studies and key metrics mentioned (PSNR, SSIM, SNR, image uniformity) are related to image quality and system performance, not the accuracy of detecting or measuring substances in biological samples.
In summary, the MAGNETOM system is a medical imaging device used for diagnosis through the interpretation of images and derived parameters by a physician, which is distinct from the function of an In Vitro Diagnostic device.
No
The input does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
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 (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
The subject device, MAGNETOM Cima.X with software syngo MR XA61A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA50A (K213693).
A high-level summary of the new and modified hardware and software is provided below:
For MAGNETOM Cima.X with syngo MR XA61:
Hardware
New Hardware:
- 3D Camera
Modified Hardware:
- Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)).
- MaRS (Measurement and Reconstruction System).
- Gradient Coil
- Cover
- Cooling/ACSC
- SEP
- GPA
- RFCEL Temp
- Body Coil
- Tunnel light
Software
New Features and Applications:
- GRE_PC
- Physio logging
- Deep Resolve Boost HASTE
- Deep Resolve Boost EPI Diffusion
- Open Recon
- Ghost reduction (DPG)
- Fleet Ref Scan
- Manual Mode
- SAMER
Modified Features and Applications:
- BEAT_nav (re-naming only).
- myExam Angio Advanced Assist (Test Bolus).
- Beat Sensor (all sequences).
- Stimulation monitoring
- Complex Averaging
Additionally, the pulse sequence MR Fingerprinting (MRF) (K213805) is now available for the subject device MAGNETOM Cima.X with syngo MR XA61A.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Not Found
Anatomical Site
Head, body, or extremities
Indicated 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
Deep Resolve Boost: TSE: more than 25,000 slices; HASTE: pre-trained on the TSE dataset and refined with more than 10,000 HASTE slices; EPI Diffusion: more than 1,000,000 slices. The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. 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 Restricted of noise and mirroring of k-space data.
Deep Resolve Sharp: on more than 10,000 high resolution 2D images. The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. 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: 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). Most importantly, the performance was evaluated by visual comparisons to evaluate e.g., aliasing artifacts, image sharpness and denoising levels.
Deep Resolve Sharp: 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 reconstructions with and without Deep Resolve Sharp.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
Software verification and validation for new or modified software features.
Sample clinical images for new or modified software features.
Image quality assessment by sample clinical images for new/modified pulse sequence types and comparison images between new/modified features and predicate device features.
Performance bench test for new and modified hardware.
Electrical, mechanical, structural, and related system safety test for system as a whole.
Electrical safety and electromagnetic compatibility (EMC) for system as a whole.
Performance bench test for local coils (SNR and image uniformity measurements, heating measurements).
Results from these tests demonstrate that the devices perform as intended and are substantially equivalent to the predicate device.
Clinical Tests: No clinical tests were conducted to support substantial equivalence for the subject devices; however, sample clinical images were provided.
Additional clinical publications were referenced for features like Deep Resolve Boost EPI Diffusion, Deep Resolve Boost HASTE, GRE_PC, Ghost reduction (DPG), Fleet Reference Scan, SAMER, and Complex Averaging.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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 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.
December 18, 2023
Siemens Medical Solutions USA, Inc. Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19355
Re: K231587
Trade/Device Name: MAGNETOM Cima.X Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: November 17, 2023 Received: November 17, 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,
D.R.
Daniel M. Krainak, Ph.D. Assistant 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)
K231587
Device Name
MAGNETOM Cima.X
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)
e-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.
-
- General Information
| Establishment: | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, USA
Registration Number: 2240869 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 25th, 2023 |
| Manufacturer: | Siemens Healthcare GmbH
Henkestr. 127
91052 Erlangen
Germany
Registration Number: 3002808157 |
| | Siemens Shenzhen Magnetic Resonance LTD
Siemens MRI Center
Hi-Tech Industrial Park (middle)
Gaoxin C. Ave., 2nd
Shenzhen 518057
P.R. CHINA
Registration Number: 3004754211 |
| 2. Contact Information | |
| | Alina Goodman
Regulatory Affairs Professional |
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: +1(317)371-8593 E-mail: alina.goodman@siemens-healthineers.com
3. Device Name and Classification
| Device/ Trade name: | MAGNETOM Cima.X |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNL. MOS |
4
4. Legally Marketed Predicate and Reference Device
- 4.1. Predicate Device
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K213693 |
| 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 Prisma |
| 510(k) Number: | K202014 |
| 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 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: LNI, MOS |
4. Intended Use
The indications for use for the subject device are the same as 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
5
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.
5. Device Description
The subject device, MAGNETOM Cima.X with software syngo MR XA61A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA50A (K213693).
A high-level summary of the new and modified hardware and software is provided below:
For MAGNETOM Cima.X with syngo MR XA61:
Hardware
New Hardware:
→ 3D Camera
Modified Hardware:
- → Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)).
- → MaRS (Measurement and Reconstruction System).
- → Gradient Coil
- → Cover
- → Cooling/ACSC
- → SEP
- → GPA
- → RFCEL Temp
- → Body Coil
- → Tunnel light
Software
New Features and Applications:
- -> GRE_PC
- → Physio logging
- -> Deep Resolve Boost HASTE
- → Deep Resolve Boost EPI Diffusion
- → Open Recon
- -> Ghost reduction (DPG)
- -> Fleet Ref Scan
- → Manual Mode
- → SAMER
Modified Features and Applications:
- → BEAT_nav (re-naming only).
- → myExam Angio Advanced Assist (Test Bolus).
- → Beat Sensor (all sequences).
- → Stimulation monitoring
- -> Complex Averaging
6
Additionally, the pulse sequence MR Fingerprinting (MRF) (K213805) is now available for the subject device MAGNETOM Cima.X with syngo MR XA61A.
6. Substantial Equivalence
MAGNETOM Cima.X with software syngo MR XA60A is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number and
Date | Product
Code | Manufacturer |
|------------------------------------------|------------------------------------------|------------------|---------------------------------------------|
| MAGNETOM Vida with syngo
MR XA50A | K213693, cleared on February
25, 2022 | LNH
LNI, MOS | Siemens Healthcare GmbH |
| Reference Device | FDA Clearance Number and
Date | Product
Code | Manufacturer |
| MAGNETOM Prisma with
syngo MR XA30A | K202014 cleared,
September 08, 2020 | LNH,
LNI, MOS | Siemens Healthcare GmbH |
| MAGNETOM Sola with syngo
MR XA51A | K221733 cleared, September
13, 2022 | LNH,
LNI, MOS | Siemens Healthcare GmbH |
| MAGNETOM Free.Max with
syngo MR XA50A | K220575 cleared, June 22,
2022 | LNH,
LNI, MOS | Siemens Shenzhen
Magnetic Resonance Ltd. |
7. Technological Characteristics
The subject device, MAGNETOM Cima.X with software syngo MR XA61A, is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.
The subject device conforms 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 device and predicate device, including new and modified hardware/software. Here is summary of differences:
| Subject Devices | Predicate Device | Reference Devices | |
|---|---|---|---|
| Hardware | MAGNETOM Cima.X | ||
| with software syngo MR | |||
| XA61A | MAGNETOM Vida with | ||
| syngo MR XA50A | |||
| (K213693) | MAGNETOM Sola with | ||
| syngo MR XA51A | |||
| (K221733) | |||
| MAGNETOM Prisma with | |||
| syngo MR XA30A | |||
| (K202014) | |||
| MAGNETOM Free.Max | |||
| with syngo MR XA50A | |||
| (K220575) | |||
| Magnet System | Yes | Yes | Yes |
| RF System | Yes | Yes | Yes |
| Transmission | |||
| technique | Yes | Yes | Yes |
| Gradient System | New or modified features as | ||
| listed in the Device | |||
| Description above | Yes | Yes | |
| Patient Table | Yes | Yes | Yes |
Summary hardware comparison table for the subject and predicate device
7
| Multi-Nuclear
Option - Supported
| Nuclei | Yes | Yes | Yes |
|---|---|---|---|
| Computer | Yes | ||
| Modified | Yes | Yes | |
| Coils | Yes | ||
| New, based on predicate: | |||
| Tx/Rx Knee 15, Tx/Rx Knee 15 | |||
| Flare, 4 Ch BI | |||
| Breast coil (already introduced | |||
| with reference system) | Yes | Yes | |
| Other HW | |||
| components | New or modified HW | ||
| components as listed in the | |||
| Device Description above | Yes | Yes |
Summary software comparison table for the subject and predicate devices
| Subject Device | Predicate Device | |
|---|---|---|
| Software | MAGNETOM Cima.X with software | |
| syngo MR XA61A | MAGNETOM Vida with syngo | |
| MR XA50A | ||
| (K213693) | ||
| Sequences | ||
| SE-based pulse sequence types | New feature as listed in the Device | |
| Description above | Yes | |
| GRE-based/Steady-State pulse | ||
| sequence types | New or modified pulse sequences | |
| as listed in the Device Description | ||
| above | Yes | |
| EPI-based pulse sequence types | New features as listed in the Device | |
| Description above | Yes | |
| Spectroscopy pulse sequence types | Yes | Yes |
| Feature and Applications | ||
| Other features and | ||
| applications such as: | ||
| -Application Suites | ||
| -myExam Assists | ||
| -Other Imaging | ||
| Applications | Modified features and | |
| applications as listed in the Device | ||
| Description above | Yes | |
| User interface and user interaction | Yes | Yes |
| Viewing and post-processing | New or modified viewing and post- | |
| processing features as listed in the | ||
| Device Description above | Yes | |
| Workflow and software utilization | Yes | Yes |
| Patient Management | Yes | Yes |
| Scan Modes and Pulse Sequences | Yes | Yes |
| Scanning | Modified and new features and | |
| applications as listed in the | ||
| Cover letter, Device Description | ||
| and Substantial Equivalence | ||
| Comparison Tables | Yes | |
| Reconstruction | New feature | |
| as listed in the Device Description | ||
| above | Yes | |
| Image Display | Yes | Yes |
| File/Data Management | Yes | Yes |
8
Additionally, the pulse sequence MR Fingerprinting (MRF) (K213805) is now available for the subject device MAGNETOM Cima.X with syngo MR XA61A.
The 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 device.
8. Nonclinical Tests
The following performance testing was conducted on the subject devices:
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Software verification and validation | New or modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
| Sample clinical images | New or modified software features | Guidance for submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices |
| Image quality assessment by sample clinical images | - new / modified pulse sequence types. |
- comparison images between the new / modified features and the predicate device features | |
| Performance bench test | new and modified hardware | |
| Electrical, mechanical, structural, and related system safety test | System as a whole | - AAMI / ANSI ES60601-1 - IEC 60601-2-33 |
| Electrical safety and electromagnetic compatibility (EMC) | System as a whole | IEC 60601-1-2 |
The following performance testing for local coils was conducted on the predicate and the reference devices and can be reused for the subject device:
| 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.
9
AI Features/Applications training and validation:
The information below shows an executive summary of training and validation dataset of the AI features:
| Deep Resolve Boost: | Deep Resolve Sharp: | |
|---|---|---|
| Training and Validation data | TSE: more than 25,000 slices HASTE: pre-trained on the TSE dataset and refined with more than 10,000 HASTE slices EPI Diffusion: more than 1,000,000 slices The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. | on more than 10,000 high resolution 2D images. The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. |
| Test Statistics and Test Results | ||
| Summary | 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). Most importantly, the performance was evaluated by visual comparisons to evaluate e.g., aliasing artifacts, image sharpness and denoising levels. | 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 reconstructions with and without Deep Resolve Sharp. |
| Equipment | 1.5T and 3T MRI systems | |
| Clinical Subgroups | No clinical subgroups have been defined for the collected dataset. | |
| Demographic Distribution | Due to reasons of data privacy, we did not record gender, age and ethnicity during data collection. | |
| Reference Standard | The acquired datasets (as described above) 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 Restricted 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. |
10
9. Clinical Tests / Publications
No clinical tests were conducted to support substantial equivalence for the subject devices; however, as stated above, sample clinical images were provided.
Furthermore, additional clinical publications were referenced to provide information on the use of the following features and functions:
| Feature | Publications |
|---|---|
| Deep Resolve Boost EPI Diffusion | [14_1] Bae SH et al., Clinical feasibility of accelerated |
| diffusion weighted imaging of the abdomen with deep | |
| learning reconstruction: Comparison with conventional | |
| diffusion weighted imaging, Eur J Radiol., 154 (2022) | |
| [14_2] Lee EJ et al., Feasibility of deep learning k- | |
| space-to-image reconstruction for diffusion weighted | |
| imaging in patients with breast cancers: Focus on | |
| image quality and reduced scan time, Eur J Radiol., 157 | |
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| image reconstruction. Diagn Interv Imaging, (2022). | |
| [14_4] Benkert T et al., Improved Clinical Diffusion | |
| Weighted Imaging by Combining Deep Learning | |
| Reconstruction, Partial Fourier, and Super Resolution, | |
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11
12
10. 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 Healthcare GmbH adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
MAGNETOM Cima.X with software syngo MR XA61A conforms to the following FDA recognized and international IEC, ISO and NEMA standards:
| Recognitio
n Number | Product
Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
|------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------|
| 19-4 | General | Medical electrical equipment - part 1:
general requirements for basic safety
and essential performance | ES60601-
1:2005/(R)2012 and
A1:2012
C1:2009/(R)2012 | AAMI / ANSI |
| 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 Edition
4.0:2014-02 | 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 | 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 | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | IEC |
| 12-195 | Radiology | NEMA MS 6-2008 (R2014)
Determination of Signal-to-Noise Ratio
and Image Uniformity for Single-
Channel Non-Volume Coils in
Diagnostic MR Imaging | MS 6-2008 (R2014) | NEMA |
| 12-349 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) | PS 3.1 - 3.20
(2022d) | NEMA |
13
| 2-258 | Biocompatibility | Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. (Biocompatibility) | 10993-1 Fifth edition 2018-08 | AAMI
ANSI
ISO |
| ------- | ------------------ | -------------------------------------------------------------------------------------------------------------------------------- | ------------------------------- | --------------------- |
|---|
11. Conclusion as to Substantial Equivalence
MAGNETOM Cima.X with software syngo MR XA61A has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA50A, 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 devices.
Siemens believes that MAGNETOM Cima.X with software syngo MR XA61A is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA50A (K213693, cleared on February 25, 2022).