(160 days)
Yes
The document explicitly mentions "Deep Resolve Boost" and "Deep Resolve Sharp" as new and modified software features, and the description of the training set details the use of a "network" trained on a large dataset for image processing, which are strong indicators of AI/ML technology being incorporated.
No.
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "a magnetic resonance diagnostic device (MRDD)" and that it "may assist in diagnosis." There is no mention of therapeutic capabilities.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the MAGNETOM Free.Max and MAGNETOM Free.Star systems are indicated for use as "magnetic resonance diagnostic devices (MRDD)". It further explains that the images and parameters derived from them, when interpreted by a trained physician, "yield information that may assist in diagnosis."
No
The device description explicitly lists both new and modified hardware features, indicating it is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images of the internal structure and/or function of the body. It assists in diagnosis when interpreted by a trained physician. This describes an in-vivo imaging device, not a device that performs tests on samples taken from the body (in vitro).
- Device Description: The description focuses on hardware and software features related to MRI scanning and image processing. There is no mention of reagents, assays, or analysis of biological samples, which are characteristic of IVDs.
- Input Imaging Modality: The input is Magnetic Resonance (MR), which is an imaging modality used on living patients, not on in vitro samples.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
No
The letter does not state that the FDA has reviewed and cleared or approved a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is explicitly marked as "Not Found."
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, MOS
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)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD)
Anatomical Site
Head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Interventional procedures
Description of the training set, sample size, data source, and annotation protocol
Sample size: 24,599 slices (part of 26,473 2D slices total for training and validation).
Sample source: in-house measurements and collaboration partners.
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).
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.
Description of the test set, sample size, data source, and annotation protocol
Validation (Test) set sample size: 1,874 slices.
Sample source: in-house measurements and collaboration partners.
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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
Performance tests conducted on the subject devices included:
- Sample clinical images for new and modified software features, pulse sequence types, based on "Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices".
- Software verification and validation for new and modified software features, based on "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Test statistics and test results for 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). 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.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 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)
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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 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:
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| 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
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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.