(64 days)
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 inages 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.
Your 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.
MAGNETOM Lumina with software syngo MR XA11B includes modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11A. A high level summary of the modified features is provided below:
Hardware
Modified Hardware
- -Gradient system with XK gradient engine (36/200): Reduction in GPA performance with unchanged hardware components
- -Cover: Adapted system design
- Tim [180x32] configuration: patient table with 180 simultaneous connectable coil elements
Software
New Features and Applications
- GOLiver: Set of optimized pulse sequences for fast and efficient imaging of the abdomen / liver. It is designed to provide consistent exam slots and to reduce the workload for the user in abdominal / liver MRI.
Other Modifications and / or Minor Changes - Turbo Suite marketing bundle: Turbo Suite is a marketing bundle of components for accelerated MR imaging offered for the MAGNETOM Lumina MR system.
Here's a breakdown of the acceptance criteria and study information for the MAGNETOM Lumina device, based on the provided document:
This document does not describe the specific acceptance criteria or a detailed clinical study demonstrating the device's performance in a way that typically includes metrics like sensitivity, specificity, or AUC, as would be expected for an AI/algorithm-based diagnostic tool. Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (MAGNETOM Vida) through non-clinical testing and adherence to recognized standards.
The "device" in question (MAGNETOM Lumina) is a Magnetic Resonance Diagnostic Device (MRDD), an MRI scanner, not an AI-powered diagnostic algorithm in the sense of providing specific disease detection or quantification with performance metrics. The new software feature "GOLiver" within the MAGNETOM Lumina is described as a set of optimized pulse sequences for imaging, designed to improve workflow, not an AI for diagnosis.
Therefore, many of the requested elements (like effect size of AI assistance, sample size for test set with ground truth, expert qualifications for ground truth, adjudication methods) are not applicable or not provided in the context of this 510(k) submission, which is for an MRI scanner itself.
However, I can extract information related to the closest aspects of acceptance criteria and testing that are present:
Acceptance Criteria and Device Performance for MAGNETOM Lumina
Given that the device is an MRI system (not an AI diagnostic algorithm), the acceptance criteria and performance evaluation are centered on safety, functionality, and image quality compared to a predicate device, rather than diagnostic accuracy metrics of an AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Safety & Essential Performance | Compliance with IEC 60601-1 series (basic safety & essential performance) | Conforms to ES60601-1:2005/(R) 2012 and A1:2012, and 60601-2-33 Ed. 3.2:2015. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (EMC requirements) | Conforms to 60601-1-2 Edition 4.0:2014-02. |
| Risk Management | Implementation of risk management process as per ISO 14971 | Compliance with ISO 14971 Second edition 2007-10 for identification and mitigation of potential hazards. |
| Usability Engineering | Application of usability engineering principles for medical devices | Conforms to 62366 Edition 1.0 2015. |
| Software Life Cycle Processes | Compliance with IEC 62304 (software life cycle processes) | Conforms to 62304:2006. Software verification and validation testing completed as per FDA guidance. |
| Image Quality (New Pulse Sequences - GOLiver) | Equivalent image quality between new pulse sequences and predicate device's pulse sequences. | Image quality assessment completed by comparing image quality, results demonstrate device performs as intended. |
| MRI Performance (General) | Compliance with FDA guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices." | Performance tests completed as per the specified FDA guidance. Results demonstrate device performs as intended. |
| Acoustic Noise Measurement | Compliance with NEMA MS 4-2010 | Conforms to MS 4-2010. |
| Characterization of Phased Array Coils | Compliance with NEMA MS 9-2008 | Conforms to MS 9-2008. |
| Digital Imaging and Communications in Medicine (DICOM) | Compliance with DICOM standards | Conforms to PS 3.1 - 3.20 (2016). |
| Biocompatibility | Compliance with ISO 10993-1 (biological evaluation of medical devices) | Conforms to 10993-1:2009/(R) 2013. |
| Intended Use | Device performs as intended for diagnosis of internal structure and/or function during various procedures. | Stated to have the same intended use as the predicate device. Non-clinical data suggests equivalent safety and performance profile. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of patients or cases in the typical sense for an AI diagnostic study. The document mentions "Sample clinical images were taken for the hardware and software feature." This implies a set of images, but the quantity or characteristics of these images are not detailed.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The phrase "Sample clinical images were taken" suggests existing data, but further details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable/not provided in the context of this submission. The "image quality assessment" was performed by implicitly qualified personnel comparing images, but there is no mention of a formal "ground truth" establishment by multiple experts with specific qualifications to evaluate diagnostic accuracy metrics typically derived from AI output.
4. Adjudication Method for the Test Set
- Not applicable/not provided. No formal adjudication method like 2+1 or 3+1 is mentioned, as this is not a study assessing diagnostic accuracy outcomes from an AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- No MRMC comparative effectiveness study was explicitly done to evaluate how human readers improve with AI vs. without AI assistance. The document refers to "MAGNETOM Lumina" as an MRI system, not an AI-assisted diagnostic tool for interpretation. The software feature (GOLiver) is for optimized image acquisition, minimizing user workflow in abdominal/liver MRI, not for diagnostic assistance to human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The MAGNETOM Lumina is an MRI device, which acquires images for a human to interpret. It is not a standalone algorithm meant to provide a diagnosis without human interaction.
7. The Type of Ground Truth Used
- For the "Image quality assessment of the new set of pulse sequences (GOLiver)," the "ground truth" implicitly referred to was a comparison against the image quality produced by the pulse sequences of the predicate device. This is a comparison of technical image characteristics rather than a clinical ground truth (e.g., pathology, surgical findings, long-term outcomes for disease presence).
8. The Sample Size for the Training Set
- Not applicable/not provided. The device is an MRI scanner. While there is software, the document doesn't describe an AI model that underwent "training" in the machine learning sense with a specific training set to learn diagnostic patterns. The "GOLiver" feature is described as "optimized pulse sequences," which implies engineering and parameter tuning, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/not provided. As there's no mention of a traditional "training set" for an AI model, the concept of establishing ground truth for it is not relevant to this document.
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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 & 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. % Mr. Martin Rajchel Regulatory Affairs Technical Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
January 24, 2019
Re: K183244
Trade/Device Name: MAGNETOM Lumina Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI and MOS Dated: November 20, 2018 Received: November 21, 2018
Dear Mr. Rajchel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D.'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K183244
Device Name
MAGNETOM Lumina
Indications for Use (Describe)
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 inages 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.
Your 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-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.
1. General Information
| Establishment | Siemens Medical Solutions USA, Inc. |
|---|---|
| 40 Liberty Boulevard | |
| Mail Code 65-1A | |
| Malvern, PA 19355, USA | |
| Registration Number: 2240869 |
Date Prepared Nov 20, 2018
Siemens Healthcare GmbH Manufacturer Henkestrasse 127 Erlangen, Bayern, Germany 91052 Registration Number: 3002808157
2. Contact Information
Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 640-4481 E-mail: martin.rajchel@siemens-healthineers.com
3. Device Name and Classification
| Device Name: | MAGNETOM Lumina |
|---|---|
| Trade Name: | MAGNETOM Lumina |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH, Secondary: LNI, MOS |
Siemens 510(k) Traditional Premarket Notification
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4. Legally Marketed Predicate Device
| Trade Name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K181433, cleared October 19, 2018 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH, Secondary: LNI, MOS |
5. Intended Use
The indications for use for the subject device is the same as the predicate device:
Your 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.
Your 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.
6. Device Description
MAGNETOM Lumina with software syngo MR XA11B includes modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11A. A high level summary of the modified features is provided below:
Hardware
Modified Hardware
- -Gradient system with XK gradient engine (36/200): Reduction in GPA performance with unchanged hardware components
- -Cover: Adapted system design
- Tim [180x32] configuration: patient table with 180 simultaneous connectable coil elements
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SIEMENS
Software
New Features and Applications
- GOLiver: Set of optimized pulse sequences for fast and efficient imaging of the । abdomen / liver. It is designed to provide consistent exam slots and to reduce the workload for the user in abdominal / liver MRI.
Other Modifications and / or Minor Changes
- Turbo Suite marketing bundle: Turbo Suite is a marketing bundle of components for accelerated MR imaging offered for the MAGNETOM Lumina MR system.
7. Technological Characteristics
The subject device, MAGNETOM Lumina with software syngo MR XA11B, is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system, and performance.
MAGNETOM Lumina with software syngo MR XA11B conforms to the standard for medical device software (IEC 62304:2006) and other relevant IEC and NEMA standards.
There are some differences in technological characteristics between the subject device and predicate device, including a new software application and modified hardware. These differences have been tested and the conclusions from the non-clinical data suggest 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 device:
- Sample clinical images were taken for the hardware and software feature.
- Image quality assessment of the new set of pulse sequences (GOLiver) was completed by comparing the image quality between the new set of pulse sequences and the pulse sequences of the predicate device.
- Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
- Performance tests were completed in accordance with the FDA quidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," dated November 18, 2016.
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
Siemens 510(k) Traditional Premarket Notification
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SIEMENS
9. Clinical Tests
No clinical tests were conducted to support substantial equivalence for the subject device: however, sample clinical images were provided to support the modified hardware and new software feature per the FDA guidance document "Submission of Premarket Notifications for Maqnetic Resonance Diagnostic Devices", dated November 18, 2016. Clinical publications were referenced to provide information on the use of some features and functions.
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 ISO 14971:2007 compliance to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, testing, and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risks. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
MAGNETOM Lumina with software syngo MR XA11B conforms to the following FDA recognized and international IEC, ISO and NEMA standards:
| RecognitionNumber | ProductArea | Title of Standard | Reference Numberand date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General | Medical electrical equipment -part 1: general requirements forbasic safety and essentialperformance | ES60601-1:2005/(R) 2012and A1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests | 60601-1-2 Edition4.0:2014-02 | IEC |
Siemens 510(k) Traditional Premarket Notification
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| RecognitionNumber | ProductArea | Title of Standard | Reference Numberand date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 12-295 | Radiology | Medical electrical equipment -Part 2-33: Particularrequirements for the basic safetyand essential performance ofmagnetic resonance equipmentfor medical diagnosis | 60601-2-33 Ed.3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application ofrisk management to medicaldevices | 14971 Secondedition 2007-10 | ISO |
| 5-96 | General | Medical devices - Application ofusability engineering to medicaldevices | 62366 Edition 1.02015 | AAMIANSIIEC |
| 13-32 | Software | Medical device software -Software life cycle processes | 62304:2006 | AAMIANSIIEC |
| 12-232 | Radiology | Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices | MS 4-2010 | NEMA |
| 12-288 | Radiology | Characterization of PhasedArray Coils for DiagnosticMagnetic Resonance Images(MRI) | MS 9-2008 | NEMA |
| 12-300 | Radiology | Digital Imaging andCommunications in Medicine(DICOM) Set 03/16/2012Radiology | PS 3.1 - 3.20(2016) | NEMA |
| 2-156 | Biocompatibility | Biological evaluation of medicaldevices - part 1: evaluation andtesting within a risk managementprocess. (Biocompatibility) | 10993-1:2009/(R)2013 | AAMIANSIISO |
11. Substantial Equivalence and Conclusion
MAGNETOM Lumina with software syngo MR XA11B is substantially equivalent to the following predicate device:
| Predicate Device | FDA ClearanceNumber and Date | Product code | Manufacturer |
|---|---|---|---|
| MAGNETOM Vida with syngo MRXA11A | K181433,cleared October19, 2018 | LNHLNI,MOS | Siemens HealthcareGmbH |
Siemens 510(k) Traditional Premarket Notification
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MAGNETOM Lumina with syngo MR XA11B includes features already cleared on the following reference device:
| Reference Device | FDA ClearanceNumber and Date | Product code | Manufacturer |
|---|---|---|---|
| syngo.via VB30Abased on syngo.via VB10A | syngo.via VB10A:K150843,cleared April 24,2015 | LLZ | Siemens HealthcareGmbH |
MAGNETOM Lumina with software syngo MR XA11B has the same intended use and same basic technological characteristics as the predicate device system, MAGNETOM Vida with syngo MR XA11A, with respect to the magnetic resonance features and functionalities. While there are some differences in technological characteristics compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device and reference device.
Siemens believes that MAGNETOM Lumina with software syngo MR XA11B is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA11A (K181433).
Siemens 510(k) Traditional Premarket Notification
§ 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.