K Number
K183244
Device Name
MAGNETOM Lumina
Date Cleared
2019-01-24

(64 days)

Product Code
Regulation Number
892.1000
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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 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.
More Information

No
The summary describes hardware and software modifications to an MRI system, including new pulse sequences and a marketing bundle for accelerated imaging. There is no mention of AI or ML in the intended use, device description, or performance studies.

No
The device is indicated for use as a magnetic device for imaging and diagnostic purposes, not for therapeutic intervention or treatment.

Yes
Explanation: The "Intended Use / Indications for Use" section states that the images and/or spectra and derived physical parameters, "when interpreted by a trained physician yield information that may assist in diagnosis."

No

The device description explicitly states that the MAGNETOM Lumina system includes "modified hardware and software" and lists specific hardware components that have been modified or added.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the system produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is a description of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
  • Device Description: The description focuses on hardware and software modifications related to the magnetic resonance imaging process and image acquisition, not on analyzing biological samples.
  • Input Imaging Modality: The input modality is Magnetic Resonance, which is an imaging technique applied to the living body.

Therefore, the MAGNETOM system described is a Magnetic Resonance Diagnostic Device (MRDD) used for in vivo imaging, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LNH, LNI, MOS

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

  • -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

  • 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.
  • Turbo Suite marketing bundle: Turbo Suite is a marketing bundle of components for accelerated MR imaging offered for the MAGNETOM Lumina MR system.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance

Anatomical Site

head, body, or extremities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician, healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Nonclinical Tests:

  • 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.

Key results: 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.

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.

K181433

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.

K150843

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 & 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

1

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

2

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

EstablishmentSiemens 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

4

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

5

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

6

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:

| Recognition
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 | 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 |

Siemens 510(k) Traditional Premarket Notification

7

| Recognition
Number | Product
Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
|-----------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------------------------|
| 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.
3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971 Second
edition 2007-10 | ISO |
| 5-96 | General | Medical devices - Application of
usability engineering to medical
devices | 62366 Edition 1.0
2015 | AAMI
ANSI
IEC |
| 13-32 | Software | Medical device software -
Software life cycle processes | 62304:2006 | AAMI
ANSI
IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4-2010 | NEMA |
| 12-288 | Radiology | Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images
(MRI) | MS 9-2008 | NEMA |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
| 2-156 | Biocompati
bility | Biological evaluation of medical
devices - part 1: evaluation and
testing within a risk management
process. (Biocompatibility) | 10993-1:2009/(R)
2013 | AAMI
ANSI
ISO |

11. Substantial Equivalence and Conclusion

MAGNETOM Lumina with software syngo MR XA11B is substantially equivalent to the following predicate device:

| Predicate Device | FDA Clearance
Number and Date | Product code | Manufacturer |
|--------------------------------------|-----------------------------------------|----------------|----------------------------|
| MAGNETOM Vida with syngo MR
XA11A | K181433,
cleared October
19, 2018 | LNH
LNI,MOS | Siemens Healthcare
GmbH |

Siemens 510(k) Traditional Premarket Notification

8

MAGNETOM Lumina with syngo MR XA11B includes features already cleared on the following reference device:

| Reference Device | FDA Clearance
Number and Date | Product code | Manufacturer |
|---------------------------------------------|-----------------------------------------------------------|--------------|----------------------------|
| syngo.via VB30A
based on syngo.via VB10A | syngo.via VB10A:
K150843,
cleared April 24,
2015 | LLZ | Siemens Healthcare
GmbH |

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