LiverMultiScan

K143020 · Mirada Medical, Ltd. · LNH · Jun 23, 2015 · Radiology

Device Facts

• Record ID: K143020
• Device Name: LiverMultiScan
• Applicant: Mirada Medical, Ltd.
• Product Code: LNH · Radiology
• Decision Date: Jun 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

LMS is indicated for use as magnetic resonance diagnostic device standalone software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows. These images and the physical parameters derived from the images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Story

Standalone software application; processes DICOM 3.0 MR image datasets from Siemens MAGNETOM Skyra scanners. Transforms raw MR data into relaxometry parameter maps (T1, cT1, T2*) and quantifies liver fat percentage using DIXON method. Operates on workstation with monitor, keyboard, mouse in clinical/hospital settings. Provides visualization, quantification tools (rulers, circular ROI), and reporting. Clinicians interpret output to assess liver tissue characteristics; aids in diagnostic workflows (e.g., liver fat evaluation). Integrates with Mirada DBx for DICOM connectivity/PACS interaction.

Clinical Evidence

Bench testing only. Validated via performance, functional, and algorithmic testing against user needs and intended use. Verification and validation performed in compliance with ISO 13485:2003 and 21 CFR Part 820. Testing included volunteer and phantom scans to confirm accuracy of quantification tools and parametric mapping.

Technological Characteristics

Software-only application; no hardware components. Operates on Microsoft Windows workstations. Utilizes DICOM 3.0 standard for data input/output. Employs DIXON method for fat quantification and relaxometry mapping (T1, cT1, T2*). Compliant with IEC 62304 software lifecycle standards.

Indications for Use

Indicated for non-invasive liver evaluation in any patient type suitable for MRI scan. Used by trained healthcare professionals (radiologists, gastroenterologists, radiographers, physicists) to assist in diagnosis.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Software syngo MR E11A for the MAGNETOM systems Aera/Skyra (K141977)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2015

Mirada Medical, Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K143020

Trade/Device Name: LiverMultiScan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 9, 2015 Received: June 10, 2015

Dear Mr. Job:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### FDA Indications for Use Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143020 Device Name

LiverMultiScan

Indications for Use (Describe)

[LMS is indicated for use as magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.

LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.

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) | <span> [X] Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# LiverMultiScan 510(k) Summary

| Date of summary: | 10 May 2015 |
|--------------------------|------------------------------------------------------------------------------------------------|
| Submitter's name: | Mirada Medical Ltd |
| Submitter's address: | Oxford Centre for Innovation<br>New Road<br>Oxford<br>Oxfordshire<br>OX1 1BY<br>United Kingdom |
| Submitter's contact: | Gwilym Owen |
| Telephone number: | [phone] |
| Device Proprietary Name: | LiverMultiScan |
| Device Common Name(s): | LiverMultiScan, LMS |
| Classification Name: | Class II: Magnetic Resonance Imaging System |
| | (892.1000) Product Code: LNH |

LiverMultiScan is Substantially Equivalent to the following Legally Marketed devices:

#### Predicate Devices

| 510(k) Number | Trade Name | Manufacturer |
|---------------|---------------------------------------------------------------|--------------|
| K141977 | Software syngo MR E11A for the<br>MAGNETOM systems Aera/Skyra | Siemens AG |

## Intended Use

LMS is indicated for use as magnetic resonance diagnostic device standalone software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.

LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.

These images and the physical parameters derived from the images, when interpreted by a trained physician, yield information that may assist in diagnosis.

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#### Device Description

LiverMultiScan (LMS) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from Siemens MAGNETOM Skyra MR Scanners. LMS runs on a workstation with color monitor, keyboard and mouse.

LMS is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

LMS allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver.

LMS provides a number of tools such as rulers and circular region of interest to be used for the assessment of regions of an image to support a clinical workflow.

LMS allows users to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.

LiverMultiScan (LMS) is intended to be used by trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists.

LiverMultiScan is an aid to diagnosis. When interpreted by a trained physician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.

LiverMultiScan offers:

- . Advanced visualization of MR data
- . Processing of MR data to quantify tissue characteristics including MR Relaxivity constants such as T2*, T1. cT1 and liver fat percentage
- . Circular Region of interest statistics
- Snapshot of images to include in a report
- Report to include region statistics, snapshot images and user-entered text
- Export of snapshot images and report to storage
- . Integration with Mirada DBx – a software module that maintains a local temporary cache of DICOM data and can interact with PACS, from which it can receive data

Mirada DBx is a medical device data system (MDDS, product code OUG, regulation number 880.6310) used for DICOM connectivity with other systems.

- Ability to send data from Mirada DBx to PACS or other DICOM nodes for archive and distribution

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### Testing

LiverMultiScan is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that LiverMultiScan meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate devices.

Verification and Validation for LiverMultiScan has been carried out in compliance with the requirements of ISO 13485:2003, CFR 21 Part 820 and in adherence to the DICOM standard.

In conclusion, performance testing demonstrates that LiverMultiScan is substantially equivalent to, and performs at least as safely and effectively as the listed predicate device. LiverMultiScan meets requirements for safety and effectiveness and does not introduce any new potential safety risks.

### Comparison to Predicate Devices

The proposed device is substantially equivalent to the predicate device image processing applications.

Although the proposed device does not contain software for image acquisition, the proposed device and predicate device support multi-slice MR data acquired using the same specific acquisition protocols, from the same scanner type and acquisition software to acquire the input data.

The proposed and predicate device include software applications which utilize MR data to visualize and enable quantify physiological characteristics in the liver to provide measurements which may be used to aid diagnosis.

The proposed device and both predicate device are software applications to facilitate the import and visualization of MR data sets.

Both the proposed device and the predicate device include applications to facilitate the import and visualization of MR data sets and include tools to enable the manipulation of the views and to enable the quantification and analysis of tissue characteristics in the liver from the MR data.

The proposed device and the predicate enable the quantification of analysis of tissue characteristics in the liver from the MR data.

The proposed device and the predicate device both support region of interest measurements derived from MR images and parametric maps of tissue characteristics.

The proposed device and predicate device facilitate the creation of a medical report containing the images and data analysis derived from quantification of liver tissue parameters.

The proposed device and predicate device reports all include tabular display of quantification statistics, parametric map images and include normal range references.

In conclusion, the proposed device (LiverMultiScan) does not result in any new potential safety risk and performs in accordance with its intended use as well as comparatively with the intended use of the chosen predicate.

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We conclude that the LiverMultiScan device is as safe and effective as the predicate devices and poses no unanswered questions with regard to safety and efficacy.

The key similarities and differences are highlighted in the following summary table.

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### Device Comparison Table

| Characteristic | LiverMultiScan | Software syngo MR E11A for the MAGNETOM systems Aera/Skyra | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| 510(k) number | Not known | K141977 | |
| Classification | Class II. 892.1000 LNH | Class II. 892.1000 LNH | |
| Intended Use | LMS is indicated for use as magnetic resonance diagnostic<br>device software application for non-invasive liver evaluation<br>that enables the generation, display and review of 2D magnetic<br>resonance medical image data and pixel maps for MR relaxation<br>times. | The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] are<br>indicated for use as a magnetic resonance diagnostic device (MRDD) that<br>produces transverse, sagittal, coronal and oblique cross sectional images,<br>spectroscopic images and/or spectra, and that displays the internal structure<br>and/or function of the head, body, or extremities. | |
| | LMS is designed to utilize DICOM 3.0 compliant magnetic<br>resonance image datasets, acquired from Siemens MAGNETOM<br>Skyra MR Scanners, to display the internal structure of the<br>abdomen including the liver. Other physical parameters derived<br>from the images may also be produced. | Other physical parameters derived from the images and/or spectra may also be produced.<br><br>Depending on the region of interest, contrast agents may be used. These images<br>and/or spectra and the physical parameters derived from the images and/or<br>spectra, when interpreted by a trained physician, yield information that may<br>assist in diagnosis.<br><br>The MAGNETOM systems may also be used for imaging during interventional<br>procedures when performed with MR compatible devices such as in-room display<br>and MR-Safe biopsy needles. | |
| | LMS provides a number of quantification tools such as rulers<br>and region of interest to be used for the assessment of regions<br>of an image to support existing clinical workflows.<br><br>These images and the physical parameters derived from the<br>images, when interpreted by a trained physician, yield<br>information that may assist in diagnosis. | | |
| Device<br>Description | LMS is a standalone software application for displaying 2D<br>Magnetic Resonance medical image data acquired from<br>Siemens MAGNETOM Skyra MR Scanners. LMS runs on a | The subject device, software syngo MR E11A for MAGNETOM Aera and<br>MAGNETOM Skyra offers two new applications, LiverLab (an application of non-<br>invasive liver evaluation) and MyoMaps (an application designed to provide a<br>means to generate pixel maps for myocardial MR relaxation times). In addition, | |
| software syngo MR E11A makes the Dot Cockpit available for the user to modify<br>workstation with color monitor, keyboard and mouse.<br>and create Siemens Dot Engine workflows in a very intuitive way which<br>LMS is designed to allow the review of DICOM 3.0 compliant<br>MR E11A also includes new and modified sequences as well as minor<br>datasets stored on the workstation and the user may also<br>modifications of already existing features. In addition, three additional coils are<br>create, display, print, store and distribute reports resulting from<br>interpretation of the datasets.<br>offered and some hardware components have been modified.<br>Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera and<br>LMS allows the display and comparison of combinations of<br>MAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11A<br>magnetic resonance images and provides a number of tools for<br>offers additional capabilities with respect to the predicate device, the<br>the quantification of magnetic resonance images, including the<br>MAGNETOM Aera and MAGNETOM Skyra have the same technological<br>determination of triglyceride fat fraction in the liver.<br>characteristics as the predicate device (K121434; Cleared November, 5, 2012).<br>LMS provides a number of tools such as rulers and circular<br>Furthermore, Siemens Medical Solutions, USA Inc., intends to market a new<br>region of interest to be used for the assessment of regions of an<br>configuration of the MAGNETOM Skyra with 24 receive channels with software<br>image to support a clinical workflow.<br>syngo MR E11A.<br>LMS allows users to create relaxometry parameter maps of the<br>The MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (new<br>abdomen which can be used by clinicians to help determine<br>production) as well as in-field upgrades for the currently installed MAGNETOM<br>different tissue characteristics to support a clinical workflow.<br>Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configuration<br>Examples of such workflows include, but are not limited to, the<br>with 24 receive channels will be offered as an ex-factory option (new<br>evaluation of the presence or absence of liver fat.<br>production).<br>The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] are<br>Indications for<br>LMS is indicated for use as magnetic resonance diagnostic<br>device software application for non-invasive liver evaluation<br>indicated for use as a magnetic resonance diagnostic device (MRDD) that<br>Use<br>that enables the generation, display and review of 2D magnetic<br>produces transverse, sagittal, coronal and oblique cross sectional images,<br>resonance medical image data and pixel maps for MR relaxation<br>spectroscopic images and/or spectra, and that displays the internal structure<br>and/or function of the head, body, or extremities.<br>times. | Characteristic | LiverMultiScan | Software syngo MR E11A for the MAGNETOM systems Aera/Skyra |
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| | | | supplements some of the support of an application specialist. The software syngo |
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| LMS is designed to utilize DICOM 3.0 compliant magnetic<br>Other physical parameters derived from the images and/or spectra may also be | | | |
| Characteristic…