Longitudinal Brain Imaging (LoBI) application

K163250 · Philips Medical Systems Nederland B.V. · LLZ · May 11, 2017 · Radiology

Device Facts

• Record ID: K163250
• Device Name: Longitudinal Brain Imaging (LoBI) application
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LLZ · Radiology
• Decision Date: May 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device. The LoBI application is intended for viewing, manipulation, 3D-visualization and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.

Device Story

LoBI is a post-processing software application for serial brain MR imaging. It ingests MR data to enable visualization, segmentation, and volumetric quantification of lesions across multiple time-points. Key features include automatic image registration, lesion matching, and the Comparative Brain Imaging (CoBI) tool, which performs mathematical subtraction of registered scans (following bias-field correction and intensity scaling) to generate color-coded intensity difference maps. Used in clinical settings by radiologists and technologists, the device supports workflow by facilitating longitudinal comparison of neurological images. Clinicians use the tabular and graphical outputs to assess disease progression and confirm the presence or absence of lesions. The physician retains final responsibility for diagnosis and treatment decisions based on these results.

Clinical Evidence

No clinical studies were required. Evidence consists of non-clinical verification and validation testing, including full functionality testing against product requirements and risk management file testing. Validation was performed using real recorded clinical data cases to simulate actual use.

Technological Characteristics

Post-processing software for MR neurological images. Supports 2D/3D sequences, automatic registration, volumetric segmentation, and lesion quantification. Connectivity via DICOM standard. Complies with ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62366-1 (usability).

Indications for Use

Indicated for adult patients to assist clinicians in viewing, manipulating, and evaluating serial neurological MR images for lesion assessment, quantification, and longitudinal comparison of disease progression.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• syngo.MR Neurology, syngo.MR Oncology (K151353)
• syngo TrueD (K101749)

Reference Devices

• I4 (Integrated Intelligent Imaging Informatics) system (K160315)
• sTT under Spectral CT Applications (K150665)
• Lung Nodule Assessment and Comparison Option (K023785)
• EBW NM2.0 (K111336)

Submission Summary (Full Text)

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May 11, 2017

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

Philips Medical Systems Nederland B.V. % Yoram Levy QA/RA Consultant Osite 31 Haavoda Street Binyamina 30500 ISRAEL

Re: K163250

Trade/Device Name: Longitudinal Brain Imaging (LoBI) application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 29, 2017 Received: May 2, 2017

Dear Yoram Levy:

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. 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) K163250

Device Name Longitudinal Brain Imaging (LoBI) application

#### Indications for Use (Describe)

The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device.

The LoBI application is intended for viewing, manipulation and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence or presence of lesions, including evaluation, follow-up and documentation of any such lesions.

The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

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Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The background is white, which makes the blue letters stand out. The font is sans-serif and appears to be a standard typeface.

# 510(K) SUMMARY

# 510(k) Number K163250 Longitudinal Brain Imaging (LoBI) application

Date prepared:

April 24, 2017

# I. Submitter's name and address

| Establishment name: | Philips Medical Systems Nederland B.V. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment address: | Veenpluis 4-6<br>5684 PC Best<br>The Netherlands |
| Establishment registration: | 3003768277 |
| Primary Contact person: | Yoram Levy, Qsite<br>QA/RA Consultant<br>31 Haavoda Street<br>Binyamina, Israel 30500<br>Tel [phone];<br>Fax [phone]<br>[e-mail] |
| Alternative contact person: | Mr. Yonel Braunstein<br>Head of Regulatory and Clinical Affairs<br>Philips Medical Systems Nederland B.V<br>E-mail: [e-mail] |
| II. Device information | |
| Trade name: | Longitudinal Brain Imaging (LoBI) application |
| Device Classification Name | System, Image processing, Radiological |
| Device Class | Class II |
| Classification Panel | LLZ |

Radiological Image Processing Software 21 CFR 892.2050

# III. Device Description:

Regulation Description

Product Code

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Philips Medical Systems' Longitudinal Brain Imaging application (LoBI) is a post processing software application intended to assist in the evaluation of serial brain imaging based on MR data.

The LoBI application allows the user to view images, perform segmentation of lesions, along with segmentation editing tool and volumetric quantification of segmented volumes and quantitative comparison between time points. LoBI application provides automatic registration between studies from different time points. for longitudinal comparison.

The LoBI application provides a supportive tool for visualization of subtle differences in the brain of the same individual across time, which can be used by clinicians as the assessment of disease progression.

The physician retains the ultimate responsibility for making the final diagnosis based on image visualization as well as any segmentation and measurement results obtained from the application.

The LoBI application is intended to be used for adult population only

#### Key Features

LoBI application has the following key features:

- 1. Longitudinal comparison between brain images in multiple studies
- 2. Support for multi-slice MR sequences (2D and 3D) and allow user to use basic viewing operations such as: Scroll, pan, zoom, windowing and annotation
- 3. Identify pre-defined data types (pre-sets) and user created hanging layouts
- 4. Automatic registration between studies (same patient, different time-points)
- 5. Single mode: allows reviewing each of the launched studies, showing multiple sequences of the same study, using the whole reading space
- 6. Tissue segmentation and editing tools allowing volumetric measurement of different lesion types
- 7. Lesion management tool allowing matching between lesions in different studies to facilitate the assessment of differences over time
- 8. CoBI feature (Comparative Brain Imaging) a supportive tool for visualization of subtle differences in lesions of the same individual across time for similar sequences. The CoBI feature provides a mathematical subtraction of scans yielding, after bias-field correction and intensity scaling, a colorcoded image of the differences in intensity between two registered scans.
- 9. Results are displayed in tabular and graphical formats.

#### 2 - 2

#### Longitudinal Brain Imaging (LoBI) application – 510k Submission

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#### [V. Intended use:

The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device.

The LoBI application is intended for viewing, manipulation, 3Dvisualization and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions.

The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.

### V. Predicate Devices:

The Longitudinal Brain Imaging (LoBI) application is substantially equivalent to the following market-cleared devices:

| | Device Name | Manufacturer | 510k No | Date of<br>Clearance |
|----------------------|------------------------------------------|-----------------------------|---------|----------------------|
| Primary<br>predicate | syngo.MR Neurology,<br>syngo.MR Oncology | Siemens Medical<br>Solution | K151353 | August 07,<br>2015 |
| Predicate | syngo TrueD | Siemens Medical<br>Solution | K101749 | August 16,<br>2010 |

#### Table 2-1 Predicates table

Further to the predicate devices, Philips has identified the following currently marketed devices as reference predicate devices of proposed Longitudinal Brain Imaging (LoBI) application:

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| Device Name | Manufacturer | 510k No | Date of Clearance |
|--------------------------------------------------------------|---------------------------|---------|-------------------|
| I4 (Integrated Intelligent<br>Imaging Informatics)<br>system | Philips Medical<br>System | K160315 | Feb 19, 2016 |
| sTT under Spectral CT<br>Applications | Philips Medical<br>System | K150665 | August 7, 2015 |
| Lung Nodule Assessment<br>and Comparison Option | Philips Medical<br>System | K023785 | Feb 10 2003 |
| EBW NM2.0 | Philips Medical<br>System | K111336 | May 24 2011 |

# Table 2-2 References table

The proposed Philips Medical Systems Longitudinal Brain Imaging (LoBI) application and its predicate devices, syngo.MR Neurology, syngo.MR Oncology (K151353) and syngo TrueD (K101749), are substantially equivalent in regards to their intended uses, clinical indications, principle of operation and fundamental technology principles.

I4 (Integrated Intelligent Imaging Informatics) system (K160315), sTT under Spectral CT Applications (K150665), Lung Nodule Assessment and Comparison Option (K023785) and EBW NM2.0 (K111336) are reference devices for their additional technologies and support the additional application functionalities and enhanced capabilities.

# VI. Substantial Equivalence to Predicate Devices

| Feature | The proposed device:<br>Longitudinal Brain Imaging<br>(LoBI) | SIEMENS MEDICAL<br>syngo.MR Neurology,<br>syngo.MR Oncology<br>(K151353) | SIEMENS MEDICAL<br>syngo TrueD ( K101749) |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification<br>Name | System, Image processing,<br>Radiological | Same | Same |
| Device Class | Class II | Class II | Class II |
| Classification<br>Panel | Radiology | Radiology | Radiology |
| Feature | The proposed device: Longitudinal Brain Imaging (LoBI) | SIEMENS MEDICAL syngo.MR Neurology, syngo.MR Oncology (K151353) | SIEMENS MEDICAL syngo TrueD (K101749) |
| Product Code | LLZ | LLZ<br>Subsequent LNH | LLZ |
| Regulation Description | Picture Archiving and communication system | Same | Same |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indication For Use | The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device. The LoBI application is intended for viewing, manipulation, 3D-visualization and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision. | The software comprising the syngo.MR post-processing applications are post-processing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use. syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images. Syngo.MR Oncology is a syngo based post-processing software for viewing, manipulating, and evaluating MR oncological images. | syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of |
| Feature | The proposed device: Longitudinal Brain Imaging (LOBI) | SIEMENS MEDICAL syngo.MR Neurology, syngo.MR Oncology (K151353) | SIEMENS MEDICAL syngo TrueD ( K101749) |
| | | | lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems. syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures. |
| Intended users | Radiologists and Technologists | Same | Same |
| Type of imaging scans | MRI | MRI | CT ,MR PET/CT and SPECT/CT |
| Intended Body part | MR neurological images. | MR neurological images. | All body |
| Loading multiple studies | Yes | Yes | Yes |
| Support 2D anatomical | Yes | Yes | Yes |
| Feature | The proposed device:<br>Longitudinal Brain Imaging<br>(LoBI) | SIEMENS MEDICAL<br>syngo.MR Neurology,<br>syngo.MR Oncology<br>(K151353) | SIEMENS MEDICAL<br>syngo TrueD ( K101749) |
| Support 3D<br>anatomical<br>sequences | Yes | Yes | Yes |
| Automatic<br>image<br>registration and<br>synchronization | Yes | Yes | Yes |
| Matching of<br>lesions | Yes | Yes | No |
| Semi-Automatic<br>segmentation<br>tools | Yes. Volumetric segmentation | Same | Same |
| Segmentation<br>editing tools | Yes | Yes | Yes |
| Matching<br>between lesions | Yes<br>A suggestion for matching of<br>segmented lesions between<br>studies is provided to the user<br>based on registration. | Yes<br>There is an option for<br>matching of the segmented<br>lesions | Yes<br>A suggestion for matching<br>of segmented lesions<br>between studies is provided<br>to the user based on<br>registration. |
| Automatic<br>calculation of<br>the<br>measurements<br>of segmented<br>lesion | Yes<br>Including Volume,<br>Min/Max/Mean etc. | Yes | Yes |
| Follow-up<br>(Tracking)<br>option | Yes.<br>Follow-up between studies.<br>Includes a compare mode<br>feature of visualization of<br>subtle differences in the brain<br>over time between<br>two<br>selected images | Yes<br>Follow-up between studies | Yes.<br>Track changes in lesion's<br>parameters and follow-up<br>between studies |
| Reporting | Results displayed in tabular<br>and graphical formats.…