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.

Device Description

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
1. 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
1. Identify pre-defined data types (pre-sets) and user created hanging layouts
1. Automatic registration between studies (same patient, different time-points)
1. Single mode: allows reviewing each of the launched studies, showing multiple sequences of the same study, using the whole reading space
1. Tissue segmentation and editing tools allowing volumetric measurement of different lesion types
1. Lesion management tool allowing matching between lesions in different studies to facilitate the assessment of differences over time
1. 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.
1. Results are displayed in tabular and graphical formats.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Philips Longitudinal Brain Imaging (LoBI) application, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards rather than explicit quantitative acceptance criteria or detailed device performance metrics in a table format. The primary "acceptance criteria" are implied by compliance with:

International and FDA-recognized consensus standards: ISO 14971, IEC 62304, IEC 62366-1, DICOM PS 3.1-3.18.
FDA guidance document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Internal Philips verification and validation processes: Ensuring the device "meets the acceptance criteria and is adequate for its intended use and specifications."

Since specific numerical performance criteria (e.g., accuracy, sensitivity, specificity for particular lesion types) and corresponding reported performance are not provided in this 510(k) summary, the table below reflects what is broadly stated.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 14971 (Risk Management)	Demonstrated
Compliance with IEC 62304 (Software Life Cycle Processes)	Demonstrated
Compliance with IEC 62366-1 (Usability Engineering)	Demonstrated
Compliance with FDA Guidance for Software in Medical Devices	Demonstrated
Compliance with DICOM PS 3.1-3.18 (DICOM Standard)	Demonstrated
Fulfillment of intended functionality (CoBI feature, registration, segmentation, measurement, etc.)	Verified through "Full functionality test" (covering detailed requirements per Product Requirement Specification) and "Validation" (using real recorded clinical data cases to simulate actual use and ensure customer needs / intended functionality fulfillment). Performance demonstrated to meet defined functionality requirements and performance claims.
CoBI feature functions correctly and meets specifications	Proven through verification activities
Meets customer needs and fulfills intended functionality (validated with real clinical data)	Proven through validation activities

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated as a number of cases or images. The validation activities used "real recorded clinical data cases." The quantity of these cases is not specified.
Data Provenance: The data used for validation consisted of "real recorded clinical data cases." No specific country of origin is mentioned. It is indicated as retrospective, as they are "recorded" data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The general statement is that "The physician retains the ultimate responsibility for making the final diagnosis," suggesting human expert involvement in clinical practice, but not explicitly defining how ground truth for the test set was established or by whom.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI Vs Without AI Assistance:

No MRMC comparative effectiveness study was done or reported. The document states explicitly: "The subject of this premarket submission. Longitudinal Brain Imaging (LoBI) application did not require clinical studies to support equivalence." The testing focused on verification and validation of the software's functionality and compliance with standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document describes the LoBI application as a "post-processing software application intended to assist in the evaluation of serial brain imaging" and emphasizes that "The physician retains the ultimate responsibility for making the final diagnosis."
While the software performs automated functions like registration, segmentation, and quantitative comparison, the validation process using "real recorded clinical data cases" seems to focus on the software's ability to provide accurate tools and information that a user would interpret.
The description of "Full functionality test" and "RMF testing" could involve standalone algorithmic performance evaluation against predefined specifications. However, an explicit "standalone" performance study as a separate regulatory study with defined metrics (e.g., algorithm-only sensitivity/specificity against ground truth) is not detailed in this summary. The focus is on the tool's supportive role for the user.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The type of ground truth used for the validation data is not explicitly specified. It refers to "real recorded clinical data cases," implying that the medical imaging data came with existing clinical interpretations or diagnoses, which would have implicitly served as a form of reference or "ground truth" for evaluating the software's utility in "confirming the absence or presence of lesions, including evaluation, quantification, follow-up and documentation." However, the method of establishing this ground truth (e.g., expert consensus, pathology) is not detailed.

8. The Sample Size for the Training Set:

The document does not provide information regarding a distinct training set sample size or how the LoBI application was developed using machine learning or AI. The product description focuses on its functionality as a post-processing application with features like automatic registration and tissue segmentation, which could be rule-based or machine learning-driven, but this is not specified, nor is training data mentioned.

9. How the Ground Truth for the Training Set Was Established:

Since a training set is not mentioned, the method for establishing its ground truth is also not provided.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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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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 4-65684 PC BestThe Netherlands
Establishment registration:	3003768277
Primary Contact person:	Yoram Levy, QsiteQA/RA Consultant31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837;Fax (972)4-638-0510Yoram@qsitemed.com
Alternative contact person:	Mr. Yonel BraunsteinHead of Regulatory and Clinical AffairsPhilips Medical Systems Nederland B.VE-mail: Yonel.Braunstein@philips.com
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 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
1. 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
1. Identify pre-defined data types (pre-sets) and user created hanging layouts
1. Automatic registration between studies (same patient, different time-points)
1. Single mode: allows reviewing each of the launched studies, showing multiple sequences of the same study, using the whole reading space
1. Tissue segmentation and editing tools allowing volumetric measurement of different lesion types
1. Lesion management tool allowing matching between lesions in different studies to facilitate the assessment of differences over time
1. 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.
1. Results are displayed in tabular and graphical formats.

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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 ofClearance
Primarypredicate	syngo.MR Neurology,syngo.MR Oncology	Siemens MedicalSolution	K151353	August 07,2015
Predicate	syngo TrueD	Siemens MedicalSolution	K101749	August 16,2010

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 IntelligentImaging Informatics)system	Philips MedicalSystem	K160315	Feb 19, 2016
sTT under Spectral CTApplications	Philips MedicalSystem	K150665	August 7, 2015
Lung Nodule Assessmentand Comparison Option	Philips MedicalSystem	K023785	Feb 10 2003
EBW NM2.0	Philips MedicalSystem	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:Longitudinal Brain Imaging(LoBI)	SIEMENS MEDICALsyngo.MR Neurology,syngo.MR Oncology(K151353)	SIEMENS MEDICALsyngo TrueD ( K101749)
DeviceClassificationName	System, Image processing,Radiological	Same	Same
Device Class	Class II	Class II	Class II
ClassificationPanel	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	LLZSubsequent 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:Longitudinal Brain Imaging(LoBI)	SIEMENS MEDICALsyngo.MR Neurology,syngo.MR Oncology(K151353)	SIEMENS MEDICALsyngo TrueD ( K101749)
Support 3Danatomicalsequences	Yes	Yes	Yes
Automaticimageregistration andsynchronization	Yes	Yes	Yes
Matching oflesions	Yes	Yes	No
Semi-Automaticsegmentationtools	Yes. Volumetric segmentation	Same	Same
Segmentationediting tools	Yes	Yes	Yes
Matchingbetween lesions	YesA suggestion for matching ofsegmented lesions betweenstudies is provided to the userbased on registration.	YesThere is an option formatching of the segmentedlesions	YesA suggestion for matchingof segmented lesionsbetween studies is providedto the user based onregistration.
Automaticcalculation ofthemeasurementsof segmentedlesion	YesIncluding Volume,Min/Max/Mean etc.	Yes	Yes
Follow-up(Tracking)option	Yes.Follow-up between studies.Includes a compare modefeature of visualization ofsubtle differences in the brainover time betweentwoselected images	YesFollow-up between studies	Yes.Track changes in lesion'sparameters and follow-upbetween studies
Reporting	Results displayed in tabularand graphical formats.	Same	Same
DICOMCommunication	Yes	Yes	Yes

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Philips Medical Systems Nederland B.V.

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Philips Medical Systems Nederland B.V.

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Philips Medical Systems Nederland B.V.

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2 - 7 Longitudinal Brain Imaging (LoBI) application – 510k Submission

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The Philips Medical Systems Longitudinal Brain Imaging (LoBI) and the identified syngo.MR Neurology, syngo.MR Oncology (K151353) and syngo TrueD (K101749) are substantially equivalent in terms of indication for use and intended users, design features, principle of operation and fundamental scientific technology, and safety and/or effectiveness.

In conclusion, Philips believes that the proposed Longitudinal Brain Imaging (LoBI) does not introduce any new potential safety and/or effectiveness issues and is substantially equivalent to the identified predicate devices, syngo.MR Neurology, syngo.MR Oncology (K151353) and syngo TrueD (K101749).

VII. Brief discussion of the nonclinical tests submitted, referenced or relied on

No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on ISPP and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

ISO 14971 Medical devices Application of risk management to medical devices
IEC 62304 Medical device software Software life cycle processes
IEC 62366-1 Medical devices Part 1:Application of usability engineering to medical devices
Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
DICOM PS 3.1-3.18 standard Digital Imaging and Communications in Medicine (DICOM) Standard

Philips Medical Systems Longitudinal Brain Imaging (LoBI) application was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.

The following verification and validation testing were conducted with the Longitudinal Brain Imaging (LoBI) application:

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. Verification- the verification activities proves that the LoBI application includes the CoBI feature, function correctly and meets its specification. The verification testing includes the following testing:
- Full functionality test- a comprehensive list of test cases which covers a specific function/feature in the application. This test covers all of the detailed requirements according to the PRS (Product Requirement Specification).
- A RMF testing- testing which covers of the test that are specifically designed to check in the risk management file
· Validation- the validation proves that the LoBI application meets the customer needs and its performance fulfills its intended functionality. The validation activities include real recorded clinical data cases in order to simulate the actual use of the application.

The test results in this 510(k) premarket notification demonstrate that Longitudinal Brain Imaging (LoBI):

Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
. Meets the acceptance criteria and is adequate for its intended use and specifications.

VIII. Brief discussion of clinical tests submitted, referenced or relied on

The subject of this premarket submission. Longitudinal Brain Imaging (LoBI) application did not require clinical studies to support equivalence.

[X. The conclusions drawn from the nonclinical and clinical tests

Verification and Validation (V&V) activities required to establish performance and functionality of Longitudinal Brain Imaging (LoBI) were performed. Testing performed demonstrated the Longitudinal Brain Imaging (LoBI) meets all defined functionality requirements and performance claims.

X. Overall conclusion:

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The Longitudinal Brain Imaging (LoBI) is substantially equivalent to the identified predicate devices, primary- syngo.MR Neurology, syngo.MR Oncology (K151353) and syngo TrueD (K101749) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, verification and validation testing demonstrate the safety and efficacy of the device to meet its intended use and specifications.

Philips Medical believes that the proposed device, Longitudinal Brain Imaging (LoBI) application, is substantially equivalent to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).