MR Permeability facilitates the radiologist in visualizing and post-processing dynamic contrast-enhanced datasets. It is an optional package within IntelliSpace Portal.
MR Permeability can be used by the radiologist to assess the micro-vascular properties by computing vascular permeability (Ktrans), tracer efflux rate (Kep), extravascular volume fraction (Ve), plasma fraction (Vp), and Area under the curve (AUC) from T1 images of brain and prostate. The applied pharmacokinetic modeling is based on the Tofts model:
The results are presented back to the user in the form of a parametric map, a table of results and in a graph.
MR Permeability facilitates the visualization of areas with increased permeability.
MR Permeability facilitates the visualization of variations in permeability.
MR Permeability is a software tool for visualizing and post processing dynamic contrast- enhanced 3D datasets, acquired to visualize areas with abnormal vascularity.

Device Description

IntelliSpace Portal is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal is a medical software system that allows multiple users to remotely access IntelliSpace Portal from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

The MR Permeability integrated into the IntelliSpace portal is used for processing MR T1 images to generate parametric maps, which help in studying micro-vascular properties. It is a client-server based application developed using Philips Informatics Infrastructure (PII) platform and is integrated into IntelliSpace portal. Communication and data exchange between client-server and with other portal components use standards like TCP/IP and DICOM.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Philips MR Permeability device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K130278) is a 510(k) premarket notification for the Philips MR Permeability device. Unlike a Pre-Market Approval (PMA) application, a 510(k) typically doesn't present a detailed study with specific quantitative acceptance criteria for clinical performance metrics (like sensitivity, specificity, accuracy) against a defined ground truth. Instead, the primary goal of a 510(k) is to demonstrate substantial equivalence to a previously legally marketed predicate device.

The "acceptance criteria" in this context are implicitly the features and functionalities of the predicate device, nordicICE Software, and the study's goal is to show that the new device performs as well as or better than this predicate.

Acceptance Criteria (Implied by Predicate Comparison) and Reported Device Performance:

Feature/Functionality	Acceptance Criteria (Predicate)	Reported Device Performance (MR Permeability)
Intended Use	nordicICE is an image processing software for trained professionals, for viewing, processing, and analysis of medical images (DICOM). It provides viewing/analysis of functional/dynamic imaging datasets (MRI, BOLD fMRI, DWI, Fiber Tracking). Specifically, the DCE Module calculates parameters related to leakage of injected contrast material from intravascular to extracellular space.	MR Permeability package facilitates radiologists in visualizing and post-processing dynamic contrast-enhanced datasets. It assesses micro-vascular properties (Ktrans, Kep, Ve, Vp, AUC) from T1 images of the brain or prostate, based on the Tofts model. Results are presented as parametric maps, tables, graphs, and facilitate visualization of increased/variations in permeability.
DICOM Compatibility	Yes	Yes
Generate Various Parametric Maps	Yes, including Ktrans, Ve, AUC, Kep, Plasma Fraction.	Yes, including Ktrans, Ve, AUC, Kep, Plasma Fraction.
Detailed analysis based on user-defined ROIs	Yes	Yes
Input based on Dynamic T1-weighted measurements	Yes	Yes
Underlay selection	Yes	Yes
Calculation based on Tofts Model	Yes	Yes
Applicable to multiple organs/tissues	Yes (general statement)	Yes - Brain and Prostate
Graph presentation of data	Yes	Yes
Safety and Effectiveness	(Implied: The predicate device is considered safe and effective for its stated intended uses.)	"The MR Permeability software does not introduce new indications for use, nor does the use of the device result in any new potential hazard." "The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use."

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

The document states: "The conclusion from testing the device against synthetic data as well clinical data is: 'Based on the test results, the MR Permeability analysis functions according to its intended use'."

Sample Size (Test Set): Not explicitly stated. The document mentions "clinical data" but does not quantify the number of cases or patients used for this testing.
Data Provenance: Not specified. It mentions "synthetic data" and "clinical data". The origin (e.g., country of origin, specific institutions) and whether the clinical data was retrospective or prospective are not provided.

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 summary. For a 510(k) focused on substantial equivalence to software, detailed expert review for ground truth establishment might not be a primary focus as it would be for novel diagnostic algorithms. The testing described appears to be more technical verification ("functions according to its intended use") rather than a clinical performance study against an expert-derived ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the evaluation described (technical verification and comparison to synthetic data/unspecified clinical data), a formal adjudication method for a test set ground truth is unlikely to have been documented in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to the predicate device in terms of functionality and safety, not on measuring human reader improvement with or without AI assistance.

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

The document mentions "The MR Permeability verification tests were performed on the complete system relative to the verification, regression and test specifications" and "testing the device against synthetic data as well clinical data." This indicates that the algorithm's performance in generating parametric maps was tested. Since the device's output (parametric maps, tables, graphs) is consumed by a radiologist, and the testing description speaks to its functionality, it implicitly covers the standalone performance of the algorithm in generating these outputs.
Yes, tests were performed on the device's ability to generate the specified parametric maps and analysis results.

7. The Type of Ground Truth Used

The ground truth implicitly used for the verification was:

Synthetic data: Likely mathematically derived "ideal" or known pharmacokinetic profiles to test the accuracy of the Tofts model calculations and parametric map generation.
Unspecified "clinical data": The nature of the ground truth for this clinical data is not specified (e.g., whether it was pathology, follow-up outcomes, or consensus readings). Given the context of a 510(k) for a post-processing tool, it's more likely that the clinical data was used to verify consistency and expected output generation rather than providing an independent 'gold standard' for disease presence/absence.

8. The Sample Size for the Training Set

This information is not provided. The 510(k) summary does not detail the development or training of the algorithm, as it's primarily concerned with demonstrating equivalence post-development.

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

This information is not provided. As with the training set size, the summary does not delve into the development methodology or ground truth establishment for algorithm training.

Summary

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PHILIPS

Philips Medical Systems Nederland B.V.

יר 30278 ₪

510(k) Summary

MAY 2 9 2013

MR Permeability

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

I. General Information

21 CFR 807.92 (a)(1), (2)

Company Name:	Philips Medical Systems
Address:	595 Miner RdCleveland, Ohio 44143USA
Contact Person:	Susan Quick
Telephone Number:	440-483-2291
Prepared (date):	2013 February 22
Manufacturing Site:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe Netherlands
Trade Name of Device:	MR Permeability
Classification:	Class II
Regulatory Section:	Picture Archiving and Communication System892.2050
ProCode:	90 LLZ

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21 CFR 807.92(a)(3):Legally marketed predicate device to which substantial equivalence is claimed:

Predicate Device:	nordicICE Software
Manufacturer:	NordicNeuroLab
Predicate Device k#:	K090546

21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification:

1. Summary of functions of the device and its major components

The following are major functions available in the application:

Selection of input TI Dynamic Contrast Enhanced (DCE) images and reference a. T1 W images.
Automatic registration. b.
Calculation of following permeability maps using default and manual Arterial c. Input Function (AIF):
- Vascular permeability (Ktrans) .
- Tracer efflux rate (Kep) .
- . Extravasular volume fraction (Ve)
- . Plasma fraction (Vp)
- Area under the curve (AUC) .
Calculation of permeability results for Region of Interest (ROI). d.
Presentation of results in form of maps, table of results and graphs. e.
દિ Standard image visualization including windowing, color LUT and fusion.
Preview and background modes of processing with saving of maps to portal g. database in background mode.
Filming and reporting by interfacing with filming and reporting applications in h.

・ .

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portal.

21 CFR 807.92(a)(5): Intended Use

MR Permeability facilitates the radiologist in visualizing and post-processing . dynamic contrast- enhanced datasets. It is an optional package within IntelliSpace Portal.
MR Permeability can be used by the radiologist to assess the micro-vascular . properties by computing vascular permeability (Ktrans), tracer efflux rate (Kep), extravascular volume fraction (Ve), plasma fraction (Vp), and Area under the curve (AUC) from T1 images of the brain or prostate. The applied pharmacokinetic modeling is based on the Tofts model.
The results are presented back to the user in the form of a parametric map, a table . of results and in a graph.
. MR Permeability facilitates the visualization of areas with increased permeabilit y.
. MR Permeability facilitates the visualization of variations in permeability.
. MR Permeability is a software tool for visualizing and post processing dynamic contrast-enhanced 3D datasets, acquired to visualize areas with abnormal vascularity.

21 CFR 807.92(a)(6): Technological Characteristics:

MR Permeability within the IntelliSpace portal is used for processing MR T1 images to generate parametric maps, which help in studying micro-vascular properties. It is a client-server based application developed using Philips Informatics Infrastructure (PII) platform and is integrated into IntelliSpace portal.

Client part of the application runs on portal client, which is a PC running standard Microsoft Windows Operating System. Typical hardware for client might include:

PC with specified operating system, system memory, monitor, keyboard and . mouse.
. Hard Disk for client software.
Network port to connect to the network. .

Server part of the application runs on portal server, which is server class hardware running standard Microsoft Windows Operating System. Typical hardware for server might include:

Server class hardware with specified operating system, system memory, . monitor, keyboard and mouse.
Hard Disk for server software and data storage. .
Network port to connect to the network. .
CD/DVD ROM drive for software installation. .

The second Portal Servers (Slave server) can be used in a master-slave scenario enabling the additional processing capacity (more users in the same time) if needed. There is only one database of studies shared between slaves and master.

The Permeability Package within IntelliSpace Portal, provided by Philips Healthcare, enables assessing variations in permeability in various tissues. The required input is a dynamic T1-weighted image series that enables analysis and required input is a dynamic 11-weighted image series marches andrysis and
visualization of variations in contrast leakage. nordicICE Perfusion/DCE Modul Page 3

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of the nordicICE Software from NordicNeuroLabs provides the same analysis and visualization, based on the same image input.

Both packages visualize and analyze or process dynamic data and changes in contrast over time. They both use permeability or leakage as the key focus of the intended use. - The nordicICE is a complete off-the-shelf PC workstation, while MR Permeability is one of the processing capabilities of our IntelliSpace Portal workstation solution. This does not affect the functionality of the software.

The MR Permeability Software Application is similar to the predicate device, nordicICE Perfusion/DCE Module which has been cleared through premarket notification and raises no new issues of safety or effectiveness.

Tabular comparison of features and specifications of MR Permeability and the predicate device nordicICE Software.

	Philips HealthcareMR Permeability	NordicImagingLab nordicICE Software(K090546)
DICOM	Yes	Yes
Intended Use	MR Permeability package facilitates theradiologist in visualizing and post-processingdynamic contrast-enhanced datasets. It is anoptional package within IntelliSpace Portal.MR Permeability Package can be used by theradiologist to assess the micro-vascularproperties by computing vascular permeability(Ktrans), tracer efflux rate (Kep),extravascular volume fraction (Ve), plasmafraction (Vp), and Area under the curve(AUC) from T1 images of the brain orprostate. The applied pharmacokineticmodeling is based on the Tofts model.The results are presented back to the user inthe form of a parametric map, a table or resultsin a graph.MR Permeability Package facilitates thevisualization of areas with increasedpermeability.MR Permeability Package is a software toolfor visualizing and post-processing dynamiccontrast-enhanced 3D datasets, acquired tovisualize areas with abnormal vascularity.	Nordic Image Control and Evaluation (nordicICE) software isan image processing software package to be used by trainedprofessionals including but not limited to physician andmedical technicians. The software runs on a standard "Off-the-shelf' PC workstation and can be used to perform imageviewing, processing and analysis or medical images. Data areimages acquired through DICOM complaint imaging devicesand modalities.nordicICE provides both viewing and analysis capabilities offunctional and dynamic imaging datasets acquired with MRIor other relevantmodalities, including blood oxygen level dependent(BOLD) fMRI, diffusion weighted MRI (DWI). FiberTracking and dynamic analysis.BOLD fMRI: BOLD analysis is used to highlightsmall magnetic susceptibility changes in the human brain inareas with altered blood-flow resulting fromneuronal activity.DWI/Fiber Tracking: Diffusion analysis is used to visualizelocal water diffusion properties from theanalysis of diffusion-weighted MRI data. Fibertracking utilize the directional dependency of the diffusion todisplay the white matter structure in thebrain.Dynamic Analysis: Dynamic analysis is used forvisualization and analysis of dynamic imaging dataof the brain, showing properties of changes incontrast over time where such techniques are useful ornecessary.nordicICE Perfusion Module: Calculation ofparameters related to tissue flow (perfusion) and tissue bloodvolumenordicICE DCE Module: calculation of parametersrelated to leakage of injected contrast material from
Generate VariousParametric Maps:	Yes	intravascular to extracellular space.Yes
KTrans	Yes	Yes
V●	Yes	Yes
AUC	Yes	Yes
Kep	Yes	Yes

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K130278

	Philips HealthcareMR Permeability	NordicImagingLab nordicICE Software
Plasma●Fraction	Yes	Yes
Detailed analysisbased on userdefined ROI`s	Yes	Yes
Input based onDynamic TI-weightedmeasurements	Yes	Yes
Underlay selection	Yes	Yes
Calculation based onTofts Model	Yes	Y es
Applicable tomultiple organs andtissucs	Yes - Brain and Prostate	Yes
Graph presentationof data	Yes	Yes

21 CFR 807.92(b)(1): Brief discussion of nonclinical tests submitted, referenced or relied on in this premarket notification:

The MR Permeability verification tests were performed on the complete system relative to the verification, regression and test specifications. Corresponding test results are included in this submission and for each specification indicate verification purpose was accomplished.

21 CFR 807.92(b)(2): Brief discussion of clinical tests submitted, referenced or relied on in this premarket notification:

The conclusion from testing the device against synthetic data as well clinical data is: "Based on the test results, the MR Permeability analysis functions according to its intended use".

All defects have been analyzed and it are confirmed that they are not safety defects and will not cause any hazardous situation on using this application.

21 CFR 807.92(b)(3): The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section:

The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use.

The MR Permeability software does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers MR Permeability to be substantially equivalent to the NordicNeuroLab nordiciCE Software (K090546).

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 29, 2013

Philips Medical Systems Nederland B.V. % Ms. Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143

Re: K130278

Trade/Device Name: MR Permeability Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 6, 2013 Received: March 7, 2013

Dear Ms. Quick:

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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Page 2 - Ms. Susan Quick

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Sm.h.7.)

for

Janine M. Morris 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): K130278

Device Name: MR Permeability

Indications for Use:

MR Permeability facilitates the radiologist in visualizing and post-processing . dynamic contrast-enhanced datasets. It is an optional package within IntelliSpace Portal.
. MR Permeability can be used by the radiologist to assess the micro-vascular properties by computing vascular permeability (Ktrans), tracer efflux rate (Kep), extravascular volume fraction (Ve), plasma fraction (Vp), and Area under the curve (AUC) from T1 images of brain and prostate. The applied pharmacokinetic modeling is based on the Tofts model:
The results are presented back to the user in the form of a parametric map, a . table of results and in a graph.
MR Permeability facilitates the visualization of areas with increased permeability. .
MR Permeability facilitates the visualization of variations in permeability. ●
MR Permeability is a software tool for visualizing and post processing dynamic � contrast- enhanced 3D datasets, acquired to visualize areas with abnormal vascularity.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Simh-7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130278

Page 1 of 1

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).