Who is the manufacturer of MR PERMEABILITY?

Philips Medical Systems Nederland B.V. filed the 510(k) submission for MR PERMEABILITY (K130278).

What is the FDA product code for MR PERMEABILITY?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MR PERMEABILITY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MR PERMEABILITY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MR PERMEABILITY

K130278 · Philips Medical Systems Nederland B.V. · LLZ · May 29, 2013 · Radiology

Device Facts

Record ID	K130278
Device Name	MR PERMEABILITY
Applicant	Philips Medical Systems Nederland B.V.
Product Code	LLZ · Radiology
Decision Date	May 29, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

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 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 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 Story

MR Permeability is a software package integrated into the IntelliSpace Portal, a multimodality thin-client server. It processes dynamic contrast-enhanced (DCE) T1-weighted MR images of the brain or prostate. Using the Tofts pharmacokinetic model, the software calculates parametric maps including vascular permeability (Ktrans), tracer efflux rate (Kep), extravascular volume fraction (Ve), plasma fraction (Vp), and Area under the curve (AUC). The system performs automatic registration of input images. Results are presented to the radiologist as parametric maps, tables, and graphs to assist in identifying areas of abnormal vascularity or increased permeability. The device operates in a client-server environment where the server performs the processing and the client provides the interface for visualization and analysis. It is intended for use by trained physicians in a clinical setting to support diagnostic decision-making regarding tissue micro-vascular properties.

Clinical Evidence

Bench testing only. The device was validated using both synthetic data and clinical data to confirm that analysis functions perform according to the intended use. No clinical trials were required.

Technological Characteristics

Client-server software application integrated into the Philips IntelliSpace Portal. Runs on standard PC/server hardware using Microsoft Windows. Utilizes TCP/IP and DICOM standards for data exchange. Implements Tofts pharmacokinetic modeling for parametric map generation. Supports ROI-based analysis.

Indications for Use

Indicated for radiologists to visualize and post-process dynamic contrast-enhanced 3D T1-weighted MRI datasets of the brain or prostate to assess micro-vascular properties and visualize areas of abnormal vascularity.

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

nordicICE Software (K090546)

Submission Summary (Full Text)

{0}------------------------------------------------ # 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 Rd Cleveland, Ohio 44143 USA | | Contact Person: | Susan Quick | | Telephone Number: | 440-483-2291 | | Prepared (date): | 2013 February 22 | | Manufacturing Site: | Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands | | Trade Name of Device: | MR Permeability | | Classification: | Class II | | Regulatory Section: | Picture Archiving and Communication System 892.2050 | | ProCode: | 90 LLZ | {1}------------------------------------------------ 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 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. 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. ・ . {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 Healthcare MR Permeability | NordicImagingLab nordicICE Software (K090546) | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DICOM | Yes | Yes | | Intended Use | MR Permeability package facilitates the radiologist in visualizing and post-processing dynamic contrast-enhanced datasets. It is an optional package within IntelliSpace Portal. MR Permeability Package 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 or results in a graph. MR Permeability Package facilitates the visualization of areas with increased permeability. MR Permeability Package is a software tool for visualizing and post-processing dynamic contrast-enhanced 3D datasets, acquired to visualize areas with abnormal vascularity. | Nordic Image Control and Evaluation (nordicICE) software is an image processing software package to be used by trained professionals including but not limited to physician and medical technicians. The software runs on a standard "Off- the-shelf' PC workstation and can be used to perform image viewing, processing and analysis or medical images. Data are images acquired through DICOM complaint imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI). Fiber Tracking and dynamic analysis. BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain. Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary. nordicICE Perfusion Module: Calculation of parameters related to tissue flow (perfusion) and tissue blood volume nordicICE DCE Module: calculation of parameters related to leakage of injected contrast material from | | Generate Various Parametric Maps: | Yes | intravascular to extracellular space. Yes | | KTrans | Yes | Yes | | V ● | Yes | Yes | | AUC | Yes | Yes | | Kep | Yes | Yes | {4}------------------------------------------------ K130278 | | Philips Healthcare MR Permeability | NordicImagingLab nordicICE Software | |-----------------------------------------------------------|---------------------------------------|-------------------------------------| | Plasma ● Fraction | Yes | Yes | | Detailed analysis based on user defined ROI`s | Yes | Yes | | Input based on Dynamic TI- weighted measurements | Yes | Yes | | Underlay selection | Yes | Yes | | Calculation based on Tofts Model | Yes | Y es | | Applicable to multiple organs and tissucs | Yes - Brain and Prostate | Yes | | Graph presentation of 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). {5}------------------------------------------------ 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. {6}------------------------------------------------ #### 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 {7}------------------------------------------------ ## 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

MR PERMEABILITY

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

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MR PERMEABILITY

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Indications for Use

Device Story

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Indications for Use

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Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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