Brain Perfusion (BP) application

K182716 · Philips Medical Systems Nederland B.V. · JAK · May 29, 2019 · Radiology

Device Facts

• Record ID: K182716
• Device Name: Brain Perfusion (BP) application
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: JAK · Radiology
• Decision Date: May 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Philips Medical Systems' Brain Perfusion (BP) application is a post processing software application intended to assist with the evaluation of an area of interest, to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast agent, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images.

Device Story

Brain Perfusion (BP) application is a post-processing software for CT brain perfusion images; inputs are dynamic/serial CT scans acquired after contrast agent injection. The device performs motion correction, detects reference arteries/veins, and calculates perfusion parameters: Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), Time to Peak (TTP), Mean Transit Time (MTT), and permeability maps. Outputs include composite images (tMIP), time-density curves, and parametric maps. Used in clinical settings by physicians and technicians; results assist in evaluating areas of interest and supporting clinical decision-making. The physician retains ultimate responsibility for diagnosis. Benefits include quantitative assessment of brain perfusion and blood-brain barrier permeability.

Clinical Evidence

No clinical data. Performance evaluation relied on bench testing, including synthetic phantom data for perfusion parameter validation and pre-clinical animal studies (rats) for permeability map validation. Histology was used as ground truth to confirm that areas of increased permeability measured by the device corresponded to blood-brain barrier disruption and hemorrhage.

Technological Characteristics

Post-processing software application; operates on CT workstations. Features include 3D motion correction, automatic reference vessel detection, and ROI template display. Implements Patlak analysis for permeability. Complies with DICOM standards (NEMA PS 3.1-3.20). Software developed per IEC 62304; usability per IEC 62366-1.

Indications for Use

Indicated for use by trained professionals, including physicians and medical technicians, to assist in the evaluation of brain perfusion using dynamic/serial CT images acquired after contrast injection.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Brain Perfusion Option (K033677)
• Olea Sphere V3.0 (K152602)

Submission Summary (Full Text)

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Philips Medical Systems Nederland B.V. % Yoram Levy Qsite General Manager Osite 31 Haavoda St. BINY AMINA, ISRAEL 30500

May 29, 2019

# Re: K182716

Trade/Device Name: Brain Perfusion (BP) application Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK, LLZ Dated: April 9, 2019 Received: April 12, 2019

#### 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182716

Device Name Brain Perfusion (BP) application

#### Indications for Use (Describe)

The Philips Medical Systems' Brain Perfusion is a post processing software application intended to assist with the evaluation of an area of interest, to generate qualitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast agent, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images.

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

| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### K182716

# 510(K) SUMMARY

# K182716 Brain Perfusion (BP) application

| Date prepared: | May 23, 2019 |
|----------------|--------------|
|----------------|--------------|

# 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 | Anat Hersch<br>Regulatory Affairs Lead, ICAP<br>Philips Medical Systems Nederland B.V<br>[e-mail] |
| II. Device information | |
| Trade name: | Brain Perfusion (BP) application |
| Device Classification Name | Computed tomography x-ray system,<br>System |
| Device Class | Class II |
| Classification Panel | Radiology |
| Product Code | JAK, LLZ |
| Regulation Number | 21 CFR 892.1750 |
| Regulation Description | Computed tomography x-ray system |

# III. Device Description:

The Philips Medical Systems' Brain Perfusion (BP) application is a post processing software to be used as an advanced visualization application of CT brain perfusion images.

# 2-1 Brain Perfusion (BP) application– Traditional 510k Submission

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The BP application is used to support the analysis of dynamic and/or serial CT brain images after injection of contrast. The BP application is intended to assist with the evaluation of an area of interest, and to generate qualitative and quantitative information about changes in image intensity over time.

The BP application presents the results as a composite (single image that is calculated from a set of time course images at a single location) images and provides perfusion parameters maps. The following parameters related to brain perfusion are calculated: Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), local bolus timing (Time to Peak (TTP)) and Mean Transit Time (MTT) and supports processing and visualization of Permeability maps.

The physician retains the ultimate responsibility for making the final diagnosis.

# Key Features:

The Brain Perfusion (BP) application has the following key features:

- Support visualization and processing of dynamic and /or serial brain CT scans 1. with contrast agent injection.
- Display the results as composite (single image calculated from a dynamic set 2. of images at a single location) images (tMIP images).
- Display time-density curves reflecting the HU contrast enhancement tracked 3. for an ROI over time.
- Support detection of reference artery, reference vein, mirror line placement 4. and brain mask.
- Supported option for 3D motion correction with anatomical alignment. ട.
- Provide Perfusion maps of Cerebral Blood Volume (CBV), Mean Transit 6. Time (MTT), Cerebral Blood Flow (CBF) and Time to Peak (TTP)..
- Provide summary maps according to default thresholds. The user may 7. manually adjust the summary maps thresholds and/or different parameters according to the physician's preference.
- Provide colored warning strips (Traffic Lights), indicating the quality of the 8. Brain Perfusion data (acquisition).
- 9. Support processing and visualization of permeability maps
- 10. Display pre-defined ROI templates for localized quantitative evaluation of perfusion information.

#### 2-2

#### Brain Perfusion (BP) application– Traditional 510k Submission

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- 11. Support automatic workflow Brain Perfusion application can generate and send automatic results to defined external destination.
# IV. Intended use and Indications for use:

The Philips Medical Systems' Brain Perfusion (BP) application is a post processing software application intended to assist with the evaluation of an area of interest, to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast agent, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images.

# V. Predicate Devices:

The following table shows the predicate devices of proposed Philips Medical Systems Brain Perfusion (BP) application:

| | Device Name | Manufacturer | 510k No | Date of Clearance |
|----------------------|---------------------------|----------------------------|---------|-------------------|
| Primary<br>predicate | Brain Perfusion<br>Option | Philips Medical<br>Systems | K033677 | November 24, 2003 |
| Predicate | Olea Sphere V3.0 | Olea Medical | K152602 | March 3, 2016 |

The proposed Philips Medical Systems Brain Perfusion (BP) application and its predicate device, Brain Perfusion Option (K033677) are substantially equivalent in regards to their intended uses, clinical indications, principle of operation and fundamental technology principles.

# VI. Substantial Equivalence to Predicate Devices

| Feature | The proposed<br>device:<br>Brain Perfusion<br>(BP) Application | Primary<br>Predicate:<br>Philips Medical<br>Brain Perfusion<br>Option (K033677) | Predicate:<br>Olea Medical<br>Olea Sphere V3.0<br>(K152602) |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Computed | Computed | System, Image |
| Classification | tomography x-ray | tomography x-ray | processing, |
| Name | system, | system | Radiological |
| Feature | The proposed<br>device:<br>Brain Perfusion<br>(BP) Application | Primary<br>Predicate:<br>Philips Medical<br>Brain Perfusion<br>Option (K033677) | Predicate:<br>Olea Medical<br>Olea Sphere V3.0<br>(K152602) |
| | System, Image<br>processing,<br>Radiological | | |
| Device Class | Class II | Class II | Class II |
| Classification<br>Panel | Radiology | Radiology | Radiology |
| Product Code | JAK, LLZ | JAK | LLZ |
| Regulation<br>Description | Computed<br>tomography x-ray<br>system | Computed<br>tomography x-ray<br>system | Picture Archiving<br>and<br>communication<br>system |
| Regulation<br>Number | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.2050 |
| Indications for<br>Use | The Philips<br>Medical Systems'<br>Brain Perfusion<br>(BP) application is<br>a post processing<br>software<br>application<br>intended to assist<br>with the evaluation<br>of an area of<br>interest, to<br>generate<br>qualitative and<br>quantitative<br>information about<br>changes in image<br>intensity over<br>time. It supports<br>the analysis of<br>dynamic/serial CT<br>after injection of<br>contrast, by<br>calculating the<br>parameters related<br>to brain perfusion | The Philips<br>Medical Systems<br>CT Brain Perfusion<br>Option is intended<br>to assist the user by<br>providing a<br>diagnostic patient<br>imaging tool to be<br>included on a CT<br>workspace. It is<br>intended to assist<br>the user-selected<br>area of interest to<br>generate<br>qualitative and<br>quantitative<br>information about<br>changes in image<br>intensity over<br>time. It supports<br>the analysis of<br>dynamic/serial<br>CT after injection<br>of contrast, by<br>calculating the<br>parameters | Olea Sphere V3.0 is<br>an image<br>processing software<br>package to be used<br>by trained<br>professionals<br>including, but not<br>limited to,<br>Physicians and<br>medical technicians.<br>The software runs on<br>a standard "off-the-<br>shelf" workstation<br>and can be used to<br>perform image<br>viewing, processing,<br>image collage and<br>analysis of medical<br>images. Data and<br>images are acquired<br>through DICOM<br>compliant imaging<br>devices and<br>modalities. […]<br>The Dynamic<br>Analysis<br>Module is used for<br>visualization and<br>analysis of dynamic<br>imaging data |
| Feature | The proposed device:<br>Brain Perfusion<br>(BP) Application | Primary Predicate:<br>Philips Medical<br>Brain Perfusion<br>Option (K033677) | Predicate:<br>Olea Medical<br>Olea Sphere V3.0<br>(K152602) |
| | results as a<br>composite (single<br>image that is<br>calculated from a<br>set of time course<br>images at a single<br>location) images. | related to brain<br>perfusion and<br>displays the<br>results as a<br>composite (single<br>image that is<br>calculated from a<br>set of time course<br>images at a single<br>location) images.<br>This software runs<br>on the Philips<br>Medical Systems<br>Brilliance™<br>Workspace of a CT<br>System. | showing properties<br>of changes in<br>contrast while<br>repeating<br>acquisitions (e.g.,<br>over time with or<br>without variable<br>Acquisition<br>parameters) where<br>such techniques are<br>useful or necessary.<br>This functionality<br>is referred to as:<br>Perfusion Module –<br>the calculation of<br>parameters related<br>to tissue flow<br>(perfusion) and<br>tissue blood<br>volume.<br>Permeability<br>Module– the<br>calculation of<br>parameters related<br>to leakage of<br>injected contrast<br>material from<br>intravascular to<br>extracellular space.<br>Arterial Spin<br>Labeling (ASL)<br>Module – the<br>calculation of<br>parameters related to<br>tissue flow based on<br>a MR technique<br>using the water in<br>arterial blood as<br>endogenous tracer to<br>evaluate the<br>perfusion.<br>Relaxometry<br>module–the<br>calculation of<br>parameters related to |
| Feature | The proposed device: Brain Perfusion (BP) Application | Primary Predicate: Philips Medical Brain Perfusion Option (K033677) | Predicate: Olea Medical Olea Sphere V3.0 (K152602) |
| | | | the MR longitudinal and transversal relaxation time and rate.<br>Metabolic module- the calculation of parameters related to the fat fraction based on a MR technique using opposed-phase imaging. |
| Intended users | Trained professionals including but not limited to physicians and medical technicians | Trained professionals including but not limited to physicians and medical technicians | Trained professionals including but not limited to physicians and medical technicians |
| Intended Body part | Brain | Brain | Brain |
| Type of scans | CT perfusion scans | CT perfusion scans | The Dynamic Analysis and Perfusion is for CT Perfusion scans. |
| Automatic motion correction | Yes | Yes | Yes |
| CBV parametric map | Yes | Yes | Yes |
| CBF parametric map | Yes | Yes | Yes |
| MTT parametric map | Yes | Yes | Yes |
| Time to Peak Enhancement (TTP) | Yes | Yes | Yes |
| Feature | The proposed<br>device:<br>Brain Perfusion<br>(BP) Application | Primary<br>Predicate:<br>Philips Medical<br>Brain Perfusion<br>Option (K033677) | Predicate:<br>Olea Medical<br>Olea Sphere V3.0<br>(K152602) |
| Visualization<br>of permeability<br>imaging map | Yes | No | Yes |
| Support<br>detection of<br>reference<br>artery | Yes | No | Yes |
| Support<br>detection of<br>reference vein | Yes | No | Yes |
| Volume<br>calculation:<br>marking the<br>total volume of<br>affected tissue<br>(3D<br>measurements) | Yes | No | Yes |
| Region of<br>Interest | Yes<br>The user can select<br>and draw the<br>Region of Interest | Yes<br>The user can select<br>and draw the<br>Region of Interest | Yes<br>The user can select<br>and draw the Region<br>of Interest |
| Result | Display results in<br>tabular and<br>graphical format | Display results in<br>tabular and<br>graphical format | Display results in<br>tabular and graphical<br>format |
| Export image<br>Option | Yes | Yes | Yes |
| DICOM<br>format<br>communication | Yes | Yes | Yes |
| Support<br>automatic<br>workflow…