(244 days)
Not Found
No
The description focuses on standard image processing techniques for calculating perfusion parameters (CBF, CBV, TTP, MTT) and permeability maps based on dynamic CT data. There is no mention of AI, ML, or related concepts like training or test sets for model development.
No
The device is a post-processing software application for analyzing CT brain perfusion images, providing diagnostic information rather than directly treating or mitigating a disease or condition.
Yes
The device aids in the evaluation of an area of interest by providing quantitative information (e.g., Cerebral Blood Flow, Cerebral Blood Volume) and displaying results as composite images, which assists trained professionals in diagnosing conditions related to brain perfusion.
Yes
The device is described as a "post processing software application" and "advanced visualization application" that operates on existing CT brain perfusion images. The description focuses solely on the software's functions (calculation of parameters, display of results) and does not mention any associated hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Philips Medical Systems' Brain Perfusion software processes medical images (CT scans) taken of the body (specifically the brain) to provide information about blood flow and volume. It does not analyze samples from the body.
- Intended Use: The intended use clearly states it's a "post processing software application intended to assist with the evaluation of an area of interest... after injection of contrast agent." This describes image analysis, not laboratory testing of biological samples.
Therefore, this device falls under the category of medical imaging software or image processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
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.
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 with contrast agent injection.
- Display the results as composite (single image calculated from a dynamic set of images at a single location) images (tMIP images).
- Display time-density curves reflecting the HU contrast enhancement tracked for an ROI over time.
- Support detection of reference artery, reference vein, mirror line placement and brain mask.
- Supported option for 3D motion correction with anatomical alignment.
- Provide Perfusion maps of Cerebral Blood Volume (CBV), Mean Transit Time (MTT), Cerebral Blood Flow (CBF) and Time to Peak (TTP)..
- Provide summary maps according to default thresholds. The user may 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 Brain Perfusion data (acquisition).
- Support processing and visualization of permeability maps
- Display pre-defined ROI templates for localized quantitative evaluation of perfusion information.
- Support automatic workflow Brain Perfusion application can generate and send automatic results to defined external destination.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals including but not limited to physicians and medical technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance evaluation testing was conducted in order to validate the proper function of the perfusion and permeability parametric maps. The subject device's perfusion parameters performance was evaluated in comparison with the predicate device according to pre-set acceptance criteria (assessment of correlation and agreement according to regression analysis characteristics). The perfusion parameters values were generated by utilizing a synthetic phantom. The performance of the perfusion parameters implemented in Brain Perfusion application has been demonstrated by meeting the acceptance criteria.
Internal performance evaluation of the Permeability maps calculation was conducted in two phases. In the technical validation, a quantitative validation using synthetic simulated data was performed in order to determine the appropriate permeability method. The Patlak analysis that was found to be most appropriate, was implemented in BP application for permeability maps. In the pre-clinical validation performed on rats, imaging during occlusion and after reperfusion were acquired. Histology was used to determine a ground truth for the status of the brain tissue and the BBB permeability. The images were compared to the histology and analyzed comparing the results of different methods. The implemented permeability method has successfully identified regions of increased permeability that correspond to ground truth permeability markers on histology. In external performance evaluations of the Permeability maps additional statistical analysis further demonstrated that areas of increased permeability measured in-vivo by imaging coincide with BBB disruption and hemorrhage area observed on gold standard histology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
| 5684 PC Best | |
| The Netherlands | |
| Establishment registration: | 3003768277 |
| Primary Contact person: | Yoram Levy, Qsite |
| QA/RA Consultant | |
| 31 Haavoda Street | |
| Binyamina, Israel 30500 | |
| Tel (972)4-638-8837 | |
| Fax (972)4-638-0510 | |
| Yoram@qsitemed.com | |
| Alternative contact person | Anat Hersch |
| Regulatory Affairs Lead, ICAP | |
| Philips Medical Systems Nederland B.V | |
| anat.hersch@philips.com | |
| II. Device information | |
| Trade name: | Brain Perfusion (BP) application |
| Device Classification Name | Computed tomography x-ray system, |
| 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
4
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).
-
- Support processing and visualization of permeability maps
-
- Display pre-defined ROI templates for localized quantitative evaluation of perfusion information.
2-2
Brain Perfusion (BP) application– Traditional 510k Submission
5
-
- 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 | ||||
| predicate | Brain Perfusion | |||
| Option | Philips Medical | |||
| 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
device:
Brain Perfusion
(BP) Application | Primary
Predicate:
Philips Medical
Brain Perfusion
Option (K033677) | Predicate:
Olea Medical
Olea Sphere V3.0
(K152602) |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Computed | Computed | System, Image |
| Classification | tomography x-ray | tomography x-ray | processing, |
| Name | system, | system | Radiological |
| Feature | The proposed
device:
Brain Perfusion
(BP) Application | Primary
Predicate:
Philips Medical
Brain Perfusion
Option (K033677) | Predicate:
Olea Medical
Olea Sphere V3.0
(K152602) |
| | System, Image
processing,
Radiological | | |
| Device Class | Class II | Class II | Class II |
| Classification
Panel | Radiology | Radiology | Radiology |
| Product Code | JAK, LLZ | JAK | LLZ |
| Regulation
Description | Computed
tomography x-ray
system | Computed
tomography x-ray
system | Picture Archiving
and
communication
system |
| Regulation
Number | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.2050 |
| 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, by
calculating the
parameters related
to brain perfusion | The Philips
Medical Systems
CT Brain Perfusion
Option is intended
to assist the user by
providing a
diagnostic patient
imaging tool to be
included on a CT
workspace. It is
intended to assist
the user-selected
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, by
calculating the
parameters | Olea Sphere V3.0 is
an image
processing software
package to be used
by trained
professionals
including, but not
limited to,
Physicians and
medical technicians.
The software runs on
a standard "off-the-
shelf" workstation
and can be used to
perform image
viewing, processing,
image collage and
analysis of medical
images. Data and
images are acquired
through DICOM
compliant imaging
devices and
modalities. […]
The Dynamic
Analysis
Module is used for
visualization and
analysis of dynamic
imaging data |
| Feature | The proposed device:
Brain Perfusion
(BP) Application | Primary Predicate:
Philips Medical
Brain Perfusion
Option (K033677) | Predicate:
Olea Medical
Olea Sphere V3.0
(K152602) |
| | results as a
composite (single
image that is
calculated from a
set of time course
images at a single
location) images. | 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.
This software runs
on the Philips
Medical Systems
Brilliance™
Workspace of a CT
System. | showing properties
of changes in
contrast while
repeating
acquisitions (e.g.,
over time with or
without variable
Acquisition
parameters) where
such techniques are
useful or necessary.
This functionality
is referred to as:
Perfusion Module –
the calculation of
parameters related
to tissue flow
(perfusion) and
tissue blood
volume.
Permeability
Module– the
calculation of
parameters related
to leakage of
injected contrast
material from
intravascular to
extracellular space.
Arterial Spin
Labeling (ASL)
Module – the
calculation of
parameters related to
tissue flow based on
a MR technique
using the water in
arterial blood as
endogenous tracer to
evaluate the
perfusion.
Relaxometry
module–the
calculation of
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.
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
device:
Brain Perfusion
(BP) Application | Primary
Predicate:
Philips Medical
Brain Perfusion
Option (K033677) | Predicate:
Olea Medical
Olea Sphere V3.0
(K152602) |
| Visualization
of permeability
imaging map | Yes | No | Yes |
| Support
detection of
reference
artery | Yes | No | Yes |
| Support
detection of
reference vein | Yes | No | Yes |
| Volume
calculation:
marking the
total volume of
affected tissue
(3D
measurements) | Yes | No | Yes |
| Region of
Interest | Yes
The user can select
and draw the
Region of Interest | Yes
The user can select
and draw the
Region of Interest | Yes
The user can select
and draw the Region
of Interest |
| Result | Display results in
tabular and
graphical format | Display results in
tabular and
graphical format | Display results in
tabular and graphical
format |
| Export image
Option | Yes | Yes | Yes |
| DICOM
format
communication | Yes | Yes | Yes |
| Support
automatic
workflow | Yes | No | Yes |
Brain Perfusion (BP) application– Traditional 510k Submission
6
7
8
9
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.
In conclusion, Philips believes that the Brain Perfusion (BP) application does not introduce any new potential safety and/or effectiveness issues and is substantially equivalent to the identified predicate device, Brain Perfusion Option (K033677).
10
VII. Brief discussion of the nonclinical tests submitted, referenced or relied on
Non-clinical performance testing has been performed on Brain Perfusion (BP) application and demonstrates compliance with the following International and FDArecognized 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
- NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Standard
- 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
- Guidance for Industry and FDA Staff Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Philips Medical Systems Brain Perfusion (BP) application was developed and tested in accordance with Philips design control measures including risk management, design review, performance evaluation, verification and validation processes.
Risk Management
Risk management activities were performed to identify, control, and monitor the hazards and hazardous situations related to the Brain Perfusion application and its intended use. Each risk has been individually assessed, and risk control measures were implemented in the product. Every risk has been reduced as far as possible and has been evaluated to have a probability of occurrence of harm of unexpected or inconceivable. It was concluded that the BP application is safe, and that the risks associated with its intended use constitute acceptable risks when weighed against the medical benefit.
Verification
11
Philips Medical Systems Brain Perfusion (BP) application verification was intended to ensure that the software fully satisfies the product requirements. Test cases were executed to verify product requirements and risk management mitigations. Design verification established the conformance of the design output to the design input requirements.
Performance Evaluation
Performance evaluation testing was conducted in order to validate the proper function of the perfusion and permeability parametric maps. The subject device's perfusion parameters performance was evaluated in comparison with the predicate device according to pre-set acceptance criteria (assessment of correlation and agreement according to regression analysis characteristics). The perfusion parameters values were generated by utilizing a synthetic phantom. The performance of the perfusion parameters implemented in Brain Perfusion application has been demonstrated by meeting the acceptance criteria.
Internal performance evaluation of the Permeability maps calculation was conducted in two phases. In the technical validation, a quantitative validation using synthetic simulated data was performed in order to determine the appropriate permeability method. The Patlak analysis that was found to be most appropriate, was implemented in BP application for permeability maps. In the pre-clinical validation performed on rats, imaging during occlusion and after reperfusion were acquired. Histology was used to determine a ground truth for the status of the brain tissue and the BBB permeability. The images were compared to the histology and analyzed comparing the results of different methods. The implemented permeability method has successfully identified regions of increased permeability that correspond to ground truth permeability markers on histology. In external performance evaluations of the Permeability maps additional statistical analysis further demonstrated that areas of increased permeability measured in-vivo by imaging coincide with BBB disruption and hemorrhage area observed on gold standard histology.
Validation
Philips Medical Systems Brain Perfusion (BP) application was intended to ensure that the software conforms to its intended use and user needs. During the
12
validation of Brain Perfusion application, physicians evaluated if the features and the workflows fulfills the user needs and enables the intended use of the application. Based on the scores provided by the physicians, it has been established that the device meets the users' needs and fulfils its intended use.
Human Factors
Philips Medical Systems Brain Perfusion (BP) application human factors validation activities was intended to minimize use errors and thereby reduce use-associated risks. Formative and Summative usability validation testing and the final usability engineering file analysis have found the Brain Perfusion application to be safe and effective for the intended use, intended users and the intended use environments.
Cybersecurity
The Brain Perfusion Application follows internal documentation on Cybersecurity which includes the information based on the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Non clinical Test Conclusion
The test results and design control activities described in this 510(k) premarket notification demonstrates that Brain Perfusion (BP) application:
- . Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and
- . Meets the acceptance criteria and is adequate for its intended use, users and specifications.
VIII. Brief discussion of clinical tests submitted, referenced or relied on
The subject of this premarket submission, Brain Perfusion (BP) application does not require clinical studies to support equivalence.
IX. The conclusions drawn from the nonclinical and clinical tests
Performance testing, verification and validation (V&V) activities required to establish performance and functionality of Brain Perfusion (BP) application
2-10 Brain Perfusion (BP) application– Traditional 510k Submission
13
were performed. Testing performed demonstrated the Brain Perfusion (BP) application meets all defined functionality requirements and performance.
X. Overall conclusion:
The Brain Perfusion (BP) application is substantially equivalent to the identified predicate device, Brain Perfusion Option (K033677) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Performance testing, verification and validation testing demonstrate that the device meets its intended use and specifications and is safe and effective.
Philips Medical believes that the proposed device, Brain Perfusion (BP) application, is substantially equivalent to its identified predicate device and is as safe and effective as its predicate device without raising different questions of safety and/or effectiveness.