(432 days)
No
The description focuses on standard image processing techniques for calculating perfusion parameters and does not mention AI or ML.
No.
The device is a post-processing software application designed to assist with the evaluation of brain perfusion by analyzing CT images; it does not directly provide therapy or treatment.
Yes
The device is explicitly described as "intended to assist with the evaluation of an area of interest" and to generate information for "calculating the parameters related to brain perfusion," which directly supports making a diagnosis, even though it states the physician retains ultimate responsibility.
Yes
The device is described as a "post processing software application" and "advanced visualization application" that analyzes existing CT images. There is no mention of any accompanying hardware or hardware components being part of 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 from the patient's body. It analyzes changes in image intensity over time after contrast injection to provide information about brain perfusion.
- No Sample Analysis: The device does not analyze biological samples taken from the patient. It analyzes data derived from the patient's body through imaging.
Therefore, while it's a medical device used for diagnosis, it falls under the category of medical imaging software rather than 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 relate to brain perfusion are calculated: Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), local bolus timing (Time to Peak (TTP)/Time to Maximum (Tmax)) 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 2. images at a single location) images (tMIP images).
- Display time-density curves reflecting the HU contrast enhancement tracked for 3. an ROI over time.
- Supports detection of reference artery, reference vein, mirror line placement and 4. brain mask.
-
- Supported option for 3D motion correction with anatomical alignment.
- Provides Perfusion maps of Cerebral Blood Volume (CBV), Mean Transit Time 6. (MTT), Cerebral Blood Flow (CBF) and Time to Peak (TTP), using the time arrival sensitive method.
-
- Provide Perfusion maps of Time to maximum (Tmax), using the time arrival insensitive method.
- Provides summary maps according to default thresholds. The user may manually 8. adjust the summary maps thresholds and/or different parameters according to the physician's preference.
- Provides colored warning strips (Traffic Lights), indicating the quality of the Brain 9. Perfusion data (acquisition).
-
- Supports processing and visualization of permeability maps
-
- Display pre-defined ROI templates for localized quantitative evaluation of perfusion information.
-
- Supports automatic workflow Brain Perfusion can generate and sends automatic results to defined external destination.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
dynamic/serial CT after injection of contrast agent
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)
Non-clinical performance testing has been performed on Brain Perfusion (BP) application and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 14971 Medical devices Application of risk management to medical devices
- IEC 62304 Medical device software Software life cycle processes
- 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
Philips Medical Systems Brain Perfusion (BP) application was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The test results 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 document, and
- . Meets the acceptance criteria and is adequate for its intended use and specifications.
The subject of this premarket submission, Brain Perfusion (BP) application did not require clinical studies to support equivalence.
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.
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
§ 892.2050 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).
0
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Philips Medical Systems Nederland B.V. % Yoram Levy Qsite General Manager Osite 31 Haavoda St. Binyamina, 30500 ISRAEL
Re: K201573
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: July 9, 2021 Received: July 13, 2021
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
August 17, 2021
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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) K201573
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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Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is a plain white, which makes the blue letters stand out prominently. The font appears to be sans-serif.
510(K) SUMMARY
Brain Perfusion (BP) application
Date prepared: July 4, 2021
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 | Ms. Vered Nitzan |
| Regulatory Affairs Lead, ICAP | |
| Philips Medical Systems Nederland B.V | |
| Phone: (972)54-9797047 | |
| E-mail: vered.nitzan@philips.com |
II. Device information
| Trade name: | Brain Perfusion (BP) application |
|---|---|
| Device Classification Name | Computed tomography x-ray system |
| Device Class | Class II |
| Classification Panel | JAK, LLZ |
| Product Code | Radiological Image Processing Software |
| Regulation Description | 21 CFR 892.1750 |
4
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.
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 relate to brain perfusion are calculated: Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), local bolus timing (Time to Peak (TTP)/Time to Maximum (Tmax)) 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 2. images at a single location) images (tMIP images).
- Display time-density curves reflecting the HU contrast enhancement tracked for 3. an ROI over time.
- Supports detection of reference artery, reference vein, mirror line placement and 4. brain mask.
-
- Supported option for 3D motion correction with anatomical alignment.
- Provides Perfusion maps of Cerebral Blood Volume (CBV), Mean Transit Time 6. (MTT), Cerebral Blood Flow (CBF) and Time to Peak (TTP), using the time arrival sensitive method.
2-2 Brain Perfusion (BP) application– Traditional 510k Submission
5
-
- Provide Perfusion maps of Time to maximum (Tmax), using the time arrival insensitive method.
- Provides summary maps according to default thresholds. The user may manually 8. adjust the summary maps thresholds and/or different parameters according to the physician's preference.
- Provides colored warning strips (Traffic Lights), indicating the quality of the Brain 9. Perfusion data (acquisition).
-
- Supports processing and visualization of permeability maps
-
- Display pre-defined ROI templates for localized quantitative evaluation of perfusion information.
-
- Supports automatic workflow Brain Perfusion can generate and sends 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 and reference devices of the proposed Philips Medical Systems Brain Perfusion (BP) application:
| | Device Name | Manufacturer | 510k No | Date of
Clearance |
|----------------------|-----------------------------|----------------------------|---------|----------------------|
| Primary
predicate | Brain Perfusion Application | Philips Medical
Systems | K182716 | May 29, 2019 |
| Reference
device | CARESTREAM Vue PACS | CARESTREAM
HEALTH, INC. | K153103 | February 12, 2019 |
6
The proposed Philips Medical Systems Brain Perfusion (BP) application and its predicate device, Brain Perfusion Application (K182716), are substantially equivalent in regards to their intended uses, clinical indications, principle of operation and fundamental technology principles. In addition to the predicate device, Philips identified the following currently marketed device, as a reference device of the proposed Brain Perfusion Application: CARESTREAM Vue PACS (K153103). The latter utilizes the added functionality which is the subject of this submission.
| Feature | The proposed
device:
Brain Perfusion
(BP) Application | Primary Predicate:
Philips
Brain Perfusion
Application
(K182716) | Reference Predicate:
CARESTREAM
Vue PACS
(K153103) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | System, Image | System, Image | System, Image |
| Classification | processing, | processing, | processing, |
| Name | Radiological | Radiological | Radiological |
| Device Class | Class II | Class II | Class II |
| Classification
Panel | Radiology | Radiology | Radiology |
| Product Code | JAK, LLZ | JAK, LLZ | 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 |
| Indication for | The Philips | The Philips | The |
| Use | Medical Systems' | Medical Systems' | CARESTREAM |
| | Brain Perfusion | Brain Perfusion | Vue PACS is an |
| | (BP) application is | (BP) application is | image |
| | a post processing | a post processing | management |
| | software | software | system. |
| | application | application | The system |
| | intended to assist | intended to assist | contains a Perfusion |
| | with the | with the | module with |
| Feature | The proposed
device:
Brain Perfusion
(BP) Application | Primary Predicate:
Philips
Brain Perfusion
Application
(K182716) | Reference Predicate:
CARESTREAM
Vue PACS
(K153103) |
| | 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 and
displays the
results as a
composite (single
image that is
calculated from a
set of time course
images at a single
location) images. | 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 and
displays the
results as a
composite (single
image that is
calculated from a
set of time course
images at a single
location) images. | interactive tools to
ease the process of
analyzing and
comparing
Computed
Tomography
Perfusion (CTP)
images of adult
patients. |
| 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 |
| Feature | The proposed
device:
Brain Perfusion
(BP) Application | Primary Predicate:
Philips
Brain Perfusion
Application
(K182716) | Reference Predicate:
CARESTREAM
Vue PACS
(K153103) |
| Type of scans | CT perfusion
scans | CT perfusion
scans | CT Perfusion
(CTP) |
| Automatic
motion
correction | Yes | Yes | Yes |
| CBV parametric
map | Yes | Yes | Yes |
| CBF parametric
map | Yes | Yes | Yes |
| MTT
parametric map | Yes | Yes | Yes |
| Tmax
parametric map | Yes | No | Yes |
| Methods used
for providing
perfusion maps | Time arrival
sensitive method
and time arrival
insensitive method | Time arrival
sensitive method | Time arrival
sensitive method
and insensitive
method |
| Time to Peak
Enhancement
(TTP) | Yes | Yes | Yes |
| Visualization of
permeability
imaging map | Yes | Yes | Yes |
| Support
detection of
reference artery | Yes | Yes | Yes |
| Support
detection of
reference vein | Yes | Yes | Yes |
| Feature | The proposed device:
Brain Perfusion
(BP) Application | Primary Predicate:
Philips Brain Perfusion
Application
(K182716) | Reference Predicate:
CARESTREAM Vue PACS
(K153103) |
| 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
Display results in
tabular and graphical
format |
| 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 | Yes | Yes |
VI. Substantial Equivalence to Predicate Devices
Brain Perfusion (BP) application– Traditional 510k Submission
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Brain Perfusion (BP) application– Traditional 510k Submission
8
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The proposed Philips Medical Systems Brain Perfusion (BP) application and its predicate devices, the primary Brain Perfusion (BP) application (K182716) is 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 (BP) application (K182716).
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 FDA-recognized consensus standards and FDA guidance document:
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Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. The overall impression is clean and professional, reflecting the brand's image.
- 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
Philips Medical Systems Brain Perfusion (BP) application was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The test results 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 document, and
- . Meets the acceptance criteria and is adequate for its intended use and specifications.
VIII. Brief discussion of clinical tests submitted, referenced or relied on
The subject of this premarket submission, Brain Perfusion (BP) application did not require clinical studies to support equivalence.
IX. The conclusions drawn from the nonclinical and clinical tests
Verification and Validation (V&V) activities required to establish performance and functionality of Brain Perfusion (BP) application were performed. Testing performed demonstrated the Brain Perfusion (BP) application meets all defined functionality requirements and performance claims.
X. Overall conclusion:
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The Brain Perfusion (BP) application is substantially equivalent to the identified predicate device, Brain Perfusion (BP) application (K182716) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, verification and validation testing demonstrate the safety and efficacy of the device to meet its intended use and specifications.
Philips Medical believes that the proposed device, Brain Perfusion (BP) application, is substantially equivalent to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.