(432 days)
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.
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.
The provided document is a 510(k) summary for the Philips Medical Systems' Brain Perfusion (BP) application. It explicitly states that "Brain Perfusion (BP) application did not require clinical studies to support equivalence." Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance.
The document discusses non-clinical tests to demonstrate compliance with international and FDA-recognized consensus standards and internal Philips verification and validation processes. However, it does not provide specific acceptance criteria or detailed results of a study (clinical or non-clinical) proving device performance against such criteria.
Therefore, most of the requested information cannot be extracted from this document, as it focuses on demonstrating substantial equivalence through comparison to a predicate device and adherence to general engineering and quality standards, rather than direct performance metrics from a comparative or standalone study.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria for device performance or report specific performance metrics for the Brain Perfusion (BP) application. It states that "The test results in this 510(k) premarket notification demonstrates that Brain Perfusion (BP) application... Meets the acceptance criteria and is adequate for its intended use and specifications," but does not elaborate on what those criteria or results are.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No clinical test set or data provenance is mentioned as no clinical studies were performed. Non-clinical tests are mentioned, but details on the "test set" (e.g., number of test cases, type of data used for verification) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. No clinical studies or use of experts for ground truth establishment are detailed in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No details on clinical test sets or adjudication methods are present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. The document explicitly states that clinical studies were not required. Therefore, no MRMC study, or any information on human reader improvement with or without AI assistance, is included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. While "non-clinical performance testing" and "verification and validation processes" are mentioned for the software, the document does not detail specific "standalone" performance studies, or quantify the algorithm's performance on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. As no clinical studies or ground truth establishment process is described for evaluating the device's performance against medical conditions.
8. The sample size for the training set
- Cannot be provided. The document describes a post-processing software application but does not mention any machine learning components that would require a "training set."
9. How the ground truth for the training set was established
- Cannot be provided. As no training set is mentioned.
Summary from the provided document:
The Philips Medical Systems' Brain Perfusion (BP) application is a post-processing software intended to assist with the evaluation of an area of interest by calculating parameters related to brain perfusion from dynamic/serial CT scans.
Key takeaway regarding performance studies:
The document explicitly states: "The subject of this premarket submission, Brain Perfusion (BP) application did not require clinical studies to support equivalence."
Instead of clinical studies, the submission relies on:
- Substantial equivalence to a predicate device (Philips Medical Systems' Brain Perfusion Application, K182716).
- Non-clinical performance testing to demonstrate compliance with international and FDA-recognized consensus standards (ISO 14971, IEC 62304, NEMA PS 3.1-3.20, IEC 62366-1) and internal Philips verification and validation processes. The document asserts that these tests demonstrated the device "Meets the acceptance criteria and is adequate for its intended use and specifications," and "meets all defined functionality requirements and performance claims." However, specific criteria and quantitative results are not provided in this summary.
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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
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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/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
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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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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 4-65684 PC BestThe Netherlands |
| Establishment registration: | 3003768277 |
| Primary Contact person: | Yoram Levy, QsiteQA/RA Consultant31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837;Fax (972)4-638-0510Yoram@qsitemed.com |
| Alternative contact person | Ms. Vered NitzanRegulatory Affairs Lead, ICAPPhilips Medical Systems Nederland B.VPhone: (972)54-9797047E-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 |
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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
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-
- 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 ofClearance | |
|---|---|---|---|---|
| Primarypredicate | Brain Perfusion Application | Philips MedicalSystems | K182716 | May 29, 2019 |
| Referencedevice | CARESTREAM Vue PACS | CARESTREAMHEALTH, INC. | K153103 | February 12, 2019 |
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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 proposeddevice:Brain Perfusion(BP) Application | Primary Predicate:PhilipsBrain PerfusionApplication(K182716) | Reference Predicate:CARESTREAMVue 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 |
| ClassificationPanel | Radiology | Radiology | Radiology |
| Product Code | JAK, LLZ | JAK, LLZ | LLZ |
| RegulationDescription | Computedtomography x-raysystem | Computedtomography x-raysystem | Picture Archiving andcommunication system |
| RegulationNumber | 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 proposeddevice:Brain Perfusion(BP) Application | Primary Predicate:PhilipsBrain PerfusionApplication(K182716) | Reference Predicate:CARESTREAMVue PACS(K153103) |
| evaluation of anarea of interest,to generatequalitative andquantitativeinformationabout changes inimage intensityover time. Itsupports theanalysis ofdynamic/serialCT after injectionof contrast, bycalculating theparametersrelated to brainperfusion anddisplays theresults as acomposite (singleimage that iscalculated from aset of time courseimages at a singlelocation) images. | evaluation of anarea of interest, togeneratequalitative andquantitativeinformationabout changes inimage intensityover time. Itsupports theanalysis ofdynamic/serialCT after injectionof contrast, bycalculating theparametersrelated to brainperfusion anddisplays theresults as acomposite (singleimage that iscalculated from aset of time courseimages at a singlelocation) images. | interactive tools toease the process ofanalyzing andcomparingComputedTomographyPerfusion (CTP)images of adultpatients. | |
| Intended users | Trainedprofessionalsincluding but notlimited tophysicians andmedicaltechnicians. | Trainedprofessionalsincluding but notlimited tophysicians andmedicaltechnicians. | Trainedprofessionalsincluding but notlimited to physiciansand medicaltechnicians. |
| Intended Bodypart | Brain | Brain | Brain |
| Feature | The proposeddevice:Brain Perfusion(BP) Application | Primary Predicate:PhilipsBrain PerfusionApplication(K182716) | Reference Predicate:CARESTREAMVue PACS(K153103) |
| Type of scans | CT perfusionscans | CT perfusionscans | CT Perfusion(CTP) |
| Automaticmotioncorrection | Yes | Yes | Yes |
| CBV parametricmap | Yes | Yes | Yes |
| CBF parametricmap | Yes | Yes | Yes |
| MTTparametric map | Yes | Yes | Yes |
| Tmaxparametric map | Yes | No | Yes |
| Methods usedfor providingperfusion maps | Time arrivalsensitive methodand time arrivalinsensitive method | Time arrivalsensitive method | Time arrivalsensitive methodand insensitivemethod |
| Time to PeakEnhancement(TTP) | Yes | Yes | Yes |
| Visualization ofpermeabilityimaging map | Yes | Yes | Yes |
| Supportdetection ofreference artery | Yes | Yes | Yes |
| Supportdetection ofreference vein | Yes | Yes | Yes |
| Feature | The proposed device:Brain Perfusion(BP) Application | Primary Predicate:Philips Brain PerfusionApplication(K182716) | Reference Predicate:CARESTREAM Vue PACS(K153103) |
| Region of Interest | YesThe user can selectand draw theRegion of Interest | YesThe user can selectand draw theRegion of Interest | YesDisplay results intabular and graphicalformat |
| Result | Display results intabular and graphicalformat | Display results intabular and graphicalformat | Display results intabular and graphicalformat |
| 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
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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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- 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.
§ 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).