(244 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 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 provided document describes the Philips Medical Systems' Brain Perfusion (BP) application, a post-processing software for CT brain perfusion images. It aims to assist in evaluating areas of interest and generating qualitative and quantitative information about changes in image intensity over time, particularly for cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), time to peak (TTP), and permeability maps.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the performance evaluation of the device as follows:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Perfusion Parameters | Comparison with predicate device according to pre-set acceptance criteria (assessment of correlation and agreement according to regression analysis characteristics). | The performance of the perfusion parameters (CBF, CBV, MTT, TTP) implemented in the Brain Perfusion application has been demonstrated by meeting the acceptance criteria in comparison with the predicate device using a synthetic phantom. |
| Permeability Maps (Technical Validation) | Determine the appropriate permeability method (quantitative validation using synthetic simulated data). | Patlak analysis was found to be most appropriate and was implemented in the BP application for permeability maps. |
| Permeability Maps (Pre-clinical Validation) | Successful identification of regions of increased permeability that correspond to ground truth permeability markers on histology for imaging during occlusion and after reperfusion in rats. | The implemented permeability method has successfully identified regions of increased permeability that correspond to ground truth permeability markers on histology. External evaluations further demonstrated that areas of increased permeability measured in-vivo by imaging coincide with BBB disruption and hemorrhage area observed on gold standard histology. |
| User Needs and Intended Use Validation | Physicians evaluate whether features and workflows fulfill user needs and enable the intended use of the application, based on specific scores. | Based on scores provided by physicians, it has been established that the device meets the users' needs and fulfills its intended use. |
| Human Factors | Minimize use errors and reduce use-associated risks based on formative and summative usability validation testing and usability engineering file analysis. | The Brain Perfusion application was found to be safe and effective for the intended use, intended users, and intended use environments. |
Note: The document does not provide specific numerical thresholds or detailed statistical results for the "pre-set acceptance criteria" or "correlation and agreement according to regression analysis characteristics" beyond stating that the criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Perfusion Parameters (Comparison with Predicate): The test set for perfusion parameters involved a synthetic phantom. The sample size (number of phantom simulations or data points generated) is not specified. The data provenance is synthetic/simulated.
- Permeability Maps (Pre-clinical Validation): The test set involved rats imaged during occlusion and after reperfusion. The number of rats or cases is not specified. The data provenance is described as "in-vivo" (animal model).
- User Validation: "Physicians evaluated..." The number of physicians and cases used for this evaluation is not specified. Data provenance is implied to be from their evaluation of the device's features and workflows.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Perfusion Parameters (Synthetic Phantom): The ground truth for the synthetic phantom is inherent in its design and the known parameters it simulates. No external experts are mentioned for establishing ground truth for this segment.
- Permeability Maps (Pre-clinical Validation): Histology was used to determine the ground truth for the status of brain tissue and BBB permeability in rats. The number of experts interpreting the histology, or their qualifications, are not specified.
- User Validation: The ground truth is effectively the "user needs" and "intended use" as evaluated by "physicians." The number of physicians is not specified, nor are their specific qualifications (e.g., number of years of experience in radiology/neurology).
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (like 2+1, 3+1, etc.) for any of the test sets.
- For the perfusion parameters, it was a comparison against data from a synthetic phantom and the predicate device.
- For permeability maps, it was a comparison against histology as ground truth.
- For user validation, it was based on scores provided by physicians.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess the improvement of human readers with AI vs. without AI assistance. The performance evaluation focused on the device's standalone output and its comparison with a predicate device and ground truth.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done.
- The "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." This assesses the algorithm's performance in generating perfusion maps.
- "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... The implemented permeability method has successfully identified regions of increased permeability that correspond to ground truth permeability markers on histology." This assesses the algorithm's ability to calculate and identify permeability.
These evaluations focus on the algorithm's outputs and their accuracy against known values or ground truth, without a human-in-the-loop component.
7. Type of Ground Truth Used
- Perfusion Parameters: The ground truth was based on the known parameters of a synthetic phantom and comparison with the outputs of a predicate device.
- Permeability Maps: The ground truth was established using histology from rats.
- User Validation: The ground truth was implicit in the user needs and intended use, assessed by physicians' evaluations.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It primarily discusses the validation and verification processes.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for any potential training set was established. It focuses on the evaluation of the final product.
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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 (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) 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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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 4-65684 PC BestThe Netherlands |
| Establishment registration: | 3003768277 |
| Primary Contact person: | Yoram Levy, QsiteQA/RA Consultant31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837Fax (972)4-638-0510Yoram@qsitemed.com |
| Alternative contact person | Anat HerschRegulatory Affairs Lead, ICAPPhilips Medical Systems Nederland B.Vanat.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
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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).
-
- 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
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-
- 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 | |
|---|---|---|---|---|
| Primarypredicate | Brain PerfusionOption | Philips MedicalSystems | 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 proposeddevice:Brain Perfusion(BP) Application | PrimaryPredicate:Philips MedicalBrain PerfusionOption (K033677) | Predicate:Olea MedicalOlea Sphere V3.0(K152602) |
|---|---|---|---|
| Device | Computed | Computed | System, Image |
| Classification | tomography x-ray | tomography x-ray | processing, |
| Name | system, | system | Radiological |
| Feature | The proposeddevice:Brain Perfusion(BP) Application | PrimaryPredicate:Philips MedicalBrain PerfusionOption (K033677) | Predicate:Olea MedicalOlea Sphere V3.0(K152602) |
| System, Imageprocessing,Radiological | |||
| Device Class | Class II | Class II | Class II |
| ClassificationPanel | Radiology | Radiology | Radiology |
| Product Code | JAK, LLZ | JAK | LLZ |
| RegulationDescription | Computedtomography x-raysystem | Computedtomography x-raysystem | Picture Archivingandcommunicationsystem |
| RegulationNumber | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.2050 |
| Indications forUse | The PhilipsMedical Systems'Brain Perfusion(BP) application isa post processingsoftwareapplicationintended to assistwith the evaluationof an area ofinterest, togeneratequalitative andquantitativeinformation aboutchanges in imageintensity overtime. It supportsthe analysis ofdynamic/serial CTafter injection ofcontrast, bycalculating theparameters relatedto brain perfusion | The PhilipsMedical SystemsCT Brain PerfusionOption is intendedto assist the user byproviding adiagnostic patientimaging tool to beincluded on a CTworkspace. It isintended to assistthe user-selectedarea of interest togeneratequalitative andquantitativeinformation aboutchanges in imageintensity overtime. It supportsthe analysis ofdynamic/serialCT after injectionof contrast, bycalculating theparameters | Olea Sphere V3.0 isan imageprocessing softwarepackage to be usedby trainedprofessionalsincluding, but notlimited to,Physicians andmedical technicians.The software runs ona standard "off-the-shelf" workstationand can be used toperform imageviewing, processing,image collage andanalysis of medicalimages. Data andimages are acquiredthrough DICOMcompliant imagingdevices andmodalities. […]The DynamicAnalysisModule is used forvisualization andanalysis of dynamicimaging data |
| Feature | The proposed device:Brain Perfusion(BP) Application | Primary Predicate:Philips MedicalBrain PerfusionOption (K033677) | Predicate:Olea MedicalOlea Sphere V3.0(K152602) |
| results as acomposite (singleimage that iscalculated from aset of time courseimages at a singlelocation) images. | related to brainperfusion anddisplays theresults as acomposite (singleimage that iscalculated from aset of time courseimages at a singlelocation) images.This software runson the PhilipsMedical SystemsBrilliance™Workspace of a CTSystem. | showing propertiesof changes incontrast whilerepeatingacquisitions (e.g.,over time with orwithout variableAcquisitionparameters) wheresuch techniques areuseful or necessary.This functionalityis referred to as:Perfusion Module –the calculation ofparameters relatedto tissue flow(perfusion) andtissue bloodvolume.PermeabilityModule– thecalculation ofparameters relatedto leakage ofinjected contrastmaterial fromintravascular toextracellular space.Arterial SpinLabeling (ASL)Module – thecalculation ofparameters related totissue flow based ona MR techniqueusing the water inarterial blood asendogenous tracer toevaluate theperfusion.Relaxometrymodule–thecalculation ofparameters 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 proposeddevice:Brain Perfusion(BP) Application | PrimaryPredicate:Philips MedicalBrain PerfusionOption (K033677) | Predicate:Olea MedicalOlea Sphere V3.0(K152602) |
| Visualizationof permeabilityimaging map | Yes | No | Yes |
| Supportdetection ofreferenceartery | Yes | No | Yes |
| Supportdetection ofreference vein | Yes | No | Yes |
| Volumecalculation:marking thetotal volume ofaffected tissue(3Dmeasurements) | Yes | No | Yes |
| Region ofInterest | YesThe user can selectand draw theRegion of Interest | YesThe user can selectand draw theRegion of Interest | YesThe user can selectand draw the Regionof Interest |
| Result | Display results intabular andgraphical format | Display results intabular andgraphical format | Display results intabular and graphicalformat |
| Export imageOption | Yes | Yes | Yes |
| DICOMformatcommunication | Yes | Yes | Yes |
| Supportautomaticworkflow | Yes | No | Yes |
Brain Perfusion (BP) application– Traditional 510k Submission
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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).
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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
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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
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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
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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.
§ 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.