SmartPerfusion
Device Facts
| Record ID | K181966 |
|---|---|
| Device Name | SmartPerfusion |
| Applicant | Philips Medical Systems Nederlands B.V. |
| Product Code | OWB · Radiology |
| Decision Date | Aug 17, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric |
Indications for Use
SmartPerfusion assists in the diagnosis of perfusion of tissues based on digital subtraction angiography (DSA) and can be used for any location in the body where DSA is used.
Device Story
SmartPerfusion is a software accessory for Philips Interventional X-ray systems; it processes digital subtraction angiography (DSA) image inputs to generate color-coded functional maps of tissue perfusion. The device calculates parameters based on time-density functions, including arrival time, time to peak, wash-in/wash-out rates, area under the curve, mean transit time, and peak density. Used in interventional suites or operating rooms by physicians (radiologists, cardiologists, surgeons) or technicians, it provides side-by-side comparisons of pre-, peri-, and post-procedural images. The software assists clinicians in visualizing perfusion changes; it does not contact the patient. It includes workflow enhancements like auto-recall of X-ray view orientations, catheter position recall, and configurable ROI tools. The output supports clinical assessment of perfusion; it is not intended for automated clinical decision-making.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical performance testing, including software verification and validation, usability engineering, and risk management assessments. Testing confirmed the device meets pre-determined specifications and conforms to recognized consensus standards (IEC 62304, IEC 62366-1, ISO 14971).
Technological Characteristics
Software-based interventional tool; runs on Interventional Workspot platform. Inputs: DSA X-ray images. Outputs: Color-coded functional perfusion maps and quantitative parameters. Connectivity: DICOM-compliant. Software architecture optimized for memory efficiency and reduced launch time. Features include manual/automatic ROI, table-side touch screen interaction, and image recall functionality.
Indications for Use
Indicated for the entire human population to assist in the diagnosis of tissue perfusion alterations using digital subtraction angiography (DSA) in any body location.
Regulatory Classification
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- 2D Perfusion (K132147)
Reference Devices
- Philips Allura Interventional X-ray system (K172822)
- Philips Azurion Interventional X-ray system (K162859)
- Interventional Workspot (K181177)
Submission Summary (Full Text)
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August 17, 2018
Philips Medical Systems Nederland B.V. % Chandrika Srinivasan Senior Regulatory Affairs Specialist Veenpluis 4-6 5684 PC Best THE NETHERLANDS
Re: K181966
Trade/Device Name: SmartPerfusion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Codes: OWB, LLZ Dated: July 20, 2018 Received: July 23, 2018
Dear Chandrika Srinivasan:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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,
Hsl. 2. Nils
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K181966
Device Name SmartPerfusion
#### Indications for Use (Describe)
SmartPerfusion assists in the diagnosis of perfusion of tissues based on digital subtraction angiography (DSA) and can be used for any location in the body where DSA is used.
| Type of Use (Select one or both, as applicable) |
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| <span style="font-size:12px"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
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| <span style="font-size:12px"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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# 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | Aug 14, 2018 | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 | |
| Primary Contact<br>Person: | Chandrika Srinivasan<br>Regulatory Affairs Officer<br>Phone: +9180 41894132<br>E-mail: chandrika.s@philips.com | |
| Secondary Contact<br>Person: | Marta Walker<br>Head of Regulatory Affairs IGT Systems<br>Phone: +31 631978546<br>E-mail: marta.walker@philips.com | |
| Device: | Trade Name: | SmartPerfusion |
| | Release Number: | Release 1.0 |
| | Classification Name: | Image intensified fluroscopic x-ray system |
| | Classification Regulation: | 21 CFR, Part 892.1650 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Primary Product Code:<br>Secondary Product Code: | OWB (Interventional Fluoroscopic X-Ray system)<br>LLZ (System, Image Processing, Radiological) |
| Predicate Device: | Trade Name: | 2D Perfusion |
| | Manufacturer: | Philips Medical Systems Nederland B.V |
| | 510(k) Clearance: | K132147 (Dec 16, 2013) |
| | Classification Name: | Image intensified fluroscopic x-ray system |
| | Classification Regulation: | 21 CFR, Part 892.1650 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Primary Product Code:<br>Secondary Product Code: | OWB (Interventional Fluoroscopic X-Ray system)<br>LLZ (System, Image Processing, Radiological) |
| Device description: | SmartPerfusion is a software product (Interventional Tool) that provides<br>color coded representation of a digital subtraction angiography (DSA). It<br>can visualize multiple functional parameters related to the time density<br>function. It also provides a comparison between pre-, peri-, and post-<br>procedural color coded images.<br>SmartPerfusion is provided as an accessory to the Philips Interventional<br>X-ray system. | |
| Indications for Use: | SmartPerfusion assists in the diagnosis of perfusion alterations of tissues<br>based on digital subtraction angiography (DSA) and can be used for any<br>location in the body where DSA is used. | |
| Patient Population | SmartPerfusion is suitable for use with the entire human population. | |
| Intended Operator<br>Profile | The Operator is a physician or other qualified healthcare professional<br>who is fully skilled and responsible for sound clinical judgment and for<br>applying the best clinical procedure, for example:<br>Interventional radiologist Interventional neuro-radiologist Vascular surgeon and Podiatrists Interventional Cardiologist Skilled radiology technician (or nurse) assisting the physician Oncologist | |
| General safety and<br>effectiveness | To facilitate safe and efficacious operation of the system by a trained<br>healthcare professional, instructions for use are provided as part of the<br>device labeling, as well as training at system handover. | |
| Clinical<br>Environment: | SmartPerfusion can be used in the control room and in the exam room of<br>an interventional suite or operating room.<br>SmartPerfusion is a software application and does not come in contact<br>with the patient. | |
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| Predicate device<br>2D Perfusion (K132147) | Proposed device<br>SmartPerfusion | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2D Perfusion assists in the<br>diagnosis of perfusion<br>alterations of tissues, based<br>on digital subtraction<br>angiography (DSA) by<br>providing color coded<br>images generated from the<br>DSA series. | SmartPerfusion assists in the<br>diagnosis of perfusion<br>alterations of tissues based<br>on digital subtraction<br>angiography (DSA) and can<br>be used for any location in<br>the body where DSA is<br>used. | Identical,<br>Substantially<br>equivalent<br>Note: for ease of<br>review, the<br>differences have<br>been underlined.<br>SE analysis:<br>The additional<br>sentence is to<br>improve clarity of<br>the use of device. |
Table 1: Indications for Use comparison with predicate device
The Indications for use is same for both the predicate and proposed device.
There are differences in Technological characteristics between the Technological characteristics: predicate device 2D Perfusion (K132147) and the proposed device SmartPerfusion, however those different technological characteristics have been demonstrated to not affect a determination of Substantial Equivalence.
The following table provides comparison of the Technological characteristics.
| Parameter | Predicate device<br>2D Perfusion (K132147) | Proposed device<br>SmartPerfusion | Conclusion |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatibility<br>with currently<br>marketed<br>Philips X-ray<br>systems | Is a software accessory to<br>currently marketed Philips<br>Allura and Azurion<br>Interventional X-ray system<br>(K172822, K162859) | same | Substantially equivalent. |
| Image input | Uses angiography X-ray<br>images as input | same | Substantially equivalent. |
| Anatomy | Anatomical area – General<br>vasculature. Not anatomy<br>specific | same | Substantially equivalent |
| Parameter | Predicate device<br>2D Perfusion (K132147) | Proposed device<br>SmartPerfusion | Conclusion |
| Core<br>Algorithm &<br>Quantification | Algorithm for generation of<br>functional images | Same | Substantially equivalent |
| Parameters<br>provided to the<br>user | 1. Arrival Time<br>2. Time to Peak (TTP)<br>3. Wash-in Rate<br>4. Width<br>5. Area under Curve (AuC)<br>6. Mean Transit Time (MTT) | Same for parameters 1 to 6.<br>Additional 2 parameters are<br>provided.<br>7. Wash out Rate:<br>The Wash-out Rate is defined<br>by the slope of the wash-out<br>curve. The Wash-out Rate<br>gives an indication of the flow<br>rate.<br>8. Peak density<br>The Peak Density is the<br>highest density value of the<br>time density curve. | Substantially equivalent<br>SE analysis: The additional<br>parameters 7 & 8 are also<br>derived from the same<br>algorithm. These parameters<br>are not used for Clinical<br>decision making. |
| Instant<br>Overview | Functional parameters are<br>displayed for a region of<br>interest based on functional<br>parameters selected. | All functional parameters are<br>displayed instantly in one<br>screen. | Substantially equivalent<br>SE analysis: All functional<br>parameters are shown at<br>once to improve user<br>experience. |
| Configurable<br>parameters | Not provided. | Among the available<br>parameters, user can sub-select<br>the parameters that will be<br>displayed on the screen. | Substantially equivalent<br>SE analysis: User is provided<br>with an option to choose the<br>parameters to be shown to<br>improve User experience. |
| Feature<br>comparison:<br>Color coded<br>image | Provides color coded<br>representation of a digital<br>subtraction angiography<br>(DSA) run. | Same with additional color<br>coded image for Wash out rate<br>is shown. | Substantially equivalent<br>SE analysis: Both the<br>products use the same<br>algorithm. Additional color<br>coded image for wash out<br>rate is also derived from the<br>same Time Density curve. |
| On screen help | Not provided. | On screen acquisition guidance<br>is provided. | Substantially equivalent<br>SE analysis: SmartPerfusion<br>displays on screen<br>help/guidance to the user to<br>improve workflow. |
| Parameter | Predicate device<br>2D Perfusion (K132147) | Proposed device<br>SmartPerfusion | Conclusion |
| Comparison<br>View | Provides a side by side<br>comparison between pre-,<br>peri-, and post-procedural<br>color coded images and<br>quantified functional<br>parameters.<br>Provides visualization of<br>contrast density over time in a<br>graphical format for a user-<br>defined region of interest | Same with additional option<br>for peripheral acquisitions to<br>compare 3 series at the same<br>time. | Substantially equivalent<br>SE analysis: The additional<br>viewing option is provided<br>for ease of use. |
| Imaging tools | Provides basic image tools<br>(zoom, pan,<br>contrast/brightness) to<br>manipulate image data that is<br>shown in the viewers | same | Substantially equivalent |
| ROI | Provides a mechanism to the<br>user to mark a region of<br>interest on an X-ray run<br>within which all the flow<br>parameters derived by<br>analyzing contrast density<br>over time are computed. | Same with additional ROI<br>drawing options like automatic<br>ROI that are user<br>editable,manual ROI, multiple<br>ROI, different ROI shapes/free<br>form ROI/user defined ROI. | Substantially equivalent<br>SE analysis: SmartPerfusion<br>provides additional options<br>to improve user experience. |
| Snapshot | Provides a mechanism to the<br>user to take a snapshot of the<br>main display area. The<br>snapshot is stored as a JPEG<br>image (compatible with<br>DICOM Secondary Capture),<br>and can be selected in the<br>Export activity for export to<br>another workstation or<br>medium | Same with additional option to<br>take a snapshot of the whole<br>screen. | Substantially equivalent<br>SE analysis: Both tools<br>provide the functionality to<br>take snapshots. Along with<br>main display area,<br>SmartPerfusion also<br>provides a mechanism to<br>take a snapshot of the whole<br>screen. In both kinds of<br>snapshots, the data is stored<br>in the same format. This<br>additional mechanism is a<br>non-mandatory part of the<br>clinical workflow and only<br>helps the user in also<br>capturing task panel and all<br>viewports in a single<br>snapshot. |
| Parameter | Predicate device<br>2D Perfusion (K132147) | Proposed device<br>SmartPerfusion | Conclusion |
| Export | Provides a mechanism to<br>export the currently displayed<br>time density curves to USB<br>removable drive | Same with additional<br>information of functional<br>parameter values for ROI. | Substantially equivalent<br>SE analysis:<br>Additional information is<br>also exported. |
| Overlay pre-<br>series & Recall<br>catheter image | Not provided. | Provides functionality to<br>achieve the same anatomical<br>positioning in a new DSA run<br>as a previously acquired DSA<br>run.<br>Provides functionality to store<br>and recall the image of the<br>catheter position to make sure<br>the runs are comparable | Substantially equivalent<br>SE analysis: This additional<br>functionality helps the<br>interventionalist in achieving<br>the same catheter &<br>anatomical position as pre<br>series before acquisition of<br>the peri- or post- series. This<br>is a non-mandatory part of<br>the product workflow. |
| APC | Not provided. | Provides functionality to auto-<br>recall X-ray view orientations<br>used to achieve the same X-ray<br>view orientation as the loaded<br>pre-series. | Substantially equivalent<br>SE analysis: This additional<br>functionality is a non-<br>mandatory part of the<br>clinical workflow. |
| Table side<br>interaction | Not provided. | Table side interaction is<br>provided through Touch screen<br>module. | Substantially equivalent<br>SE analysis: This additional<br>functionality improves user<br>experience. This is a non-<br>mandatory part of the<br>clinical workflow. |
| Software<br>Architecture<br>improvements | Not provided. | Architecture improvements<br>to facilitate software<br>maintenance, reduce launch<br>time for acquisition<br>guidance, easy portability<br>on the hosting platform,<br>more memory efficient,<br>ability to handle more<br>number of frames. | Substantially equivalent<br>SE analysis: These technical<br>changes do not affect the<br>clinical workflow. |
| Software<br>platform | 2D Perfusion is a software<br>medical device, which runs<br>on Interventional Workspot<br>(K181177). | Same | Substantially equivalent |
Table 2: Technological characteristics comparison-Classification & Design attributes and functionality
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Summary of Non-Clinical Performance Data: Non-clinical performance testing has been performed on the proposed device SmartPerfusion and the proposed device demonstrates compliance with the following FDA recognized consensus standards and FDA guidance documents:
- IEC 62304 Edition 1.1 2015-06 Medical device software Software life ● cycle processes. FDA/CDRH recognition number 13-79;
- IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0 including corrigendum, 2015). FDA/CDRH recognition number 5-114;
- ISO 14971 Second Edition 2007-03-01 Medical devices Application ● of risk management to medical devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40;
- ISO15223-1 Third Edition 2016-11-01 Medical devices Symbols to ● be used with medical device labels, labelling and information to be supplied - Part 1: General requirement. FDA/CDRH recognition number 5-117:
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016). FDA/CDRH recognition number 12-300
- "Guidance for Industry and FDA Staff Guidance for the Content of ● Premarket Submissions for Software Contained in Medical Devices", May 11, 2005 (document number 337);
- "Guidance for Industry and FDA Staff Applying Human Factors and ● Usability Engineering to Medical Devices", February 3, 2016 (document number 1757);
- "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014 (document number 1825);
- "Guidance for Industry and FDA Staff The 510(k) Program: ● Evaluating Substantial Equivalence in Premarket Notifications [510(k)] ", July 28, 2014 (document number 1766).
- Guidance for Industry. FDA Reviewers and Compliance on "Guidance . for Off-the-Shelf Software Use in Medical Devices, September 1999"
Software verification testing has been performed to verify the modifications as per pre-determined System Requirements Specification and acceptance criteria.The verification tests and acceptance criteria were identified based on Risk Assessent. Cybersecurity risks were assessed and privacy and Security requirements were identified and verification tests were performed to verify safety risk control measures from the Detailed Risk Management Matrix and to verify the Privacy and Security requirements for SmartPerfusion have been implemented. Verification results demonstrated that all executed tests were passed.
Non clinical software validation testing has been performed to validate the intended use, claims, user needs, service user needs, effectiveness of safety messures and Instructions for use.
Software validation testing has been performed to validate that SmartPerfusion conforms to its intended use, claims and user needs.
All these tests were used to support substantial equivalence of the subject device and demonstrate that SmartPerfusion:
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. 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. Based on the information provided above, the proposed device SmartPerfusion is substantially equivalent to the predicate device 2D Perfusion (K132147) in terms of safety and effectiveness. SmartPerfusion does not require a clinical study as the substantial equivalence Summary of with the predicate device 2D Perfusion (K132147) is demonstrated with the Clinical Performance Data: following attributes: Indication for use; ● Technological characteristics; . . Non-clinical performance testing, including safety and effectiveness. Non-clinical performance data provides sufficient evidence that the subject device works as intended The verification and validation test results of the modified device SmartPerfusion described above support the safety and effectiveness of the product. It conforms to the intended use, the user needs and the claims and is therefore considered substantially equivalent to the predicate device 2D Perfusion (K132147). SmartPerfusion is substantially equivalent to the predicate device 2D Perfusion Substantial (K132147) in terms of indications for use, technological characteristics and Equivalence Conclusion: safety and effectiveness. The modifications made in the proposed device SmartPerfusion are within the controls and predetermined specifications. Additionally, non-clinical performance tests provided in this 510(k) premarket notification demonstrated substantial equivalence to the predicate device and ensured that the modifications are implemented successfully. Verification and Validation tests were conducted to verify the modifications listed and conformance to international and FDA-recognized consensus standards and guidance documents were provided. These tests demonstrate that SmartPerfusion is substantially equivalent to the predicate device and is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness concerns.
