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 Description

SmartPerfusion is a software product (Interventional Tool) that provides color coded representation of a digital subtraction angiography (DSA). It can visualize multiple functional parameters related to the time density function. It also provides a comparison between pre-, peri-, and post- procedural color coded images. SmartPerfusion is provided as an accessory to the Philips Interventional X-ray system.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a specific study that demonstrates the device meets these criteria in the format requested. The document is a 510(k) summary for the Philips SmartPerfusion device. It states that non-clinical performance testing demonstrated compliance with FDA recognized consensus standards and guidance documents, and that verification and validation tests were performed. However, it does not provide:

A table of specific acceptance criteria and detailed reported device performance.
Information on sample sizes used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
Adjudication methods.
Results of a multi-reader multi-case (MRMC) comparative effectiveness study, nor did it mention an effect size for human readers with and without AI assistance.
A standalone algorithm performance study.
The type of ground truth used (e.g., pathology, outcomes data).
The sample size for the training set or how ground truth for the training set was established.

The document indicates that the device does not require a clinical study because substantial equivalence with the predicate device (2D Perfusion, K132147) was demonstrated through:

Indications for use
Technological characteristics
Non-clinical performance testing, including safety and effectiveness.

It explicitly states: "SmartPerfusion does not require a clinical study as the substantial equivalence Summary of with the predicate device 2D Perfusion (K132147) is demonstrated with the 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)."

Therefore, based on the provided text, I cannot complete the requested tables and information fields for acceptance criteria and study details.

Summary

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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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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Chandrika SrinivasanRegulatory Affairs OfficerPhone: +9180 41894132E-mail: chandrika.s@philips.com
Secondary ContactPerson:	Marta WalkerHead of Regulatory Affairs IGT SystemsPhone: +31 631978546E-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:Secondary Product Code:	OWB (Interventional Fluoroscopic X-Ray system)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:Secondary Product Code:	OWB (Interventional Fluoroscopic X-Ray system)LLZ (System, Image Processing, Radiological)
Device description:	SmartPerfusion is a software product (Interventional Tool) that providescolor coded representation of a digital subtraction angiography (DSA). Itcan visualize multiple functional parameters related to the time densityfunction. It also provides a comparison between pre-, peri-, and post-procedural color coded images.SmartPerfusion is provided as an accessory to the Philips InterventionalX-ray system.
Indications for Use:	SmartPerfusion assists in the diagnosis of perfusion alterations of tissuesbased on digital subtraction angiography (DSA) and can be used for anylocation in the body where DSA is used.
Patient Population	SmartPerfusion is suitable for use with the entire human population.
Intended OperatorProfile	The Operator is a physician or other qualified healthcare professionalwho is fully skilled and responsible for sound clinical judgment and forapplying the best clinical procedure, for example:Interventional radiologist Interventional neuro-radiologist Vascular surgeon and Podiatrists Interventional Cardiologist Skilled radiology technician (or nurse) assisting the physician Oncologist
General safety andeffectiveness	To facilitate safe and efficacious operation of the system by a trainedhealthcare professional, instructions for use are provided as part of thedevice labeling, as well as training at system handover.
ClinicalEnvironment:	SmartPerfusion can be used in the control room and in the exam room ofan interventional suite or operating room.SmartPerfusion is a software application and does not come in contactwith the patient.

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Predicate device2D Perfusion (K132147)	Proposed deviceSmartPerfusion	Comparison
2D Perfusion assists in thediagnosis of perfusionalterations of tissues, basedon digital subtractionangiography (DSA) byproviding color codedimages generated from theDSA series.	SmartPerfusion assists in thediagnosis of perfusionalterations of tissues basedon digital subtractionangiography (DSA) and canbe used for any location inthe body where DSA isused.	Identical,SubstantiallyequivalentNote: for ease ofreview, thedifferences havebeen underlined.SE analysis:The additionalsentence is toimprove clarity ofthe 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 device2D Perfusion (K132147)	Proposed deviceSmartPerfusion	Conclusion
Compatibilitywith currentlymarketedPhilips X-raysystems	Is a software accessory tocurrently marketed PhilipsAllura and AzurionInterventional X-ray system(K172822, K162859)	same	Substantially equivalent.
Image input	Uses angiography X-rayimages as input	same	Substantially equivalent.
Anatomy	Anatomical area – Generalvasculature. Not anatomyspecific	same	Substantially equivalent
Parameter	Predicate device2D Perfusion (K132147)	Proposed deviceSmartPerfusion	Conclusion
CoreAlgorithm &Quantification	Algorithm for generation offunctional images	Same	Substantially equivalent
Parametersprovided to theuser	1. Arrival Time2. Time to Peak (TTP)3. Wash-in Rate4. Width5. Area under Curve (AuC)6. Mean Transit Time (MTT)	Same for parameters 1 to 6.Additional 2 parameters areprovided.7. Wash out Rate:The Wash-out Rate is definedby the slope of the wash-outcurve. The Wash-out Rategives an indication of the flowrate.8. Peak densityThe Peak Density is thehighest density value of thetime density curve.	Substantially equivalentSE analysis: The additionalparameters 7 & 8 are alsoderived from the samealgorithm. These parametersare not used for Clinicaldecision making.
InstantOverview	Functional parameters aredisplayed for a region ofinterest based on functionalparameters selected.	All functional parameters aredisplayed instantly in onescreen.	Substantially equivalentSE analysis: All functionalparameters are shown atonce to improve userexperience.
Configurableparameters	Not provided.	Among the availableparameters, user can sub-selectthe parameters that will bedisplayed on the screen.	Substantially equivalentSE analysis: User is providedwith an option to choose theparameters to be shown toimprove User experience.
Featurecomparison:Color codedimage	Provides color codedrepresentation of a digitalsubtraction angiography(DSA) run.	Same with additional colorcoded image for Wash out rateis shown.	Substantially equivalentSE analysis: Both theproducts use the samealgorithm. Additional colorcoded image for wash outrate is also derived from thesame Time Density curve.
On screen help	Not provided.	On screen acquisition guidanceis provided.	Substantially equivalentSE analysis: SmartPerfusiondisplays on screenhelp/guidance to the user toimprove workflow.
Parameter	Predicate device2D Perfusion (K132147)	Proposed deviceSmartPerfusion	Conclusion
ComparisonView	Provides a side by sidecomparison between pre-,peri-, and post-proceduralcolor coded images andquantified functionalparameters.Provides visualization ofcontrast density over time in agraphical format for a user-defined region of interest	Same with additional optionfor peripheral acquisitions tocompare 3 series at the sametime.	Substantially equivalentSE analysis: The additionalviewing option is providedfor ease of use.
Imaging tools	Provides basic image tools(zoom, pan,contrast/brightness) tomanipulate image data that isshown in the viewers	same	Substantially equivalent
ROI	Provides a mechanism to theuser to mark a region ofinterest on an X-ray runwithin which all the flowparameters derived byanalyzing contrast densityover time are computed.	Same with additional ROIdrawing options like automaticROI that are usereditable,manual ROI, multipleROI, different ROI shapes/freeform ROI/user defined ROI.	Substantially equivalentSE analysis: SmartPerfusionprovides additional optionsto improve user experience.
Snapshot	Provides a mechanism to theuser to take a snapshot of themain display area. Thesnapshot is stored as a JPEGimage (compatible withDICOM Secondary Capture),and can be selected in theExport activity for export toanother workstation ormedium	Same with additional option totake a snapshot of the wholescreen.	Substantially equivalentSE analysis: Both toolsprovide the functionality totake snapshots. Along withmain display area,SmartPerfusion alsoprovides a mechanism totake a snapshot of the wholescreen. In both kinds ofsnapshots, the data is storedin the same format. Thisadditional mechanism is anon-mandatory part of theclinical workflow and onlyhelps the user in alsocapturing task panel and allviewports in a singlesnapshot.
Parameter	Predicate device2D Perfusion (K132147)	Proposed deviceSmartPerfusion	Conclusion
Export	Provides a mechanism toexport the currently displayedtime density curves to USBremovable drive	Same with additionalinformation of functionalparameter values for ROI.	Substantially equivalentSE analysis:Additional information isalso exported.
Overlay pre-series & Recallcatheter image	Not provided.	Provides functionality toachieve the same anatomicalpositioning in a new DSA runas a previously acquired DSArun.Provides functionality to storeand recall the image of thecatheter position to make surethe runs are comparable	Substantially equivalentSE analysis: This additionalfunctionality helps theinterventionalist in achievingthe same catheter &anatomical position as preseries before acquisition ofthe peri- or post- series. Thisis a non-mandatory part ofthe product workflow.
APC	Not provided.	Provides functionality to auto-recall X-ray view orientationsused to achieve the same X-rayview orientation as the loadedpre-series.	Substantially equivalentSE analysis: This additionalfunctionality is a non-mandatory part of theclinical workflow.
Table sideinteraction	Not provided.	Table side interaction isprovided through Touch screenmodule.	Substantially equivalentSE analysis: This additionalfunctionality improves userexperience. This is a non-mandatory part of theclinical workflow.
SoftwareArchitectureimprovements	Not provided.	Architecture improvementsto facilitate softwaremaintenance, reduce launchtime for acquisitionguidance, easy portabilityon the hosting platform,more memory efficient,ability to handle morenumber of frames.	Substantially equivalentSE analysis: These technicalchanges do not affect theclinical workflow.
Softwareplatform	2D Perfusion is a softwaremedical device, which runson Interventional Workspot(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.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
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.(b)
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.