The IVUS modality of the iLab™ Polaris Multi-Modality Guidance System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.

Indications for Auto Pullback Use (IVUS Only)

Automatic Pullback is indicated when the following occurs:

· The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.

· The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.

· Two-dimensional, longitudinal reconstruction of the anatomy is desired.

Device Description

iLab™ Polaris Multi-Modality Guidance System consists of hardware and software components which aid in supporting Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the DFR™ (Diastolic hyperemia-Free Ratio) feature of the iLab™ Polaris Multi-Modality Guidance System:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the DFR™ feature is its equivalence to the iFR® (Instantaneous Wave-Free Ratio) modality, with both being compared against Fractional Flow Reserve (FFR) as a reference standard. The study aimed to demonstrate that DFR™ has comparable diagnostic performance to iFR® when assessing coronary lesion severity without hyperemia.

Acceptance Criteria / Metric	Target / Predicate Performance (iFR®)	Reported Device Performance (DFR™)
Equivalence to iFR® when compared to FFR	No statistically significant difference between iFR and FFR as a reference standard, with highly overlapping 95% confidence intervals.	No statistically significant difference between DFR and iFR when compared to FFR as a reference standard, with highly overlapping 95% confidence intervals; all parameters passed pre-defined test criteria.
Agreement with iFR® (using iFR® 0.89 cutoff)	N/A (DFR™ is compared to iFR®)	97.6% Accuracy (99.2% Specificity and 95.8% Sensitivity) in agreement with iFR® using the 0.89 cutoff for assessing hemodynamic severity of coronary lesions.
Waveform performance equivalency to predicate/reference pressure wires	Demonstrated equivalency of bench FFR, iFR, and DFR measurements to original values from VERIFY2 dataset.	Demonstrated waveform performance equivalency of the Comet pressure wire to Volcano and St Jude pressure wires. The agreement between measurements was evaluated using linear regression with confidence intervals and Bland-Altman plot, showing no statistical difference.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The test set for DFR™ and Smart Minimum validation consisted of pre-recorded patient level data.
Data Provenance: The data was acquired from two clinical trials:
- VERIFY2
- CONTRAST
- Geographic Origin (implied): Not explicitly stated, but clinical trials like VERIFY2 and CONTRAST are typically multi-center studies that can involve patients from various countries. The document does not specify the countries of origin.
- Retrospective/Prospective: The data appears to be retrospective as it is described as "pre-recorded patient level data acquired from VERIFY2 and CONTRAST clinical trials" for the purpose of validating the new software features.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth for the test set (i.e., FFR values). However, given that FFR is considered the "reference standard" and typically relies on highly trained cardiologists/interventionalists, it can be inferred that these values were established by qualified medical professionals during the original clinical trials (VERIFY2 and CONTRAST).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). The FFR values used as the reference standard were presumably established as part of the original clinical trials' protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported here. The study focuses on the algorithmic performance of DFR™ in comparison to iFR® and FFR, rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone (algorithm only) performance study was conducted. The document describes:

"Smart Minimum and DFR were validated with non-clinical test methods"
"iFR data from the CONTRAST dataset was re-generated using a bench iFR setup with a commercially available Volcano FFR system."
"BSC also demonstrated the waveform performance equivalency of the Comet pressure wire to the Volcano pressure wires... and St Jude pressure wires..."
The primary comparison is between DFR™ and iFR® (both algorithms) against FFR (the reference standard).

The data presented (97.6% Accuracy, 99.2% Specificity, 95.8% Sensitivity) reflects the algorithmic performance of DFR™ in classifying lesions.

7. Type of Ground Truth Used

The primary ground truth used for evaluating DFR™ and iFR® was Fractional Flow Reserve (FFR).
Additionally, the "original iFR values" from the VERIFY2 dataset served as a reference for validating the bench iFR setup.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size of a training set for the DFR™ algorithm. The validation was performed using pre-recorded patient data from existing clinical trials (VERIFY2 and CONTRAST). It's common for such algorithms to be developed and potentially trained on various datasets prior to this validation, but those details are not included in this submission summary.

9. How the Ground Truth for the Training Set Was Established

Since information on a specific training set or its sample size is not provided, how its ground truth was established is also not described in the document.

Summary

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July 2, 2019

Boston Scientific Corporation Mugdha Dongre Sr. RA Specialist 150 Baytech Drive San Jose, California 95134

Re: K191008

Trade/Device Name: iLab Polaris Multi-Modality Guidance System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DSK, IYO, ITX Dated: April 15, 2019 Received: April 16, 2019

Dear Mugdha Dongre:

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/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.

Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K191008

Device Name

iLab™ Polaris Multi-Modality Guidance System

Indications for Use (Describe)

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

The Imaging Catheters generate ultrages and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.

Indications for Auto Pullback Use (IVUS Only)

Automatic Pullback is indicated when the following occurs:

· The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.

· The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.

· Two-dimensional, longitudinal reconstruction of the anatomy is desired.

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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Submitter's Name andAddress	Boston Scientific Corporation150 Baytech Drive,San Jose CA 945134USA
Contact Name andInformation	Mugdha DongreSr. Regulatory Affairs SpecialistTel: 408.635.7239Email: Mugdha.Dongre@bsci.com
Trade Name	iLab™ Polaris Multi-Modality Guidance System
Common Name	Computer Diagnostic ProgrammableBlood Pressure ComputerUltrasonic Pulsed Echo Imaging SystemDiagnostic Ultrasonic Transducer
Classification Name	21 CFR 870.1425 (Programmable Diagnostic Computer)21 CFR 870.1110 (Blood Pressure Computer)21 CFR 892.1560 (Ultrasonic Pulsed Echo Imaging System)21 CFR 892.1570 (Diagnostic Ultrasonic Transducer)
Product Code	DQK (Computer, Diagnostic, Programmable)DSK (Computer, Blood-Pressure)IYO (System, Imaging, Pulsed Echo, Ultrasonic)ITX (Transducer, Ultrasonic, Diagnostic)
Predicate Name	iLab™ Polaris Multi - Modality Guidance System	K151613	October 6, 2015
Reference Devices	Volcano IFR Modality	K133323	March 14, 2014
Device Description	iLab™ Polaris Multi-Modality Guidance System consists ofhardware and software components which aid in supportingIntravascular Ultrasound (IVUS), Fractional Flow Reserve(FFR) and Diastolic hyperemia-Free Ratio™ (DFR™)functionalities.

510(k) Summary per 21 CFR 807.92

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Traditional 510(k) Notification iLab Polaris Multi-Modality Guidance System Polaris 2.10 Software

Image /page/4/Figure/1 description: The image shows a flowchart of the iLab™ Polaris Multi-Modality Guidance System with Polaris 2.10. The system has two main branches: Physiology and IVUS. The Physiology branch further divides into FFR and DFR. The image also includes a text description of the software update, its features, and its intended use in cardiovascular procedures.

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	Polaris 2.10 Software
Intended Use/Indicationsfor Use	the patient). For example, technical artifacts include: removalof the pressure wire or opening the manifold to flush. SmartMinimum does not modify or exclude waveform data frombeing presented to the user. Overall physiologicalmeasurement performance remains unchanged.
	The IVUS modality of the iLab™ Polaris Multi-ModalityGuidance System is intended for ultrasound examinations ofintravascular pathology. Intravascular ultrasound is indicatedin patients who are candidates for transluminal interventionalprocedures such as angioplasty and atherectomy.FFR and DFR™ are intended for use in catheterization andrelated cardiovascular specialty laboratories to compute, anddisplay various physiological parameters based on the outputfrom one or more electrodes, transducers, or measuringdevices.
	FFR and DFR are indicated to provide hemodynamicinformation for use in the diagnosis and treatment of patientsthat undergo measurement of physiological parameters.
	The Imaging Catheters generate ultrasound images and areintended for ultrasound examination of vascular and cardiacpathology. Boston Scientific manufactures a wide variety ofcatheters for different applications. The recommended use ofeach of these catheters may vary depending on the size andtype of the catheter. Please refer to the Imaging CatheterDirections for Use, packaged with each catheter.Indications for Auto Pullback Use (IVUS Only) -
	Automatic Pullback is indicated when the following occurs:The physician/operator wants to standardize themethod in which intravascular ultrasound images areobtained and documented: procedure-to-procedure,operator-to-operator. The physician/operator wants to make linear distancedeterminations post-procedurally, which requires theimaging core of a catheter to be pulled back at a
	known uniform speed. Two-dimensional, longitudinal reconstruction of theanatomy is desired.
Device TechnologyCharacteristics andComparison to PredicateDevice	The Polaris 2.10 software upgrade introduces two newfeatures; Diastolic hyperemeia- Free Ratio (DFRTM) andSmart Minimum. Smart Minimum feature is applicable onlyduring the calculation of Fractional Flow Reserve (FFR).

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BSC's Diastolic hyperemia-Free Ratio (DFR™), introduced by the Polaris 2.10 software update, is designed to offer users an index that is subatantially equivalent to Volcano's iFR Modality (reference device K133323) in assessing the hemodynamic severity of a coronary lesion without administration of a hyperemic agent.

The algorithms used to calculate iFR® and DFR™ have similar measuring points:

Parameters	iFR®	DFRTM
ClinicalApplication	Resting FlowAssessmentwithoutHyperemia	Resting FlowAssessmentwithoutHyperemia
Measure Output	Mean Pd overMean Pa	Mean Pd overMean Pa
AlgorithmPerformance	Fully AutomaticReal-timeMeasurement	Fully AutomaticReal-timeMeasurement
MeasureFrequency	Every Beat	Every Beat
Cardiac Phase	>50% DiastolicPeriod	>50% DiastolicPeriod
AveragingMethod	Five BeatsAverage	Five BeatsAverage
MeasurePrecondition	Pd Normalized toPa	Pd Equalized toPa

BSC compared the diagnostic performance of the Diastolic hyperemia-Free Ratio (DFR) to the Instantaneous Wave-Free Ratio (iFR) by comparing respective indices (DFR and iFR) to Fractional Flow Reserve (FFR) for the purposes of supporting a determination of substantial equivalence between DFR and iFR. There was no statistically significant difference between iFR and DFR when compared to FFR as a reference standard. All parameters passed the pre-defined test criteria with highly overlapping 95% confidence intervals; supporting a determination of substantial equivalence between DFR and iFR diagnostic performance.

The statistical comparison conducted between the two methods demonstrated that BSC DFR™ and Volcano iFR® have high equivalence output with the same raw waveform. Using the same cutoff value as that of iFR® of 0.89 in assessment of the hemodynamic severity of coronary lesions,

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	Polaris 2.10 SoftwareDFR™ measurements were in agreement with iFR® with97.6% Accuracy (99.2 % Specificity and 95.8% Sensitivity).
	Polaris 2.10 utilizes the same fundamental technology withthe same intended use and indication of use as that of thepredicate (K151613) and reference device (K133323). ThePolaris 2.10 software update does not impact the intended use,indication of use, performance, manufacturing process or anyother system hardware components of the iLab™ PolarisMulti-Modality Guidance System and its associatedaccessories i.e, Comet Pressure guidewire and compatibleultrasound catheters. No new risks or issues of safety andeffectiveness are raised by this change.
	In addition, verification and validation addresses themodifications between the predicate and the subject device,further supporting a determination that the subject device issubstantially equivalent to that of the predicate device.
Non-Clinical PerformanceData	Non-clinical data includes Software Verification andValidation testing and non-clinical bench test methodsperformed on Polaris 2.10 algorithm.
	Smart Minimum and DFR were validated with non-clinicaltest methods, in which the non-clinical data were sourcedfrom pre-recorded patient level data acquired from VERIFY2and CONTRAST clinical trials. iFR data from theCONTRAST dataset was re-generated using a bench iFRsetup with a commercially available Volcano FFR system.The accuracy of regenerated iFR data from this bench methodwas validated by demonstrating the equivalency of the benchiFR measurements to the original iFR values in the completeVERIFY2 dataset.
	BSC also demonstrated the waveform performanceequivalency of the Comet pressure wire to the Volcanopressure wires used in VERIFY2 and St Jude pressure wiresused in CONTRAST. A validation study was performed in abench setup consisting of a pressurized chamber to regeneratepatient pressure signals. The accuracy of this bench methodwas validated by demonstrating the equivalency of the benchFFR, iFR and DFR measurements to their original values inthe complete VERIFY2 dataset. The agreement between thetwo measurements was evaluated in accordance with the FDAstatistical analysis guidance including linear regression withlower and upper confidence intervals, Bland-Altman plot
Polaris 2.10 Software
	measurements were determined equivalent with no statisticaldifference found using the above analytical methods.
	Software Verification and Validation testing demonstratedcompliance with following international and FDA- recognizedconsensus standards and FDA guidance documents:
	- IEC 62304 Medical device software- Software lifecycle processes, (Edition 1.1 2015-06). FDA/CDRHrecognition number 13-79
	- FDA Guidance issued on May 11, 2005, Guidance forthe Content of Premarket Submissions for SoftwareContained in Medical Devices
	- FDA Guidance issued on March 13, 2007, StatisticalGuidance on Reporting Results from StudiesEvaluating Diagnostic Tests
Clinical Performance Data	Not applicable; determination of substantial equivalence isbased on an assessment of non-clinical performance data.
Conclusion	iLab™ Polaris Multi- Modality Guidance System (subjectdevice with Polaris 2.10 software) is substantially equivalentto the currently marketed predicate device, iLab™ PolarisMulti- Modality Guidance System (K151613) in terms ofindications for use, technological characteristics and safetyand effectiveness.The modifications to the predicate device are withinpredetermined specifications. Additionally, non-clinicalperformance tests provided in this 510(k) premarketnotification demonstrate substantial equivalence to thepredicate device and that conformance to IEC standards andguidance documents have been appropriately addressed. Thetests performed support substantial equivalence of themodified device and demonstrate that the iLab™ PolarisMulti- Modality Guidance System, is as safe and effective asits predicate device without raising any new safety and/oreffectiveness concerns

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Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).