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.

Device Description

The AVVIGO Guidance System is a medical device system that consists of a touchscreen tablet with battery, a digital pen, a power supply and cable which can be mounted to a mobile pole via the pole docking station or set on tabletop via the desktop docking station. The tablet is a nonsterile, non-implantable tablet computer controlled by a graphic user interface (GUI) displayed on a touchscreen. The tablet is powered by either AC line power or a lithium polymer battery.

The system software displays patient's blood pressure measurements that are received from the coronary pressure guidewire and transducer that is connected to a FFR Link. The FFR Link digitizes and wirelessly streams the data which is displayed on the tablet.

AI/ML Overview

The provided text describes the AVVIGO™ Guidance System, a medical device intended for use in catheterization laboratories to compute and display physiological parameters like FFR (Fractional Flow Reserve) and DFR (Diastolic Hyperemia-free Ratio). The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the iLab™ Polaris Multi-Modality Guidance System, rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the AVVIGO™ Guidance System's diagnostic accuracy.

Therefore, the requested information specifically regarding acceptance criteria for a diagnostic performance study, reported device performance against those criteria, sample sizes, ground truth establishment methods for test and training sets, expert qualifications, and MRMC study details cannot be fully extracted from this document, as it emphasizes non-clinical performance and substantial equivalence.

However, based on the non-clinical performance mentioned, here's what can be inferred and what information is missing:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) for FFR/DFR calculation. Instead, it refers to conformity with standards and successful completion of verification and validation testing for software, hardware, packaging, and electrical safety.

Acceptance Criteria Category	Reported Device Performance
Software Conformance	Passed IEC 62304 and FDA Guidance for Industry (May 11, 2005) requirements for software in medical devices.
Hardware Conformance	Passed FDA Guidance for Industry (August 14, 2013) for Radio Frequency Wireless Technology, ANSI AAMI ES 60601-1, and IEC 60601-1-2 (Edition 3).
Electrical Safety	In compliance with ANSI/AAMI ES60601-1:2005+A2 (R2012) A1 and other applicable electrical standards.
Functional Modality (FFR/DFR display)	The system shall calculate and display FFR and DFR values as specified, based on Pd and Pa trend values, non-zero Pa, and recording initiation. It displays Pa/Pd waveforms and DFR windows during recording.

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document states "Non-clinical Performance" and explicitly says "Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data. Substantial Equivalence is based on non-clinical performance data." This indicates that no clinical test set for FFR/DFR diagnostic performance was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set with ground truth for diagnostic performance was described.

4. Adjudication method for the test set:
Not applicable, as no clinical test set with ground truth for diagnostic performance was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was mentioned or performed, as the substantial equivalence determination was based on non-clinical performance. The device is a computational system for physiological parameters, not an AI to assist human readers in interpreting images or complex data in an MRMC setting.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone algorithm/system for computing and displaying FFR/DFR. The non-clinical performance testing validated its functionality against technical requirements and standards. However, the document doesn't provide specific standalone performance metrics like accuracy against a gold standard for FFR/DFR values, but rather confirms its compliance with relevant engineering and software standards for operation and display.

7. The type of ground truth used:
For the non-clinical performance, the "ground truth" would be the expected output or behavior according to the design specifications and applicable medical device standards (e.g., correct calculation of FFR from simulated pressure inputs, accurate display of waveforms). No clinical ground truth (like pathology, expert consensus on disease presence based on FFR/DFR, or outcomes data) was used for this 510(k) submission.

8. The sample size for the training set:
Not applicable. The document describes a "Guidance System" that calculates and displays physiological parameters, not an AI/machine learning model that would typically undergo a training phase with a dedicated dataset. The software development likely involved unit testing, integration testing, and system validation, but not in the context of a "training set" for an AI model.

9. How the ground truth for the training set was established:
Not applicable, as there was no described training set for an AI/machine learning model. The software's functionality is based on established physiological equations and data processing methods, not learned patterns from a training dataset.

Summary

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July 23, 2020

Boston Scientific Corporation Kevin Catalano Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311

Re: K201713

Trade/Device Name: AVVIGOTM Guidance System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 22, 2020 Received: June 23, 2020

Dear Kevin Catalano:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, & Monitoring Devices Office of cardiovascular Devices 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) K201713

Device Name AVVIGO™ 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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--------------------------	--------------------------

| X | Prescription Use (Part 21 CFR 801 Subpart D)

|Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the words "Boston Scientific" in a stylized, serif font. The words are stacked on top of each other, with "Boston" on the top line and "Scientific" on the bottom line. The text is a dark blue color. The image appears to be a logo or branding element for the company Boston Scientific.

300 Boston Scientific Way Marlborough, MA 01752-1234 508-683-4000 www.bostonscientific.com

510(k) Summary per 21 CFR 807.92

Sponsor	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Kevin CatalanoSenior Regulatory Affairs SpecialistThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2413Fax: 763-257-6482e-mail: Kevin.Catalano@bsci.com
Date Prepared	June 22, 2020
Proprietary Name	AVVIGO™ Guidance System
Common Name	Computer Diagnostic ProgrammableBlood Pressure Computer
Product Code	DQKDSK
Classification	Class II, 21 CFR 870.1425
Predicate Device	iLab™ Polaris Multi -Modality Guidance SystemK201178, May 29, 2020

Device Description

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Intended Use/Indications for Use

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.

Comparison of Technological Characteristics

The AVVIGO Guidance System is substantially equivalent to the predicate device, Polaris 2.12 (iLab 3.12) K201178, in intended use, fundamental design technology and FFR/DFR modalities, including DFR Equalization, and performance features.

Characteristic	Predicate Device (K201178)- iLab Polaris Multi-ModalityGuidance System	Proposed Device - AVVIGOGuidance System	Comment
Indication forUse/Intended Use	The IVUS modality of theiLab™ Polaris Multi-ModalityGuidance System is intendedfor ultrasound examinations ofintravascular pathology.Intravascular ultrasound isindicated in patients who arecandidates for transluminalinterventional proceduressuch as angioplasty andatherectomy.FFR and DFR™ are intendedfor use in catheterization andrelated cardiovascularspecialty laboratories tocompute, and display variousphysiological parametersbased on the output from oneor more electrodes,transducers, or measuringdevices. FFR and DFR areindicated to providehemodynamic information foruse in the diagnosis andtreatment of patients thatundergo measurement ofphysiological parameters.The Imaging Cathetersgenerate ultrasound imagesand are intended forultrasound examination ofvascular and cardiacpathology. Boston Scientificmanufactures a wide variety	FFR and DFR are intended foruse in catheterization andrelated cardiovascularspecialty laboratories tocompute, and display variousphysiological parametersbased on the output from oneor more electrodes,transducers, or measuringdevices.FFR and DFR are indicated toprovide hemodynamicinformation for use in thediagnosis and treatment ofpatients that undergomeasurement of physiologicalparameters.	SubstantiallyEquivalentAVVIGO is notintended forIVUS.

	of catheters for differentapplications. Therecommended use of each ofthese catheters may varydepending on the size andtype of the catheter. Pleaserefer to the Imaging CatheterDirections for Use, packagedwith each catheter.Indications for Auto PullbackUse (IVUS Only)Automatic Pullback isindicated when the followingoccurs:- The physician/operatorwants to standardize themethod in which intravascularultrasound images areobtained and documented:procedure-to-procedure,operator-to-operator.- The physician/operatorwants to make linear distancedeterminations post-procedurally, which requiresthe imaging core of a catheterto be pulled back at a knownuniform speed.- Two-dimensional,longitudinal reconstruction ofthe anatomy is desired.
Overall Design	Two PCs (Acquisition andImaging Processors)One BCM (BluetoothCommunication Module)One Imaging DisplayOne Control PanelOne AC Power IsolationTransformerOne Rolling Cart Assembly(includes necessary cablinginternal to the cart)One Printer	Tablet (with AVVIGOSoftware, touchscreen,Battery, and onboardBluetooth)Power SupplyDigital PenPower CableTablet Mobile PoleDocking StationDesktop Docking StationTablet Mobile Pole (packagedseparately)	SubstantiallyEquivalentBoth systemsuse the sameinputs andprovide thesame outputs tothe user.TabletintegratesBluetoothcapability.
Connectivity toFFR Link;acquisition of Pdand Pa data	Bluetooth connection	Bluetooth connection	Same
StandardConformity	IEC 62304 Medical devicesoftware- Software lifecycle	IEC 62304 Medical devicesoftware- Software lifecycle	Same
	processes, Edition 1.1 2015-06). FDA/CDRHrecognition number 13-79	processes, Edition 1.1 2015-06). FDA/CDRHrecognition number 13-79
	ANSI AAMI BP-22:1994 (R)2016- Blood PressureTransducers. FDA recognitionnumber 3-44	ANSI AAMI BP-22:1994 (R)2016- Blood PressureTransducers. FDA recognitionnumber 3-44
	ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012-Medical Electrical Equipment-Part1: General requirementsfor Basic Safety and EssentialPerformance. FDArecognition number-19-4	ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012-Medical Electrical Equipment-Part1: General requirementsfor Basic Safety and EssentialPerformance. FDA recognitionnumber-19-4
	IEC 60601-1-2 Edition 3:2007-03 - Medical ElectricalEquipment - Part 1-2: GeneralRequirements for BasicSafety and EssentialPerformance - CollateralStandard: ElectromagneticCompatibility – Requirementsand Tests- FDA recognitionnumber-19-1	IEC 60601-1-2:2014 4th Ed.Medical electrical equipment -Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagnetic disturbances- Requirements and testsFDA/CDRH recognitionnumber 19-8
CompatibleAccessories	Motordrive Unit, MDU5 PlusSterile Bag, Disposable andPermanent Pullback Sled,FFR Link, BluetoothCommunication Module(BCM)Pressure SensitiveGuidewires• Comet• Comet IIIntravascular ImagingCatheters• OptiCross™• OptiCross™ 18• 6OptiCross™ 18• OptiCross™ HD• OptiCross™ 6 HD• Ultra Ice Plus	FFR LinkPressure SensitiveGuidewires-CometComet II	SubstantiallyEquivalentAVVIGO is notintended tosupport IVUSwhich requiresthe use of theMD5 plusmotordrive anddisposable orpermanent sledcomponents.Additionally,AVVIGOcontainsonboardBluetootheliminatingneed for BCM.
Patient Contact	Non-patient contacting	Non-patient contacting	Same
Ergonomics ofthe User Interface	The iLab User Interfaceconsists of a console with atouch screen and Windows	The AVVIGO User Interfaceconsists of a tablet with atouch screen and Windows	SubstantiallyEquivalentAVVIGO utilizes
	based software GraphicalUser Interface (GUI).	based software GraphicalUser Interface (GUI).	support theGUI.
SoftwareTechnology	The iLab System is aWindows 7 based device.	The AVVIGO System is aWindows 10 based device.	SubstantiallyEquivalent
			Both OperatingSystems areWindows basedhowever, theAvvigo SystemOS has beenupdated toWindows 10.
DICOM	DICOM 3.0, Auto-save stillframes & scalable filecompression, Supportslossless and lossy JPEGcompression. Supports USMulti-frame Greyscale, (PixelData), US Multi-FrameGreyscale (Screenshot), SecCapture (Screenshot), TrueColor Multi Frame SecondaryCapture (Screenshot)	DICOM 3.0, Auto-save stillframes & scalable filecompression, Supportslossless and lossy JPEGcompression. Supports USMulti-frame Greyscale, (PixelData), US Multi-FrameGreyscale (Screenshot), SecCapture (Screenshot), TrueColor Multi Frame SecondaryCapture (Screenshot)	Same
ElectromagneticCompatibility andElectrical Safety	In compliance with ANSI/AAMIES60601- 1:2005+A2 (R2012)A1 and other applicableelectrical standards	In compliance with ANSI/AAMIES60601- 1:2005+A2 (R2012)A1 and other applicableelectrical standards	Same
FunctionalModality	IVUS and Physiology (FFR/DFR)	Physiology (FFR/ DFR)	SubstantiallyEquivalent
			AVVIGO is notintended tosupport IVUS.
SoftwareRequirementsRelated toDiagnostics	The system shall calculateand display the FFR valuewhen the following are met:● Pd and Pa trend valuesare available● Pa trend value is not 0● Recording has started● Display FFR Value inRecord is enabled inSystem Profile● If disabled, value iscalculated but notdisplayed.	The system shall calculateand display the FFR valuewhen the following are met:● Pd and Pa trend valuesare available● Pa trend value is not 0● Recording has started● Display FFR Value inRecord is enabled inSystem Profile● If disabled, value iscalculated but notdisplayed.	Same
	The system shall display the following during DFR run recording Pa waveform Pd waveform Pa and Pd DFR windows Recorded time	The system shall display the following during DFR run recording Pa waveform Pd waveform Pa and Pd DFR windows Recorded time	Same

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K201713

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Non-clinical Performance

Determination of substantial equivalence is based on an assessment of non-clinical performance data which includes software, hardware, packaging and electrical safety verification and validation carried out on the AVVIGO Guidance System. Testing was conducted according to applicable international standards, FDA recognized consensus standards, and the same wellestablished test methods and criteria applied to the predicate device. The following standards and guidance are applicable in demonstration of substantial equivalence related to software:

. IEC 62304 Medical Device Software - Software Lifecycle Processes, (edition 1.1 2015-06) FDA recognition: 13-79.
FDA Guidance for Industry, Issued May 11, 2005, Guidance for the Content of Premarket ● Submissions for Software Contained in Medical Devices.

The following standards and guidance are applicable in demonstration of substantial equivalence related to Hardware:

FDA Guidance for Industry, Issued August 14, 2013, Radio Frequency Wireless ● Technology in Medical Devices.
ANSI AAMI ES 60601-1: 2005/(R)2012 and A1:2012- Medical Electrical Equipment-. Part1: General requirements for Basic Safety and Essential Performance. FDA recognition number-19-4
. IEC 60601-1-2 Edition 3: 2007-03 – Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests- FDA recognition number-19-1

Clinical Performance Data

Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data. Substantial Equivalence is based on non-clinical performance data.

Conclusion

Based on a comparison of intended use, fundamental design technology, FFR/DFR modalities, including DFR Equalization and performance features, the AVVIGO Guidance System is substantially equivalent to the predicate device. A comparison of the modified and predicate devices, along with verification and validation testing applicable to the modified device, supports a conclusion of substantial equivalence and raise no new issues of safety and effectiveness.

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).