ILUMIEN System with AptiVue Software version D.3 by Abbott Medical

The ILUMIEN™ system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The ILUMIEN system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

Device Description

ILUMIEN™ with AptiVue™ Software (version D.3) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. FFR, Pd/Pa at rest, and RFR physiological waveforms measured by the system are used to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure).

AI/ML Overview

The provided FDA 510(k) summary for the ILUMIEN System with AptiVue Software version D.3 describes the device's equivalence to predicate devices, focusing on the addition of a new physiological index, RFR. However, it explicitly states, "No new clinical testing was completed, nor relied upon, in support of this Special 510(k)." This means there is no specific study described within this document that "proves the device meets the acceptance criteria" in the traditional sense of a new clinical trial for this specific software version.

Instead, the submission relies on:

Equivalence to existing cleared devices: The new software version D.3 is deemed equivalent to the predicate ILUMIEN™ system (K150237) and the OPTIS™ Systems with AptiVue™ Version E.5 Software (K183320). The RFR feature is identical to the one cleared under K183320.
Verification and Validation (V&V) testing: This includes software V&V and a usability study to demonstrate safety and effectiveness and ensure the device performs as intended with the new features. These are typically internal engineering and validation tests, not clinical studies with a ground truth established by experts for a specific diagnostic performance metric.

Therefore, many of the requested details about acceptance criteria met by a specific study, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or provided in this document for the new software version D.3. The document focuses on demonstrating that the modifications do not raise new questions of safety or effectiveness compared to already cleared devices.

Here's an attempt to fill in the table and answer the questions based only on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance (Based on Equivalence)

Since no new clinical study was performed for this specific submission, direct "acceptance criteria" and "reported device performance" in terms of diagnostic metrics are not provided for version D.3. Instead, the "acceptance" is based on demonstrating equivalence to predicate devices that presumably met their own acceptance criteria when originally cleared.

Acceptance Criterion (Implicit for Equivalence)	Reported Device Performance (as demonstrated by equivalence)
Intended Use: Device maintains its intended use for imaging coronary arteries and computing physiological parameters.	The ILUMIEN System with AptiVue D.3 software maintains the same indications for use as the predicate ILUMIEN system (K150237) and the OPTIS Systems (K183320), specifically for imaging coronary arteries and computing physiological parameters (OCT, FFR, Pd/Pa, and now RFR).
Operational Characteristics & Fundamental Design: No significant changes impacting safety/effectiveness.	The D.3 software is equivalent to the predicate ILUMIEN™ system (K150237) for operational characteristics and fundamental design. The modifications (adding RFR and support for Dragonfly OpStar catheter) do not alter the fundamental scientific technology or intended use.
RFR Feature Performance: RFR calculations are consistent and safe.	The RFR feature implemented in D.3 is identical to the cleared AptiVue software version E.5 (K183320) on the OPTIS systems. This implies that its performance, as established during the clearance of K183320, is maintained. (Specific performance metrics for RFR are not provided in this document, but would have been part of K183320's submission). The device user interface, overall functionality, the RFR feature, and associated risks remain identical to the cleared E.5 version.
Safety and Effectiveness: Demonstrated through V&V testing.	Verification and Validation testing (including software V&V and a usability study) were completed to demonstrate safety and effectiveness and ensure the subject device performs as intended.

Study Details (Based on the provided document)

Since "No new clinical testing was completed, nor relied upon, in support of this Special 510(k)," many of the questions below cannot be answered directly from the provided text for the ILUMIEN System with AptiVue Software D.3. The answers reflect what is stated or explicitly absent.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for a new clinical study for D.3.
- For the usability study mentioned under "Verification and Validation," sample size, data provenance, and retrospective/prospective nature are not provided in this document. These are generally internal tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No new clinical study requiring expert ground truth establishment for a test set was performed or relied upon for this submission. The RFR feature is based on its previous clearance where such ground truth would have been established.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No new clinical study requiring adjudication was performed or relied upon.
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. The document explicitly states "No new clinical testing was completed, nor relied upon." There is no mention of an MRMC study or AI assistance. The device is for physiological parameter computation and display, not an AI diagnostic aid for human readers in the traditional sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated for the D.3 update. The device "will further compute and display various physiological parameters." While the computation of RFR is an algorithm's standalone function, the performance details of this computation, particularly as a new standalone study for D.3, are not provided. Its equivalence to the previously cleared E.5 software is emphasized.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly provided for D.3. For the RFR feature, the ground truth methodology would have been established during the clearance of the predicate device (K183320). Generally, physiological parameters like FFR, Pd/Pa, and RFR are compared against either direct pressure measurements or established physiological models as ground truth.
The sample size for the training set
- Not applicable. This submission focuses on software updates and equivalence, not a new algorithm development requiring a separate training set. The algorithms for FFR, Pd/Pa, and RFR were developed and likely trained (if applicable to their computational nature) during previous versions or predicate clearances.
How the ground truth for the training set was established
- Not applicable. As above, no new training set is described as being used for this submission.

Summary

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December 17, 2019

Abbott Medical Anita Xavier RA Project Manager 4 Robbins Road Westford, Massachusetts 01886

Re: K192267

Trade/Device Name: ILUMIEN System with AptiVue Software version D.3 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ Dated: November 18, 2019 Received: November 21, 2019

Dear Anita Xavier:

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,

Nicole Gillette Acting 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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Indications for Use

510(k) Number (if known) K192267

Device Name

ILUMIEN System with AptiVue Software version D.3

Indications for Use (Describe)

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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510(k) Number	K192267
Date Prepared	20 November 2019
Submitter Name &Address	Abbott Medical4 Robbins RoadWestford, MA 01886
Contact Person	Anita XavierRegulatory Affairs Project ManagerPhone: (408) 674 8367Email: anita.xavier@abbott.com
Alternative ContactPerson	Jose MarquezAssociate Director, Regulatory AffairsPhone: (978) 577-3578Email: jose.marquez1@abbott.com
Proprietary/TradeName	ILUMIEN System with AptiVue Software version D.3
Common/UsualName	ILUMIEN Systems
Product ClassificationCode	Product Code: NQQ
Product RegulationNumber and Name	21 CFR 892.1560
Device Class	II
Predicate Device	Primary: ILUMIEN™ System (K150237), cleared 05 May 2015Secondary: ILUMIEN™ OPTIS™, OPTIS™ Integrated, OPTIS™ Mobile (K183320),cleared 02 April 2019
Device Description	ILUMIEN™ with AptiVue™ Software (version D.3) perform Optical CoherenceTomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio(RFR) procedures and provide images of the coronary arteries in patients who arecandidates for transluminal interventional procedures. FFR, Pd/Pa at rest, and RFRphysiological waveforms measured by the system are used to assess the severity of acoronary lesion by measuring the pressure drop across the lesion (distal vs proximalpressure).
Indications for Use/Intended Use	The ILUMIEN™ system with a compatible Dragonfly™ imaging catheter is intendedfor the imaging of coronary arteries and is indicated in patients who are candidates fortransluminal interventional procedures. The compatible Dragonfly imaging catheters areintended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™imaging catheters are not intended for use in the left main coronary artery or in a targetvessel which has undergone a previous bypass procedure.The ILUMIEN system is intended for use in the catheterization and relatedcardiovascular specialty laboratories and will further compute and display variousphysiological parameters based on the output from one or more electrodes, transducers,or measuring devices. The physician may use the acquired physiological parameters,along with knowledge of patient history, medical expertise and clinical judgment todetermine if therapeutic intervention is indicated.

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ILUMIENT™ with AptiѴиет™ Version D.3 software is equivalent to the predicateILUMIENT™ system (K150237) for intended use, operational characteristics, andfundamental design of the device. Changes to technological characteristics of the devicedo no raise different questions of safety or effectiveness.ILUMIENT™ with AptiѴиет™ Version D.3 software is equivalent to the OPTISTMSystems with AptiVue™ Version E.5 Software (K183320).The tables below provide a comparison of the subject device to the primary andsecondary predicate devices.
Comparison ofSubject to PredicateDevice	Feature	ILUMIEN Systems withversion D.2 Software (PrimaryPredicate)	ILUMIENT™ Systems withAptiVue Software VersionD.3 (Proposed)
	Indications forUse	The ILUMIEN imaging systemwith C7 Dragonfly™ DUO orDragonfly™ OPTIS ImagingCatheter is intended for theimaging of coronary arteries andis indicated in patients who arecandidates for transluminalinterventional procedures. TheC7 Dragonfly™ DUO orDragonfly™ OPTIS ImagingCatheter is intended for use invessels 2.0 to 3.5 mm indiameter. The Dragonfly™ DUOor Dragonfly™ OPTISImaging Catheter is not intendedfor use in the left main coronaryartery or in a target vessel whichhas undergone a previous bypassprocedure.	The ILUMIENT™ system witha compatible Dragonfly™imaging catheter is intendedfor the imaging of coronaryarteries and is indicated inpatients who are candidatesfor transluminalinterventional procedures.The compatible Dragonflyimaging catheters areintended for use in vessels 2.0to 3.5 mm in diameter. Thecompatible Dragonfly™imaging catheters are notintended for use in the leftmain coronary artery or in atarget vessel which hasundergone a previous bypassprocedure.
		The ILUMIEN imaging systemwill further acquire radiofrequency signal outputs fromboth a distal intracoronarypressure transducer and aproximal aortic pressuretransducer to determine thephysiological parameter,Fractional Flow Reserve (FFR).The physician may use the FFRparameter, along with knowledgeof patient history, medicalexpertise and clinical judgmentto determine if therapeuticintervention is indicated.	The ILUMIEN system isintended for use in thecatheterization and relatedcardiovascular specialtylaboratories and will furthercompute and display variousphysiological parametersbased on the output from oneor more electrodes,transducers, or measuringdevices. The physician mayuse the acquired physiologicalparameters, along withknowledge of patient history,medical expertise and clinicaljudgment to determine iftherapeutic intervention isindicated.
	Intended Use	Same as Indications for Use	The AptiVue™ D-seriessoftware is intended for use
Measurement& DisplayFeatures	OCT recordings, Pd/Parecordings and FFRphysiological waveforms	only with compatibleILUMIENT™ imagingsystems. The ILUMIENimaging system with acompatible Dragonfly™imaging catheter is intendedfor the imaging of coronaryarteries and is indicated inpatients who are candidatesfor transluminalinterventional procedures.
DesignModifications	NA	OCT recordings, Pd/Pa atrest, FFR, and RFRphysiological waveforms.Modifications to the softwareincluded the addition of a newphysiological index namedRFR and support for theDragonfly OpStar catheter
Feature	OPTIS Systems with AptiVueSoftware Version E.5(Secondary Predicate)	ILUMIENT™ Systems withAptiVue Software VersionD.3 (Proposed)
Indications forUse	The OPTIS imaging system witha compatible Dragonfly™imaging catheter is intended forthe imaging of coronary arteriesand is indicated in patients whoare candidates for transluminalinterventional procedures. Thecompatible Dragonfly™ imagingcatheters are intended for use invessels 2.0 to 3.5 mm indiameter. The compatibleDragonfly™ imaging cathetersare not intended for use in theleft main coronary artery or in atarget vessel which hasundergone a previous bypassprocedure.The OPTIS imaging system isintended for use in thecatheterization and relatedcardiovascular specialtylaboratories and will furthercompute and display variousphysiological parameters basedon the output from one or moreelectrodes, transducers, ormeasuring devices. Thephysician may use the acquiredphysiological parameters, alongwith knowledge of patient	The ILUMIENT™ imagingsystem with a compatibleDragonfly™ imaging catheteris intended for the imaging ofcoronary arteries and isindicated in patients who arecandidates for transluminalinterventional procedures.The compatible Dragonfly™imaging catheters areintended for use in vessels 2.0to 3.5 mm in diameter. Thecompatible Dragonfly™imaging catheters are notintended for use in the leftmain coronary artery or in atarget vessel which hasundergone a previous bypassprocedure.The ILUMIENT™ imagingsystem is intended for use inthe catheterization and relatedcardiovascular specialtylaboratories and will furthercompute and display variousphysiological parametersbased on the output from oneor more electrodes,transducers, or measuringdevices. The physician may

	Intended Use	The AptiVue™ E-seriessoftware is intended for use onlywith compatible OPTISTMimaging systems. OPTISTMimaging systems are intended foruse in the catheterization andrelated cardiovascular specialtylaboratories.	The AptiVue™ D-seriessoftware is intended for useonly with compatibleILUMIEN™ imagingsystems. The ILUMIENimaging system with acompatible Dragonfly™imaging catheter is intendedfor the imaging of coronaryarteries and is indicated inpatients who are candidatesfor transluminalinterventional procedures.
	Measurement& DisplayFeatures	OCT recordings, Pd/Parecordings, RFR and FFRphysiological waveforms	OCT recordings, Pd/Parecordings, RFR and FFRphysiological waveforms
	The modifications in the proposed D.3 software version do not affect the intended use ofthe ILUMIEN System with AptiVue D.3 software nor do they alter the fundamentalscientific technology of the system. There was no increase in existing risks with theaddition of the RFR feature. The same RFR feature that was cleared under K183320 forAptiVue software version E.5 on the OPTIS systems has been implemented in theproposed AptiVue software version D.3. The device user interface, overall functionality,the RFR feature and the risks associated with the overall implementation of the RFRalgorithm in the proposed D.3 software remain identical to the cleared AptiVue softwareversion E.5.
	Verification and Validation testing were completed to demonstrate safety andeffectiveness and ensure that the subject device performs as intended. Designverification and validation included the following:
Summary on Non-Clinical Testing	●	Software Verification and Validation - performed to ensure that the subjectdevice meets requirements and functions as intended● Usability Study - performed to evaluate the usability and possible use errorsthat may lead to patient safety issues with the introduction of the new featureson the graphical user interface
Summary of ClinicalTesting		No new clinical testing was completed, nor relied upon, in support of this Special510(k).
Statement ofEquivalence	ILUMIEN™ with AptiVue™ Version D.3 software is equivalent to the predicateILUMIEN™ system (K150237) for intended use, operational characteristics, andfundamental design of the device. Changes to technological characteristics of the devicedo no raise different questions of safety or effectiveness
		ILUMIEN™ with AptiVue™ Version D.3 software is equivalent to the OPTIS™systems with AptiVue™ Version E.5 software (K183320) for the Resting Full-CycleRatio physiological index.

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Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).