The OPTIS imaging 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 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 OPTIS imaging 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

OPTISTM with AptiVueTM Software (version E.5) 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

Here's an analysis of the acceptance criteria and study information for the ILUMIEN OPTIS with AptiVue Software version E.5, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the validation of the Resting Full-cycle Ratio (RFR) feature, comparing its diagnostic performance against Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR). The acceptance criteria are implicitly defined by achieving comparable diagnostic accuracy and agreement metrics.

Metric (vs FFR)	Acceptance Criteria (Implicit: Comparable to iFR-FFR)	Reported Device Performance (RFR-FFR)
Diagnostic Accuracy	Comparable to 92.2% [89.5%, 94.4%]	93.6% [91.1%, 95.6%]
Percent Positive Agreement	Comparable to 88.8% [84.1%, 92.5%]	91.3% [86.9%, 94.5%]
Percent Negative Agreement	Comparable to 95.4% [92.1%, 97.6%]	95.8% [92.6%, 97.9%]
Positive Predictive Value (PPV)	Comparable to 94.7% [90.9%, 97.2%]	95.2% [91.6%, 97.6%]
Negative Predictive Value (NPV)	Comparable to 90.2% [86.1%, 93.5%]	92.3% [88.4%, 95.1%]
Diagnostic Accuracy Outside the Grey Zone	Comparable to 86.8% [82.4%, 90.4%]	88.5% [84.1%, 92.0%]
Lesions free from Hyperemic Agents	Comparable to 58.9% [54.4%, 63.2%]	55.5% [51.0%, 59.9%]
Patients free from Hyperemic Agents	Comparable to 54.3% [49.5%, 59.1%]	50.8% [46.0%, 55.6%]

2. Sample Size and Data Provenance:

The document does not explicitly state the exact sample size for the test set. However, it refers to a "prospective study... of RFR for the physiological assessment of coronary artery disease in real-world patients." The confidence intervals provided in the table, such as "91.1%, 95.6%" for diagnostic accuracy, indicate a substantial number of cases. Given the context of a 510(k) summary, specific details on country of origin are typically not provided, but the language suggests a clinical trial setting. The study was prospective.

3. Number of Experts and Qualifications:

The document does not specify the number of experts used to establish the ground truth for the test set, nor their qualifications.

4. Adjudication Method:

The document does not explicitly describe an adjudication method for the test set. It outlines a "RFR-FFR Hybrid Method Result Interpretation" which includes a grey zone where the decision would be "based on FFR." This implies FFR serves as the primary ground truth, and the RFR values are being compared against it.

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

No MRMC study is mentioned. The document focuses on the performance of the RFR algorithm itself compared to established physiological indices (FFR and iFR). There is no information provided regarding the effect size of human readers improving with AI assistance vs. without AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was done. The "Summary of RFR Validation Study" directly compares the diagnostic accuracy and agreement metrics of the RFR algorithm (standalone, or hybrid with FFR for the grey zone) against FFR as the gold standard, and against iFR-FFR for equivalence.

7. Type of Ground Truth Used:

The ground truth used is primarily Fractional Flow Reserve (FFR). For the RFR-FFR hybrid method, when RFR falls within a defined grey zone (0.86 ≤ RFR ≤ 0.93), the decision is explicitly stated to be "based on FFR." Therefore, FFR serves as the reference standard for determining ischemia-causing lesions.

8. Sample Size for the Training Set:

The document does not provide information about the sample size for the training set used to develop the AptiVue Software.

9. How the Ground Truth for the Training Set was Established:

The document does not provide information on how the ground truth for the training set was established. It describes the validation study of the RFR feature, not the development process of the software.

Summary

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April 2, 2019

Abbott Medical Steve Vitale Regulatory Project Manager One St. Jude Medical Drive St. Paul, Minnesota 55117

Re: K183320

Trade/Device Name: ILUMIEN OPTIS. OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NOO Dated: March 7, 2019 Received: March 8, 2019

Dear Steve Vitale:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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

Sincerely,

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183320

Device Name

ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5

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) Summary
Per 21 CFR §807.92
510(k) Number	K183320
Date Prepared	27 November 2018
Submitter Name &Address	St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN 55117
Contact Person	Steve VitaleRegulatory Affairs SpecialistPhone: (651) 756-2420Fax: (651) 756-3301Email: steve.vitale@abbott.com
Alternative ContactPerson	Marlene PetersonSenior Regulatory Affairs ManagerPhone: (651) 756-3268Fax: (651) 756-3301Email: marlene.peterson@abbott.com
Proprietary/TradeName	ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5
Common/Usual Name	OPTIS or OPTIS Systems
Product ClassificationCode	Product Code: NQQ
Product RegulationNumber and Name	21 CFR 892.1560
Device Class	II
Predicate Device	Primary: OPTIS Systems with E.4 Software (K160878), cleared 29 June 2016Secondary: Volcano iFR® Modality (K133323), cleared 14 March 2014
Device Description	OPTISTM with AptiVueTM Software (version E.5) 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 OPTIS imaging system with a compatible DragonflyTM imaging catheter is intendedfor the imaging of coronary arteries and is indicated in patients who are candidates fortransluminal interventional procedures. The compatible DragonflyTM imaging cathetersare intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible DragonflyTMimaging catheters are not intended for use in the left main coronary artery or in a targetvessel which has undergone a previous bypass procedure.The OPTIS imaging 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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Features	OPTIST™ Systems with AptiVue™ Version E.5 Software (Proposed Device)	OPTIST™ Systems with version E.4 Software (K160878) (Predicate Device)
Intended Use	The AptiVue™ E-series software is intended for use only with compatible OPTIST™ imaging systems. OPTIST™ imaging systems are intended for use in the catheterization and related cardiovascular specialty laboratories.	The AptiVue™ E-series software is intended for use only with compatible OPTIST™ imaging systems. OPTIST™ imaging systems are intended for use in the catheterization and related cardiovascular specialty laboratories.
Indications for Use/ Intended Use	The OPTIS imaging 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 OPTIS imaging 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	The OPTIS imaging system with Dragonfly™ DUO or Dragonfly™ OPTIST™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ DUO or Dragonfly™ OPTIST™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ DUO or Dragonfly™ OPTIST™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS imaging system will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated
Measurement& Display	OCT recordings, FFR, Pd/Pa atrest, and RFR physiological	OCT recordings, FFR and Pd/Paat rest physiological waveforms
Features	waveforms
Table 2: OPTIST™ compared to Predicate (K133323)
Features	OPTIST™ Systems with AptiVue™Version E.5 Software (ProposedDevice)	Volcano iFR® Modality - K133323(Predicate Device)
IntendedUse	The AptiVue™ E-series softwareis intended for use only withcompatible OPTIST™ imagingsystems. OPTIST™ imagingsystems are intended for use in thecatheterization and relatedcardiovascular specialtylaboratories.	The Volcanos5TM/s5i/CORE/CORETM MobilePrecision Guided Therapy System isused for the qualitative andquantitative evaluation of vascularmorphology in the coronary arteriesand vessels of the peripheralvasculature. It is also indicated as anadjunct to conventional angiographicprocedures to provide an image ofvessel lumen and wall structures.
		The pressure feature is intended foruse in all blood vessels, includingcoronary and peripheral arteries, tomeasure intravascular blood pressureduring diagnostic angiography and/orinterventional procedures
Indicationsfor Use	The OPTIS imaging system with acompatible Dragonfly™ imagingcatheter is intended for theimaging of coronary arteries and isindicated in patients who arecandidates for transluminalinterventional procedures. Thecompatible Dragonfly™ imagingcatheters are intended for use invessels 2.0 to 3.5 mm in diameter.The compatible Dragonfly™imaging catheters are not intendedfor use in the left main coronaryartery or in a target vessel whichhas undergone a previous bypassprocedure.The OPTIS imaging system isintended for use in thecatheterization and relatedcardiovascular specialtylaboratories and will furthercompute and display variousphysiological parameters based onthe output from one or moreelectrodes, transducers, ormeasuring devices. The physicianmay use the acquiredphysiological parameters, alongwith knowledge of patient history,medical expertise and clinicaljudgment to determine if	The iFR® Modality of thes5/sSiCORE/CORE Mobile PrecisionGuided Therapy System is indicated inall blood vessels, including coronaryand peripheral arteries, to measureintravascular blood pressure duringdiagnostic angiography and/orinterventional procedures.The iFR® Modality is intended to beused in conjunction with currentlymarketed Volcano pressure wires.

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		therapeutic intervention is indicated.
	RelevantDisplayFeatures	RFR resting full cycle ratio	iFR instant wave free ratio
Summary on Non-Clinical Testing	Verification and Validation testing were completed to demonstrate safety and effectiveness and ensure that the subject device performs as intended. Design verification and validation included the following: Software Verification and Validation - performed to ensure that the subject device meets requirements and functions as intended Usability Study - performed to evaluate the usability and possible use errors that may lead to patient safety issues with the introduction of the new features on the graphical user interface
Summary of ClinicalTesting	No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k). However, a prospective study was performed to determine the diagnostic utility of RFR for the physiological assessment of coronary artery disease in real world patients. The results of the study showed equivalence between resting full-cycle ratio (RFR) and instantaneous wave-free ratio (iFR).RFR-FFR Hybrid Method Result InterpretationThe following gray zone and criteria for determining positive (ischemia causing) and negative (non-ischemia causing) were used for RFR result interpretation: RFR < 0.86: Positive (ischemia causing) 0.86 ≤ RFR ≤ 0.93: Gray zone, decision will be based on FFR FFR ≤ 0.8: Positive (ischemia causing) FFR > 0.8: Negative (non-ischemia causing) RFR > 0.93: Negative (non-ischemia causing) Summary of RFR Validation StudyThe results of the study showed comparable diagnostic accuracy, percent positive agreement, percent negative agreement, PPV, and NPV values between the RFR-FFR and iFR-FFR hybrid approaches (reference Table 3).
		Table 3: Summary of RFR Validation Results	RFR-FFR	iFR-FFR
		Diagnostic Accuracy	93.6%[91.1%, 95.6%]	92.2%[89.5%, 94.4%]
		Percent Positive Agreement	91.3%[86.9%, 94.5%]	88.8%[84.1%, 92.5%]
		Percent Negative Agreement	95.8%[92.6%, 97.9%]	95.4%[92.1%, 97.6%]
		PPV	95.2%[91.6%, 97.6%]	94.7%[90.9%, 97.2%]
		NPV	92.3%[88.4%, 95.1%]	90.2%[86.1%, 93.5%]
		Diagnostic Accuracy Outside the Grey Zone	88.5%[84.1%, 92.0%]	86.8%[82.4%, 90.4%]
		Lesions free from Hyperemic Agents	55.5%[51.0%, 59.9%]	58.9%[54.4%, 63.2%]
		Patients free from Hyperemic Agents	50.8%[46.0%, 55.6%]	54.3%[49.5%, 59.1%]

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Statement of	OPTISTTM with AptiVueTM Version E.5 software is equivalent to the predicate OPTISTTM system (K160878) for intended use, operational characteristics, and fundamental design of the device. Changes to technological characteristics of the device do no raise different questions of safety or effectiveness
Equivalence	OPTISTTM with AptiVueTM Version E.5 software is equivalent to the Philips' Volcano iFR® Modality (K133323) for the Resting Full-Cycle Ratio physiological index (see Table 2).

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. 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). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.