Ilumien Optis, Optis Integrated, Optis Mobile

K183320 · St. Jude Medical (Now Abbott Medical) · NQQ · Apr 2, 2019 · Radiology

Device Facts

• Record ID: K183320
• Device Name: Ilumien Optis, Optis Integrated, Optis Mobile
• Applicant: St. Jude Medical (Now Abbott Medical)
• Product Code: NQQ · Radiology
• Decision Date: Apr 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K183320 · Apr 2, 2019	Ilumien Optis, Optis Integrated, Optis Mobile	St. Jude Medical (Now Abbott Medical)	Prospective clinical study of real-world patients	A prospective study was performed to determine the diagnostic utility of RFR for the physiological assessment of coronary artery disease in real-world patients, demonstrating equivalence between RFR and iFR.	RFR; iFR; diagnostic utility; real-world patients

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
RFR Validation Study; Prospective study	Real-world patients undergoing physiological assessment of coronary artery disease	iFR-FFR hybrid approach	Diagnostic accuracy, percent positive agreement, percent negative agreement, PPV, NPV

Indications for 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.

Device Story

OPTIS imaging system performs Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures; used in catheterization and cardiovascular specialty laboratories by physicians. System inputs include OCT imaging data from Dragonfly catheters and pressure signals from transducers; processes signals to compute physiological parameters (FFR, RFR, Pd/Pa at rest). Output displayed on system monitor; assists physicians in assessing coronary lesion severity and determining need for therapeutic intervention. Benefits include improved diagnostic assessment of coronary artery disease without requiring hyperemic agents in all cases.

Clinical Evidence

Prospective study evaluated diagnostic utility of RFR in real-world patients. Results demonstrated equivalence between RFR and iFR. RFR-FFR hybrid method showed 93.6% diagnostic accuracy (91.1-95.6% CI) compared to 92.2% (89.5-94.4% CI) for iFR-FFR. Positive agreement 91.3% vs 88.8%; negative agreement 95.8% vs 95.4%.

Technological Characteristics

System performs OCT, FFR, and RFR. Uses Dragonfly imaging catheters. Software-based computation of physiological parameters from pressure transducers and electrodes. Connectivity via catheter interface to OPTIS console. Software version E.5.

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring coronary artery imaging (vessels 2.0-3.5 mm diameter). Contraindicated for use in the left main coronary artery or target vessels with previous bypass procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OPTIS Systems with E.4 Software (K160878)
• Volcano iFR® Modality (K133323)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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 &<br>Address | St. Jude Medical<br>One St. Jude Medical Drive<br>St. Paul, MN 55117 |
| Contact Person | Steve Vitale<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternative Contact<br>Person | Marlene Peterson<br>Senior Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Proprietary/Trade<br>Name | ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5 |
| Common/Usual Name | OPTIS or OPTIS Systems |
| Product Classification<br>Code | Product Code: NQQ |
| Product Regulation<br>Number and Name | 21 CFR 892.1560 |
| Device Class | II |
| Predicate Device | Primary: OPTIS Systems with E.4 Software (K160878), cleared 29 June 2016<br>Secondary: Volcano iFR® Modality (K133323), cleared 14 March 2014 |
| Device Description | OPTISTM with AptiVueTM Software (version E.5) perform Optical Coherence<br>Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio<br>(RFR) procedures and provide images of the coronary arteries in patients who are<br>candidates for transluminal interventional procedures. FFR, Pd/Pa at rest, and RFR<br>physiological waveforms measured by the system are used to assess the severity of a<br>coronary lesion by measuring the pressure drop across the lesion (distal vs proximal<br>pressure). |
| Indications for Use/<br>Intended Use | The OPTIS imaging system with a compatible DragonflyTM imaging catheter is intended<br>for the imaging of coronary arteries and is indicated in patients who are candidates for<br>transluminal interventional procedures. The compatible DragonflyTM imaging catheters<br>are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible DragonflyTM<br>imaging catheters are not intended for use in the left main coronary artery or in a target<br>vessel which has undergone a previous bypass procedure.<br>The OPTIS imaging system is intended for use in the catheterization and related<br>cardiovascular specialty laboratories and will further compute and display various<br>physiological parameters based on the output from one or more electrodes, transducers,<br>or measuring devices. The physician may use the acquired physiological parameters,<br>along with knowledge of patient history, medical expertise and clinical judgment to<br>determine 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<br>& Display | OCT recordings, FFR, Pd/Pa at<br>rest, and RFR physiological | OCT recordings, FFR and Pd/Pa<br>at rest physiological waveforms |
| Features | waveforms | |
| Table 2: OPTIST™ compared to Predicate (K133323) | | |
| Features | OPTIST™ Systems with AptiVue™<br>Version E.5 Software (Proposed<br>Device) | Volcano iFR® Modality - K133323<br>(Predicate Device) |
| Intended<br>Use | The AptiVue™ E-series software<br>is intended for use only with<br>compatible OPTIST™ imaging<br>systems. OPTIST™ imaging<br>systems are intended for use in the<br>catheterization and related<br>cardiovascular specialty<br>laboratories. | The Volcano<br>s5TM/s5i/CORE/CORETM Mobile<br>Precision Guided Therapy System is<br>used for the qualitative and<br>quantitative evaluation of vascular<br>morphology in the coronary arteries<br>and vessels of the peripheral<br>vasculature. It is also indicated as an<br>adjunct to conventional angiographic<br>procedures to provide an image of<br>vessel lumen and wall structures. |
| | | The pressure feature is intended for<br>use in all blood vessels, including<br>coronary and peripheral arteries, to<br>measure intravascular blood pressure<br>during diagnostic angiography and/or<br>interventional procedures |
| Indications<br>for Use | The OPTIS imaging system with a<br>compatible Dragonfly™ imaging<br>catheter is intended for the<br>imaging of coronary arteries and is<br>indicated in patients who are<br>candidates for transluminal<br>interventional procedures. The<br>compatible Dragonfly™ imaging<br>catheters are intended for use in<br>vessels 2.0 to 3.5 mm in diameter.<br>The compatible Dragonfly™<br>imaging catheters are not intended<br>for use in the left main coronary<br>artery or in a target vessel which<br>has undergone a previous bypass<br>procedure.<br>The OPTIS imaging system is<br>intended for use in the<br>catheterization and related<br>cardiovascular specialty<br>laboratories and will further<br>compute and display various<br>physiological parameters based on<br>the output from one or more<br>electrodes, transducers, or<br>measuring devices. The physician<br>may use the acquired<br>physiological parameters, along<br>with knowledge of patient history,<br>medical expertise and clinical<br>judgment to determine if | The iFR® Modality of the<br>s5/sSiCORE/CORE Mobile Precision<br>Guided Therapy System is indicated in<br>all blood vessels, including coronary<br>and peripheral arteries, to measure<br>intravascular blood pressure during<br>diagnostic angiography and/or<br>interventional procedures.<br>The iFR® Modality is intended to be<br>used in conjunction with currently<br>marketed Volcano pressure wires. |

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| | | therapeutic intervention is indicated. | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------|-------------------------|
| | Relevant<br>Display<br>Features | RFR resting full cycle ratio | iFR instant wave free ratio | |
| Summary on Non-<br>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 Clinical<br>Testing | 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).<br>RFR-FFR Hybrid Method Result Interpretation<br>The 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 Study<br>The 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%<br>[91.1%, 95.6%] | 92.2%<br>[89.5%, 94.4%] |
| | | Percent Positive Agreement | 91.3%<br>[86.9%, 94.5%] | 88.8%<br>[84.1%, 92.5%] |
| | | Percent Negative Agreement | 95.8%<br>[92.6%, 97.9%] | 95.4%<br>[92.1%, 97.6%] |
| | | PPV | 95.2%<br>[91.6%, 97.6%] | 94.7%<br>[90.9%, 97.2%] |
| | | NPV | 92.3%<br>[88.4%, 95.1%] | 90.2%<br>[86.1%, 93.5%] |
| | | Diagnostic Accuracy Outside the Grey Zone | 88.5%<br>[84.1%, 92.0%] | 86.8%<br>[82.4%, 90.4%] |
| | | Lesions free from Hyperemic Agents | 55.5%<br>[51.0%, 59.9%] | 58.9%<br>[54.4%, 63.2%] |
| | | Patients free from Hyperemic Agents | 50.8%<br>[46.0%, 55.6%] | 54.3%<br>[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). |