s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System

K173860 · Volcano Corporation · IYO · Apr 11, 2018 · Radiology

Device Facts

• Record ID: K173860
• Device Name: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
• Applicant: Volcano Corporation
• Product Code: IYO · Radiology
• Decision Date: Apr 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Volcano s5™/s5i/CORE™ Mobile Precision Guided Therapy System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm. The FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used for a pullback assessment, the iFR modality is intended as a visual aid in decision making by indicating the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

Device Story

System provides intravascular imaging and pressure measurement for coronary and peripheral vasculature. Inputs include ultrasound signals from imaging catheters and pressure data from compatible pressure wires. System processes signals to provide qualitative/quantitative morphology, blood flow (ChromaFlo), and pressure indices (FFR, iFR). Used in cath labs by physicians to guide revascularization. iFR modality uses 0.89 cut-point to identify ischemia, replacing hybrid strategies. Output displayed on monitors to assist in lesion assessment and procedural decision-making. Benefits include reduced need for adenosine-mediated hyperemia and associated patient discomfort.

Clinical Evidence

Supported by ADVISE II, DEFINE-FLAIR, and iFR-SWEDEHEART studies. ADVISE II (n=not specified) showed iFR 0.89 cut-point matches FFR 0.80 (sensitivity 73.0%, specificity 87.8%, AUC 0.90). DEFINE-FLAIR (n=2492) and iFR-SWEDEHEART (n=2017) were prospective randomized trials comparing iFR vs FFR. Primary endpoint (mortality, MI, unplanned revascularization at 12 months) met non-inferiority. iFR showed significant reduction in adenosine-related adverse symptoms (3.0% vs 68.3% in iFR-SWEDEHEART; 3.1% vs 30.8% in DEFINE-FLAIR, p<0.001).

Technological Characteristics

Mobile imaging/pressure system. Components: PIM, custom PCI boards, bedside/control room monitors, pressure wires (SmartWire II, PrimeWire, Verrata). Connectivity: Ethernet (DICOM), USB. Software: FFR v2.5. Electrical safety: Defibrillation-proof isolation via optical isolators and 5KV transformers. Operating range: 10-35°C, 10-95% RH.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures in coronary and peripheral vasculature. Used for evaluation of vascular morphology, blood flow, and intravascular pressure measurement. iFR modality indicated for coronary revascularization decision-making using a 0.89 ischemic threshold cut-point.

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

• Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System (K133323)
• FFR v2.5 (K170133)

Reference Devices

• K133641
• K140291
• K150441
• K153369

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 11, 2018

Volcano Corporation Christopher McLellan Manager. Regulatory Affairs 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K173860

Trade/Device Name: s5/s5i/CORE/CORE Mobile Precision Guided Therapy System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: March 9, 2018 Received: March 12, 2018

Dear Christopher McLellan:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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, M & Thillel 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) K173860

### Device Name

Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System

### Indications for Use (Describe)

The Volcano System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm.

The FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure angiography and/or interventional procedures.

The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

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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### Submitter l.

Volcano Corporation

3721 Valley Center Drive San Diego, CA 92130

Contact Person: Kimberly Simon

Telephone: [phone] E-mail: [e-mail]

Date Prepared: December 19, 2017

### II. Device

| Name of Device: | Volcano s5 ™ /s5i/CORE/CORE™ Mobile Precision Guided<br>Therapy System |
|-----------------------|------------------------------------------------------------------------|
| Common or Usual Name: | Ultrasonic pulsed echo imaging system. |
| Classification Name: | System, Imaging, Pulsed Echo, Ultrasonic (21 CFR 892.1560) |
| Regulatory Class: | II |
| Product Code: | IYO |

#### III. Predicate Device

Volcano s5 ™/s5i/CORE/CORE™ Mobile Precision Guided Therapy System (K133323).

## Secondary Predicate Device

FFR v2.5 (K170133)

Reference Submissions for the Volcano s5 ™/s5i/CORE/CORE™ Mobile Precision Guided Therapy System:

- K133641
- . K140291
- K150441
- K153369

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#### IV. Device Description

The Volcano s5 TM/s5i/CORETM Mobile Precision Guided Therapy System is a mobile imaging and pressure management system as previously described in K133323. The subject device incorporates the Volcano iFR® Modality cleared in K133323.

Pressure measurement is captured through the use of currently marketed pressure wires compatible with the currently marketed s5/s5i/CORE/CORE Mobile imaging and pressure measurement system.

### V. Indications for Use

The Volcano s5™/s5i/CORE™ Mobile Precision Guided Therapy System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

The FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic

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catheterization procedure. When used for a pullback assessment, the iFR modality is intended as a visual aid in decision making by indicating the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

#### VI. Comparison with the Predicate Device

The predicate device is the currently marketed Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System iFR Modality (cleared under K133323 with the same trade name). This submission is for a change in the indications for use of the currently marketed device. The indications for use for the iFR Modality of the subject device has been revised to reflect the currently recognized, and clinically supported physiological, dichotomous 0.89 intravascular pressure index from a hybrid approach of 0.75 – 0.80 to provide information to help inform decisions on whether to perform or defer percutaneous coronary intervention (PCl). In the coronary anatomy, the iFR Modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization during diagnostic catheterization procedure. When used for a pullback assessment, the iFR modality is intended as a visual aid in decision making by indicating the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The Volcano FFR and iFR Modality Operator's Manual is being revised to include a dichotomous cutpoint for Instantaneous Wave-free Ratio (iFR) guidance in coronary revascularization decision-making to replace the hybrid approach described in the Volcano FFR and iFR Modality Operator's Manual of the currently marketed device. There are no changes to the device materials or intended use.

The Volcano s5/s5i/CORE Mobile Intravascular Imaging and Pressure System and the predicate device share the same intended use. These devices are software measure blood pressure in the coronary and peripheral vasculature.

The Volcano s5™/s5i/CORE™ Mobile Precision Guided Therapy System and the predicate device share the same general operating principal. Both devices use the same pressure wires and are both compatible with only the Volcano imaging and pressure systems.

Volcano s5™/s5i/CORE/CORE™ Mobile Precision Guided Therapy System and the predicate device share the same technological features.

The only difference between the Volcano s5/s5i/CORE/CORE Mobile Intravascular Imaging and Pressure System with iFR "Modality and the predicate device is the indications for use. The indications for use for the iFR Modality of the subject device has been changed to measure intravascular blood pressure using the iFR Modality diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used for a pullback assessment, the iFR modality is intended as a visual aid in decision making by indicating the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The similarities between the subject Volcano s5/s5i/CORE/CORE Mobile Intravascular Imaging and Pressure System and the predicate device are illustrated in the table below.

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| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision<br>Guided Therapy System iFR Modality – K133323<br>(Predicate Device) | Volcano s5/s5i/CORE/CORE<br>Mobile Precision Guided<br>Therapy System<br>(Subject Device) |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The iFR Modality of the s5™/s5i/CORE/CORE™<br>Mobile Series Precision Guided Therapy System is<br>indicated in all blood vessels, including coronary<br>and peripheral arteries, to measure intravascular<br>blood pressure during diagnostic angiography<br>and/or interventional procedures. The iFR Modality<br>is intended to be used in conjunction with<br>currently marketed Volcano pressure wires. | The Volcano<br>s5™/s5i/CORE/CORE™ Mobile<br>Precision Guided Therapy<br>System is used for the<br>qualitative and quantitative<br>evaluation of vascular<br>morphology in the coronary<br>arteries and vessels of the<br>peripheral vasculature. It is<br>also indicated as an adjunct to<br>conventional angiographic<br>procedures to provide an<br>image of vessel lumen and wall<br>structures.<br>ChromaFlo is indicated for<br>qualitative blood flow<br>information from peripheral<br>and coronary vasculature; flow<br>information can be an adjunct<br>to other methods of estimating<br>blood flow and blood<br>perfusion.<br>VH IVUS is intended to be used<br>in conjunction with imaging<br>catheters during diagnostic<br>ultrasound imaging of the<br>peripheral and coronary<br>vasculature. The Volcano VH<br>IVUS System is intended to<br>semi-automatically visualize<br>boundary features and perform<br>spectral analysis of RF<br>ultrasound signals of vascular<br>features that the user may wish |
| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision<br>Guided Therapy System iFR Modality – K133323<br>(Predicate Device) | Volcano s5/s5i/CORE/CORE<br>Mobile Precision Guided<br>Therapy System<br>(Subject Device) |
| | | routine diagnostic ultrasound<br>imaging examinations.<br>The pressure feature is<br>intended for use in all blood<br>vessels, including coronary and<br>peripheral arteries, to measure<br>intravascular blood pressure<br>during diagnostic angiography<br>and/or interventional<br>procedures.<br>Rotational 45MHz feature is<br>intended for the qualitative<br>and quantitative evaluation of<br>vascular morphology in the<br>coronary arteries and<br>vasculature as an adjunct to<br>conventional angiographic<br>procedures to provide an<br>image of the vessel lumen and<br>the wall structures. The<br>Pullback feature of the PIMr<br>withdraws the imaging core<br>within the protective sheath for<br>a maximum of 15 cm.<br>The FFR v2.5 Modality of the<br>s5/s5i/CORE and CORE Mobile<br>Precision Guided Therapy<br>System is indicated in all blood<br>vessels, including coronary and<br>peripheral arteries, to measure<br>intravascular blood pressure<br>during diagnostic angiography<br>and/or interventional<br>procedures. |
| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision<br>Guided Therapy System iFR Modality – K133323<br>(Predicate Device) | Volcano s5/s5i/CORE/CORE<br>Mobile Precision Guided<br>Therapy System<br>(Subject Device) |
| | | The iFR Modality is intended to<br>be used in conjunction with<br>currently marketed Volcano<br>pressure wires. In the coronary<br>anatomy, the iFR modality has<br>a diagnostic cut-point of 0.89,<br>which represents an ischemic<br>threshold and can reliably<br>guide revascularization<br>decisions during diagnostic<br>catheterization procedure.<br>When used for a pullback<br>assessment, the iFR modality is<br>intended as a visual aid in<br>decision making by indicating<br>the relative location and<br>severity of the stenoses such<br>as, multiple lesions or diffuse<br>disease. |
| Pressure Wires | SmartWire II, PrimeWire, PrimeWire Prestige,<br>PrimeWire Prestige Plus, Verrata, Verrata PLUS | SAME |
| Patient Isolation | Contained in the Patient Interface Module (PIM):<br>Electronic and Electrical Defibrillation proof<br>Isolation through 8mm bare fiberglass PCA<br>creepage with optical isolators and specially<br>wound transformers with 5KV insulation. | SAME |
| Environmental<br>Operating<br>Temperature,<br>Humidity and<br>Pressure Range | Operating Temperature: +10°C to +35°C Operating / Storage Humidity: 10% ≤ RH ≤ 95% Non-condensing Operating Pressure Range: 70-106kPa (526.3 – 797 mmHG) Storage Pressure Range: 50-106kPa (376 – 797 mmHg) | SAME |
| Display | Control room | SAME |
| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision<br>Guided Therapy System iFR Modality – K133323<br>(Predicate Device) | Volcano s5/s5i/CORE/CORE<br>Mobile Precision Guided<br>Therapy System<br>(Subject Device) |
| | 19" Non-medical grade powered through an<br>isolation transformer<br>Exam room | |
| | Use an existing Monitor in "Monitor Bank" Add a 19: non-medical grade to the x-ray boom (requires isolated power) 15" or 17" DC Powered Medical Grade Monitor mounted on the patient exam table 19" Monitor mounted on an additional boom (requires isolated power) | |
| User Controls | Control Console<br>Custom control panel that can be placed in control room or mounted bedside Touch Pad Custom touch pad that is mounted bedside Joy Stick Custom joystick that can be mounted bedside | SAME |
| Signal Processing | Base Band (identical custom PCI boards used) | SAME |
| FFR | Through identical custom PCI board | SAME |
| iFR® | Through identical custom PCI board (same custom PCI board as used for FFR) | SAME |
| Inputs | 100-240 VAC 50/60Hz Power Catheter/PIM connection ECG. Aortic high-level (from hemodynamic system) Ethernet (for DICOM Worklist) USB (for control devices) PS2 (for control devices) Touchpad | SAME |
| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision<br>Guided Therapy System iFR Modality – K133323<br>(Predicate Device) | Volcano s5/s5i/CORE/CORE<br>Mobile Precision Guided<br>Therapy System<br>(Subject Device) |
| | - Joystick | |
| Outputs | - Monitor display: 1280 x 1024 resolution<br>- 19" Monitor<br>- 19" Boom Monitor<br>- 17" Bedside Monitor<br>- Printer | SAME |
| Patient Interface<br>Module (PIM) | Compatible with Digital IVUS, Rotational IVUS, FFR<br>Pimmette | SAME |
| Connection to PIMs | Via direct connection to CPU or Connection Box | SAME |
| Accessories and<br>Peripherals | Bedside Touchpad Controller, Joystick Controller,<br>Connection Box, Control Console | SAME |
| Imaging<br>Specifications | Imaging boards and software | SAME |
| FFR Software<br>(includes iFR<br>Modality) | FFR Software Version v2.3 | FFR Software Version v2.5<br>(cleared in K170133) |

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### VII. Performance Data

The subject device is the same as the currently marketed predicate device. There are no changes to the pressure measurement wires for collection of data using the iFR" Modality. Performance data establishing the electrical safety and electromagnetic compatibility (EMC) of the device was previously reviewed in K133641 and K140291.

### VIII. Clinical Data

Clinical evidence suggests the adoption of a dichotomous cut-point for Instantaneous Wave-free Ratio (iFR) guidance in coronary revascularization decision-making rather than the use of a hybrid approach as was previously documented in the Volcano FFR and iFR Modality Operator's Manual.

The clinical data submitted to support the proposed modifications is documented in the ADVISE II, DEFINE-FLAIR and iFR SWEDEHEART studies. The ADVISE II study demonstrated that Traditional 510(k) for Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System

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an iFR cut-point of 0.89 matches best with an FFR ischemic cut-point of 0.80 with a specificity of 87.8% and sensitivity of 73.0% (C statistic: 0.90 (95% confidence interval (CI): 0.88 to 0.92, p < 0.001]).1

The use of this dichotomous cut-point for iFR-guided revascularization was compared to FFR-guided revascularization in two large prospective randomized controlled trials. 3 DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization) enrolled 2492 patients with coronary artery disease in a 1:1 ratio to undergo revascularization using either FFR or iFR-guidance. The second study, iFR-SWEDEHEART (Instantaneous Wave-free Ratio versus Fractional Flow Reserve in Patients with Stable Angina Pectoris or Acute Coronary Syndrome) was similar; it enrolled 2017 patients with coronary artery disease included in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). The registry contains data on patients from all 30 coronary intervention centers in Sweden plus a single site in Iceland.

Both studies had a primary end-point that was the composite rate of all-cause mortality, non-fatal myocardial infarction or unplanned revascularization within 12 months after the index procedure. The non-inferiority margin was 3.4 in DEFINE-FLAIR, and 3.2 in iFR-SWEDEHEART. Both studies met their respective primary endpoint by demonstrating non-inferiority at 12 months:

| DEFINE-FLAIR: | 6.8% (iFR) vs 7.0% (FFR); D = -0.2%; 95% CI, -2.3 to 1.8; P<0.001 |
|-----------------|-------------------------------------------------------------------|
| iFR-SWEDEHEART: | 6.7% (iFR) vs 6.1% (FFR); D = 0.7; 95% CI, -1.5-2.8, P=0.007 |

Both studies also demonstrated a significant reduction in adverse effects associated with the adenosine-mediated hyperemia required for FFR-guidance. 68.3% of patients in the FFR arm of iFR-SWEDEHEART reported chest discomfort, while only 3.0% of patients in the iFR arm reported any chest discomfort (P<0.001). Similarly, DEFINE-FLAIR patients in the FFR group reported adverse procedural signs or symptoms in 30.8% of cases compared to 3.1% in the iFR group (P<0.001).

The iFR guided procedures demonstrated a significant reduction in acute adverse signs or symptoms associated with the adenosine-mediated hyperemia required for FFR. The use of iFR in stable ischemic heart disease is now considered appropriate by the major American cardiology societies. A hybrid iFR-FFR strategy is thus outdated.

⁴ Escaned J, Echavarria-Pinto M, Garcia HM, et. al. Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II). JACC Cardiovasc Interv. 2015 May;8(6):824-33.

² Davies JE, Sen S, Dehbi H-M, et. al. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834.

³ Götberg M, Christiansen EH, Gudmundsdottir IJ, et al. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823.

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### IX. Conclusions

Based upon the information submitted in this premarket notification 510(k), the Volcano s5™/s5i/CORE/CORE™ Mobile Precision Guided Therapy System is substantially equivalent to the currently marketed predicate devices.