VOLCANO IFR MODALITY

K133323 · Volcano Corporation · IYO · Mar 14, 2014 · Radiology

Device Facts

• Record ID: K133323
• Device Name: VOLCANO IFR MODALITY
• Applicant: Volcano Corporation
• Product Code: IYO · Radiology
• Decision Date: Mar 14, 2014
• 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
K133323 · Mar 14, 2014	VOLCANO IFR MODALITY	Volcano Corporation	Prospective, observational, multi-center registry (ADVISE II)	The ADVISE II registry was used to evaluate the diagnostic utility of the iFR modality in assessing coronary stenosis relevance compared to FFR in a real-world clinical setting.	Registry; Real-world registry; Coronary stenosis; Diagnostic utility

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
ADVISE II (Adenosine Vasodilator Independent Stenosis Evaluation); Prospective, observational, non-randomized, double blind, global, multi-center registry	Patients with coronary stenoses between 40-90% by visual assessment on angiography; Sample Size: 690 lesions; Number of Sites: Multi-center	Fractional Flow Reserve (FFR)	Diagnostic accuracy of iFR compared to FFR; assessment of clinical value of iFR to characterize coronary stenosis severity

Indications for Use

The iFR® Modality of the s5/s5i/CORE/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.

Device Story

Volcano iFR Modality is software for the s5/s5i/CORE/CORE Mobile Precision Guided Therapy System. It processes intravascular pressure signals collected via compatible pressure wires during diagnostic or interventional procedures. The software isolates the cardiac wave cycle where intracoronary resistance is naturally constant and minimized, and flow is maximized. This allows for pressure measurement without the administration of hyperemic agents (e.g., adenosine). The system is used in clinical settings by physicians. The output is a pressure measurement (iFR value) displayed to the clinician, which is used to assess coronary stenosis severity. A 'Hybrid' approach is utilized: if iFR values fall within a specific range (0.86–0.93), the clinician performs FFR with a hyperemic agent to determine lesion category; otherwise, the iFR value alone is used. This reduces the need for hyperemic agents in a significant portion of patients, potentially improving procedural efficiency and patient comfort.

Clinical Evidence

Clinical evidence provided by the ADVISE II registry (N=690 lesions). Study compared iFR hybrid approach (iFR ≤ 0.85 or ≥ 0.94) against FFR (≤ 0.80) as the reference standard. Results: Sensitivity 90.7% (95% CI: 86.4%–94.0%), Specificity 96.2% (95% CI: 93.9%–97.7%), and Diagnostic Accuracy 94.2% (95% CI: 92.2%–95.8%). The hybrid approach avoided hyperemic agent administration in 65.1% of patients.

Technological Characteristics

Software-based modality for existing Volcano s5/s5i/CORE/CORE Mobile imaging and pressure measurement systems. Uses existing compatible pressure wires. Operates by signal processing of intravascular pressure data to identify the wave-free period of the cardiac cycle. No changes to hardware or pressure measurement wires.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures in coronary or peripheral arteries requiring intravascular blood pressure measurement.

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 (K123898)

Submission Summary (Full Text)

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K133323

# 510(K) SUMMARY

| SPONSOR: | Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Neeta Sharma<br>Director, Regulatory Affairs<br>Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130<br>Tel: [phone]<br>Fax: [phone] |
| DATE PREPARED: | March 12, 2014 |
| DEVICE: | Volcano iFR® Modality |
| TRADE NAME: | Volcano iFR® Modality |
| COMMON NAME: | Ultrasonic Pulsed Echo Imaging System |
| CLASSIFICATION: | 21 CFR Part 892.1560<br>IYO: System, Imaging, Pulsed Echo, Ultrasonic<br>Class II Device |
| PREDICATE DEVICE: | Volcano s5/s5i/CORE/CORE Mobile Precision Guided<br>Therapy System (K123898) |
| DEVICE DESCRIPTION: | The Volcano iFR® Modality is new software that calculates<br>blood pressures in the coronary and peripheral vasculature<br>through isolation of the cardiac wave cycle where<br>intracoronary resistance is naturally constant and<br>minimized and where intracoronary flow is maximized.<br>This results in the ability to measure pressure without the<br>administration of a hyperemic agent.<br><br>Pressure measurement is captured through the use of<br>currently marketed pressure wires compatible with the<br>currently marketed s5/s5i/CORE/CORE Mobile imaging<br>and pressure measurement system. |
| INTENDED USE: | The Volcano s5™/s5i/CORE/CORE™ Mobile Precision<br>Guided Therapy System is used for the qualitative and<br>quantitative evaluation of vascular morphology in the |

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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.

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

## COMPARISON OF CHARACTERISTICS:

## PERFORMANCE DATA:

Performance testing completed for a determination of substantial equivalence included the following:

The proposed device the same as the currently marketed

changes to the pressure measurement wires for collection of

device with the exception of software. There are no

- . Software Validation
data using the iFR® Modality.

- Repeatability and Reproducibility of measurements
- . Clinical Data

One primary clinical study was used to provide clinical data in support of the iFR® modification. ADVISE II (Adenosine Vasodilator Independent Stenosis Evaluation) was a prospective, observational, non-randomized, double blind, global, multi-center registry sponsored by Volcano Corporation investigating the diagnostic utility of iFR in assessing coronary stenosis relevance (NCT01740895). The purpose of this registry was to assess the clinical value of iFR to characterize, without concomitant administration of hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as determined with fractional flow reserve (FFR).

In ADVISE II, data were obtained in patients with coronary stenoses between 40-90% by visual assessment on angiography. These lesions were interrogated by FFR assessment with a Volcano Corporation pressure wire. A per lesion analysis was recorded with both baseline and hyperemic measurements. The baseline recording was used to calculate iFR at the core lab using the HARVEST software (investigators were blinded to the iFR results). This iFR value was compared with the FFR value measured in the same recording during maximal hyperemia. The FFR assessment was obtained using standard guidelines for the FFR procedure with the patient's heart being functionally stressed by a hyperemic agent called adenosine at 140 mcg/kg/min.

## Study Results

Of the 690 lesions assessed in the ADVISE II analysis the patient characteristics were: mean age was 63.6 + 10.8, 68.8% were Male, 77.9% with Hypertension, 34.6% had Diabetes, 21.6% were

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Smokers and 33.9% had a prior MI. The clinical presentations of the patients varied with the majority (50.3%) presenting with stable angina and 25.4% presenting with unstable angina. 18.4% of patients had presented with myocardial ischemia in a non-invasive stress test, 3.3% presenting with a STEMI that was more than 48 hours, 5.5% presenting with an NSTEMI more than 48 hours and 7.7% deemed "Other."

The counts provided in the cells of the below 2x3 matrix were provided by the study core laboratory. The Hybrid approach specifies that, for iFR values between and including 0.86 and 0.93, FFR is performed to determine lesion category. Hence, the 114 lesions in the top cell of the center column are categorized as "negative" because FFR is >0.80; conversely, the 99 lesions in the bottom cell of the center column are categorized as "positive" because FFR is ≤ 0.80.

Image /page/2/Figure/3 description: The image is a matrix comparing negative and positive FFR and iFR values. For negative FFR (>0.80) and negative iFR (≥ 0.94), the value is 311. For negative FFR and the FFR Zone (iFR 0.86 to 0.93), the value is 114, and for negative FFR and positive iFR (≤ 0.85), the value is 17. For positive FFR (≤ 0.80) and negative iFR, the value is 23, for positive FFR and the FFR Zone, the value is 99, and for positive FFR and positive iFR, the value is 126.

Two hundred and forty eight (248) lesions were ischemic as determined by the reference method (FFR ≤ 0.80); of these 225 were properly categorized by the Hybrid method: there were 23 false negatives. Four hundred and forty two (442) lesions were not ischemic as determined by the reference method (FFR > 0.80); of these, 425 were properly categorized by the Hybrid method; there were 17 false positive lesions.

The overall accuracy of sensitivity, specificity, positive value, negative predictive value and diagnostic accuracy were:

| Parameter | Estimate | 95% CI |
|---------------------------|-----------------|----------------|
| Sensitivity | 90.7% (225/248) | [86.4%, 94.0%] |
| Specificity | 96.2% (425/442) | [93.9%, 97.7%] |
| Positive Predictive Value | 93.0% (225/242) | [89.0%, 95.9%] |
| Negative Predictive Value | 94.9% (425/448) | [92.4%, 96.7%] |
| Diagnostic Accuracy | 94.2% (650/690) | [92.2%, 95.8%] |

Note: All iFR values falling within the FFR Zone were deferred to FFR for determination of treatment and were therefore accounted for as true positives or true negatives per FFR criteria.

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These lesions (or patients) represent the group that is not spared from hyperemic agent when using the hybrid iFR/FFR approach.

The iFR Hybrid Approach Analysis performed on the independently-held ADVISE II dataset, was the first prospective, real world registry comparing iFR and demonstrated a statistically high correlation (sensitivity 90.7% for FFR less than or equal to 0.80. specificity 96.2% for FFR greater than 0.80). The hybrid method would have avoided the need to use a hyperemic agent in 65.1% of this patient population.

| Parameter | Percentage Free From<br>Hyperemic Agent | 95% CI |
|---------------------------------|-----------------------------------------|----------------|
| Lesions free from<br>Adenosine | 69.1% (477/690) | [65.5%, 72.6%] |
| Patients free from<br>Adenosine | 65.1% (389/598) | [61.1%, 68.9%] |

- The ADVISE II study illustrated a 5.8%. i.e., (17+23)/690, classification discordance . between the iFR Hybrid Approach and FFR. Among 477 lesions that would be assessed without hyperemia by the iFR Hybrid Approach, 40 (17+23) were due to classification discordance.
- Lesion is free from Adenosine if iFR ≤ 0.85 or iFR ≥ 0.94 o
- Patient is free from Adenosine if all of his/her lesions are free from Adenosine �
- Excludes patients for whom no iFR value is available ●

The results of the performance data demonstrate equivalence to the predicate device.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MD 20993-0002

March 14, 2014

Volcano Corporation Necta Sharma Regulatory Affairs Director 3721 Valley Centre Drive, Suite 500 San Diego, CA 92130

#### Re: K133323

Trade/Device Name: Volcano iFR Modality Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: February 7, 2014 Received: February 10, 2014

### Dear Ms. Sharma.

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 warrantics. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (sec above) into cither 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.

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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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FDA

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 Statement

510(k) Number (if known) K133323

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Volcano iFR® Modality Device Name

### Indications for Use

The iFR® Modality of the s5/s5i/CORE/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.

Prescription Use X (Per 21 CFR 801.109) OR

Over the Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE),

Date:
2014.03.14
07:40:01 -04'00'
for Bram Zuckerman

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