Volcano iFR Modality, iFR Scout feature

K150441 · Volcano Corporation · IYO · Mar 20, 2015 · Radiology

Device Facts

• Record ID: K150441
• Device Name: Volcano iFR Modality, iFR Scout feature
• Applicant: Volcano Corporation
• Product Code: IYO · Radiology
• Decision Date: Mar 20, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The iFR® 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.

Device Story

The Volcano iFR Scout is a software feature for the existing Volcano iFR Modality; it enables assessment of coronary and peripheral artery lesions and vessels in a resting state without hyperemic agents. The system processes input from Volcano pressure wires and ECG signals. The iFR Scout feature allows users to record pressure measurements while pulling a pressure sensor back through a vessel; it generates a map of wave-free pressure gradient iFR values along the vessel length and a distal iFR value. Used in clinical settings (e.g., cath lab) by physicians during diagnostic or interventional procedures. The output, displayed as a map of pressure gradients alongside pressure waveforms and ECG, assists clinicians in determining the degree of disease and the significance of specific lesions or vessel segments, facilitating clinical decision-making regarding treatment.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through software verification and validation testing.

Technological Characteristics

Software feature for existing Volcano s5/s5i/CORE/CORE Mobile systems. Uses intravascular pressure wire sensing. Connectivity via existing system architecture. Software-based processing of pressure and ECG signals to calculate wave-free pressure gradients.

Indications for Use

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

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 iFR® Modality (K133323)

Submission Summary (Full Text)

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Public Health Service

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

March 20, 2015

Volcano Corporation Neeta Sharma Director, Regulatory Affairs 3721 Valley Centre Dr, Suite 500 San Diego, California 92130

Re: K150441

Trade/Device Name: Volcano iFR Modality, iFR Scout Feature Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: February 19, 2015 Received: February 20, 2015

Dear Neeta 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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Shawn W. Forrest -S

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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## Indication for Use Statement

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### 510(k) Number (if known)

Page 1 of 1

Volcano iFR® Modality Device Name

### Indication for Use

The iFR® 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.

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)

510(k) Premarket Notification for Volcano iFR® Scout™

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K150441 page 1 of 2

## 510 (k) SUMMARY

| SPONSOR: | Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Neeta Sharma<br>Director, Regulatory Affairs<br>Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130<br>Tel: [phone]<br>Fax :( 858) 720-0335 |
| DATE PREPARED: | February 19, 2015 |
| DEVICE: | Volcano iFR ® Modality |
| TRADE NAME: | Volcano iFR ® Scout™ |
| 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 iFR® Modality (K133323) |
| DEVICE DESCRIPTION: | New software feature have been added to the iFR Modality<br>Live iFR and iFR Pullback that allow the assessment of a<br>lesion (single cycle iFR measurement) or vessel (pullback<br>measurement) in a resting condition without the<br>requirement of a hyperemic agent. Both features,<br>collectively referred to as the iFR® Scout allow the user to<br>assess a length of vessel by placing the pressure sensor<br>distally, record/measure, and pull the sensor back through<br>the vessel to a stopping point. This generates a map of the<br>wave-free pressure gradient iFR values along the vessel and<br>a distal iFR value that represents the condition of the vessel<br>at the most distal point of the recording. |
| INTENDED USE: | The iFR® Modality of the s5/sSiCORE/CORE Mobile<br>Precision Guided Therapy System is indicated in all blood<br>vessels, including coronary and peripheral arteries, to |

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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.

#### COMPARISON OF CHARACTERISTICS:

The iFR® Scout™ feature will enable iFR measurements to be recorded along a length of vessel. This feature will provide iFR data that can be used to determine the degree of disease in the vessel as well as the relative significance of individual lesions or diseased segments along the length of the vessel. The results of the iFR pullback measurement are displayed as a map of the pressure gradient and an adjacent display of the pressure waveforms and ECG, similar to the current spot measurement display.

#### PERFORMANCE DATA:

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

- Software Verification ●
- o Software Validation

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