SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz

K153369 · Volcano Corporation · IYO · Dec 22, 2015 · Radiology

Device Facts

• Record ID: K153369
• Device Name: SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
• Applicant: Volcano Corporation
• Product Code: IYO · Radiology
• Decision Date: Dec 22, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Volcano s5i®/CORE™ and 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. The VH® IVUS System 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 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. The iFR® Modality of the s5/s5//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. 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 PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

Device Story

System uses IVUS catheters with distal transducers to emit/receive high-frequency sound waves; transforms acoustic impedance data into 360° cross-sectional grayscale images. Features include VH IVUS for semi-automatic border detection and plaque classification; ChromaFlo for color-mapped blood flow velocity; FFR/iFR modalities for pressure measurement using guide wires and aortic pressure data. Used in cath labs by physicians; CORE Control Pad provides touch-screen GUI for case navigation and measurements. iFR modality calculates pressure gradients during resting cardiac cycle without hyperemic agents; iFR Pullback generates pressure maps along vessel length. System aids clinical decision-making by visualizing vessel morphology, plaque composition, and hemodynamic significance of lesions.

Clinical Evidence

Bench testing only. Performance data included software verification and simulated use/usability validation to demonstrate equivalence to predicate devices.

Technological Characteristics

Ultrasonic pulsed echo imaging system; IVUS catheters with distal transducers; pressure guide wires; CORE Control Pad touch-screen accessory. Connectivity: CPU-based system with GUI. Software: Windows 7 OS. Features: VH IVUS (spectral analysis), ChromaFlo (color flow mapping), FFR/iFR pressure modalities.

Indications for Use

Indicated for patients requiring qualitative/quantitative evaluation of vascular morphology in coronary and peripheral arteries. Used as an adjunct to angiography for imaging vessel lumen/wall structures, blood flow/perfusion assessment, and intravascular blood pressure measurement during diagnostic or interventional 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

• CORE/CORE Mobile Precision Guided Therapy Systems (K133641)
• s5/s5i Intravascular Ultrasound Imaging & Pressure Systems (K140291)
• Volcano iFR Modality (K133323)
• Volcano iFR Scout (K150441)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a sans-serif font and is black. To the left of the text is a symbol that appears to be three lines that are curved.

Public Health Service

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

December 22, 2015

Volcano Corporation Brian Park Sr. Regulatory Affairs Specialist 3721 Valley Centre Drive San Diego, CA 92130

Re: K153369

Trade/Device Name: Volcano s5/s5i/CORE and CORE Mobile Precision Guided Therapy Systems Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, DSK, DSA Dated: November 20, 2015 Received: November 23, 2015

Dear Brian Park:

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 (reporting of medical device

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related 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 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,

Mitchell Stein

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) K153669

#### Device Name

Volcano s5/s5i/CORE and CORE Mobile Precision Guided Therapy Systems

#### Indications for Use (Describe)

The Volcano s5i®/CORE™ and 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.

The VH® IVUS System 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 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.

The iFR® Modality of the s5/s5//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.

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 PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

| 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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# 510(K) SUMMARY

| SPONSOR: | Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Brian Park<br>Sr. Regulatory Affairs Specialist<br>Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130<br>Tel: [phone]<br>Fax: [phone] |
| DATE PREPARED: | November 20, 2015 |
| DEVICE: | Volcano s5/s5i/CORE® and CORE® Mobile Precision<br>Guided Therapy Systems |
| TRADE NAME: | Volcano s5/s5i/CORE® and CORE® Mobile Precision<br>Guided Therapy Systems |
| COMMON NAME: | Ultrasonic Pulsed Echo Imaging System |
| CLASSIFICATION: | 892.1560, Ultrasonic Pulsed Echo Imaging System, II, IYO<br>870.1110, Blood Pressure Computer, II, DSK<br>870.2900, Patient Transducer and Electrical Cable, II, DSA |
| PREDICATE DEVICE: | CORE/CORE Mobile Precision Guided Therapy Systems<br>(K133641)<br>s5/s5i Intravascular Ultrasound Imaging & Pressure<br>Systems (K140291)<br>Volcano iFR Modality (K133323)<br>Volcano iFR Scout (K150441) |
| DEVICE DESCRIPTION: | The Volcano s5i®/CORE™ and CORE™ Mobile Precision<br>Guided Therapy System provides qualitative and<br>quantitative evaluation of vascular morphology in the<br>coronary arteries and vessels of the peripheral vasculature.<br>It is also indicated as an adjunct to conventional<br>angiographic procedures to provide an image of vessel<br>lumen and wall structures. Intravascular ultrasound (IVUS)<br>utilizes the acoustic impedance of vascular structures to |

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provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves.

The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional image.

These grayscale images can then be enhanced using VH IVUS. VH analysis provides automatic border detection for the vessel and lumen borders, as well as plaque composition. Plaque is automatically classified into four categories in order to simplify interpretation of the IVUS image

Alternatively, the ChromaFlo feature can be used to identify the blood flow. The ChromaFlo feature uses patented technology to provide a visual depiction of blood flow through the vessel. This is accomplished by overlaying a two-dimensional color mapping of relative blood flow velocity onto the grayscale ultrasound image.

In the FFR (or pressure) mode, the system acquires intraluminal data from a pressure guide wire while simultaneously taking aortic pressure data from the established ECG/EKG catheterization laboratory equipment. The system will measure pressure from the transducer on the guide wire both proximal and distal to a lesion and will calculate the fractional flow reserve (FFR).

The iFR® Modality is similar to the FFR Modality in that both modalities are capable of taking pressure measurements and both modalities have the identical indications for use and use the identical pressure wires. The primary difference is a new software algorithm that evaluates a portion of the cardiac wave cycle. The FFR Modality is calculated based on the entire cardiac wave cycle, whereas the iFR® Modality is calculated by isolation of the cardiac wave cycle where intracoronary resistance is naturally constant and minimized and where intracoronary flow is maximized. This results in the ability to measure pressure without administration of a hyperemic agent with the iFR® Modality whereas the FFR Modality is calculated after administration of a hyperemic agent.

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iFR® Pullback and Live iFR are new features added to the iFR® Modality that will allow the assessment of a lesion (spot measurement) or vessel (pullback measurement) in a resting condition without the requirement of a hyperemic agent. The iFR® Pullback feature will allow the user to assess a length of vessel by placing the pressure sensor distally, beginning recording/measuring, and pulling the sensor back through the vessel to a stopping point. This generates a "map" of the wave-free pressure gradient iFR® values along the vessel and a distal iFR® value that represents the condition of the vessel at the most distal point of the recording.

The rotational mode is available on the system with the Revolution catheter connected to the system via the PIMr (SpinVision). Cross-sectional images from inside the vessel are displayed on the monitor allowing the user to make measurements.

The CORE™ Control Pad is a touch screen accessory that is a secondary controller in the Volcano s5i®/CORE™ and CORE™ Mobile Precision Guided Therapy System (integrated and mobile systems). Images, data, and case navigation controls are relayed to and from the CORE™ Control Pad display via the system central processing unit (CPU). These images, data and controls are presented in a graphical user interface (GUI) displayed on the touch screen of the CORE™ Control Pad. The user may use the GUI to navigate IVUS and FFR cases and to make measurements on intravascular ultrasound images that are presented on the primary system display.

The Volcano s5i®/CORE™ and CORE™ Mobile Precision INDICATIONS FOR USE: 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.

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The VH® IVUS System 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.

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.

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.

## COMPARISON OF CHARACTERISTICS:

Via this submission, Volcano proposes the following software changes:

- · Update the operating system of the Systems and CCP from Windows XP to Windows 7
- Update the software of the currently cleared CCP accessory to allow the user to use the CCP to switch the System easily between the FFR and iFR Modalities and activate iFR Scout on Systems that contain iFR and iFR Scout software

## PERFORMANCE DATA:

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

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- . Software Verification
- . Simulated Use / Usability Validation

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