VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM

K111706 · Volcano Corporation · IYO · Jul 15, 2011 · Radiology

Device Facts

• Record ID: K111706
• Device Name: VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
• Applicant: Volcano Corporation
• Product Code: IYO · Radiology
• Decision Date: Jul 15, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Volcano s5™/s5i™ Series Intravascular Imaging and Pressure 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 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 semiautomatically 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 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 provides intravascular ultrasound (IVUS) imaging and pressure measurement for coronary and peripheral vasculature. Inputs: RF ultrasound signals from imaging catheters; pressure data from guidewires; aortic pressure from ECG/EKG equipment. Processing: System console performs quantitative/qualitative image analysis; semiautomatic boundary visualization; spectral analysis of RF signals (VH IVUS); and pressure data acquisition. Output: High-resolution intraluminal images; blood flow information (ChromaFlo); pressure measurements. Used in Cath Lab by physicians/technicians. Connection Box accessory consolidates cable management for bedside peripherals and patient interface modules (PIMs). Output aids clinical decision-making during diagnostic angiography and interventional procedures by providing detailed vascular morphology and hemodynamic data.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included design verification of the Connection Box PCA, drop testing, IPX4 fluid ingress testing, reliability HALT testing, MTBF testing, electrical safety, and electromagnetic compatibility (EMC) testing. All results met established acceptance criteria.

Technological Characteristics

System includes console (tower/portable/integrated), PIMs, and Connection Box. Imaging: Pulsed echo ultrasonic imaging. Pressure: Intravascular pressure sensing via guidewire. Connectivity: Integrated with 3rd party angiography equipment and ECG/EKG systems. Software: Semiautomatic boundary visualization and spectral analysis of RF signals. Accessory: Connection Box (non-patient contact).

Indications for Use

Indicated for qualitative/quantitative evaluation of vascular morphology in coronary and peripheral arteries; adjunct to angiography for vessel lumen/wall imaging; qualitative blood flow assessment (ChromaFlo); semiautomatic boundary visualization and spectral analysis of RF ultrasound signals (VH IVUS); and intravascular blood pressure measurement in all blood vessels during diagnostic/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

• Volcano s5™/s5i™ Intravascular Ultrasound Imaging System (K082229)

Submission Summary (Full Text)

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SPONSOR: Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 CONTACT/SUBMITTER: Jwala Jawharkar Regulatory Affairs Specialist 2870 Kilgore Road Rancho Cordova, CA 95670 Tel. [phone] Fax: [phone] DATE OF SUBMISSION: June 16, 2011 DEVICE: Volcano s5™/sSiTM Intravascular Ultrasound Imaging System Trade Name: Volcano s5TM/s5iTM Intravascular Ultrasound Imaging System Common Name: Ultrasonic pulsed echo imaging system Classification: 892.1560 Ultrasonic pulsed echo imaging system, II, IYO 870.1110 Blood Pressure Computer, II, DSK 870.2900 Patient Transducer and Electrical Cable, II, DSA PREDICATE DEVICE: Volcano s5TM/s5i™ Intravascular Ultrasound Imaging System (K082229)

### 510(k) SUMMARY

The 510(k) Summary is submitted as required by section 807.92(a)

# DEVICE DESCRIPTON:

The Volcano s5™/s5i™ Intravascular Ultrasound Imaging and Pressure System is available in 3 configurations: (1) a tower or a portable model, (2) an integrated model, (3) an integrated model with communication capabilities with 3d party angiography equipment. There are two (2) operating modes available for all three models of the Volcano s5/s5i Imaging and Pressure system, namely: (1) the Intravascular Ultrasound (IVUS) imaging mode and (2) the pressure mode.

When operating the IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both quantitatively and qualitatively. When operating in pressure mode, the system acquires intraluminal data from a pressure guidewire while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. Catheters and guidewires are connected to the system via the Patient Interface Modules (PIMs).

## INDICATIONS FOR USE:

The Volcano s5™/s5i™ Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral

11706

JUL 15 2011

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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 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 semiautomatically 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 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:

The proposed device is identical to the currently marketed device except for the addition of the Connection Box, which is the subject of this submission. The Connection Box offers ease of use by consolidating all the cables from the trench and providing a manageable interface panel for connecting bedside peripherals and patient interface modules in the Cath Lab. They share intended use, same design characteristics, and the same fundamental scientific technology.

### PERFORMANCE DATA:

Applicable testing was performed as required by the Quality System to evaluate the modifications to the Volcano s5/s5i Intravascular Imaging and Pressure System. The following tests were performed:

- . Connection Box PCA (Printed Circuit Assembly) design verification test
- Connection Box drop test �
- . Connection Box IPX4 fluid ingress test
- t Reliability HALT test
- . Connection Box Power Distribution PCA MTBF test
- . Electrical safety test
- . Electromagnetic Compatibility test

The test results were found to be acceptable by the respective test plans and protocols.

The changes to the device involve an accessory that does not come in contact with the patient or any fluid path, thus Biocompatibility testing was not required.

Special 510(k) Volcano s5™/s5i™ Intravascular Ultrasound Imaging System Proprietary and Confidential Information

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Volcano Corporation c/o Ms. Jwala Jawharkar Regulatory Affairs Specialist 2870 Kilgore Road Rancho Cordova, CA 95670

JUL 15 2011

Re: K11706

Trade/Device Name: Volcano s5™/s5i™ Intravascular Ultrasound Imaging System Regulatory Number: 21 CFR 892.1560 Regulation Name: Pulsed Echo Ultrasonic Imaging System Regulatory Class: II (two) Product Code: IYO, DSA, DSK Dated: June 16, 2011 Received: June 17, 2011

Dear Ms. Jawharkar:

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.

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.

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Page 2 – Ms. Jwala Jawharkar

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-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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;

Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 11706

#### Indications for Use Statement

510(k) Number (if known): ...

Device Name: Volcano s5™/s5i™ Intravascular Ultrasound Imaging System

#### Indications for Use:

The Volcano s5™/s5i™ Series Intravascular Imaging and Pressure 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 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 semiautomatically 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 wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

OR

Over the Counter Use (Part 21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| <i>for</i> (Division Sign-Off)<br>Division of Cardiovascular Devices | Page 1 of 1 |
| 510(k) Number | KL111706 |