VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001

K051920 · Volcano Corporation · IYO · Aug 19, 2005 · Radiology

Device Facts

• Record ID: K051920
• Device Name: VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
• Applicant: Volcano Corporation
• Product Code: IYO · Radiology
• Decision Date: Aug 19, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Volcano s5 Imaging System is used for the qualitative and quantitative evaluation of voreally be imhaging 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.

Device Story

Volcano s5 Imaging System comprises imaging catheter, patient interface module, and system console. System acquires and displays high-resolution intraluminal images for qualitative/quantitative analysis. Used as adjunct to interventional therapies (e.g., balloon angioplasty). ChromaFlo feature provides 2D color map of relative blood flow overlaid on grayscale images. In-Line Digital option provides 2D, 360-degree rotation, and longitudinal vessel views. Operated by clinicians in clinical settings to visualize vessel lumen and wall structures; assists in interventional decision-making and procedural guidance. Benefits include improved diagnostic visualization and assessment of blood flow/perfusion during vascular procedures.

Clinical Evidence

Bench testing only. Performance data evaluated modifications to the system; results met all test plans and protocols, establishing safety and effectiveness for the intended use.

Technological Characteristics

Ultrasonic pulsed echo imaging system (21 CFR 892.1560). Components: imaging catheter, patient interface module, system console. Features: grayscale imaging, ChromaFlo (color flow mapping), In-Line Digital (360-degree/longitudinal views). Connectivity: system console for image processing and display. Sterilization: catheters marketed separately.

Indications for Use

Indicated for qualitative and quantitative evaluation of coronary and peripheral vasculature, and as an adjunct to conventional angiography for imaging vessel lumen and wall structures. ChromaFlo indicated for qualitative blood flow information in peripheral and coronary vasculature as an adjunct to other perfusion estimation methods. Prescription use only.

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

• Cathscanner III Imaging System (K944004)
• ColorFlo Option for the Oracle In Vision Intravascular Ultrasound Imaging System (K963290)
• Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System (K965223)
• InVision Imaging System (K031148)

Reference Devices

• Visions catheter (K982329)
• Avanar catheter (K000820)
• Eagle Eye catheter (K031346)

Submission Summary (Full Text)

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AUG 1 9 2005

Submitter: Volcano Corp.

## 510(k) SUMMARY

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

| Submitter Name: | Volcano Corp. |
|-----------------------------------------------|-----------------------------------------------------------------------------|
| Contact Person: | Michelle J. Badal, RAC<br>Manager, Regulatory Affairs |
| Address: | 2870 Kilgore Road<br>Rancho Cordova, CA 95670 |
| Phone Number: | 916-861-0287 |
| Fax Number: | 916-638-8112 |
| Date Prepared: | July 14, 2005 |
| Device Trade Name: | Volcano s5 Imaging System |
| Device Common Name: | Ultrasonic imaging system |
| Classification Name,<br>Number, Product Code: | Ultrasonic pulsed echo imaging system<br>21 CFR 892.1560, Product Code: IYO |

#### Predicate Device:

Cathscanner III Imaging System cleared under K944004; ColorFlo Option for the Oracle In Vision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; and InVision Imaging System cleared under K031148

### Device Description:

The Volcano s5 Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5 Imaging System can be an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital option displays a two-dimensional, 360 rotations and longitudinal view of the vessel.

The imaging catheters are all marketed under separate premarket notifications; Visions catheter K982329, Avanar catheter K000820 and Eagle Eye K031346.

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#### Intended Use:

Volcano s5 Imaging System is used for the qualitative and quantitative evaluation of voreally be imhaging 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.

#### Performance Data:

Applicable testing was performed to evaluate the modifications to the Volcano s5 Imaging System. The test results were found to be acceptable as required by the respective test plans and protocols.

#### Conclusion:

The testing reported in this 510(k) establishes the device is safe and effective for its intended use and substantially equivalent to the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 9 2005

Volcano Corp c/o Michelle J. Badal, RAC 2870 Kilgore Road Rancho Cordova CA 95670

Re: K051920

: 18031920
Trade/Device Name: Volcano S5 Imaging System, Model 804200-001 Regulation Number: 21 CFR 892.1560 Regulation Name: System, Imaging, Pulsed Echo, Ultrasonic Regulatory Class: Class II Product Code: IYO Dated: July 14, 2005 Received: July 15, 2005

Dear Ms. Badal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) promise is substantially equivalent (for the indications felerenced above and nave determing ally marketed predicate devices marketed in interstate for use stated in the encrosate) to regions of the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The T ou may, therefore, market and recession, and include requirements for annual registration, listing of general condois provisions of the tice, 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 If your device is crassimod (600 a00 70) in the existing major regulations affecting your device can may oc subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be advised that I DTT brisanteat your device complies with other requirements of the Act that I Dri has made a assocd regulations administered by other Federal agencies. You must of any I ederal statutes and regaraments, including, but not limited to: registration and listing (21

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Page 2 - Ms. Michelle J. Badal

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fatt 607); adomig (DF CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = I mis letter will anow you to begin finding of substantial equivalence of your device to a legally premarket notheadon: "The Driver of and on the sification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific arrive 10. Jour as [phone]. Also, please note the regulation entitled, Comacs the Office of Companisemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

051920 510(k) Number (if known):

Device Name: Volcano s5 Imaging System

Indications for Use:

The Volcano s5 Imaging System is used for the qualitative and quantitative The Volcano 35 milaging bystem is the coronary arteries and vessels of the evaluation of vasculature. It is also indicated as an adjunct to conventional peripheral vasculature. It is anot marcally an image of vessel lumen and wall structures.

ChromaFlo® is indicated for qualitative blood flow information from peripheral Chromal 10 - 13 micioused for qualiformation can be an adjunct to other methods of estimating blood flow and blood perfusion.

L

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number /<050/920

Over-The-Counter Use X Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANÓTHER PAGE OF NEEDED)

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

(Posted November 13, 2003)