EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

K092596 · Volcano Corporation · OBJ · Dec 10, 2009 · Cardiovascular

Device Facts

• Record ID: K092596
• Device Name: EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
• Applicant: Volcano Corporation
• Product Code: OBJ · Cardiovascular
• Decision Date: Dec 10, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Eagle Eye Platinum Digital IVUS catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature. This device is not currently indicated for use in cerebral vessels. The Eagle Eye Platinum Digital IVUS catheters are designed for as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Device Story

Intravascular ultrasound (IVUS) catheter; utilizes cylindrical ultrasound transducer array to radiate acoustic energy and detect echoes; generates real-time images of coronary and peripheral vessel lumen and wall structures. Used in interventional cardiology/catheterization labs by physicians; tracks over 0.014" guidewire; percutaneous or surgical cut-down insertion. Hub connects to Volcano imaging systems (In-Vision, s5, s5i) via patient interface module. Provides visual output for clinicians to assess vascular morphology; adjunct to angiography. Redesign of Eagle Eye Gold catheter body; maintains identical ultrasound signal processing.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Cylindrical ultrasound transducer array; 0.014" guidewire compatibility; radio-opaque markers for positioning; hub interface for Volcano imaging systems. Materials updated for biocompatibility. Operates with Volcano VH IVUS system software v1.2 or higher.

Indications for Use

Indicated for evaluation of vascular morphology in coronary and peripheral blood vessels as an adjunct to conventional angiography to image vessel lumen and wall structures. Not indicated for use in cerebral vessels.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Eagle Eye Gold IVUS Imaging Catheter (K073473)

Submission Summary (Full Text)

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Volcano Corporation August 14, 2009

Eagle Eye® Platinum Digital IVUS Catheter
Abbreviated 510(k)

Abbreviated 510(k)

Section 5: 510(k) Summary Submitter Name: Volcano Corporation Address: 2870 Kilgore Road Rancho Cordova, CA 95670 Contact: Donovan Mav Regulatory Affairs Engineer DEC 1 0 2009 Phone: [phone] Fax: [phone] E-mail: [e-mail] Date Prepared: August 14, 2009 Eagle Eye® Platinum Digital IVUS Catheter Device Trade Name: Device Common Name: Intravascular IVUS Imaging Catheter Classification Name: Diagnostic Intravascular Catheter, 870.1200 Diagnostic Ultrasound Transducer, 892.1570 Classification Code: OBJ: Catheter, Ultrasound, Intravascular ITX: Transducer, Ultrasonic, Diagnostic Eagle Eye® Gold IVUS Imaging Catheter, 510(k) Number K073473, Predicate Device: Classification Code: OBJ, Regulation Number 870.1200

## Device Description:

Eagle Eye® Platinum Digital IVUS Catheters incorporate a cylindrical ultrasound transducer array used to radiate acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The Eagle Eye" Platinum catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 rnm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The Eagle Eye Platinum catheter is introduced percutaneously or via surgical cut down into the vascular system.

Two types of markers are used along the shaft length:

- Three radio-opaque markers applied along the length of the distal inner-shaft to aide in positioning the 1. catheter in the vascular anatomy during an angiographic procedure.
- A pair of brachial and femoral (one each) shaft markers located on the outer proximal shaft aid in gauging 2. the IVUS transducer position relative to the guiding catheter tip when introducing the EEP catheter through the guiding catheter.

A hub fitting is attached to the proximal end of the catheter via an integrated strain relief and provides a channel for the ultrasound scanner leads to interface electrically with the patient interface module (PIM) connector of the imaging system.

The Eagle Eye Platinum eatheters may only be used with the Volcano In-Vision imaging System, Volcano st, or Volcano s5i Imaging Systems. The catheters are designed to work with Volcano VH IVUS system software v 1.2 or higher. This catheter will not operate if connected to any other imaging system. 034

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Volcano Corporation August 14, 2009

Eagle Eye® Platinum Digital IVUS Catheter Abbreviated 510(k)

Intended Use: . Eagle Eye . Platinum Digital.IVUS catheters are designed for use-in the evaluation of vascularmorphology in blood vessels of the coronary and perioderal varies were areas-sections in vasuality such vessels. This device is not currently indicated for use in cerebral vessels. The Eagle Eye PPatinum Digital IVUS catheters are designed for as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Intended Users: Eagle Eye® Platinum Digital IVUS catheters are designed and intended for single use by interventional cardiologists and cardiac catheterization lab staff.

Device Design Requirements: Biocompatibility, shelf life, sterilization, package integrity, and design verification testing will be performed to prove that the materials and manifacturing processes selected for the cather body of the Eagle Eye® Platinum catheter do not pose a significant safety risk to the patient.

Substantial Equivalence Discussion: The Eagle Eye® Platinum Digital IVUS Catheter uses the same fundamental scientific technologies and has the same intended use as that of the predicate device the Fagle Eye Gold IVUS Imaging Catheter. The Eagle Eye Platinum atheter is a redesign of the catheter body elements of the Eagle Eye Gold only and does not change the ultrasound signal or signal processing used for the predicate device. The ultrasound scanner of the Eagle Eye" Platinum is identical to that of the Eagle Eye Gold however the blood contacting materials not included in the ultrasound scanner and the catherer body manufacturing processes have been changed and updated to represent current state of the art materials and methods.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

Volcano Corporation C/O Donovan May, Regulatory Affairs Engineer 2870 Kilgore Rd. Rancho Cordova, CA 95670

DEC 1 0 2009

Re: K092596

Trade/Device Name: Eagle Eye Platinum Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: November 11, 2009 Received: November 13, 2009

Dear Mr. May:

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.

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

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Page 2 – Mr. Donovan May

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 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. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Volcano Corporation August 14, 2009

Eagle Eye® Platinum Digital IVUS Catheter Abbreviated 510(k)

Section 4: Indications for Use

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510(k) Number (if known): K092596

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## Device Name: Eagle Eye® Platinum Digital IVUS Catheter

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Indications for USe: Eagle vascular morphology in blood vessels of the coronary and period for use in the evaluation of
inage of such vessels This device is the coronary and perioheral vasculation of image of such vessels. This device is not currently indicated for use in cerebral vessels.
Platinum Dicital IVUS cathers are docience for use in cerebral vessels. The Eagle Platinum Digital WUS cather contently nucated for use in cerebral vessels. The Eagle Eye"
Platinum Digital IVUS catheters are designed for use as an adjunct to conventional a provide an image of the vessel lumen and wall structures.

| Prescription Use | <b>YES</b> (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use | <b>NO</b> (21 CFR 801 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | | |
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| Division of Cardiovascular Devices | Page 1 of 1 | |
| 510(k) Number | KP92596 | 033 |