REVOLUTION 45MHZ IVUS IMAGING CATHETER

K080891 · Volcano Corporation · OBJ · May 12, 2008 · Cardiovascular

Device Facts

• Record ID: K080891
• Device Name: REVOLUTION 45MHZ IVUS IMAGING CATHETER
• Applicant: Volcano Corporation
• Product Code: OBJ · Cardiovascular
• Decision Date: May 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Revolution® 45 MHz Rotational IVUS Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidate for transluminal coronary interventional procedures.

Device Story

The Revolution 45 MHz Rotational IVUS Imaging Catheter is a diagnostic intravascular catheter used for ultrasound imaging of coronary arteries. It functions as an ultrasonic pulsed echo imaging system. The device is used by clinicians during transluminal coronary interventional procedures to visualize coronary intravascular pathology. The catheter provides real-time ultrasound images to assist the physician in assessing the vessel, which informs clinical decision-making during interventional procedures. The device is a modification of a previously cleared predicate, specifically featuring an updated double-seal pouch packaging design.

Clinical Evidence

No clinical data. Bench testing was performed in accordance with design controls to evaluate the impact of the packaging modification. Results indicate the device is comparable to the predicate.

Technological Characteristics

45 MHz rotational IVUS imaging catheter; ultrasonic pulsed echo imaging system; diagnostic intravascular catheter. Packaging modified to include a double seal. No other changes to fundamental scientific technology or materials.

Indications for Use

Indicated for patients who are candidates for transluminal coronary interventional procedures requiring intravascular ultrasound examination of coronary arteries.

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

• Revolution® 45 MHz Rotational Imaging Catheter (K050995)

Submission Summary (Full Text)

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Volcano Corporation

Kos0891 Pg 1 of 2

### 510 (K) Summary Revolution™ 45 MHz Rotational IVUS Imaging Catheter

| Date Prepared: | March 28, 2008 | |
|-------------------|---------------------------------------------------------------------|-------------|
| Submitted by: | Volcano Corporation<br>2870 Kilgore Rd.<br>Rancho Cordova, CA 95670 | MAY 12 2008 |
| Contact person: | Jennifer Motto<br>Specialist, Regulatory Affairs | |
| Phone number: | [phone] | |
| Facsimile number: | [phone] | |
| Device Name: | Revolution ^TM 45 MHz Rotational IVUS Imaging Catheter | |

# Classification name:

- Class . 870.1200 Diagnostic Intravascular catheter 11 . 892.1560 Ultrasonic pulsed echo imaging system 11 892.1570 Diagnostic ultrasonic transducer . -
### Predicate Device:

The Revolution® 45 MHz Rotational Imaging Catheter is substantially equivalent to the Revolution® 45 MHz Rotational Imaging Catheter cleared under K050995 on 06/20/2005.

### Intended Use:

The Revolution® 45 MHz Rotational IVUS Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidate for transluminal coronary interventional procedures.

### Device Technological Characteristics and Comparison to Predicate Device:

The Revolution® 45 MHz Rotational IVUS Imaging Catheter is substantially equivalent to the Revolution® 45 MHz Rotational Imaging Catheter cleared under K050995 on 06/20/2005. Modifications include implementation of a double seal on the pouch packaging.

The Revolution® 45 MHz Rotational Imaging Catheter uses the same fundamental scientific technologies and has the same intended use as that of the predicate device, Revolution® 45 MHz Rotational Imaging Catheter.

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# Performance Data:

Applicable testing was performed in accordance with Design Controls including a risk analysis addressing the impact of modifications to the device and components. The test results indicate the subject device is comparable to the predicate device.

#### Conclusion:

Revolution® 45 MHz Rotational Imaging Catheter has the same Intended Use and utilizes the same fundamental scientific technology as that of the predicate device. Revolution® 45 MHz Rotational Imaging Catheter cleared under K050995 on 06/20/2005.

Implementation of the double seal to the pouch package does not raise any new questions regarding safety and efficacy. The test results and a declaration of conformity with design controls support a determination of substantial equivalence of the subject device to the predicate device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 12 2008

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

Re: K080891

Trade/Device Name: Revolution 45 MHz Rotational IVUS Imaging Catheter Regulation Number: 21 CFR 870, 1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: OBJ Dated: March 5, 2008 Received: March 6. 2008

Dear Ms. Motto:

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 such 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. Jennifer Motto

proceed to the market.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Bettmann/Cor

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

# Indications for Use

510(k) Number (if known): Ko8089 |

Device Name: Revolution® 45MHz Rotational Catheter

Indications for Use:

The Revolution catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Blummenauer

(Division Sign-Off) Division of Cardlovaso 510(k) Number

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