CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER

K023880 · ETHICON, Inc. · DWF · Dec 11, 2002 · Cardiovascular

Device Facts

• Record ID: K023880
• Device Name: CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
• Applicant: ETHICON, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The catheter is designed to occlude the coronary sinus, deliver cardioplegic solution to the coronary sinus and monitor the coronary sinus pressure during cardiopulmonary bypass.

Device Story

The CardioVations Steerable Coronary Sinus Catheter is a 9 Fr., three-lumen catheter used during cardiopulmonary bypass. The device functions by inflating a distal balloon to occlude the coronary sinus; the three lumens facilitate balloon inflation, delivery of cardioplegic solution, and monitoring of coronary sinus pressure. It is intended for use by clinicians in a surgical setting. The device provides mechanical access and pressure monitoring capabilities to assist in myocardial protection during bypass procedures.

Clinical Evidence

Bench testing only; results of verification testing indicate the product meets established performance requirements.

Technological Characteristics

9 Fr. three-lumen catheter with distal balloon. Mechanical device for coronary sinus occlusion, cardioplegia delivery, and pressure monitoring. No software or electronic components.

Indications for Use

Indicated for occlusion of the coronary sinus, delivery of cardioplegic solution, and monitoring of coronary sinus pressure during cardiopulmonary bypass in patients undergoing cardiopulmonary bypass.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Endocoronary Sinus Catheter

Submission Summary (Full Text)

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K623880

DEC 1 1 2002

# ATTACHMENT V

510(k) SUMMARY

| Statement | Information supporting claims of substantial equivalence, as<br>defined under the Federal Food, Drug, and Cosmetic Act,<br>respecting safety and effectiveness is summarized below. For the<br>convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule ".... 510(k) Summaries<br>and 510(k) Statements ...." (21 CFR 807) and can be used to<br>provide a substantial equivalence summary to anyone requesting it<br>from the Agency. | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | MODIFIED DEVICE NAME: | CardioVations Steerable<br>Coronary Sinus Catheter |
| | PREDICATE DEVICE NAME: | Endocoronary Sinus Catheter |
| Device Description | The Steerable Coronary sinus Catheter is a 9 Fr., three-lumen<br>catheter in the distal balloon. The three lumen are used to inflate<br>the balloon (to occlude the coronary sinus), monitor coronary sinus<br>pressure and for delivery of cardioplegia solution. | |
| Intended Use | The catheter is designed to occlude the coronary sinus, deliver<br>cardioplegic solution to the coronary sinus and monitor the<br>coronary sinus pressure during cardiopulmonary bypass. | |
| Indications Statement | The Steerable Coronary Sinus Catheter is indicated for occlusion<br>of the coronary sinus, delivery of cardioplegic solution, and<br>monitoring of coronary sinus pressure during cardiopulmonary<br>bypass. | |
| Technological<br>Characteristics | The modified device has the same technological characteristics as<br>the predicate device. The form, fit, function and method of<br>operation are similar. | |
| | Continued on next page | |
| Performance Data | Results of verification testing indicates that the product meets the<br>established performance requirements. | |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>subject device is substantially equivalent to the predicate devices<br>under the Federal Food, Drug and Cosmetic Act. | |
| Contact | Peter Cecchini<br>Manager<br>Regulatory Affairs<br>ETHICON, Inc.<br>Rt. 22 West<br>Somerville, NJ 08876-0151 | |
| Date | November 20, 2002 | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DFC 11 2002

Ethicon, Inc. c/o Mr. Peter Cecchini Route 22 West Somerville, NJ 08876

Re: K023880

CardioVations Steerable Coronary Sinus Catheter Regulation Number: 870.4210 Regulation Name: CPB Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: November 20, 2002 Received: November 21, 2002

Dear Mr. Cecchini:

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.

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

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#### Page 2 - Mr. Peter Cecchini

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 (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. 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 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

L

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):

Device Name:

CardioVations Steerable Coronary Sinus Catheter

Indications for Use:

The Steerable Coronary Sinus Catheter is indicated for occlusion of the coronary sinus, delivery of cardioplegic solution, and monitoring of coronary sinus pressure during cardiopulmonary bypass.

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

Image /page/4/Figure/8 description: The image shows a form with two options: "Prescription Use" and "Over-The Counter Use". The "Prescription Use" option has a checkmark next to it, indicating that it has been selected. Below the options, there is a signature and a number "K02 3880".

CardioVations Steerable Coronary Sinus Catheter ETHICON, Inc.