CARDIMA ABLATION SYSTEM

K022008 · Cardima, Inc. · OCL · Jan 29, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K022008
• Device Name: CARDIMA ABLATION SYSTEM
• Applicant: Cardima, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Jan 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

Device Story

Cardima Ablation System utilizes radiofrequency (RF) energy to ablate cardiac tissue. Device used during cardiac surgery by surgeons to perform tissue ablation. System delivers RF energy to target site; intended to achieve therapeutic tissue destruction. Benefits include surgical management of cardiac arrhythmias or other conditions requiring tissue ablation. Operation involves standard electrosurgical principles.

Clinical Evidence

Bench testing only. In-vitro performance testing demonstrated safety and effectiveness. Biocompatibility testing confirmed compliance with ISO 10993-1 standards.

Technological Characteristics

Electrosurgical cutting and coagulating device; utilizes radiofrequency energy for tissue ablation. Materials meet ISO 10993-1 biocompatibility requirements. Class II device under 21 CFR 878.4400.

Indications for Use

Indicated for ablation of cardiac tissue during cardiac surgery using radiofrequency energy. Intended for prescription use.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Boston Scientific Electrosurgical Probe (K981981)
• AtriCure Bipolar Coagulator (K011722)
• Medtronic Cardioblate Surgical Ablation Pen (K013392)

Submission Summary (Full Text)

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This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: June 17, 2002

| 510(k) number: | K022008 |
|----------------|---------|
|----------------|---------|

JAN 2 9 2003

## Applicant Information:

Cardimal. Inc. 47266 Benicia Street Fremont. CA 94538-7330

## Contact Person

| Marianne Baldwin | |
|------------------|----------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

## Device Information:

Classification: Class II Trade Name: Cardima® Ablation System Classification Name: Electrosurgical Cutting and Coaqulating Device

#### Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the Boston Scientific Electrosurgical Probe (K981981), the AtriCure Bipolar Coagulator (K011722); and the Medtronic Cardioblate Surgical Ablation Pen (K013392).

#### Intended Use:

The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

# Test Results:

- Performance
Results of in-vitro testing demonstrate that the Cardima Ablation System is safe and effective for its intended use.

#### Biocompatibility

The materials used in the Cardima Ablation System meets the requirements of ISO 10993-1.

Summary: Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its head turned to the left. The eagle's body is formed by three curved lines. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

MAR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardima, Inc. c/o Robert A. Chin, Ph.D. Regulatory Consultant 25 Hartford Avenue San Carlos, CA 94070

R

Re: K022008

Trade/Device Name: Cardima Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulating device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: November 15, 2002 Received: November 19, 2002

Dear Dr. Chin:

This letter corrects our substantially equivalent letter of January 29, 2003.

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 (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 - Dr. Eric Chin

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 continue marketing vour 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

ee.gmee

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):
K022008

Device Name:

Cardima® Ablation System

Indications for Use:

The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K022008

Prescription Use
(Per 21 CFR 801.109)
OR
Over-the Counter Use **__**

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)