MODIFICATION TO: CARDIMA ABLATION SYSTEM

K060715 · Cardima, Inc. · OCL · May 15, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060715
• Device Name: MODIFICATION TO: CARDIMA ABLATION SYSTEM
• Applicant: Cardima, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: May 15, 2006
• Decision: SESE
• Submission Type: Special
• 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 consists of disposable ablation probe with stabilization sheath, reusable INTELLITEMP energy management device, and cables. Device used during cardiac surgery by physicians to ablate cardiac tissue via radiofrequency energy. System delivers RF energy to target tissue to achieve coagulation/ablation. Output controlled by energy management unit. Intended to facilitate cardiac surgical procedures.

Clinical Evidence

Bench testing only. In-vitro performance testing demonstrated the system is safe and effective for its intended function.

Technological Characteristics

System comprises a disposable ablation probe with stabilization sheath and a reusable INTELLITEMP energy management device. Utilizes radiofrequency energy for tissue ablation. Class II electrosurgical device.

Indications for Use

Indicated for the ablation of cardiac tissue during cardiac surgery using radiofrequency energy.

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

• Cardima Ablation System (K022008)

Submission Summary (Full Text)

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Ko60715

# 510 (k) Summary

Page 181

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: March 16, 2006

510(k) number:

11 11 1 5 2005

#### Applicant Information:

Cardima, Inc.

47266 Benicia Street

Fremont, CA 94538

| Contact Person: | Eric Chan, Ph.D. |
|-----------------|------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### Device Information:

| Classification: | Class II |
|----------------------|----------------------------------------------------------|
| Trade Name: | Cardima Ablation System |
| Classification Name: | Electrosurgical Device and accessories (21 CFR 870.4400) |

#### Equivalent Device:

The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Cardima Ablation System (K022008)

## Intended Use:

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

## Device Description:

The Cardima Ablation System consists of the disposable Cardima Ablation Probe with Stabilization Sheath, the reusable INTELLITEMP® energy management device, and associated cables.

## Test Results:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

MAR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardima, Inc. c/o Eric Chan, Ph.D. Vice President, Product Development 47266 Benicia Street Fremont, CA 94538-73303

Re: K060715

Trade/Devices Name: Cardima Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: April 21, 2006 Received: April 21, 2006

Dear Dr. Chan:

This letter corrects our substantially equivalent letter of May 15, 2006.

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 Chan

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 (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 continue 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]. 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.

elgmee.

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):

Cardima Ablation System Device Name:

Indications for Use:

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

Prescription Use ﮯ (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 ( of Device Evaluation (ODE) (Division Sign-Division of General, Restorative, and Neurological Devices Page __ of_

KOSOTIS

Cardima, Inc.