ATRICURE BIPOLAR SYSTEM

K043579 · AtriCure, Inc. · OCL · Jul 5, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K043579
• Device Name: ATRICURE BIPOLAR SYSTEM
• Applicant: AtriCure, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Jul 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.

Device Story

AtriCure Bipolar System consists of bipolar clamping hand-piece (Isolator) and reusable Ablation and Sensing Unit (ASU) generator. Device used during cardiac surgery by surgeons to ablate cardiac tissue. System delivers energy to create lines of electrical conduction block in heart. Surgeon operates hand-piece to clamp tissue; generator provides energy for ablation. Clinical benefit includes creation of conduction block to treat cardiac arrhythmias. Device is used in surgical environment.

Clinical Evidence

Clinical data provided demonstrated the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively. Preclinical product testing was also conducted to evaluate conformance to product specifications.

Technological Characteristics

System comprises a bipolar clamping hand-piece and a reusable generator (Ablation and Sensing Unit). Materials are biocompatible per ISO 10993-1. Energy delivery is bipolar radiofrequency for tissue ablation. Device is intended for surgical use.

Indications for Use

Indicated for the ablation of cardiac tissue during surgery in patients requiring cardiac tissue ablation.

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

• Atricure Bipolar System (K020919)
• Medtronic Cardioblate Pen (K013392)
• Boston Scientific Cobra Cardiac Surgical Probe (K013873)
• CryoCath SurgiFrost Cryosurgical Device with FrostByte Clamp (K040690)
• AFx Microwave Ablation System (K003978)
• Epicor Medical Ultracinch Tissue Ablation Device (K040641)

Submission Summary (Full Text)

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## 510(k) Summary

K043579
page 1/2

General Information

| Classification | Device, Electrosurgical, Cutting and<br>Coagulation and Accessories (21CFR878.440) |
|----------------|------------------------------------------------------------------------------------|
| Trade Name | AtriCure Bipolar System |
| Manufacturer | AtriCure, Inc.<br>6033 Schumacher Park Drive<br>West Chester, OH 45069 |
| Contact | Elsa Abruzzo<br>Vice President, Clinical and Regulatory Affairs |

#### Intended Use

The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.

#### Predicate Devices

The predicate devices for the AtriCure Bipolar System are the Atricure Bipolar System (K020919), the Medtronic Cardioblate Pen (K013392), the Boston Scientific Cobra Cardiac Surgical Probe (K013873), the CryoCath SurgiFrost Cryosurgical Device with FrostByte Clamp (K040690), the AFx Microwave Ablation System (K003978) and the Epicor Medical Ultracinch Tissue Ablation Device (K040641).

#### Device Description

The Atricure Bipolar System is comprised of a bipolar clamping hand-piece with integral cable (Isolator™), and a re-useable generator, (Ablation and Sensing Unit, ASU).

#### Materials

All materials used in the manufacture of the AtriCure Bipolar System are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.

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## Testing

K043579
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Appropriate preclinical product testing was conducted to evaluate conformance to the product specification and demonstrate substantial equivalence to predicate devices. Clinical data demonstrating the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively were also provided in support of this submission.

## Summary of Substantial Equivalence

The AtriCure Bipolar System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

AtriCure, Inc. CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Atricure, Inc. c/o Ms. Elsa C. Abruzzo Vice President of Regulatory and Clinical Affairs 6033 Schumacher Park Dr. West Chester, OH 45069

Re: K043579

Trade/Device Name: Atricure Bipolar 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: March 30, 2007 Received: April 6, 2007

Dear Ms. Abruzzo:

This letter corrects our substantially equivalent letter of July 5, 2007.

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 - Ms. Elsa C. Abruzzo

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 yours,

el. Mdl.

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

page i/1

510(k) Number (if known) K043579

Device Name: AtriCure Bipolar (Transpolar) System

Indications for Use:

The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.

Prescription Use . X (Part 21 CRF 801 Subpart D) AND/OR

Over-The-Counter Use (21 CRF 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.S. Wilhelme for Biam Zuckerman

diovascular Devices

510(k) I

AtriCure, Inc. CONFIDENTIAL