ATRICURE ISOLATOR TRANSPOLAR PEN

K050459 · AtriCure, Inc. · OCL · Jun 13, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050459
• Device Name: ATRICURE ISOLATOR TRANSPOLAR PEN
• Applicant: AtriCure, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Jun 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Isolator ™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Device Story

Isolator Transpolar pen is a sterile, single-use electrosurgical device; used in conjunction with an electrosurgical generator to deliver radiofrequency (RF) current. Operated by surgeons during cardiac surgery to ablate cardiac tissue. Device transforms RF energy from the generator into thermal energy at the tissue interface to achieve ablation. Benefits include targeted tissue destruction for cardiac procedures. No complex software or automated algorithms described.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing conducted in accordance with ISO 10993-1 for biocompatibility and product specification conformance.

Technological Characteristics

Electrosurgical device for RF energy delivery. Materials are biocompatible per ISO 10993-1. Single-use, sterile form factor. Operates via connection to an external electrosurgical generator.

Indications for Use

Indicated for cardiac tissue ablation during cardiac surgery.

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

• Medtronic Cardioblate Pen (K013392)
• Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132)
• AtriCure Bipolar System (K020919)

Submission Summary (Full Text)

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JUN 1 0 2005 AtriCure®

K050459

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#### 510(k) Summary

General Information

| Classification | Class II |
|----------------|------------------------------------------------------------------------|
| Trade Name | Isolator™ Transpolar™ pen |
| 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 Isolator ™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

#### Predicate Devices

The predicate device for the Isolator Transpolar Pen are the Medtronic Cardioblate Pen (K013392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132) and the AtriCure Bipolar System (K020919).

#### Device Description

The Isolator Transpolar pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.

#### Materials

All materials used in the manufacture of the Isolator Transpolar Pen 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.

#### Testing

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices.

## Summary of Substantial Equivalence

The Isolator Transpolar Pen is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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MAR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Atricure, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K050459 Atricure Isolator™ Transpolar™ Pen 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 11, 2005 Received: March 16, 2005

Dear Mr. Job:

This letter corrects our substantially equivalent letter of June 10, 2005.

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 - Mr. Mark Job

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,

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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# AtriCure®

## Indications for Use

510(k) Number (if known): Ko50459

Device Name: Atricure Isolator™ Transpolar™ pen

Indications For Use:

The Isolator™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Prescription Use __________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhummer
(Division Sign-Off)

ion of Cardiovascular Devices

510(k) Number K050459

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