ATRICURE COOLRAIL LINEAR PEN

K073605 · AtriCure, Inc. · OCL · Mar 11, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073605
• Device Name: ATRICURE COOLRAIL LINEAR PEN
• Applicant: AtriCure, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Mar 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Coolrail™ Linear Pen (Coolrail Pen) is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Device Story

Coolrail Linear Pen is a sterile, single-use electrosurgical device. Used in conjunction with an electrosurgical generator to deliver radiofrequency (RF) current for cardiac tissue ablation. Operated by surgeons during cardiac surgical procedures. Device facilitates tissue ablation via RF energy delivery. Benefits include targeted cardiac tissue destruction as required during surgery.

Clinical Evidence

Bench testing only. Testing conducted to evaluate conformance to product specifications and substantial equivalence to predicate devices. Biocompatibility testing performed in accordance with ISO 10993-1.

Technological Characteristics

Sterile, single-use electrosurgical device. Energy source: radiofrequency current (via external generator). Materials: biocompatible, tested per ISO 10993-1. Form factor: linear pen configuration.

Indications for Use

Indicated for ablation of cardiac tissue during cardiac surgery. Prescription use only.

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 Isolator Transpolar Pen (K050459)
• Medtronic Cardioblate Monopolar Pen (K013392)
• Boston Scientific Flex 4 Ablation Probe (K003978)

Submission Summary (Full Text)

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# COOLRAIL LINEAR PEN 510(k) SUMMARY

# General Information

MAR 1 1 2008

| Classification | Class II |
|----------------|--------------------------------------------------------------------|
| Trade Name | Coolrail linear pen |
| Manufacturer | AtriCure, Inc<br>6033 Schumacher Park Dr<br>West Chester, OH 45069 |
| Contact | Alison M. Grimaldi<br>Clinical & Regulatory Engineer II |

# Indications for Use

The Coolrail™ Linear Pen (Coolrail Pen) is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

# Predicate Devices

The predicate devices for the Coolrail Linear Pen are the AtriCure Isolator Transpolar Pen (K050459), the Medtronic Cardioblate Monopolar Pen (K013392), and the Boston Scientific Flex 4 Ablation Probe (K003978).

# Device Description

The Coolrail Linear 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 Coolrail Linear 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 Coolrail Linear Pen is equivalent to the predicate products. The indications for use, basic overall funcation, and materials used are substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2008

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

Re: K073605 Atricure Coolrail Linear 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: December 20, 2007 Received: December 21, 2007

Dear Mr. Job:

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.

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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 agencics. 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 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]. 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/industry/support/index.html.

Sincerely yours,

[signature]

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: Coolrail Linear Pen

Indications for Use:

The Coolrail™ Linear Pen is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

X Prescription Use (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)

(Division Sign-Off) ardiovascular Devices Divisi 510(k) Number

AtriCure, Inc.