COOLRAIL LINEAR PEN MODEL MCRI

K122611 · AtriCure, Inc. · OCL · Sep 26, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122611
• Device Name: COOLRAIL LINEAR PEN MODEL MCRI
• Applicant: AtriCure, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Sep 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coolrail™ linear pen is a sterile, single use electrosurgery 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 during cardiac surgery to ablate cardiac tissue. Device connects to an external electrosurgical generator to deliver radiofrequency (RF) energy. Operated by surgeons in an OR setting. Output is RF current for tissue ablation; intended to create lesions in cardiac tissue. Benefits include surgical ablation capability for cardiac procedures.

Clinical Evidence

No clinical data. Bench testing performed per 21 CFR 820.30 and AtriCure's Quality System to verify conformance to design controls and specifications.

Technological Characteristics

Sterile, single-use electrosurgical device. Delivers radiofrequency energy via an electrosurgical generator. Patient-contacting materials tested for biocompatibility per ISO 10993-1.

Indications for Use

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

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

• Coolrail Linear Pen (K073605)

Submission Summary (Full Text)

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### 510(k) Summary

#### General Information

| Classification | Class 2 |
|---------------------|--------------------------------------------------------------------------------------------------------|
| Trade name | Coolrail Linear Pen |
| Classification Name | Surgical Device, For Ablation Of Cardiac Tissue<br>(21 CFR 878.4400, Product Code OCL) |
| Manufacturer | AtriCure, Inc.<br>6217 Centre Park Dr.<br>West Chester, OH 45069<br>P: 513-755-4100<br>F: 513-755-4108 |
| Contact | James Lucky, RAC<br>Vice President Quality Systems and Regulatory Affairs |
| Date of Submission | August 24, 2012 |

#### 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.

#### Cleared Device

The device proposed for modification in this submission is the Coolrail Linear Pen cleared via 510(k) K073605 on March 11, 2008.

#### 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 in the modified Coolrail Linear Pen are suitable for their intended use. Testing was previously conducted on all patient contacting materials in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all appropriate materials.

#### Testinq

Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Coolrail Linear Pen conformance to design controls and specification. Testing determined that the modified Coolrail Linear Pen conformed to design controls and product specifications.

#### Summary of Equivalence

The modified Coolrail Linear Pen proposed in this submission is considered substantially equivalent to the Coolrail Linear Pen cleared via K073605. The indications for use, basic overall function, and materials used are substantially equivalent.

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K122611

Coolrail Linear Pen Page 64 of 90

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AtriCure Inc. c/o Mr. James Lucky VP of quality Systems and Regulatory Affairs 6217 Center Park Dr. West Chester, OH 45069

SEP 26 2012

Re: K122611

- Trade/Device Name: Coolrail Linear Pen
Regulation Number: 21 CFR 870.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories. . · Regulatory Class: Class II (two) Product Code: OCL Dated: August 24, 2012 Received: August 27, 2012

Dear Mr. Lucky:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. James Lucky

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

D. Zuckerman, M.D.

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 electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

× 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)

vision Sign-Off)

vision of Čardiovascular Devices

510(k) Number K122611

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