← Product Code [OCL](/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL) · K073605 # ATRICURE COOLRAIL LINEAR PEN (K073605) _AtriCure, Inc. · OCL · Mar 11, 2008 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K073605 ## Device Facts - **Applicant:** AtriCure, Inc. - **Product Code:** [OCL](/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL.md) - **Decision Date:** Mar 11, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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](/device/K050459.md)) - Medtronic Cardioblate Monopolar Pen ([K013392](/device/K013392.md)) - Boston Scientific Flex 4 Ablation Probe ([K003978](/device/K003978.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # COOLRAIL LINEAR PEN 510(k) SUMMARY # General Information MAR 1 1 2008 | Classification | Class II | |----------------|--------------------------------------------------------------------| | Trade Name | Coolrail linear pen | | Manufacturer | AtriCure, Inc
6033 Schumacher Park Dr
West Chester, OH 45069 | | Contact | Alison M. Grimaldi
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. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. 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. {2}------------------------------------------------ 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 {3}------------------------------------------------ # 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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K073605](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K073605) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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