The AtriCure Ablation System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (Isolator® Transpolar Clamps or Isolator Synergy™ Clamps) intended for the ablation of soft tissues and an accessory instrument guide (Glidepath™ Tape). The clamp handpieces are connected via an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU2) or an Isolator Switch Matrix (ASB3) console.

AI/ML Overview

This document, K063630, is a 510(k) summary for the AtriCure Ablation System. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria for performance, nor does it describe a study to prove the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing de novo performance metrics or studies against them. The review process for a 510(k) typically involves showing that the new device is as safe and effective as a predicate device, often through technological comparisons and performance data that demonstrate the new device does not raise new questions of safety or effectiveness.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because these elements are not present. The document focuses on regulatory approval based on equivalence, not on a detailed clinical or performance study demonstrating specific acceptance criteria.

The "Testing" section merely states: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." This is a high-level statement and does not provide the specifics of any such tests or their results against defined acceptance criteria.

Summary

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Ka63630.

ATTACHMENT 7 510(k) SUMMARY

510(k) Summary

General Information

Classification	Class II
Trade Name	AtriCure Ablation System	JAN 26 2007
Manufacturer	AtriCure, Inc.6033 Schumacher Park DriveWest Chester, OH 45069
Contact	Elsa AbruzzoVice President, Clinical and Regulatory Affairs

Intended Use

The AtriCure Ablation System is intended to ablate soft tissues during general surgery using radiofrequency energy.

Predicate Devices

The predicate devices for the AtriCure Ablation System are the AtriCure Bipolar System (K020919), the AtriCure Transpolar™ System (K052893), and the Medtronic Cardioablate Surgical Ablation System (K060400)

Device Description

Materials

All materials in the AtriCure Ablation System are suitable for their intended 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 AtriCure Ablation System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Regulatory Technology Services, LLC % Mr. Mark Job Responsible Third Party Official 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K063630

Trade/Device Name: Atricure Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2006 Received: December 6, 2006

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.

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 (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.

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Page 2 - Mr. Mark Job

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) 276-0115 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,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __

1061630

Device Name: AtriCure Ablation System

Indications For Use:

The AtriCure Ablation System is intended to ablate soft tissues during general 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)

Styph. Rood

ision Sign-Off) "sion of General, Restorative and Neurological Devices

Number K063630

Page 1 of 1

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.