ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1

K020919 · AtriCure, Inc. · GEI · Apr 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020919
• Device Name: ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
• Applicant: AtriCure, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.

Device Story

System consists of single-use bipolar handpiece and reusable Ablation and Sensing Unit (ASU). Handpiece jaws grasp tissue (up to 10mm thick); electrodes deliver RF bipolar energy to ablate/coagulate tissue. ASU monitors tissue conductance and temperature via embedded sensors. Operator uses footswitch to initiate RF energy; ASU automatically terminates output based on backup timer or when threshold conductance is reached, signaling complete ablation via visual/audible indicators. Used in OR by surgeons. Benefits include controlled tissue ablation and real-time feedback on ablation status.

Clinical Evidence

Bench testing only. Device performance validated against industrial/international standards including ANSI/AAMI HF 18, ISO 10993 (biocompatibility), ISO 11607 (packaging), ISO 11135 (sterilization), and IEC/EN 60601 series (electrical safety and electromagnetic compatibility).

Technological Characteristics

Bipolar RF electrosurgical system. Components: reusable ASU (RF PCB, microprocessor, measurement/display PCBs) and single-use handpiece with electrodes and temperature sensors. Energy: RF bipolar near AM frequency band. Connectivity: footswitch interface. Standards: ANSI/AAMI HF 18, ISO 10993, ISO 11607, ISO 11135, IEC/EN 60601-1, 60601-1-1, 60601-1-2, 60601-2-2, 60601-1-4, UL 2601-1.

Indications for Use

Indicated for ablation and coagulation of soft tissue during general, ENT, thoracic, gynecological, and urological surgical 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

• AtriCure Bipolar Coagulation System (K011722)
• AtriCure Bipolar Coagulation System (K010122)

Submission Summary (Full Text)

{0}------------------------------------------------

# APR 1 9 2002

AtriCure Incorporated

# Special 510(k) – AtriCure Bipolar System

## 510(k) SUMMARY ATRICURE COAGULATION SYSTEM 510(k) NOTIFICATION KXXXX

| | K 020 919 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | |
| Manufacturer: | AtriCure Incorporated<br>6033 Schumacher Park Drive<br>West Chester, OH 45069-3863<br>[phone]<br>Fax [phone]<br>Est. Reg. No. 3003502 |
| Contact Person: | Mark L. Friedman, Ph.D.<br>Vice President of Quality Assurance & Regulatory Affairs<br>AtriCure Incorporated |
| Date Prepared: | [to be added after 510(k) process] |
| Device Description | |
| Classification: | Class II |
| Trade Name: | AtriCure Bipolar System |
| Generic/Common Name: | Electrosurgical cutting and coagulation device and<br>Accessories 21CFR 878.4400 |

#### Predicate Devices

- 1. AtriCure Inc. AtriCure Bipolar Coagulation System K011722
- 2. AtriCure Inc. AtriCure Bipolar Coagulation System K010122

#### Indication For Use Statement

The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.

## Product Description

The system is comprised of the Bipolar Handpiece (single patient use) with integral cable and the re-usable Ablation and Sensing Unit (ASU).

The ASU is a portable reusable device that produces and delivers RF bipolar energy near the AM frequency band to coagulate and ablate biological tissue. The device consists of a RF PCB (printed circuit board), microprocessor PCB, measurement PCB, display PCB, AC power supply, power entry module, volume control, footswitch Interface, and Handpiece interface. Front panel indicators include an LED temperature display, a LCD graphics conductance display, and LED lamps indicating power on, fault condition, ready state, RF on, and conductance state. The ASU limits the amount of voltage, current and time at which power is output to the Handpiece. Upon reaching a threshold conductance, the ASU will light a visual indicator and sound an audible tone signaling that the conditions for a complete ablation have been satisfied. A footswitch is included in the Ablation System to activate RF energy delivery.

{1}------------------------------------------------

## Special 510(k) - AtriCure Bipolar System

K020919
2 of 2

The system delivers Bipolar RF energy to tissue that is clamped between the Handpiece jaws. Pressing of the footswitch initiates the RF energy output. RF energy output is terminated by releasing the footswitch or upon expiration of the RF backup timer.

The Handpiece connects to the ASU and utilizes Bipolar RF energy to ablate tissue that is clamped between the instrument jaws. The Handpiece includes a set of jaws that are capable of grasping tissue up to 10mm in thickness. Each jaw is comprised of an electrode with surrounding insulators and imbedded temperature-sensing element allowing for the transfer of energy to tissue and the monitoring of temperature rise by the tissue. The handle includes a lever that applies a controlled force to the tissue in the jaws. At a predetermined force the jaws latch. A trigger is provided to release the latch at the end of the ablation.

The AtriCure Bipolar System meets the following performance industrial/international standards.

| ANSI/AAMI HF 18 | Electrosurgical Devices |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993/EN 30993 | Biological Evaluation of Medical Devices |
| ISO 11607 | Packaging for Terminally Sterilized Medical Devices |
| ISO 11135 | Medical Devices, Validation and Routine Control of Ethylene<br>Oxide Sterilization |
| IEC/EN 60601-1 | Medical Electrical Equipment - Part 1: General Requirements<br>for Safety |
| IEC/EN 60601-1-1 | Medical Electrical Equipment - Collateral Standard: Safety<br>Requirements for Medical Device Systems |
| IEC/EN 60601-1-2 | Medical Electrical Equipment - Part 1: General Requirements<br>for Safety 2: Collateral Standard: Electromagnetic<br>Compatibility - Requirements and Tests |
| IEC/EN 60601-2-2 | Medical Electrical Equipment - Part 2-2: Particular<br>Requirements for the Safety of High Frequency<br>Surgical Equipment |
| IEC/EN 60601-1-4 | Medical Electrical Equipment - Part 1-4: General<br>Requirements for safety - Collateral Standard:<br>Programmable Electrical Medical Systems |
| UL 2601-1 | Standard for Safety: Medical Electrical Equipment |

## Summary

As contained in this 510(k) summary, the AtriCure Bipolar System is substantially equivalent to the predicate devices identified.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 9 2002

Mark L. Friedman, Ph.D. Vice President of Quality Assurance and Regulatory Affairs AtriCure, Inc. 6033 Schumacher Park Drive West Chester. Ohio 45069-3863

Re: K020919

Trade/Device Name: AtriCure Bipolar System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 19, 2002 Received: March 21, 2002

Dear Dr. Friedman:

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 for association 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 Crth 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.

{3}------------------------------------------------

Page 2 - Mark L. Friedman, Ph.D.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

R. Mark A. Millener

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page

919 0 8/1 510(k) Number (if known):

Device Name:_AtriCure_Bipolar_System

Indications For Use:

"The AtriCure Bipolar System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology and Urology surgical procedures."

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kozo919

for Mark N. Melkerson

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_

(Optional Format 3-10-98)