ATRICURE BIPOLAR COAGULATION SYSTEM

K011722 · AtriCure, Inc. · GEI · Aug 30, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011722
• Device Name: ATRICURE BIPOLAR COAGULATION SYSTEM
• Applicant: AtriCure, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 30, 2001
• Decision: SESE
• Submission Type: Traditional
• 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

AtriCure Bipolar Coagulation System comprises bipolar coagulator (handle with grasping jaws) and electrosurgical generator. Device used in OR by surgeons for soft tissue ablation/coagulation. Bipolar coagulator grasps tissue between electrodes; RF energy applied to coagulate tissue via heating. Generator delivers 750 mA current; monitors impedance, voltage, current, power, and tissue temperature (up to 125°C). Impedance increase indicates coagulation progress; 400 ohms typically indicates fully coagulated tissue. Surgeon uses generator display and temperature readings to determine extent of coagulation. Benefits include controlled tissue coagulation up to 2 mm from electrode, 4 mm width, 60 mm length, for tissue <10 mm thick.

Clinical Evidence

Bench testing only. Performance verified against industrial/international standards including ANSI/AAMI HF 18, ANSI C101-1992, AAMI ESI-1993, ISO 10993 (biocompatibility), ISO 11137 (sterilization), and IEC/EN 60601 series (electrical safety and electromagnetic compatibility). No clinical data provided.

Technological Characteristics

Bipolar RF electrosurgical system. Components: Bipolar coagulator (handle/jaws) and electrosurgical generator. Materials: Standard biocompatible medical-grade materials. Energy: RF energy, 750 mA current, max 75V. Connectivity: Standalone generator with digital display for impedance, current, voltage, power, and temperature. Sterilization: Gamma irradiation (ISO 11137). Standards: ANSI/AAMI HF 18, IEC/EN 60601-1, IEC/EN 60601-2-2, UL 2601-1.

Indications for Use

Indicated for ablation and coagulation of soft tissue in patients undergoing General, ENT, Thoracic, Gynecology, and Urology 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

• Ethicon Non-Stick Bipolar Forceps (K973384)
• Link Technology's Non-Stick Bipolar Forceps (K992931)
• Rita Model 1500 Electrosurgical RF Generator (K993944)
• Somnus Medical Technologies Model S1 Electrosurgical Generator (K000501)
• Symbiosis Bipolar Forceps (K950286 and K951387)
• Kirwan Medical Bipolar Forceps (K945975 and K955001)
• CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930)
• Heartport Inc. Heartport Maze System (K970496)
• EndoCare Cryocare Cryosurgical System (K980110)
• CyroGen Cardiac Cryosurgical Unit (K974320)
• CyroGen Cryosurgical Unit and Accessories (K003050)
• Galil Medical Cryo-Hit 200 (K991517)
• Galil Medical Cryo-Hit (K993965)

Submission Summary (Full Text)

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

#### AtriCure Incorporated

### 510(k) SUMMARY ATRICURE COAGULATION SYSTEM 510(k) NOTIFICATION K010112 and K01XXXX

# KO11722

General Information

AtriCure Medical Corporation Manufacturer: 6033 Schumacher Park Drive West Chester, OH 45069-3863 [phone] Fax [phone] Est. Req. No. XXXXXXXX

AUG 3 0 2001

Mark L. Friedman, Ph.D. Contact Person: Vice President of Quality Assurance & Regulatory Affairs AtriCure Medical Corporation

[to be added after 510(k) process]

Date Prepared:

Device Description

Class II Classification: AtriCure Bipolar Coagulation System Trade Name: Electrosurgical cutting and coagulation device and Generic/Common Name: Accessories 21CFR878.4400

#### Predicate Devices

- 1. Ethicon Non-Stick Bipolar Forceps (K973384)
- 2. Link Technology's Non-Stick Bipolar Forceps (K992931).
- 3. The generator accessory is equivalent to the currently marketed Rita Model 1500 Electrosurgical RF Generator, which received clearance under K993944
- 4. Somnus Medical Technologies Model S1 Electrosurgical Generator K000501
- 5. Symbiosis Bipolar Forceps (K950286 and K951387)
- 6. Kirwan Medical Bipolar Forceps (K945975 and K955001)
- 7. CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930)
- 8. Heartport Inc. Heartport Maze System (K970496)
- 9. EndoCare Cryocare Cryosurgical System (K980110)
- 10. CyroGen Cardiac Cryosurgical Unit (K974320)
- 11. CyroGen Cryosurgical Unit and Accessories (K003050)
- 12. Galil Medical Cryo-Hit 200(K991517)
- 13. Galil Medical Cryo-Hit (K993965)

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

#### 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 AtriCure Bipolar Coagulation System consists of two components: AtriCure Bipolar Coagulator and AtriCure Bipolar Electrosurgical Generator.

The Bipolar Coagulator is substantially equivalent to the predicate Bipolar Forceps in that each consists of a handle connected to a pair of grasping jaws with electrodes on each jaw arm. All the devices utilize the same bipolar Electrosurgical technology, i.e., radio frequency (RF) energy, to coagulate the tissue by heating. The Bipolar Coagulator contains a negative and positive electrode on opposite jaw arms. The function of the Bipolar Coagulator and predicate devices is the same, current flows from a negatively charged pole through the tissue to a positively charged pole. The Bipolar Coagulator is provided as a sterile single patient use device and is provided in a variety of shapes and sizes. The Bipolar Coagulator is constructed with standard biocompatible materials used in medical devices involved in tissue contact.

The Bipolar Coagulator is designed to grasp tissue between the electrodes. When the energy is applied, the tissue touching the electrodes is coagulated. The field of coagulation extends up to 2 mm from the electrode. Area of coagulated tissue will be up to 4 mm in width or up to 60 mm in length. Fully coagulated tissue can be achieved for tissue thickness less than 10 mm.

The Electrosurgical Generator is set to deliver 750 mA of current. As tissue coagulation proceeds the impedance increases. The voltage is set to not exceed 75 Volts. When a voltage of 75 Volts is reached, the impedance increases and current flow decreases with voltage maintained at 75 Volts. Impedance of 400 ohms typically indicates fully coagulated tissue. The unit will display impedance, current, voltage, and power on the front of the generator. The unit will also monitor the temperature of the coagulated tissue and has a range up to 125 degrees Celsius. The surgeon may also use this temperature reading as a point of reference to determine the extent of tissue coagulation.

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

ANSI/AAMI HF 18 ANSI C101-1992

«

Electrosurgical Devices American National Standard for Leakage Current for Appliances

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

| AAMI ESI-1993 | Safe Current Limits for Electromedical<br>Apparatus |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993/EN 30993<br>ISO 11607 | Biological Evaluation of Medical Devices<br>Packaging for Terminally Sterilized Medical<br>Devices |
| ISO 11137 | Sterilization of Health Care Products,<br>Sterilization of Gamma Irradiation |
| IEC/EN 60601-1 | Medical Electrical Equipment - Part 1: General<br>Requirements for Safety |
| IEC/EN 60601-1+1 | Medical Electrical Equipment - Collateral<br>Standard: Safety Requirements for Medical<br>Device Systems |
| IEC/EN 60601-2 | Medical Electrical Equipment - Part 1: General<br>Requirements for Safety 2: Collateral Standard<br>Electromagnetic Compatibility - Requirements<br>and Tests |
| IEC/EN 60601-2-2 | Medical Electrical Equipment - Part 2-2:<br>Particular Requirements for the Safety of High<br>Frequency Surgical Equipment |
| EN 46001 | Application of EN ISO 9001 to the Manufacture<br>of Medical Devices |
| UL 2601-1 | Standard for Safety: Medical Electrical<br>Equipment |
| UL 544 | Standard for Safety: Medical and Dental<br>Equipment |
| UL 498 | Standard for Safety: Attachment Plugs and<br>Receptacles |

#### Summary

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

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping profiles facing right. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2001

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

Re: K011722

Trade/Device Name: AtriCure Bipolar Coagulation System Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: May 31, 2001 Received: June 4, 2001

Dear Dr. Friedman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls Coonisions of the Act. The general controls provisions of the Act include requirements for annual provisions of article from the read 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

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

This letter will allow you to begin marketing your device as described in your 510ks) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri miding of backan.com vour device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice tor your do need contact the Office of Compliance at additionally 809.10 for in Vitto diagnosus as rices, promotion and advertising of your device, [phone]. Addinonally, for questions of [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranuming by receired to perine Act may be obtained from the Division of Small information on your responsionnes ander the rise in its toll-free number [phone] or
Manufacturers International and Consumer Assistance at its toll-free number (8 Manufacturers international and Solass "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Susan Wacker Fox

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

{5}------------------------------------------------

Page_1 of_f

510(k) Number (if known): K011722

Device Name: AtriCure Bipolar Coagulation System

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division Sigi-On)
Division of General, Restorative Division of Gical Devices

510(k) Number K011722

(Optional Format 3-10-98)