INCIRCLE BI-POLAR RF ABLATION SYSTEM

K070711 · Rfa Medical, Inc. · GEI · Apr 24, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070711
• Device Name: INCIRCLE BI-POLAR RF ABLATION SYSTEM
• Applicant: Rfa Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

Device Story

InCircle™ Bi-Polar RF Ablation System is a sterile, disposable, hand-held electrosurgical device. It utilizes opposing electrodes to deliver bi-polar radiofrequency (RF) energy to soft tissue. The device is intended for use in percutaneous, laparoscopic, and intraoperative surgical procedures. It operates in conjunction with standard FDA-cleared RF generators (e.g., Boston Scientific RF3000, RITA Medical Systems 1500X). The physician operates the device to achieve thermal coagulation/ablation of target tissue. The system provides a localized thermal effect, allowing for controlled tissue destruction, which benefits patients by enabling minimally invasive surgical interventions.

Clinical Evidence

Bench testing and functional testing were performed to verify performance and ensure the device does not raise new questions of safety or efficacy compared to the predicate devices. No clinical data was provided.

Technological Characteristics

Sterile, disposable, hand-held bi-polar RF electrosurgical device. Complies with ANSI/AAMI HF-18:2001 and IEC 60601-2-2:2006 standards. Operates via bi-polar RF energy delivered through opposing electrodes. Designed for use with external RF generators.

Indications for Use

Indicated for thermal coagulation of soft tissues in percutaneous, laparoscopic, and intraoperative surgical procedures. For prescription use only.

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

• Boston Scientific Concerto™ Bipolar Needle Electrode (K040785, K050361, K060419)
• Rita Medical Systems StarBurst™ XII Electrosurgical Device (K010060)

Reference Devices

• Boston Scientific (RadioTherapeutics) RF3000 (K000241)
• RITA Medical Systems 1500X (K983214)

Submission Summary (Full Text)

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

RFA Medical, Inc.

070711

Page 1 of

510(k) Notification
InCircle™ Bi-Polar RF Ablation System

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### A. Name, Address, Phone and Fax Number of Applicant

APR 2 4 2007

RFA Medical, Inc. 40874 Calido Place Fremont, CA 94539, USA Telephone: [phone] Fax: [phone]

Contact Person Nancy Lincé Regulatory Affairs Consultant Telephone: [phone] [phone] Fax:

## ். Date Prepared

B.

February 9, 2007

#### D. Device Name

Trade Name: InCircle™ Bi-Polar RF Ablation System Classification Name: Electrosurgical cutting and coagulation device and accessories

## E. Performance Standards

The RFA Medical InCircle™ Bi-Polar RF Ablation Device has been designed to comply with the applicable sections of ANSI/AAMI American Standard for Electrosurgical Devices HF-18:2001 and the International Electrotechnical Commission Standard for Electrosurgical Devices IEC 60601-2-2:2006.

## F. Device Description

The RFA Medical InCircle™ Bi-Polar RF Ablation System is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device that utilizes opposing sets of Electrodes to coagulate/ablate a region of soft tissue using bi-polar RF energy. The device is designed for in percutaneous, laparoscopic, and intraoperative surgical use procedures. The device is designed for use with standard FDA cleared generators, such as the Boston RF Scientific Corporation (RadioTherapeutics) RF3000 (K000241) and the RITA Medical Systems 1500X (K983214).

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

K O'70711

RFA Medical, Inc.

Page 2 of (2)

InCircle™ Bi-Polar RF Ablation System

## G. Intended Use

The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

#### H. Substantial Equivalence

The RFA Medical InCircle™ Bi-Polar RF Ablation System is substantially equivalent to the Boston Scientific Concerto™ Bipolar Needle Electrode (K040785, K050361, and K060419) and Rita Medical Systems StarBurst™ XII Electrosurgical Device (K010060). The InCircle has a similar intended use, materials of construction, and principles of operation as the predicate Both the subject and predicate devices are designed to devices. coagulate/ablate tissue by delivering RF energy with the use of electrodes.

#### l. Summary of Data

Bench testing/functional testing was performed on the RFA Medical InCircle™ Bi-Polar RF Ablation System to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

RFA Medical, Inc. % KEMA Quality B.V. Ms. Patricia L. Murphy 4377 County Line Road Chalfont, Penssylvania 18914

APR 2 4 2007

Re: K070711

Trade/Device Name: InCircle™ Bi-Polar RF Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 11, 2007 Received: April 12, 2007

Dear Ms. Murphy:

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.

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

Page 2 - Ms. Patricia L. Murphy

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your is one of substantial equivalence of your device to a legally premainted 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

for Pete Rummo

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

Enclosure

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

RFA Medical, Inc.

## Indications for Use Statement

510(k) Number (if known): K 070071

Device Name:

InCircle™ Bi-Polar RF Ablation System

Indications for Use:

The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

**Prescription Use** * *

OR (per 21 CFR 801.109) Over-The-Counter Use_

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

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

| 510(k) Number | K070711 |
|---------------|---------|
|---------------|---------|

Appendix B

Page 1 of 1