COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR

K023733 · Ingenjorsfirman Bjorn Bergdahl AB · GEI · May 14, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023733
• Device Name: COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
• Applicant: Ingenjorsfirman Bjorn Bergdahl AB
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 14, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Coagulation of soft tissue during surgery.

Device Story

Coa-Comp/M Automatic Bipolar Coagulator is an electrosurgical device used for soft tissue coagulation during surgery. It utilizes radio frequency (RF) energy, specifically a pure sine-wave at 512 kHz, to achieve coagulation. The device delivers a maximum power output of 40W into a 100 Ohm load. It is intended for use by surgeons in a clinical or surgical setting. The device functions by applying RF energy to tissue to induce hemostasis. It is substantially equivalent to previously marketed bipolar coagulators.

Technological Characteristics

Electrosurgical bipolar coagulator; RF energy source; pure sine-wave output at 512 kHz; maximum power output 40W into 100 Ohms; Class II device.

Indications for Use

Indicated for coagulation of soft tissue during surgery.

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

• CBC-1 Coa-Comp Anti Sticking Bipolar Coagulator (K870149)
• CBC-2 Bipolar Coagulator (K870177)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and effectiveness.

## K023733

# Submitter:

MAY 1 4 2003

Ingenjörsfirman Björn Bergdahl AB Hällesås byväg 31 427 51 Billdal Sweden

## Contact person:

Björn Bergdahl Hällesås byväg 31 427 51 Billdal Sweden phone [phone], fax [phone] [e-mail]

# Device:

# Coa-Comp/M Automatic Bipolar Coagulator. Class II device.

For coagulation of soft tissue during surgery using Radio Frequency, a pure sine-wave with frequency 512 kHz. Maximum power output 40W into 100 Ohms.

The device has same characteristics and data as predicate devices: CBC-1 Coa-Comp Anti Sticking Bipolar Coagulator and CBC-2 Bipolar Coagulator, Radionics Inc, 22 Terry Ave. Burlington, MA 01803, USA. K870149 and K870177. Those devices were manufactured by Ingenjörsfirman Björn Bergdahl AB, (address as above).

B. Bergdahl
Björn Bergdahl

2003-05-02

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's emblem in the center. The emblem features a stylized representation of a human figure with three flowing lines above it, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2003

Mr. Biörn Bergdahl Ingenjörsfirman Björn Bergdahl AB Hällesås byväg 31 427 51 Billdal Sweden

Re: K023733

Trade/Device Name: Coa-Comp/M Automatic Bipolar Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 9, 2003 Received: February 19, 2003

Dear Mr. Bergdahl:

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. Björn Bergdahl

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 [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) you may obtain. 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,

Miriam C. Provost

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

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2003-05-02

510(k) Number K 023773

Device Name: Coa-Comp/M Bipolar Coagulator.

Indications For Use:

Coagulation of soft tissue during surgery.

.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K623733