CONCERTO BIPOLAR NEEDLE ELECTRODE

K040785 · Boston Scientific Corp · GEI · Apr 28, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040785
• Device Name: CONCERTO BIPOLAR NEEDLE ELECTRODE
• Applicant: Boston Scientific Corp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 28, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Concerto™ Bipolar Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Device Story

Concerto™ Bipolar Needle Electrode is a disposable electrosurgical device for thermal coagulation necrosis of soft tissue. It features a needle with two electrically independent opposing arrays housed in an insulated delivery cannula. A handle mechanism allows individual deployment of arrays into targeted tissue. The device connects to a Boston Scientific radiofrequency (RF) generator; energy passes between the two arrays to heat surrounding tissue. Bipolar technology eliminates the need for grounding pads. Used by clinicians in a clinical setting for ablation of nonresectable liver lesions. The device provides a localized thermal effect to achieve tissue necrosis, benefiting patients by enabling minimally invasive treatment of liver lesions.

Clinical Evidence

Bench testing only. The device was tested for compliance with ANSI/AAMI HF-18/2001 and IEC 60601-2-2/2001 standards for electrosurgical devices.

Technological Characteristics

Disposable electrosurgical needle electrode; bipolar technology; two electrically independent opposing arrays; insulated delivery cannula; handle-actuated array deployment. Complies with ANSI/AAMI HF-18/2001 and IEC 60601-2-2/2001. Energy source: external RF generator.

Indications for Use

Indicated for thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

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

• Reflect Bipolar/Monopolar Needle Electrode

Submission Summary (Full Text)

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APR 2 8 2004

Special 510(k) Concerto™ Bipolar Needle Electrode

March 26, 2004

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# Summary of Safety and Effectiveness

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

K040785

| General Information | Submitter: Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760<br>508-652-5003 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Nicholas Condakes |
| General Provisions | |
| Trade Name: | Concerto™ Bipolar Needle Electrode |
| Classification Name: | Electrode, Electrosurgical |
| Name of Predicate Devices | Reflect Bipolar/Monopolar Needle Electrode |
| Classification | Class II |
| Performance Standards | The Concerto Bipolar Electrode 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 60601-2-2/2001. |

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Concerto™ Bipolar Needle Electrode March 26, 2004

## Intended Use and Device Description

Concerto™ Bipolar Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. The Concerto™ Bipolar Needle Electrode is a disposable, electrosurgical device used for coagulation necrosis of soft tissue. The device consists of a needle with two electrically independent opposing arrays that are contained within an insulated delivery cannula. The arrays are attached to a handle mechanism that allows the arrays to be individually deployed out from the cannula into the targeted tissue. The ConcertoTM Bipolar Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes between the two arrays and heats the No grounding pads are tissue surrounding and in between the arrays. required due to the device's Bipolar technology.

## Summary of Substantial Equivalence

The Concerto™ Bipolar Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2004

Mr. Nicholas Condakes Regulatory Specialist II Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760

Re: K040785

Trade/Device Name: Concerto™ Bipolar Needle Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 26, 2004 Received: March 29, 2004

Dear Mr. Condakes:

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 complics 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 CHR 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. Nicholas Condakes

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 premaince hoticated 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 If you desire 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 other Economics, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/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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## Indications For Use KO40785 510(k) Number (if known) Concerto™ Bipolar Needle Electrode Device Name: Concerto™ Bipolar Needle Electrode is intended to be used in conjunction Indications with a Boston Scientific radiofrequency (RF) generator for the thermal for Use coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------|------------------------------------------------------------|--------|
| Prescription Use (Per 21 CFR 801 Subpart D) | Miriam C. Provost | |
| | (Division Sign-Off) | |
| | Over-The-Counter Use (21 CFR 807 Subpart C) | |
| | Division of General, Restorative, and Neurological Devices | |
| | <i>Confidential</i><br>Boston Scientific Corporation | 000067 |
| 510(k) Number | K040785 | |