CONCERTO BIPOLAR NEEDLE ELECTRODE

K060419 · Boston Scientific Corp · GEI · Mar 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060419
• Device Name: CONCERTO BIPOLAR NEEDLE ELECTRODE
• Applicant: Boston Scientific Corp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 13, 2006
• 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. The Concerto™ Bipolar Needle Electrode is a disposable, electrosurgical device used for coagulation necrosis of soft tissue.

Device Story

Disposable electrosurgical device; used with Boston Scientific RF generator for thermal coagulation necrosis of soft tissues; specifically nonresectable liver lesions. Device features needle with two electrically independent opposing arrays inside insulated delivery cannula; handle mechanism allows individual array deployment into target tissue. Bipolar technology eliminates need for grounding pads; energy passes between arrays to heat surrounding tissue. Used in clinical settings by physicians; output is thermal energy for tissue ablation; benefits include localized destruction of nonresectable lesions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bipolar electrosurgical needle electrode; two independent opposing arrays; insulated delivery cannula; handle deployment mechanism. Complies with ANSI/AAMI HF-18/2001 and IEC 60601-2-2/2001. Energy source: RF generator.

Indications for Use

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

• Concerto™ Bipolar Needle Electrode (K060419)

Submission Summary (Full Text)

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KO60419 Special 510(k) Modified Concerto™ Bipolar Needle Electrode February 16, 2006

MAR 1 3 2006

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## 510(k) Summary

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

| General<br>Information | Submitter: Boston Scientific Corporation<br>100 Boston Scientific Way<br>Marlborough, MA 01752<br>508-683-4003 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Nicholas Condakes |
| General<br>Provisions | Trade Name: Concerto ^™ Bipolar Needle Electrode |
| | Classification Name: Electrode, Electrosurgical |
| Name of<br>Predicate<br>Devices | Concerto ^™ Bipolar Needle Electrode |
| Classification | Class II |
| Performance<br>Standards | The modified Concerto Bipolar Needle Electrode has been designed to<br>comply with the applicable sections of ANSI/AAMI American Standard for<br>Electrosurgical Devices HF-18/2001 and the International Electrotechnical<br>Commission Standard for Electrosurgical Devices, IEC 60601-2-2/2001. |

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Intended Use Concerto™ Bipolar Needle Electrode is intended to be used in conjunction and Device with a Boston Scientific radiofrequency (RF) generator for the thermal Description 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 Concerto™ Bipolar Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes between the two arrays and heats the tissue surrounding and in between the arrays. No grounding pads are required due to the device's Bipolar technology. The Concerto™ Bipolar Needle Electrode has been tested and compared to Summary of Substantial All data gathered demonstrate this device as the predicate device. Equivalence substantially equivalent. No new issues of safety or efficacy have been raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corp c/o Mr. Nicholas Condakes Sr. Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752

Re: K060419

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: February 28, 2006 Received: March 1, 2006

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 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

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## Page 2 - Mr. Nicholas Condakes

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. 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]. 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/dsma/dsmamain.html

Sincerely vours.

ell. Mdl

-+1'11--

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

Enclosure

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K060419

## Indications for Use

510(k) Number (if known):

Device Name: Concerto™ Bipolar Needle Electrode

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

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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510(k) Number_ Ko60419

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