MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290

K092009 · Boston Scientific Corporation · GEI · Nov 6, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K092009
• Device Name: MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290
• Applicant: Boston Scientific Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 6, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

LeVeen SuperSlim Needle Electrode is an electrosurgical accessory used for thermal ablation of soft tissue. Device consists of a pre-shaped, multi-armed electrode array housed within a delivery cannula; attached to a handle mechanism for deployment into targeted tissue. Operated by a physician in a clinical setting, the device connects to an external RF generator. RF energy is delivered from the array to a patient ground pad, heating surrounding tissue to induce coagulation necrosis. Output is thermal energy; clinical benefit is the ablation of nonresectable liver lesions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electrosurgical electrode array; multi-armed, pre-shaped design; delivery cannula; handle deployment mechanism. Energy source: external RF generator. Connectivity: wired connection to generator and patient ground pad.

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

• LeVeen Needle Electrode (K000032)
• LeVeen Needle Electrode (K982556)

Submission Summary (Full Text)

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K092005

## SECTION 5 510(K) SUMMARY

#### 510(K) SUMMARY

#### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: [phone] Fax: [phone]

Contact: Jennifer A. Kimball Director Regulatory Affairs Date Prepared: July 2, 2009

### 2. Device:

Trade Name: LeVeen SuperSlim Needle Electrode Common Name: Electrode, Electrosurgical Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Classification: Class II

#### 3. Predicate Device:

Boston Scientific Corporation's LeVeen Needle Electrode, K000032 Boston Scientific Corporation's LeVeen Needle Electrode, K982556

#### 4. Device Description:

The description of the proposed modified LeVeen Needle Electrode is the same as the predicate devices. The LeVeen SuperSlim Needle Electrode consists of a pre-shaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into targeted tissue. The device is connected to a generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.

# 5. Intended Use:

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

NOV - 6 2009

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# 6. Technological Characteristics:

The technological characteristics are identical to the predicate device.

# 7. Performance Data:

Testing has been completed to demonstrate that the proposed changes do not result in any new issues of safety or effectiveness.

# 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed changes do not raise any new issues of safety or effectiveness.

ﮨﮯ۔

# 000011

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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 an abstract symbol resembling a stylized eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Boston Scientific Corporation % Ms. Jennifer Kimball Director Regulatory Affairs 100 Boston Scientific Way Marlborough, Massachusetts 01545

NOV - 6 2009

.Re: K092009

Trade Name: Modifications to: LeVeen SuperSlim Needle Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulation Class: II Product Code: GEI Dated: October 8, 2009 Received: October 9, 2009

Dear Ms. Kimball:

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 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 cormly with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 – Ms. Jennifer Kimball

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you doshe specific ad roo sor your your your contrices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation only the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours

Puc Pailton m Ve

Des

Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4 INDICATIONS FOR USE STATEMENT

Indications for Use:

510(k) Number (if known): To Be Determined

Device Name: LeVeen SuperSlim Needle Electrode

Indications For Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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 Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | 1092009 |

Special Premarket Notification, LeVeen SuperSlim Needle Electrodes