LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE

K140495 · Boston Scientific Corp · GEI · Apr 17, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140495
• Device Name: LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
• Applicant: Boston Scientific Corp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LeVeen™ Needle Electrode Family (which includes the LeVeen™ Standard Needle Electrode System and the LeVeen™ CoAccess™ Need Electrode System) is intended to be used in conjunction with the RF3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Device Story

Monopolar electrosurgical needle electrode systems used for thermal coagulation necrosis of soft tissue; includes Standard and CoAccess variants. Standard system features pre-shaped, multi-armed electrode array in delivery cannula; CoAccess system includes insulated introducer cannula with locking stylet and electrode array. Devices connect to RF3000 generator; RF energy passes from array to patient ground pad to heat surrounding tissue. Used by clinicians for ablation of nonresectable liver lesions. Output is thermal energy for tissue necrosis; clinical benefit is destruction of targeted soft tissue lesions.

Clinical Evidence

Bench testing only. Performance testing included cannula/introducer mechanical integrity (tensile, compression, adhesion, connection strength), biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, latex), and electrical safety per IEC 60601-1 and IEC 60601-2-2.

Technological Characteristics

Monopolar electrosurgical needle electrode; PEEK insulation; Lexan resin hub; multi-armed electrode array; RF energy source; manual deployment mechanism; compliant with IEC 60601-1:2005 and IEC 60601-2-2:2009.

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

• LeVeen™ Standard Needle Electrode System (K982556)
• LeVeen™ CoAccess™ Needle Electrode System (K012315)

Reference Devices

• LeVeen™ SuperSlim™ Needle Electrode System (K113090)

Submission Summary (Full Text)

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#### Boston Scientific Corporation

#### SECTION 6 510(K) SUMMARY (K140495) . page 1 of 4

#### 1. Submitter:

Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311-1566 Telephone: [phone] Fax: [phone]

Contact: Matt Beauchane Regulatory Affairs Specialist Date Prepared: 'April 8, 2014

2. Device:

Trade Name: LeVeen™ Standard Needle Electrode System and LeVeen™ CoAccess™ Needle Electrode System Electrode, Electrosurgical Common Name: Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Panel: General & Plastic Surgery Classification: Class II

#### 3. Predicate Device:

Boston Scientific Corporation's LeVeen™ Standard Needle Electrode System (K982556) Boston Scientific Corporation's LeVecn™ CoAccess™ Needle Electrode System (K012315) ·

#### 4. Device Description:

LeVeen Standard Needle Electrode System:

The description of the proposed LeVeen Standard Needle Electrode System is the same as the predicate LeVeen Standard Needle Electrode System. The LeVeen Standard Needle Electrode System 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.

#### LeVeen™Standard Necdle Electrode System and LeVeen™ CoAccess™ Needle Electrode System 6-1

APR 1 7 2014

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#### Boston Scientific Corporation

#### 510(K) SUMMARY (K140495) page 2 of 4

LeVeen CoAccess Needle Electrode System:

The description of the proposed LeVcen CoAccess Needle Electrode System is the same as the predicate LeVeen CoAccess Needle Electrode System. The LeVeen CoAccess Needle Flectrode System is a disposable, monopolar electrosurgical device used for the coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.

The LeVeen CoAccess Needle Electrode System consists of the CoAccess' Introducer (an insulated cannula with a locking stylet) and the LeVeen CoAccess Electrode (array with integrated deployment handle) capable of fixed coaxial placement within the insulated cannula. The LeVeen CoAccess Electrode also has an array of wires that is deployed into the targeted soft tissue.

#### 5. Intended Use:

The LeVeen™ Needle Electrode Family (which includes the LeVeen™ Standard Needle Electrode System and the LeVeen™ CoAccess™ Need Electrode System') is intended to be used in coniunction with the RF3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

#### 6. Technological Characteristics:

The proposed LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System devices will have PEEK insulation. The currently cleared LeVeen Standard Needle Electrode System (K982556) and LeVeen CoAccess Needle Electrode System (K012315) insulation material is FEP. This change is identical to the LeVeen™ SuperSlim™ Meedle Electrode System cannula insulation material change that received 510(k) clearance per K113090.

The proposed CoAccess Introducer will have a hub made of Lexan resin material. The currently cleared CoAccess Introducer (K012315) has a hub made of Eastalloy resin material.

#### 7. Performance Data:

Performance bench testing, biocompatibility testing, and electrical testing were performed on the proposed LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System with PEEK insulation, which demonstrates the PEEK insulation met the required specifications for the completed design verification, biocompatibility tests, and electrical tests.

#### LeVeen™ Standard Needle Electrode System and LeVeen™ Needle Electrode System 6-2

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Boston Scientific Corporation

### 510(K) SUMMARY (K140495) page 3 of 4

6-3

Also, performance bench testing and biocompatibility testing were performed on the proposed CoAccess introducer with the Lexan hub to demonstrate that the Lexan hub met the required specifications for the completed design verification and biocompatibility tests.

The following performance bench tests were performed:

- LeVeen Standard Needle Electrode System: .
- Insulated Cannula Outer Diameter (OD) o
- Cannula Insulation Adhesion o
- Cannula Tensile ಂ
- Cannula/Array Housing Handle Compression Strength ಂ
- LeVeen CoAccess Needle Electrode System:
- Introducer Cannula Length o
- Insulated Introducer Cannula OD ্র
- Introducer Insulation Adhesion ס
- o Introducer Cannula Luminal Access
- Introducer-Electrode Connection Strength 0
- Introducer Tensile Strength o
- Introducer Cannula Compression Strength 0
- Introducer Insulation ০
- Stylet Protrusion from Introducer Cannula o
- Array Housing Protrusion from Introducer Cannula o
- 0 Insulation Protrusion
- Introducer Cannula Luer ಂ

The following biocompatibility tests were performed:

- Cytotoxicity o
- Sensitization .
- Irritation
- Acute Systemic Toxicity .
- Latex .

Testing was performed per the requirements of the following electrical standards:

- IEC 60601-1:2005 Medical Electrical Equipment, Part 1: General Safety . Requirements
- IEC 60601-2-2:2009 Medical Electrical Equipment, Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment

Traditional 510(k) Premarket Notification Frankleika 970(1) Promation System and LeVeen™ CoAccess™ Needle Electrode System

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#### Boston Scientific Corporation .

·

## 510(K) SUMMARY (K140495) page 4 of 4

. 1

## 8. Conclusion:

The LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System are substantially equivalent to the currently cleared LeVeen Standard Needle Electrode System (K982556) and LeVeen CoAccess Needle Electrode System (K012315) as they are similar to the predicate devices in Intended Use / Indications for Use, fundamental design, function, device materials, packaging, sterilization, operating principles, and fundamental scientific technology.

.

#### Traditional 510(k) Premarket Notification LeVeen™ Standard Needle Electrode System and LeVeen™ CoAccess™ Needle Electrode System 6-4

'

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17. 2014

Boston Scientific Corporation Mr. Matt Beauchane Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311

Re: K140495

Trade/Device Name: LeVeen" Standard Electrode System and Leveen" CoAccess" Need Electrode System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 26, 2014 Received: February 27, 2014

Dear Mr. Beauchane:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Matt Beauchane

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 5 INDICATIONS FOR USE STATEMENT

## 510(k) Number: K 140495

Device Name:

LeVeen™ Standard Needle Electrode System and LeVeen™ CoAccess™ Need Electrode System

Indications for Use:

The LeVeen™ Needle Electrode Family (which includes the LeVeen™ Standard Needle Electrode System and the LeVeen™ CoAccess™ Need Electrode System) is intended to be used in conjunction with the RF3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Prescription Use × (Part 21 CFR 801 Subpart D)

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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)

# Joshua C. N