BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE

K112233 · Bovie Medical Corporation · GEI · Jan 27, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K112233
• Device Name: BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
• Applicant: Bovie Medical Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas and a retractable blade for cutting and coagulation of soft tissue for use during both open and laparoscopic surgical procedures.

Device Story

Single-use electrosurgical handpiece; compatible with ICON GS generator (GS100) and reusable cable (GS-807-RC). Features finger-activated button; manual retractable cutting blade; helium gas delivery. Operation: helium gas flows to distal tip; excited by high electric field to create plasma stream for coagulation; mechanical blade used for tissue excision. Used in OR by surgeons for open or laparoscopic procedures. Programmable memory device requires unique code for generator operation. Benefits: provides dual-modality (plasma coagulation and mechanical cutting) in single device; facilitates soft tissue management.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and compliance with electrical safety standards (IEC 60601-1, IEC 60601-2-2).

Technological Characteristics

Monopolar electrosurgical handpiece; helium gas plasma coagulation; manual retractable cutting blade. Compatible with ICON GS generator. Complies with IEC 60601-1 (2005) and IEC 60601-2-2 (2009). Includes programmable memory device for generator identification. Laparoscopic model features 27 cm extended tip.

Indications for Use

Indicated for cutting and coagulation of soft tissue during open and laparoscopic surgical procedures in patients requiring electrosurgery.

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

• Bovie® ICON GS Electrosurgical Handpiece (K090586)

Submission Summary (Full Text)

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P

JAN 2 7 2012

K 112233 PAGE LOF 3

## 510(k) SUMMARY

# (As Required per 21 CFR 807.92(c))

### GENERAL INFORMATION:

| 510k Owner's Name | Bovie Medical Corporation | |
|-------------------|----------------------------------------------------------------------------|--|
| Address | 5115 Ulmerton Road<br>Clearwater, Florida 33760-4004 | |
| Telephone Number: | [phone] | |
| FAX Number: | [phone] | |
| Contact Person | Richard A. Kozloff<br>Vice-President; Quality Assurance/Regulatory Affairs | |
| Date Prepared: | August 2, 2011 | |

### DEVICE DESCRIPTION:

| Trade Name: | Bovie® J-Plasma Handpiece with Retractable Cutting Blade |
|----------------------|--------------------------------------------------------------------|
| Common Name: | Cutting and Coagulation Electrosurgical Device |
| Classification Name: | Electrosurgical Cutting and Coagulation Devices and<br>Accessories |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed | |
| Predicate Device(s): | Bovie® ICON GS Electrosurgical Handpiece (K090586) |

### Included Accessories:

| | J-Plasma Handpiece with Retractable Cutting Blade | Bovie® ICON GS Electrosurgical Handpiece<br>(Predicate Device) |
|--------------------------|---------------------------------------------------|----------------------------------------------------------------|
| Reusable Handpiece Cable | GS807-RC<br>(510k K090586) | GS807-RC<br>(510k K090586) |

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### 510(k) SUMMARY

### (As Required per 21 CFR 807.92(c))

#### DEVICE FUNCTION, TECHNOLOGY, AND INTENDED USE:

The Bovie® J-Plasma Handpiece with Retractable Cutting Tip are single use devices designed to be compatible only with the ICON GS generator (GS100) and reusable cable (GS-807-RC) cleared under 510k K-090586. There are device models for both open and laparoscopic surgical procedures (GS-018C and GS-270C respectively). These handpieces contain a programmable memory device that requires a unique code for the generator to operate. Each handpiece has a button for finger activation of the generator. Once activated, helium gas flows out the distal end of the device where gas molecules are excited by the high electric field resulting in a plasma stream. The handpiece that is intended for open procedures does not have an extended shaft. The handpiece intended for laparoscopic procedures has a 27 cm extended tip. Both handpieces contain a retractable cutting blade that can be extended manually for excising tissue.

#### INTENDED USE:

#### Plasma:

The Bovie J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas plasma for coagulation of soft tissue during both open and laparoscopic surgical procedures.

#### Blade:

The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes a retractable blade for cutting of soft tissue during both open and laparoscopic surgical procedures.

#### ELECTRICAL STANDARDS:

Both named devices and the predicate are designed to comply with the following electrical standards:

| IEC 60601-1: | Standard for Safety Medical Electrical Equipment, Part 1: General<br>Requirements for Safety (2005) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-2: | Medical Electrical Equipment - Part 2-2: Particular Requirements for the<br>Basic Safety and Essential Performance of High Frequency Surgical<br>Equipment and High Frequency Surgical Accessories (2009) |

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# 510(k) SUMMARY

# (As Required per 21 CFR 807.92(c))

| Characteristics | Bovie® J-Plasma Handpiece<br>with Retractable Cutting<br>Blade<br>(This Submission) | Bovie® ICON GS<br>Electrosurgical Handpiece<br>(K-090586) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Plasma:<br>The Bovie® J-Plasma<br>Handpiece with Retractable<br>Cutting Blade is an<br>electrosurgical device that<br>utilizes helium gas plasma<br>for coagulation of soft tissue<br>during both open and<br>laparoscopic surgical<br>procedures.<br><br>Blade:<br>The Bovie® J-Plasma<br>Handpiece with Retractable<br>Cutting Blade is an<br>electrosurgical device that<br>utilizes a retractable blade<br>for cutting of soft tissue<br>during both open and<br>laparoscopic surgical<br>procedures. | An electrosurgical device<br>that utilizes Helium gas for<br>the coagulation of soft<br>tissues during open soft<br>tissue surgery. |
| Electrical Safety<br>Standards | IEC60601-2-2, IEC60601-1 | IEC60601-2-2, IEC60601-1 |
| Output Energy | | |
| Coagulation | 40 Watts (100% Setting on<br>ICON GS Generator) | 40 Watts (100% Setting on<br>ICON GS Generator) |
| Delivery System | Monopolar | Monopolar |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bodies, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the department's name, which is written in a circular fashion around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

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

Bovie Medical Corporation % Mr. Richard A. Kozloff Vice President; Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760

JAN 2 7 2012

#### Re: K112233

Trade/Device Name: BOVIE® J-Plasma Handpiece with Retraceable Cutting Blade Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI

Dated: January 19, 2012

Received: January 20, 2012

#### Dear Mr. Kozloff:

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 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); 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 - Mr. Richard A. Kozloff

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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 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 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/defaultshtm./

Sincerely vours,

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

Enclosure

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#### Indications for Use

510(k) Number (if known):

Device Name: Bovie® J-Plasma Handpiece with Retractable Cutting Blade

Indications for Use:

The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas and a retractable blade for cutting and coagulation of soft tissue for use during both open and laparoscopic surgical procedures.

Prescription Use ✔ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-

(Division (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112233

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