Bovie Ultimate High Frequency Electrosurgical Generator

K142975 · Bovie Medical Corporation · GEI · Dec 12, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142975
• Device Name: Bovie Ultimate High Frequency Electrosurgical Generator
• Applicant: Bovie Medical Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bovie Ultimate™ High Frequency Electrosurgical Generator is indicated for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic sucrival procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces

Device Story

Multipurpose electrosurgical generator (BVX-100H) delivers RF energy and/or helium gas plasma for soft tissue cutting, coagulation, and ablation. Used in hospital operating rooms by surgeons. Device features multiple cut, blend, coagulation, and bipolar modes; includes monopolar/bipolar outputs and helium gas outlet. Integrates return electrode contact quality monitoring (NEM) to prevent patient burns. User interface includes wattage/gas flow selection, LED displays, and alarm indicators. Device combines features of two predicate generators. Output waveforms (frequency/duration) determine clinical effect. Healthcare providers use handpieces or footswitches to activate energy delivery, enabling precise tissue management during surgery.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (high-frequency surgical equipment) was demonstrated to establish substantial equivalence.

Technological Characteristics

High-frequency electrosurgical generator; RF energy and helium gas plasma output. Features: 2 cut modes (up to 300W), 3 blend modes, 3 coagulation modes, 3 bipolar modes. Includes return electrode monitoring (NEM). Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, RoHS (2011/65/EU). Connectivity: Monopolar/bipolar ports, helium gas outlet, footswitch ports. Software: Single component for user interface.

Indications for Use

Indicated for cutting, coagulating, and ablating soft tissue during open and laparoscopic surgical procedures using RF energy and/or helium gas plasma. J-Plasma function restricted to dedicated Bovie J-Plasma handpieces.

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 IDS-310 High Frequency Electrosurgical Generator (K134054)
• Bovie ICON GS Generator (K090586)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

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

December 12, 2014

Bovie Medical Corporation Mr. Moshe Citronowicz Senior Vice-President 5115 Ulmerton Road Clearwater, Florida 33760

Re: K142975

Trade/Device Name: Bovie Ultimate " High Frequency Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 2, 2014 Received: October 14, 2014

Dear Mr. Citronowicz:

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

{1}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/Resourcesfor You/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

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

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K142975

Device Name

Bovie Ultimate™ High Frequency Electrosurgical Generator

Indications for Use (Describe)

The Bovie Ultimate™ High Frequency Electrosurgical Generator is indicated for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic sucrival procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete the and review the collection of information. Send comments regarding this burden estimate or any other spect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K142975 Page 1 of 5

# 510(k) SUMMARY

# (Submitted As Required per 21 CFR 807.92)

# GENERAL INFORMATION:

| Submitter Name: | Bovie Medical Corporation |
|---------------------------------------|----------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 3007593903 |
| Submitter Address: | 5115 Ulmerton Road<br>Clearwater, Florida 33760-4004<br>United States of America |
| Submitter Telephone Number: | [phone] |
| Submitter FAX Number: | [phone] |
| Contact Person: | Moshe Citronowicz<br>Senior Vice-President |
| Date Prepared: | October 2, 2014 |

# DEVICE IDENTIFICATION:

| Proprietary Name: | Bovie Ultimate™ High Frequency Electrosurgical<br>Generator |
|------------------------------------------|-------------------------------------------------------------------|
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Model Number: | BVX-100H |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed<br>Predicate Device(s): | 510(k) Number: K134054 |
| | Primary Predicate Device Name: |
| | Bovie IDS-310 High Frequency Electrosurgical<br>Generator |
| | Manufacturer: Bovie Medical Corporation |
| | 510(k) Number: K090586 |
| | Secondary Predicate Name: |
| | Bovie ICON GS Generator |

{4}------------------------------------------------

## K142975 Page 2 of 5

Manufacturer: Bovie Medical Corporation 510(k) SUMMARY

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

#### Indications

The Bovie Ultimate™ High Frequency Electrosurgical Generator is used for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic surgical procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces.

#### Device Description/Characteristics

The Bovie Ultimate™ High Frequency Electrosurgical Generator (BVX-100H) is a multipurpose electrosurgical device used for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic surgical procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces. The generator combines the features of two cleared electrosurgical generators. The device is intended to be used in the Hospital Operating Room environment.

It features two (2) cut modes up to 300 watts, three (3) blend modes, three (3) coagulation modes, and three (3) bipolar modes. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. The generator offers one (1) monopolar handpiece output, one (1) monopolar foot controlled output, one (1) bipolar handpiece output, one (1) bipolar foot controlled output, and one J Plasma (helium) gas outlet. The generator has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The padsensing feature allows the user to use either a split or solid return electrode. This feature is not required when using Helium gas mode for soft tissue coagulation. The Bovie Ultimate™ High Frequency Electrosurgical Generator contains a single software component that is solely used to support the user interface.

The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. It is also designed to meet the requirements of the European Restriction of Hazardous Substances Directive (2011/65/EU) directive.

The device consists of the generator, power cord, and a User's Guide. The main device components are a front panel containing the power button, wattage selection buttons, gas flow (rate) selection buttons, pulsing, LED numeric displays, alarm and return electrode indicator lights, and connector ports for accessories. The back panel consists of Helium

{5}------------------------------------------------

## K142975 Page 3 of 5

gas access ports, footswitch ports, volume controls, a power cord outlet, and a fuse. Internal components include printed circuit boards, speakers, and cabling.

Bench testing was performed to demonstrate that the generator met design specifications and to establish substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance with the following:

IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance

## 510(k) SUMMARY

## (Submitted As Required per 21 CFR 807.92)

IEC 60601-1-2: 2007

Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests

IEC 60601-2-2: 2007

Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

#### Substantial Equivalence:

| Characteristic | Bovie Ultimate™<br>High Frequency<br>Electrosurgical<br>Generator<br>(This Submission) | Bovie IDS-310<br>High Frequency<br>Electrosurgical<br>Generator<br>(K134054)<br>Primary Predicate | Bovie ICON GS<br>Generator<br>(K090586)<br>Secondary<br>Predicate |
|--------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Regulation and<br>Product Code | 21 CFR 878.4400 /<br>GEI | 21 CFR 878.4400 /<br>GEI | 21 CFR 878.4400 /<br>GEI |

{6}------------------------------------------------

| | | | K142975 Page 4 of 5 |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | Is used for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic surgical procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces. | Is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. | Utilizes helium gas for the coagulation of soft tissues during open soft tissue surgery. |
| Energy Type | High Frequency (RF) | High Frequency (RF) | High Frequency (RF) |
| Output | Monopolar and Bipolar | Monopolar and Bipolar | Monopolar and Bipolar |

{7}------------------------------------------------

# 510(k) SUMMARY

# (Submitted As Required per 21 CFR 807.92)

# Substantial Equivalence:

| Characteristic | Bovie Ultimate™<br>High Frequency<br>Electrosurgical<br>Generator<br>(BVX-100H)<br>(This Submission) | Bovie IDS-310<br>High Frequency<br>Electrosurgical<br>Generator<br>(K134054)<br>Primary Predicate | Bovie ICON GS<br>Generator<br>(GS100)<br>(K090586)<br>Secondary<br>Predicate |
|---------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Cut Modes | Has Two Cut Modes | Has Two Cut Modes | Not Applicable to<br>this Device |
| Blend Modes | Has Three Blend<br>Modes | Has Four Blend<br>Modes | Not Applicable to<br>this Device |
| Monopolar<br>Connectors | One | Dual | Not Applicable to<br>this Device |
| Plasma Connector | One | Not Applicable to<br>this Device | One |
| Auto Bipolar | Does Not Have<br>Auto Bipolar | Has Auto Bipolar | Not Applicable to<br>this Device |
| Bovie Bipolar | Does Not Have<br>Bovie Bipolar | Has Bovie Bipolar | Not Applicable to<br>this Device |
| Output Gas Flow | 1.0 - 5.0<br>Liters/minute | Not Applicable to<br>this Device | 1.0 - 5.0<br>Liters/minute |
| Bipolar Handpiece<br>Activation | Supported | Supported | Not Applicable to<br>this Device |
| Gas In Use Indicator | Present | Not Applicable to<br>this Device | Not Present |

## Conclusions

The Bovie Ultimate™ High Frequency Electrosurgical Generator has the same intended use, operating procedures, principles of operation, and utilizes the same technology as the predicate devices. The Bovie Ultimate™ High Frequency Electrosurgical Generator does not raise additional issues of safety or efficacy compared to the predicate devices.