The Bovie Ultimate® Electrosurgical Generators are indicated for delivery of radiofrequency 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 Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.

Device Description

Bovie Ultimate® Gen 2 Electrosurgical Generator is a multipurpose electrosurgical device that delivers high frequency electrical energy to cut and coagulate soft tissue. It can also deliver Helium gas plasma energy (J-Plasma) for the cutting, coagulation, and ablation of soft tissue.

The Ultimate Gen 2 electrosurgical generator is the next generation of the original Bovie Ultimate®. The Ultimate Gen 2 has offers the same electrosurgical modes and has the same performance specifications as the original Bovie Ultimate, but the Ultimate Gen 2 will be compatible with the new Bovie J-Plasma Precise Open handpiece passive accessory.

The Bovie J-Plasma Precise Open Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with the Bovie Ultimate Gen 2 electrosurgical generator for the delivery of radiofrequency energy and/or a helium plasma gas for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The handpiece utilizes a retractable blade or needle electrode to ignite the helium gas to create the plasma.

AI/ML Overview

This document is a 510(k) premarket notification for electrosurgical devices, primarily comparing a new generation device to a predicate device. It does not contain information typically found in an AI/ML device study.

Therefore, the requested information cannot be fully provided from this document as it relates to clinical performance studies for AI/ML devices. I will extract the information that is present, or state its absence.

Acceptance Criteria and Study for an AI/ML Device:

This document describes an electrosurgical device (Bovie J-Plasma Precise Open Handpieces & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator), not an AI/ML device. Therefore, the requested information regarding AI/ML device performance and studies is not applicable.

However, I can provide a summary of the performance testing performed for this electrosurgical device, as detailed in the document.

1. Table of Acceptance Criteria and Reported Device Performance (for Electrosurgical Device):

The document lists performance tests but does not present specific quantitative acceptance criteria or reported performance values in a table format that allows for direct comparison against pre-defined thresholds. Instead, it indicates that testing was performed to "assure that the Bovie J-Plasma Precise Open Handpiece and the Ultimate Gen 2 meet performance requirements." The "Objective" column in the provided table serves as a high-level acceptance criterion for each test. The study confirms device performance and demonstrates equivalent tissue effect.

Test	Objective	Reported Device Performance
Mechanical Verification and Functionality	Verify the mechanical functionality of the handpiece	Confirmed, no issues mentioned
Electrical Verification (Handpiece)	Verify the electrical functionality and safety of the handpiece	Confirmed, no issues mentioned
Electrical Verification (Ultimate Gen 2 Gen)	Verify the electrical functionality and safety of the Ultimate Gen 2 Generator.	Confirmed, no issues mentioned
Inspectional Verification	Document parameters that can be verified through inspection for the Ultimate Gen 2 gen.	Confirmed, no issues mentioned
Plasma Characteristics	Measure effect of generator settings on the plasma stream, plasma stream characterization	Confirmed, no issues mentioned
FPGA Validation for the Main Board	Perform testing required to verify Main Board FPGA.	Confirmed, no issues mentioned
FPGA Validation for the Display Board	Perform testing required to verify Display Board FPGA.	Confirmed, no issues mentioned
Performance Evaluation	Confirm device performance on various tissue types	Confirmed device performance and equivalent tissue effect*

*The document states: "The Bovie J-Plasma Precise® Open Handpiece and Ultimate Gen 2 were subjected to verification testing that confirmed device performance and demonstrated equivalent tissue effect between the J-Plasma passive accessory and active accessory."

Regarding AI/ML specific questions:

Sample size used for the test set and the data provenance: Not applicable. This document does not describe an AI/ML device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this electrosurgical device is its ability to perform its intended functions (cutting, coagulation, ablation) and meet safety standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/2 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 a stylized image of a bird-like figure, possibly representing an eagle, with three overlapping profiles.

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

March 8, 2017

Bovie Medical Corporation Ms. Rubiela Maldonado Regulatory Affairs Manager 5115 Ulmerton Road Clearwater, Florida 33760

Re: K170188

Trade/Device Name: Bovie J-Plasma Precise Open Handpieces & Bovie Ultimate Gen 2 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: January 23, 2017 Received: January 24, 2017

Dear Ms. Maldonado:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

Jennifer R. Stevenson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170188

Device Name

The Bovie Ultimate® Electrosurgical Generators, and Bovie J-Plasma Precise Open® Handpiece

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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 and review the collection of information. Send comments regarding this burden estimate or any other aspect 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 PRAStaff@fda.hhs.gov

"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."

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GENERAL INFORMATION:

Submitter Name:	Bovie Medical Corporation
Establishment Registration Number:	3007593903
Submitter Address:	5115 Ulmerton RoadClearwater, Florida 33760-4004United States of America
Submitter Telephone Number:	(727) 803-8508
Submitter FAX Number:	(727) 322-4465
Contact Person:	Rubiela MaldonadoRegulatory Affairs Manager
Contact email:	Rubiela.Maldonado@boviemed.com
Date Prepared:	January 10, 2017

DEVICE IDENTIFICATION:

Proprietary Name:	Bovie J-Plasma Precise Open® Handpiece & BovieUltimate® Gen 2 High Frequency ElectrosurgicalGenerator
Common Name:	Electrosurgical Generator, Accessory
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories
Model Numbers:	Multiple
Classification:	21CFR 878.4400; Class II; Product Code GEI
Legally Marketed Predicate Device(s):	510(k) Numbers: K112233, K151325, K152570 & K142975Predicate Device Name: Bovie J-Plasma Handpiece & Bovie Ultimate High Frequency Electrosurgical Generator

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INTENDED USE/INDICATIONS

The Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.

BOVIE ULTIMATE GEN 2 ELECTROSURGICAL GENERATOR

DEVICE DESCRIPTION

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Image /page/5/Picture/2 description: The image shows a Bovie Ultimate electrosurgical unit. The unit has multiple settings for different surgical procedures, including cut, coag, bipolar, and J-plasma. The display shows the power settings for each mode, with values such as 300 for cut, 820 for coag, 850 for bipolar, and 100 for J-plasma. The unit also has settings for gas flow and pulsing, with values of 5.0 L/min and 100 for on/off time, respectively.

Figure 1. Ultimate Gen 2 BVX-200H

Ultimate electrosurgical generators features two (2) cut modes up to 300 watts, three (3) blend modes, three (3) coagulation modes, three (3) bipolar modes and J-plasma mode adjustable up to 40W power (100%) and 1-5 LPM helium gas flow. 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 is designed to comply with applicable Medical Electrical Equipment safety standards, and is designed to meet the requirements of the European Restriction of Hazardous Substances Directive (2011/65/EU) directive.

BOVIE J-PLASMA PRECISE OPEN HANDPIECE

DEVICE DESCRIPTION

The Bovie J-Plasma Precise Open handpiece represents an enhancement of the original Bovie I-Plasma Handpiece:

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Ergonomic shape
Lighter, due to removal of internal transformer
. Has 2 buttons to select either standard monopolar coagulation or J-Plasma. Original handpiece has only one button for activation of J-Plasma.
. The shaft on the new Bovie J-Plasma Precise Open Handpiece with blade electrode can be rotated which can be used rotate the blade. This enables the user to place the blade in the desired orientation.

Image /page/6/Picture/8 description: The image shows a dental curing light. The curing light is black and purple with a gray switch and two buttons, one blue and one purple. The light has a long, thin tip and a curved end.

Figure 1. Bovie J-Plasma Precise Open Handpiece

There are no technological differences or changes to principle of operation. An additional button on the device gives the user the ability to use the monopolar coagulation mode on the Bovie Ultimate Electrosurgical Generator.

There are no changes to the principle of operation or the method of application, and no changes to sterilization methods.

PERFORMANCE TESTING

Performance testing to assure that the Bovie J-Plasma Precise Open Handpiece and the Ultimate Gen 2 meet performance requirements were performed and are summarized in the following tables:

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Test	Objective	Protocols
Mechanical Verificationand Functionality	Verify the mechanical functionality of the handpiece	VR-1476VR-1496
Electrical Verification	Verify the electrical functionality and safety of thehandpiece	VR-1476
Electrical Verification	Verify the electrical functionality and safety of theUltimate Gen 2 Generator.	VR-1610031
Inspectional Verification	Document parameters that can be verified throughinspection for the Ultimate Gen 2 generator.	VR-1610032
Plasma Characteristics	Measure effect of generator settings on the plasmastream, plasma stream characterization	VR-1496
FPGA Validation for theMain Board	Perform testing required to verify Main Board FPGA.	VR-1491
FPGA Validation for theDisplay Board	Perform testing required to verify Display Board FPGA.	VR-1490
Performance Evaluation	Confirm device performance on various tissue types	VR-1496

BOVIE ULTIMATE GEN 2 ELECTROSURGICAL GENERATOR SUBSTANTIAL EQUIVALENCE

Feature/Characteristic	Bovie Ultimate Gen 2Electrosurgical Generator(This Submission)	Bovie UltimateElectrosurgical Generator(Predicate device 510(k)K142975
Intended Use / Indicationsfor Use	The Bovie Ultimate® ElectrosurgicalGenerators are indicated for deliveryof radiofrequency energy and/orhelium gas plasma to cut, coagulateand ablate soft tissue during open andlaparascopic surgical procedures. TheJ-plasma portion of the generator canbe used only with dedicated Bovie J-Plasma handpieces.	The Bovie UltimateElectrosurgical Generatorsare used for the delivery ofhelium gas plasma forcutting, coagulation, andablation of soft tissue duringopen and laparascopicsurgical procedures.The Bovie J-PlasmaHandpiece is compatible onlywith Bovie Ultimategenerators.

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Feature/Characteristic	Bovie Ultimate Gen 2Electrosurgical Generator(This Submission)	Bovie UltimateElectrosurgical Generator(Predicate device 510(k)K142975
Technology / Energy Used,Delivered	Uses High Frequency Radiofrequency (RF) energy to create clinical effect. The electrical properties of the waveform (frequency, peak, and duration) produce the clinical effect (i.e. coagulation and cutting). For soft tissue coagulation using Helium gas, the flow rate produces clinical effect (i.e. coagulation and ablation).	Uses High Frequency Radiofrequency (RF) energy to create clinical effect. The electrical properties of the waveform (frequency, peak, and duration) produce the clinical effect (i.e. coagulation and cutting). For soft tissue coagulation using Helium gas, the flow rate produces clinical effect (i.e. coagulation and ablation).
User Interface	Push buttons, Seven segment display and LEDs.	Push buttons, Seven segment display and LEDs.
Available Modes	Cut (2), Blend (3), Coagulation (3: pinpoint, spray, gentle), Bipolar (3: Macro, Micro, Standard ), and J-Plasma (2 -with Active accessory and with Passive accessory)	Cut (2), Blend (3), Coagulation (3: pinpoint, spray, gentle), Bipolar (3: Macro, Micro, Standard), and J-Plasma (1)
Electrical Safety Standards/Compatibility with OtherDevices	Complies with IEC60601-1 (third edition), IEC60601-2(electromagnetic compatibility), and IEC60601-2-2 standard for the safety of electrosurgical equipment.	Complies with IEC60601-1 (third edition), IEC60601-2(electromagnetic compatibility), and IEC60601-2-2 standard for the safety of electrosurgical equipment.

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Feature/Characteristic	Bovie Ultimate Gen 2ElectrosurgicalGenerator(This Submission)	Bovie UltimateElectrosurgical Generator(Predicate device 510(k)K142975
ProductDimensions	Length14.75"Depth18.1"Height6.5"Weight20lbs.	Length14.75"Depth18.1"Height6.5"Weight20lbs.
Power Input	Mains Frequency50-60HzMains Voltage100-240VAC +/- 10%Maximum PowerConsumption650VA	Mains Frequency50-60HzMains Voltage100-240VAC +/- 10%Maximum PowerConsumption504 VA

BOVIE J-PLASMA PRECISE OPEN HANDPIECE

SUBSTANTIAL EQUIVALENCE

Feature/Characteristic	Bovie J-Plasma Precise Open Handpiece	Bovie J-Plasma Handpiece(Predicate K112233, K151325,K152570)
Intended Use /Indications for Use	The Bovie J-Plasma Precise Open®Handpiece is intended to be used inconjunction with the Bovie Ultimate®electrosurgical generator for thedelivery of radiofrequency energyand/or a helium gas plasma forelectrosurgical cutting, coagulation andablation of soft tissue during opensurgical procedures. The Bovie J-PlasmaPrecise Open® Handpiece is compatiblewith Bovie Ultimate® ElectrosurgicalGenerators BVX-200H, and BVX-200P.	K112233- The Bovie® J-PlasmaHandpiece with RetractableCutting Blade is an electrosurgicaldevice that utilizes helium gas anda retractable blade for cutting andcoagulation of soft tissue for useduring both open andlaparoscopic surgical procedures.K151325, K152570- The Bovie J-Plasma Precise Open® Handpieceis used for the delivery of heliumgas plasma for cutting,coagulation, and ablation of softtissue during open surgicalprocedures.The Bovie J-Plasma Handpiece iscompatible only with Bovie

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		Ultimate Generators.
Procedures	Open	Open and Laparascopic
Energy Type	Helium gas plasma	Helium gas plasma
Output	Monopolar	Monopolar
User Interface	Straight	Straight
Shaft Working Lengths	44mm, 150mm	18mm, 150mm, 270mm 330mm, 450mm
Shaft Outer Diameter	5mm	5mm
Tip Configuration	Blade, Needle	Blade
Blade Extension	Maximum 10mm	Maximum 10mm
Blade Width x Thickness	0.4mm x 0.08mm	0.4mm x 0.08mm
Compatibility	Only with Bovie Ultimate Gen 2 Generators	Only with Bovie Ultimate Generators
Connector	Bovie Proprietary	Bovie Proprietary

CONCLUSION

The Bovie Ultimate® Gen 2 Electrosurgical Generator has the same intended use, principles of operation, and utilizes the same technology as the predicate device. The Bovie Ultimate Gen 2 Electrosurgical Generator provides standard electrosurgical energy and J-Plasma energy, the same as the original Bovie Ultimate Generator.

There are no changes to the performance specifications, electrosurgical modes, or maximum power settings of the new generator compared to the original. When connected to an active handpiece accessory, the Bovie Ultimate Gen 2 performs identically to the original Ultimate. The primary difference between the Ultimate Gen 2 and the original Ultimate is that the Ultimate Gen 2 offers compatibility with a J-Plasma passive handpiece accessory. This involves supplying standard monopolar coagulation energy to the J-Plasma handpiece connection and providing a passive J-Plasma mode. The Ultimate Gen 2 is compatible with both active and passive accessories.

The Bovie J-Plasma Precise Open Handpiece is intended for cutting, coagulation, and ablation of soft tissue. The Bovie J-Plasma Precise Open Handpiece has the same intended use and energy source as the predicate device. There are no technological differences, no changes to the principle of operation or the method of application.

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The differences between the predicate and subject handpieces are related to the shape, the removal of the transformer to reduce weight for easier handling, and the addition of a coagulation button on the handpiece to give the user the ability to use coagulation mode on the Bovie Ultimate Electrosurgical generator without having to switch to a secondary electrode handpiece. The new handpiece also offers the ability to rotate the blade electrode for optimal positioning.

The Bovie J-Plasma Precise® Open Handpiece and Ultimate Gen 2 were subjected to verification testing that confirmed device performance and demonstrated equivalent tissue effect between the J-Plasma passive accessory and active accessory. There is no new technology or any differences that would raise new or different questions of safety or efficacy.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.