The Bovie J-Plasma Precise Flex Handpiece is used for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.

The Bovie J-Plasma Precise Flex Handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.

Device Description

The Bovie J-Plasma Precise Flex handpiece, is an electrosurgical accessory that is connected to a Bovie Ultimate Electrosurgical Generator and used to deliver helium gas plasma (J-Plasma) and standard electrosurgical monopolar coagulation during surgical procedures. The accessory has a flexible shaft that can be advanced through a cannula during minimally invasive surgical procedures. The handpiece is activated by the generator footswitch.

The primary difference between the Bovie J-Plasma Precise Flex handpiece and currently available Bovie J-Plasma handpieces is that the Bovie J-Plasma Precise Flex handpiece has a flexible shaft that can be controlled with graspers, forceps, or grasping instruments during minimally invasive surgical procedures.

The Bovie J-Plasma Precise Flex handpiece uses the same basic technology and delivers the same J-Plasma helium plasma energy as currently available J-Plasma handpieces (K151325, K152570, K170188) and are compatible only with Bovie Ultimate electrosurgical generators.

AI/ML Overview

The provided text describes the Bovie J-Plasma Precise Flex Handpiece, an electrosurgical accessory. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study that proves the device meets those criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with acceptance criteria.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document provides a table of tests performed but does not explicitly state specific acceptance criteria in measurable terms. It describes the objective of each test and the protocols used, but not the pass/fail thresholds.

Test	Objective	Reported Performance (from summary description)
Electrical Verification	Verify the electrical functionality and safety of the handpiece	Meets objective by complying with IEC Electrical Safety Standards
Bench Equivalency	Measure effect of generator settings on the plasma stream, plasma stream characterization	Demonstrated equivalent tissue effect as the predicate device J-Plasma handpiece
Mechanical Performance	Verify the mechanical functionality of the handpiece	Demonstrated ability of the J-Plasma Precise Flex device to be grasped and maneuvered
Electromagnetic Compatibility	EMC testing for emissions and immunity	Implied compliance, as no issues are reported and it's a standard regulatory test for electrosurgical devices

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The tests listed are primarily bench and electrical verification, which typically do not involve human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests described (electrical, bench, mechanical, EMC) are primarily engineering and technical verifications, not typically requiring expert interpretation of clinical data for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Given the nature of the tests (bench, electrical, mechanical), an adjudication method like 2+1 or 3+1, which is common in clinical imaging studies for ground truth establishment, would not be applicable.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study is typically associated with AI-powered diagnostic devices, not electrosurgical handpieces. The device described is a surgical instrument, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is an electrosurgical handpiece, not an AI algorithm. It's a hand-held tool used by a surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench equivalency testing, the "ground truth" for tissue effect was established by comparison to the predicate J-Plasma handpiece. This would likely involve observable and measurable tissue effects (e.g., coagulation depth, cutting efficiency) under controlled bench conditions. For electrical, mechanical, and EMC tests, the ground truth is simply meeting predefined engineering specifications and regulatory standards.

8. The sample size for the training set

This information is not provided. The device is not an AI/ML product, so the concept of a "training set" in the context of machine learning does not apply.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/ML product.

In summary, the provided document is a 510(k) summary for an electrosurgical handpiece, focusing on substantial equivalence. It outlines technical performance tests but lacks the detailed clinical study data, acceptance criteria, ground truth establishment methods, and sample sizes that would be found in a clinical trial report or for AI/ML device submissions.

Summary

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

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 stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

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

May 1, 2017

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

Re: K170777

Trade/Device Name: Bovie J-Plasma Precise Flex Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 14, 2017 Received: March 15, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device

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

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 (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

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

Indications for Use

510(k) Number (if known) K170777

Device Name Bovie J-Plasma Precise Flex Handpiece

Indications for Use (Describe)

The Bovie J-Plasma Precise Flex Handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.

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

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CER 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."

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

Image /page/3/Picture/0 description: The image shows the word "Bovie" in a bold, blue font. Above the word is a curved, light blue line with a blue dot at the end. The "®" symbol is located at the bottom right of the word.

510(k) SUMMARY

(Submitted As Required per 21 CFR 807.92)

GENERAL INFORMATION:

Submitter Name:	Bovie Medical Corporation
Establishment RegistrationNumber:	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
Date Prepared:	March 14, 2017
DEVICE IDENTIFICATION:
Proprietary Name:	Bovie® J-Plasma® Precise Flex Handpiece
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 MarketedPredicate Device(s):	510(k) Numbers: K152325, K152570, K170188Predicate Device Name: Bovie J-Plasma PreciseHandpieces

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

510(k) K170777

510(k) SUMMARY

510(k) Number: K140378

Predicate Device Name: OmniGuide Laser System with FlexGuide™ Ultra

Manufacturer: OmniGuide Incorporated

INTENDED USE/INDICATIONS

The Bovie J-Plasma Precise Flex handpiece is used for the delivery of radiofrequency energy and/or helium gas plasma for electrosurgical cutting, coagulation, and ablation of soft tissue. It is intended for use with grasping instruments during minimally invasive surgical procedures.

The Bovie J-Plasma Precise Flex handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.

DEVICE DESCRIPTION

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

Image /page/5/Picture/1 description: The image shows the word "Bovie" in a bold, sans-serif font. The word is a dark blue color. Above the word is a light blue curved line with a dot at the end. The registered trademark symbol is located to the bottom right of the word.

510(k) SUMMARY

PERFORMANCE TESTING

Performance testing to assure that the Bovie J-Plasma Precise Flex Handpiece meets performance requirements was performed and is summarized in the following tables:

Test	Objective	Protocols
Electrical Verification	Verify the electrical functionality and safety of thehandpiece	VR-1510
Bench Equivalency	Measure effect of generator settings on the plasmastream, plasma stream characterization	VR-1511
MechanicalPerformance	Verify the mechanical functionality of the handpiece	VP 1529
ElectromagneticCompatibility	EMC testing for emissions and immunity	VR-1512

SUBSTANTIAL EQUIVALENCE

The Bovie J-Plasma Precise Flex handpiece is intended for cutting, coagulation, and ablation of soft tissue. The Bovie J-Plasma Precise FlexHandpiece has the same intended use and energy source as the predicate device, J-Plasma Handpiece. There are no changes to the principle of operation or the method of application. There is no new technology or differences that would raise new or different questions of safety or efficacy and no changes to the principle of operation.

The Bovie J-Plasma Precise Flex handpiece it is intended for use with a grasping accessory during minimally invasive surgical procedures as the other predicate device, OmniGuide Laser System with FleGuide™ Ultra.

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

510(k) SUMMARY

Feature/Characteristic	Bovie J-Plasma Precise® Flex	Predicate Bovie® J-PlasmaHandpiece(K170188, K151325,K152570)	OmniGuide Laser Systemwith FlexGuide UltraK140378
Intended Use /Indications for Use	The Bovie J-Plasma Precise®Flexible Handpiece is used forthe delivery of radiofrequencyenergy and/or a helium gasplasma for electrosurgicalcutting, coagulation, andablation of soft tissue. It isintended for use with agrasping instruments duringminimally invasive surgicalprocedures.The Bovie J-Plasma PreciseOpen Handpiece is compatiblewith Bovie Ultimate GeneratorsBVX-200H and BVX-200P.	K170188- intended to beused in conjunction withthe Bovie Ultimate®electrosurgical generatorfor the delivery ofradiofrequency energyand/or a helium gasplasma for electrosurgicalcutting,coagulation and ablation ofsoft tissue during opensurgical procedures.The Bovie J-Plasma PreciseOpen® Handpiece iscompatible with BovieUltimate® ElectrosurgicalGenerators BVX-200H, andBVX-200P.	The OmniGuide LaserSystem with FlexGuide™Ultra, which includes theFELS 25A Laser, BeamPathFibers and theFlexGuide™ Ultrahandpiece, is indicated foruse to enable the surgeonto perform incision,excision, ablation,vaporization andcoagulation of body softtissues including intra-oraltissues. This system isintended for use with agrasper in the followingmedical specialties: generallaparoscopic surgicalprocedures, gynecologiclaparoscopic surgicalprocedures, urologicsurgical procedures,otorhinolaryngology
General Descriptionof Procedures	Laparoscopic or minimallyinvasive surgical procedures	Open and Laparascopic,minimally invasiveprocedure through cannula	surgical procedures.Medical specialties: generallaparoscopic surgicalprocedures, gynecologiclaparoscopic surgicalprocedures, urologicsurgical procedures,otorhinolaryngologysurgical procedures.
Energy Type	Helium gas plasmaMonopolar coagulation	Helium gas plasmaMonopolar coagulation	Laser
Device Activation	Footswitch activation only, nohand activation	Hand Activation orFootswitch Activation	Footswitch activation only,no hand activation
Feature/Characteristic	Bovie J-Plasma Precise® Flex	Predicate Bovie® J-PlasmaHandpiece(K170188, K151325,K152570)	OmniGuide Laser Systemwith FlexGuide UltraK140378
Grasping Feature	Yes	No	Yes
Shaft	Flexible	Straight	Flexible
Shaft Working Length	500mm	18mm, 270mm, 150mm,330mm, 450mm	600mm
Compatible Cannuladiameter	8mm	5mm	12mm
Tip Configuration	Blade, Needle	Same	Spatula
Blade Extension	Maximum 10mm in 2mmincrements	Same	N/A
Blade Width xThickness	0.4mm x 0.08mm	Same	4 mm
Tip protector	Ceramic nozzle	Same	Cycloolefin Polymer (COP)
Plasma Settings	Maximum 40 watts, 1-5 lpmgas flow	Same	N/A
Compatibility	Compatible only with BovieUltimate Generator (BVX-300H,BVX-200P)	Compatible with OriginalUltimate (BVX-100H) andUltimate Generators (BVX-200H, BVX-200P)	OmniGuide Laser System
Connector	Bovie Proprietary	Same	OmniGuide
Electrical Safety	Complies with IEC ElectricalSafety Standards	Same	Same
Transformer	None	None — K170188	N/A

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

Image /page/7/Picture/0 description: The image shows the word "Bovie" in a stylized font. The word is in a dark blue color. Above the word is a light blue curved line with a dot at the end.

510(k) SUMMARY

CONCLUSION

The Bovie J-Plasma Precise Flex Handpiece is intended for cutting, coagulation, and ablation of soft tissue. The Bovie J-Plasma Precise Flex Handpiece has the same intended use and energy source as the predicate device, J-Plasma Handpiece. There are no changes to the principle of operation and there is no new technology or technology differences that would raise new or different questions of safety or efficacy.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the word "Bovie" in a dark blue font. Above the word is a light blue curved line with a dot at the end. The word "Bovie" is the logo for a company.

510(k) SUMMARY

The primary differences between the subject device J-Plasma handpiece and the predicate J-Plasma handpieces is the flexible shaft that can be manipulated via grasping accessories. The grasping feature is the same as the predicate device OmniGuide Laser System with FlexGuide Ultra.

The Bovie J-Plasma Precise® Flex Handpiece was subjected to verification testing that confirmed device performance and demonstrated equivalent tissue effect as the predicate device J-Plasma handpiece. Simulated use testing demonstrated the ability of the J-Plasma Precise Flex device to be grasped and maneuvered.

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.