The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of helium plasma for cutting, coagulation of soft tissue during open and laparoscopic surgical procedures.

The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Open® Handpieces are compatible with electrosurgical Generators BVX-200H, and BVX-200P.

Device Description

The Renuvion/J-Plasma Handpieces are sterile, single use electrosurgical accessories intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Handpieces are available with a retractable cutting blade tip for excising tissue. The blade tip serves as an electrode to generate helium plasma.

The Renuvion/J-Plasma Precise devices are available in 15cm, 27cm and 33cm lengths for use in laparoscopic or open surgical procedures. The 27cm are standard lengths for laparoscopic instruments and are compatible with standard 5mm trocars.

The Renuvion/J-Plasma Precise Open devices are available in 44mm and 150mm for used in open surgical procedures.

AI/ML Overview

This document describes the Renuvion/J-Plasma Precise Handpiece and Renuvion/J-Plasma Precise Open Handpiece, intended for use with compatible electrosurgical generators for soft tissue cutting, coagulation, and ablation during open and laparoscopic surgical procedures.

Here's an analysis of the acceptance criteria and the supporting studies:

Table of acceptance criteria and the reported device performance:

Test / Acceptance Criteria	Reported Device Performance
Mechanical & Electrical Verification and Functionality
Pneumatic Testing	Verified
Electrical Continuity Test	Verified
Cable Flexure / Tension Test	Verified
Connector Dielectric Strength Test	Verified
Mold Stress Test	Verified
Free-fall Drop Test	Verified
Insertion/Extraction Integrity (Reduced insertion/extraction force to plug/unplug)	Verified (The document specifically notes a reduction in insertion/extraction force compared to predicate devices, indicating this was a design change tested and met)
Usability Evaluation	Protocol executed to verify and validate usability "as it relates to safety." (Satisfactorily conducted)
Biocompatibility Testing (for external communicating device with indirect blood path, < 24 hours)	Conducted per FDA Blue Book Memo #G95-1 and ISO 10993-1. Included Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Hemolysis, and Material Mediated Pyrogen. Verification testing for changed patient-contacting components (flow tube coupler and O-ring) was satisfactorily conducted.

Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes for each mechanical, electrical, usability, or biocompatibility test. It mentions "Performance testing" was performed, indicating that multiple units were likely tested for each criterion. The data provenance is internal testing performed by the manufacturer, Bovie Medical Corporation. The tests are prospective as they were performed on the new device models to demonstrate their safety and efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The tests described are primarily engineering, electrical, and biological evaluations, typically not requiring medical experts for "ground truth" establishment in the same way clinical studies would. The "usability evaluation" would have involved users, but their qualifications are not specified beyond being relevant to using the "J-Plasma Pistol Grip Handpiece."
Adjudication method for the test set:

This information is not provided and is not typically relevant for the type of engineering and biocompatibility testing described. The tests would likely have pass/fail criteria based on predefined specifications.
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:

No, an MRMC comparative effectiveness study was not done. This device is an electrosurgical handpiece, not an AI diagnostic or assistance tool, so such a study would not be applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, this is an electrosurgical handpiece, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.
The type of ground truth used:

The ground truth for the various tests was based on:
- Engineering Specifications: For mechanical and electrical tests (e.g., connector dielectric strength, cable flexure, integrity of insertion/extraction force).
- Regulatory Standards: For biocompatibility testing (ISO 10993 guidelines, FDA Blue Book Memorandum #G95-1).
- Safety and Efficacy Requirements: For usability evaluation, ensuring the device is safe and performs as intended.
The sample size for the training set:

This concept is not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established:

This concept is not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.

Summary

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March 12, 2019

Bovie Medical Corporation Topaz Kirlew Executive Director of OA & RA 5115 Ulmerton Road Clearwater, Florida 33760

Re: K183610

Trade/Device Name: Renuvion/J-Plasma Precise Handpiece and Renuvion/J-Plasma Precise Open Handpieces Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 11, 2019 Received: January 15, 2019

Dear Dr. Topaz Kirlew:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Long Long H. H. Chen -S Date: 2019.03.12 Chen -S 13:26:07 -04'00' 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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Indications for Use

510(k) Number (if known) K183610

Device Name

The Renuvion®/J-Plasma® Precise Handpiece and The Renuvion®/J-Plasma® Precise Open Handpiece

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Bovie.

510(k) Summary

Submitted by:	Bovie Medical Corporation5115 Ulmerton Road Clearwater, Florida 33760 -4004United States of America
Contact Person:	Rubiela MaldonadoRegulatory Affairs ManagerPhone: (727) 803-8508Fax: (727) 803-4491
Submission Correspondent:	Topaz KirlewVP, Quality Assurance & Regulatory AffairsPhone: (727) 803-8617Email: topaz.kirlew@apyxmedical.com
Date Prepared:	December 21, 2018
Trade Name:	Renuvion®/J-Plasma® Precise Handpiece andPrecise Open Handpiece
Common Name:	Electrosurgical Handpiece
Classification:	Class II per 21CFR 878.4400 -ElectrosurgicalCutting and Coagulation Device and AccessoriesProduct Code GEI
Predicate Devices:	Bovie J-Plasma Handpiece K151325 &Bovie J-Plasma Precise Open K170188

Intended Use / Indications for Use:

The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.

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

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Device Description Renuvion/J-Plasma Handpieces (J-Plasma Precise and Precise Open):

The Renuvion/J-Plasma Precise Open devices are available in 44mm and 150mm for used in open surgical procedures.

Intended Use & Technological Characteristics

The handpieces have the same intended use as the predicate devices. There are no technological differences or changes to the principle of operation or to the method of application. There are no changes to sterilization methods.

The design of Handpieces compared to the predicate devices are identical except for the following differences:

. The plug connector to the generator is dimensioned so that it will establish a pneumatic seal connection before an electrical connection (pins shortened, and O-ring added to replace silicone seal).
Reduced insertion/extraction force to pluq/unplug the device to/from the generator.

Performance Data

Performance testing to assure that the Renuvion/J-Plasma Precise and Precise Open Handpieces met performance requirements were performed and are summarized in the following table:

Test	Objective
Mechanical & ElectricalVerification andFunctionality	Verify the mechanical and electrical functionality ofthe handpiece Pneumatic Testing Electrical Continuity test Perform Cable Flexure / Tension Test Connector Dielectric Strength Test Mold Stress Test Free-fall Drop Test Insertion/Extraction Integrity
Usability Evaluation	The purpose of this protocol is to verify andvalidate the usability of the J-Plasma Pistol GripHandpiece as it relates to safety.

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Biocompatibility Testing

The biocompatibility evaluation for the Renuvion/J-Plasma Handpieces was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of evaluations included the following testing:

l Cytotoxicity
I Sensitization
Irritation
Systemic toxicity
트 Hemolysis
. Material Mediated Pyrogen

The Renuvion/J-Plasma handpieces are an external communicating device with an indirect blood path contact for a duration of less than 24 hours; Biocompatibility has been established per ISO 10993 guidelines for this category. Due to the redesign of the plug connector, changes on materials were made to two patient contacting components, flow tube coupler and O-ring. Biocompatibility verification testing was satisfactorily conducted for these components.

Conclusion

There is no difference between the predicates, Precise J-Plasma handpiece and Precise Open handpiece and the Subject devices in terms of intended use, principle of operation, and the technology used for device performance. There is no new technology and there are no differences that would raise new or different questions of safety or efficacy.

Verification and validation testing of the Renuvion/J-Plasma handpieces demonstrate that the devices perform as intended.

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.