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

The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.

Device Description

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

The blade can be extended in 2mm increments from 0 to 10mm from the distal tip of the shaft via a ratcheted slider and retracted via a release latch. The device is activated via pressing the purple activation trigger. The handpiece is to be used with compatible electrosurgical generators, BVX-200H or BVX-200P, manufactured by Apyx Medical.

The Renuvion®/J-Plasma® Precise Handpiece is available in a 33 cm length for use in laparoscopic or open surgical procedures. The 33 cm is a standard length for laparoscopic instruments and are compatible with standard 5 mm trocars.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from Apyx Medical Corporation for their Renuvion®/J-Plasma® Precise Handpiece (Model # BVX-330 BPS). This submission describes a modification of an already cleared device and aims to demonstrate substantial equivalence to previously marketed predicate devices. Therefore, the "acceptance criteria" and "device performance" described are focused on proving this equivalence through various tests rather than establishing initial clinical efficacy with novel endpoints.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Test Objective	Reported Device Performance (Result)
Mechanical Performance & Functionality: Verify Mechanical functionality of the Renuvion®/J-Plasma® Precise Handpiece.	Mechanical functionality requirements met.
Tissue Effect (Plasma Activation): Verify that the tissue effects are similar between the subject device and the Primary Predicate device (K183610 & K151325).	Tissue effects are equivalent between the subject device and Primary Predicate device.
Tissue Effect (Monopolar Coagulation): Verify that the tissue effects are similar between the subject device and the Reference device (K183610 & K170188).	Tissue effects are equivalent between the subject device and Reference device.
Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-2 standards.	Determined to be in conformance with these standards.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 standard.	Determined to be in conformance with this standard.
Biocompatibility: Evaluation in accordance with FDA guidance "Use of International Standard ISO 10993-1" for cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, and material mediated pyrogen/pyrogenicity.	Biocompatibility has been established per ISO 10993 guidelines for the device's classification (external communicating device with indirect blood path contact < 24 hours). Biocompatibility verification testing was satisfactorily conducted.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes (e.g., number of units tested) for the individual bench tests. The tests were performed as "bench testing," meaning they were conducted in a laboratory setting, not on human or animal subjects. The data provenance is internal to Apyx Medical Corporation and based on their design and development procedures and risk assessment in accordance with ISO 14971. No geographical provenance (country of origin for data) is specified beyond the company's location in Clearwater, Florida, USA. The tests are retrospective in the sense that they are comparing a modified device to previously cleared predicates, rather than a de novo clinical investigation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For bench testing related to mechanical functionality, electrical safety, EMC, and biocompatibility, "experts" in the traditional sense of medical specialists establishing ground truth (like radiologists reading images) are not typically involved. Instead, the ground truth is defined by established engineering standards, material science principles, and biological safety guidelines. For tissue effect tests, conclusions are drawn from bench experiments and comparison to predicate devices, where the "ground truth" would be the observed tissue response under controlled conditions, compared to the known response of the predicate. The document doesn't detail the personnel or their qualifications who interpreted these tissue effects.

4. Adjudication Method for the Test Set:

An adjudication method (like 2+1 or 3+1 expert review) is not applicable here. These methods are common for clinical imaging studies where there's subjectivity in interpretation. For the bench tests described (mechanical, electrical, EMC, biocompatibility, and comparing tissue effects), the results are typically objectively measured and evaluated against predefined thresholds or comparative equivalence, not through expert consensus on subjective findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed, nor is it applicable to this submission. MRMC studies are used to evaluate the diagnostic performance of a device (often AI-based) in a clinical setting with multiple human readers and cases, typically to assess how the device aids human interpretation. This submission is for an electrosurgical handpiece, and the performance assessment is based on physical and biological characteristics, not diagnostic interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study is not applicable here. This device is a surgical instrument, not an algorithm or AI system. Its function is directly performed by the device itself, often with a human operator, but its primary performance endpoints are physical effects (cutting, coagulation) and safety, not an algorithmic output that could be independently evaluated.

7. The Type of Ground Truth Used:

The ground truth used for these tests is generally based on:

Engineering Specifications and Standards: For mechanical performance, electrical safety, and EMC, the ground truth is defined by established industry and international standards (e.g., IEC 60601 series) and the device's own design specifications.
Predicate Device Performance: For tissue effects, the ground truth for "equivalence" is the documented and cleared performance of the primary predicate device (for J-Plasma mode) and the reference device (for Monopolar Coagulation mode). The results of the subject device are compared to these established performances.
Biological Safety Guidelines: For biocompatibility, the ground truth is established by international standards like ISO 10993 guidelines, which define acceptable biological responses for device materials.

8. The Sample Size for the Training Set:

This information is not applicable because this is a medical device, not an AI/ML product that requires a training set for algorithm development. The "design controls process" and "verification and validation" mentioned refer to engineering and quality assurance processes for medical devices, not to machine learning training.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for an AI/ML algorithm involved in this device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 30, 2019

Apyx Medical Corporation (formerly Bovie Medical) Dr. Topaz Kirlew Vice President OA & RA 5115 Ulmerton Road Clearwater, Florida 33760

Re: K191484

Trade/Device Name: Renuvion/J-Plasma Precise Handpiece (Model # BVX-330 BPS) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 4, 2019 Received: June 4, 2019

Dear Dr. 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.

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542 of the Act); 21 CFR 1000-1050.

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 and Part 809: 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191484

Device Name

Renuvion®/J-Plasma® Precise Handpiece (BVX-330 BPS)

Indications for Use (Describe)

The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible 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 Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange with a blue triangle in the upper left corner of the "A". Below the word "Apyx" is the word "MEDICAL" in blue. The TM symbol is in the upper right corner of the logo.

1. General Information:

Submitted by:	Apyx Medical Corporation (formerly Bovie Medical)5115 Ulmerton RoadClearwater, Florida 33760 -4004United States of America
Establishment Registration #:	3007593903
Submitter FAX Number:	(727) 322-4465
Contact Person:	Dr. Topaz Kirlew, Vice President, QA & RA5115 Ulmerton RoadClearwater, Florida 33760 -4004United States of AmericaPhone: (727) 803-8617Email: topaz.kirlew@apyxmedical.com
Date Prepared:	July 30, 2019
Trade Names (Model Number):	Renuvion®/J-Plasma® Precise Handpiece(BVX-330 BPS)
Common Name:	Electrosurgical Handpiece
Classification:	Class II per 21CFR 878.4400 - ElectrosurgicalCutting and Coagulation Device and AccessoriesProduct Code GEI
Predicate Devices:	Primary Predicate DeviceRenuvion®/ J-Plasma® Precise Handpiece (K183610 &K151325)
	Reference DeviceRenuvion®/ J-Plasma® Precise Open Handpiece(K183610 & K170188)

2. Intended Use / Indications for Use:

The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.

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Image /page/4/Picture/0 description: The image shows the logo for Apyx Medical. The logo consists of the word "Apyx" in orange, with a blue triangle in the upper left corner of the "A". Below the word "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, and the colors are bright and eye-catching.

3. Device Description Renuvion/J-Plasma Precise Handpiece:

4. Technological Characteristics:

The subject device, Renuvion®J-Plasma® Precise Handpiece (without the transformer) is a modification to the legally marketed Primary Predicate Device (K183610 & K151325) with the same name. The modification consists of a design change to remove the transformer from the base of this pistol shaped handpiece (HP) and the addition of the Monopolar Coagulation mode. This removal of the transformer from the handpiece is being implemented to improve manufacturability and device ergonomics. There is no change to the handpiece geometry or shaft length, no change to materials and no technology or performance change other than changes in product specifications. There is no change to the Indications for Use or operational principles.

The Subject, Primary Predicate and Reference devices all use the same basic technology, deliver the same J-Plasma helium plasma energy and are compatible only with the Electrosurgical Generators (BVX-200H and BVX-200P) manufactured by Apyx Medical.

The removal of the transformer from the subject device handpiece improves ergonomics since it is 39% lighter than the Primary Predicate device (K183610 & K151325) and improves manufacturability (efficiency, cost and speed).

The removal of the transformer from the handpiece does not affect the functionality of the handpiece because the compatible electrosurgical generators (BVX-200H and BVX-200P) have transformers already built into them and are capable of supporting the subject device without any changes to these generators. The Reference Device (Renuvion/J-Plasma Precise Open Handpiece, K183610 & K170188) also functions by using the transformer in the

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Image /page/5/Picture/0 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a small blue triangle replacing the "A". Below "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, with a focus on the company name.

electrosurgical generator resulting in the following identical characteristics being shared with the subject device:

. The internal transformer located at the base of the handpiece has been removed.
트 Availability of the Monopolar Coagulation feature (via optional foot pedal) for enhanced coagulation - gives the user the ability to use the Monopolar Coagulation mode on the compatible electrosurgical generator without having to switch to a secondary electrode handpiece.
. Can access 'Contact J-Plasma' by double clicking the button or foot pedal which tells the compatible electrosurgical generator that the intention is to cut (this feature on the compatible electrosurgical generators was cleared in K170188).

Bench testing has demonstrated that the tissue effect of the subject device and the Primary Predicate device (Renuvion/J-Plasma Precise Handpiece, K183610 & K151325) using the J-Plasma mode are equivalent and bench testing has also demonstrated that the tissue effect of the subject device and the Reference device (Renuvion/J-Plasma Precise Open Handpiece, K183610 & K170188) using the Monopolar Coagulation mode are equivalent. The results of design validation demonstrate that the tissue effect meets the user needs for cutting, coagulation and ablation of soft tissue.

The Apyx J-Plasma Precise Handpiece is pictured below with the circled area depicting the location at the base of the handpiece where the transformer has been removed.

Image /page/5/Figure/9 description: The image shows a medical device with several labeled parts. The device has a long, thin shaft extending from a handle. The handle features an advance slider, an activation button, and a slider release. The image also points out that the device has no transformer and a connector cable.

5. Performance Data:

a) Bench Testing

All testing performed on the subject device, Renuvion®/J-Plasma® Precise Handpiece (without transformer), was derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness of the design modification in

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Image /page/6/Picture/0 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a blue triangle replacing the left side of the "A". Below "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, with a focus on the company name.

accordance with Apyx Medical's design and development procedures. The test methodology and acceptance criteria were developed from the same standards and internal Design and Development procedures used for clearance of the Primary Predicate and Reference devices.

Performance testing to assure that the subject device met performance requirements was conducted in accordance with protocols to verify design specifications. The testing performed is summarized in the following table:

Test	Objective	Result
MechanicalPerformance &Functionality	Verify Mechanical functionality of theRenuvion®/J-Plasma® Precise Handpiece	Mechanical functionalityrequirements met
Tissue Effect(PlasmaActivation)	Verify that the tissue effects are the similarbetween the subject device and the PrimaryPredicate device (K183610 & K151325)	Tissue effects are equivalentbetween the subject deviceand Primary Predicatedevice
Tissue Effect(MonopolarCoaqulation)	Verify that the tissue effects are the similarbetween the subject device and the Referencedevice (K183610 & K170188)	Tissue effects are equivalentbetween the subject deviceand Reference device

b) Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device. Renuvion/J-Plasma Precise Handpiece (without transformer). The handpiece complies with the IEC 60601-1, and IEC 60601-2-2 standards for safety and the IEC 60601-1-2 standard for EMC. The subject device, Renuvion/J-Plasma Precise Handpiece (without transformer), was determined to be in conformance with these standards.

c) Biocompatibility Testing

The biocompatibility evaluation for the subject device, Renuvion/J-Plasma Precise Handpiece (without transformer), was conducted in accordance with the FDA guidance; "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process." The Biocompatibility testing for the patient and user contacting materials for the subject device, Renuvion/J-Plasma Precise Handpiece (without transformer), was either conducted or was previously submitted to the FDA in 510(k)s cleared under the Primary Predicate and Reference devices (K183610, K151325 & K170188). The battery of evaluations included the following testing:

Cytotoxicity ■
Sensitization
트 Irritation
트 Systemic toxicity
Hemolysis ■

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Image /page/7/Picture/1 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a blue triangle in place of the letter "A". Below the word "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, and the colors are bright and eye-catching.

Material Mediated Pyrogen/Pyrogenicity
The Renuvion/J-Plasma Precise Handpiece (subject device) is 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. Biocompatibility verification testing was satisfactorily conducted for the subject device.

6. Substantial Equivalence:

	Subject Device	1º Predicate Device	Reference Device
Feature/Characteristic	Renuvion®/J-PlasmaPrecise HP(without transformer)	Renuvion®/J-PlasmaPrecise HP(K138610 & K151325)	Renuvion®/J-PlasmaPrecise Open HP(K138610 & K170188)
Intended Use	Same	Same	Similar
Energy Source	RF Generator; Only withBovie/Apyx J-PlasmaGenerators	Same	Same
Location ofTransformer	ElectrosurgicalGenerator	Handpiece	ElectrosurgicalGenerator
Handpiece weight	221.3 g	362.8 g	N/A
Energy Type	Helium gas plasma;Monopolar coagulation	Helium gas plasma	Helium gas plasma;Monopolar coagulation
Output	Monopolar	Same	Same
Plasma settings	Maximum 40 watts, 1-5LPM gas flow	Same	Same
MonopolarCoagulation Mode& Settings	Yes; Maximum 120watts, 1-5 lpm gas flow	No - feature notavailable	Yes; Maximum 120watts, 1-5 lpm gas flow
MonopolarCoagulation TissueEffect	Same	N/A - feature notavailable	Same
Plasma ActivationTissue Effect	Same	Same	N/A
Device Activation	Hand Activation with 1button (J-Plasma) oroptional Foot Activationwith 2-foot pedals (J-Plasma, monopolarcoagulation)	Hand Activation with 1button (J-Plasma)	Hand Activation with 2buttons (J-Plasma,monopolar coagulation)or optional FootActivation with 2-footpedals (J-Plasma,monopolar coagulation)
SystemComponents	Same	Same	Same
User Interface	Straight	Same	Same
Connector	Company Proprietary -per design changereflected in K183610that establishes both	Same	Same

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Image /page/8/Picture/0 description: The image shows the logo for Apyx Medical. The logo consists of the word "Apyx" in orange, with a blue triangle in the negative space of the "A". Below the word "Apyx" is the word "MEDICAL" in blue. The "TM" symbol is in the upper right corner of the logo.

Feature/Characteristic	Subject Device	1° Predicate Device	Reference Device
	Renuvion®/J-PlasmaPrecise HP(without transformer)	Renuvion®/J-PlasmaPrecise HP(K138610 & K151325)	Renuvion®/J-PlasmaPrecise Open HP(K138610 & K170188)
pneumatic seal andelectrical connection

7. Conclusion:

The subject device, Renuvion® / J-Plasma® Precise Handpiece (without the transformer), has the same intended use, indications for use, operational principles, device ergonomics, handle geometry, handpiece geometry, and shaft length as the originally designed Primary Predicate device (Renuvion/J-Plasma Precise Handpiece, K183610 & K151325) of the same name.

The technological difference between the subject and Primary Predicate devices is the physical location of the transformer (moved from the handpiece to the electrosurgical generator) to reduce weight for easier handling as well as improve manufacturability, and availability of the Monopolar Coagulation feature (via optional foot pedal) to give the user the ability to use the Monopolar Coagulation mode on the compatible electrosurgical generator without having to switch to a secondary electrode handpiece. Bench testing has demonstrated that the tissue effects of the subject device are equivalent to the tissue effects of the Primary Predicate device (Renuvion/J-Plasma Precise Handpiece, K183610 & K151325) in the J-Plasma mode and the tissue effects of the subject device are also equivalent to the Reference device (Renuvion/J-Plasma Precise Open Handpiece, K183610 & K170188) in the Monopolar Coagulation mode.

The subject device's safety and performance have been confirmed by results of the performance bench testing and the design change has gone through the design controls process and the proper verification and validation demonstrate that the device performs as intended. Therefore, there are no differences that would raise new or different questions regarding safety or effectiveness as the subject device, Primary Predicate device and the Reference device all operate in a similar manner with an equivalent range of tissue treatment parameters.

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.