The Apyx Plasma/RF Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation of soft tissue during open surgical procedures. The Apyx Plasma/RF Handpiece is compatible with the Electrosurgical Generators, BVX-200H and BVX-200P, owned by Apyx Medical.

Device Description

The Apyx Plasma/RF Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of 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. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation.

The Apyx Plasma/RF Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).

AI/ML Overview

The provided text describes the performance data for the Apyx Plasma/RF Handpiece (K191542) to demonstrate its substantial equivalence to predicate devices, focusing on non-clinical testing.

Here's the breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

This section synthesizes the various tests and their outcomes as presented in the document.

Test Category	Acceptance Criteria/Objective	Reported Device Performance/Result
Bench Testing
Mechanical Verification & Functionality	Verify mechanical functionality of the Apyx Plasma/RF Handpiece.	Mechanical functionality requirements met.
Energy & Power Output	Verify via calorimetric testing that the tissue effects are equivalent between the subject device (Apyx Plasma/RF Handpiece), primary predicate device (Renuvion/J-Plasma® Precise Open Handpiece - K183610 & K170188), and predicate device (Renuvion/J-Plasma® Precise Handpiece - K183610 & K151325). Aim to show all deliver the same amount of energy to tissue at equivalent generator settings.	There are no significant differences in energy and power outputs between the subject device, Primary Predicate devices owned by Apyx Medical; all 3 devices will deliver the same amount of energy to tissue at equivalent generator settings.
Electrical Safety & EMC
Standards Compliance	Complies with ANSI/AAMI/IEC 60601-1:2015/(R)2012 and A1:2012, AAMI/ANSI/IEC 60601-2-2:2017 for safety, and AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) for EMC.	The Apyx Plasma/RF System was determined to be in conformance with these standards.
Biocompatibility Testing
ISO 10993 Compliance	Evaluation in accordance with FDA Guidance "Use of International Standard ISO 10993-1" and AAMI/ANSI/ISO 10993-1:2009/(R2013). Focus on cytotoxicity, sensitization, systemic toxicity, irritation, hemolysis, and material-mediated pyrogen/pyrogenicity for an external communicating device with an indirect blood path contact for <24 hours.	Biocompatibility has been established per ISO 10993 guidelines for this category. Biocompatibility verification testing was satisfactorily conducted for the subject device.
Pre-Clinical & Ex-Vivo Studies
Tissue Temperature Profile Equivalency	Compare tissue temperature profiles of the subject device and predicate devices (Renuvion/J-Plasma® Precise Open Handpiece and Renuvion/J-Plasma® Precise Handpiece) via device activation on porcine skin. Objective: demonstrate equivalent heating of tissue.	The subject device (Apyx Plasma/RF Handpiece) and predicate devices (Renuvion/J-Plasma® Precise Open Handpiece & Renuvion/J-Plasma® Precise Handpiece) all heat tissue in an equivalent manner and are substantially equivalent in terms of tissue effect for the coagulation of soft tissue.
Maximum Internal & External Temperature Study	Quantify internal and external tissue temperatures (via thermal video camera) resulting from Renuvion/J-Plasma® technology for soft tissue coagulation in a live porcine model. Determine effect of multiple variables and worst-case scenario (six consecutive passes in the same area). Acceptance (implied): epidermal surface temperature remains below 41°C and safe limits (below 47°C).	The porcine skin epidermal surface temperature remained below 41°C and within safe limits (below 47°C) even with 6 passes in the same area. The results demonstrate that safe skin temperatures are maintained with Renuvion/J-Plasma® Technology, and skin temperature monitoring is not indicated due to its unique mechanism of action.
Thermal Tissue Effect Comparison (Ex-vivo)	Verify that the Apyx Plasma/RF Handpiece produces an equivalent ex-vivo tissue effect (depth and lateral spread of thermal effect) when compared to the predicate device across a range of power and flow settings, including worst-case clinical scenarios.	The depth and lateral spread (i.e., average of length and width) of thermal effect measured for the Apyx Plasma/RF handpiece were equivalent to the predicate device's thermal effect as measured over a range of power and flow settings which include worst-case clinical scenarios. The quantitative results demonstrated that the tissue effects of all subject device models (APYX-27-TP, APYX-15-TP and APYX-15-SP) are equivalent to the predicate device's effect.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not explicitly stated for each individual test. The document mentions "testing involved device activation on porcine skin" for the tissue temperature profile equivalency and "a live porcine model" for the maximum temperature study. For ex-vivo studies, it states "several tissue types (i.e., muscle, liver, kidney)."
Data Provenance:
- Country of Origin: Not specified but typically assumed to be conducted in the US or collaborating international laboratories if not stated otherwise for FDA submissions.
- Retrospective or Prospective: Prospective, as these were specific tests designed and executed to evaluate the new device and its equivalence to predicates.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable: For this device, the "ground truth" is based on objective, quantifiable physical and biological measurements (e.g., temperature, power output, tissue necrosis depth, mechanical integrity, standard safety compliance), not subjective expert interpretation of images or clinical outcomes that would require expert consensus. Therefore, no "experts" in the sense of clinicians establishing ground truth for a diagnostic test were used. The ground truth is defined by established engineering and biological standards and quantitative measurements.

4. Adjudication Method

None (Not Applicable): As the ground truth is based on objective measurements and compliance with established standards, there is no need for an adjudication method typically used in studies involving subjective interpretation (e.g., by radiologists).

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

No: No MRMC comparative effectiveness study was performed or described. This type of study is more relevant for diagnostic AI tools where human readers interpret medical images. This submission focuses on the safety and performance equivalence of a surgical electrosurgical handpiece through bench and animal testing.

6. Standalone Performance (Algorithm Only)

Yes, In essence: The studies described are inherently "standalone" in the sense that they evaluate the device's technical and biological performance directly, rather than its performance in assisting human operators or interpreting data for them. The device itself (the Apyx Plasma/RF Handpiece) is the "system" being tested for its intrinsic capabilities (e.g., cutting, coagulation, ablation effectiveness, and safety). There is no "human-in-the-loop" performance being measured in these specific tests, as they focus on the physical and biological effects generated by the device.

7. Type of Ground Truth Used

Objective Measurements and Standard Compliance: The ground truth for these studies is based on:
- Benchmarking against Predicate Devices: Demonstrating equivalent electrical output and tissue effects.
- Physical Measurements: Calorimetric energy/power output, mechanical functionality, thermal video camera measurements for tissue temperature, depth and lateral spread of thermal effect in tissue.
- Compliance with Standards: Electrical safety (IEC 60601 series) and Biocompatibility (ISO 10993 series).
- Biological Outcomes (Animal/Ex-vivo): Observation of tissue heating, coagulation, and ablation effects in porcine models and various tissue types.

8. Sample Size for Training Set

Not Applicable / Not Provided: This device is a medical instrument, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's design is based on established engineering principles and iterative development, not data-driven machine learning.

9. How Ground Truth for Training Set Was Established

Not Applicable: As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here. The device's performance is verified against design specifications and established safety and efficacy benchmarks through the testing described.

Summary

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October 11, 2019

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

Re: K191542

Trade/Device Name: Apyx Plasma/RF Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 10, 2019 Received: June 11, 2019

Dear 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

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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-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 531-542 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K191542

Device Name

Apyx Plasma/RF Handpiece (APYX-15-SP, APYX-15-TP and APXY-27-TP)

Indications for Use (Describe)

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/2 description: The image shows the logo for Aryx Medical. The logo features the word "Aryx" in orange, with a blue triangle replacing the "A". Below "Aryx" is the word "MEDICAL" in blue. The logo is simple and modern, with a focus on the company name.

K191542

1. General Information:

Submitted by:	Apyx Medical Corporation (formerly Bovie Medical)5115 Ulmerton Road Clearwater, 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:	June 10, 2019
Trade Names (Model Numbers):	Apyx Plasma/RF Handpiece(APYX-15-SP, APYX-15-TP, APYX-27-TP)
Common Name:	Electrosurgical Handpiece
Classification:	Class II per 21CFR 878.4400 - ElectrosurgicalCutting and Coagulation Device and AccessoriesProduct Code GEI
Predicate Devices:	Primary Predicate DevicesRenuvion®/J-Plasma® Precise Open Handpiece(K183610 & K170188)Renuvion/J-Plasma® Precise Handpiece(K183610)Reference DevicesThermi Temperature Controlled Radiofrequency (RF)System (K173582) & Thermi Injectable RF Electrodes(K170116)

2. Indications for Use:

The Apyx Plasma/RF Handpiece (HP) 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 Apyx Plasma/RF

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Image /page/4/Picture/2 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the word "Apyx" in a stylized font. A small blue triangle is present to the left of the word. Below "Apyx" is the word "MEDICAL" in blue, with a horizontal blue line underneath.

Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P owned by Apyx Medical.

3. Device Description:

Image /page/4/Figure/9 description: The image shows a medical device setup. A red helium tank is connected to a regulator with a pressure gauge. A generator (ESU) is connected to a handpiece and cable, a foot switch, and a grounding pad.

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Image /page/5/Picture/2 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.

K191542

4. Technological Characteristics:

The Apyx Plasma/RF Handpiece is a modification to the primary predicate device that was cleared in K183610 & K170188 (Renuvion®/J-Plasma® Precise Open Handpiece). There are no changes to indications for use, principle of operation, mechanism of action or sterilization methods.

The Apyx Plasma/RF Handpiece as compared to the primary predicate device (K183610 & K170188) has only the following differences in technological characteristics:

V All models will have a side port configuration to allow the plasma to exit the handpiece through the side vs. from the point tip.
All 3 configurations will have a 'bullet shape' point tip and the electrode is not extendable.
V The handle is thicker, and the shaft diameter is smaller (3.0 mm shaft vs. 5.0 mm shaft) and more flexible with tip distance indicators at the end.
Shaft length of one model is 27cm long (the primary predicate device used for clearance of the Renuvion/J-Plasma® Precise Open Handpiece is the Renuvion/J-Plasma® Handpiece (K151325) that has a shaft length of 27cm and was also cleared in K183610).

The Apyx Plasma/RF Handpiece with its components is pictured below.

Image /page/5/Figure/13 description: The image shows a medical device with several labeled components. The device has a long, thin flexible shaft with energy exit portals and tip distance indicators at the end. The device also has a handle with an activation button, a plug connector, and a cable.

Results of bench and animal testing demonstrate that the Apyx Plasma/RF Handpiece is at least as safe and effective as the primary predicate devices.

5. Performance Data:

a. Bench Testing

All testing performed on the Apyx Plasma/RF System was derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness

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Image /page/6/Picture/2 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the word "Apyx" in a stylized font. A small blue triangle is positioned to the left of the word. Below "Apyx", the word "MEDICAL" is written in blue, using a simpler, sans-serif font.

K191542

of the design modification in 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 devices owned by Apyx Medical. Performance testing to assure that the subject Apyx Plasma/RF System met performance requirements was conducted in accordance with protocols to verify design specifications. The testing performed are summarized in the following table:

Test	Objective	Result
MechanicalVerification &Functionality	Verify Mechanical functionality of theApyx Plasma/RF Handpiece	Mechanical functionalityrequirements met
Energy & PowerOutput	Verify via Calorimetric testing that thetissue effects are equivalent betweenthe devices sharing the Renuvion/J-Plasma technology that are ownedby Apyx Medical – Subject device (Apyx Plasma/RFHandpiece); Primary Predicate device clearedunder K183610 & K170188(Renuvion/J-Plasma® PreciseOpen Handpiece); and Predicate device cleared underK183610 & K151325(Renuvion/J-Plasma® PreciseHandpiece)	There are no significantdifferences in energy andpower outputs between thesubject device, PrimaryPredicate devices ownedby Apyx Medical; all 3devices will deliver thesame amount of energy totissue at equivalentgenerator settings

b. Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the Apyx Plasma/RF System. The handpiece complies with the ANSI/AAMI/IEC 60601-1:2015/(R)2012 and A1:2012, and AAMI/ANSI/IEC 60601-2-2:2017 standards for safety and the AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) standard for EMC. The Apyx Plasma/RF System was determined to be in conformance with these standards.

c. Biocompatibility Testing

The biocompatibility evaluation for the Apyx Plasma/RF Handpiece was conducted in accordance with the June 16, 2016 FDA Guidance, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the AAMI/ANSI/ISO 10993-1:2009/(R2013) standard,

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"Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". The battery of testing was either conducted or was previously submitted to the FDA in 510(k)s cleared under the predicate devices (K183610, K151325 & K170188). The battery of evaluations included the following testing:

Cvtotoxicity
Sensitization
Systemic toxicity ■
■
트 Irritation

■

Hemolysis
Material Mediated Pyrogen/Pyrogenicity

The Apyx Plasma/RF 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. Pre-Clinical & Ex-Vivo Studies:

a. Tissue Temperature Profile Equivalency Pre-clinical testing was conducted to establish and compare the tissue temperature profiles of the devices owned by Apyx Medical and that share the Renuvion/J-Plasma technology: the subject device (Apyx Plasma/RF Handpiece), the predicate devices (Renuvion/J-Plasma® Precise Open Handpiece and Renuvion/J-Plasma® Precise Handpiece). Testing involved device activation on porcine skin while capturing the skin temperatures using a thermal video camera. Testing demonstrated that the three devices heat tissue in an equivalent manner.
b. Maximum Temperature Study for Renuvion/J-Plasma Technology Family A preclinical study was conducted in a live porcine model to quantify the internal and external tissue temperatures (via a thermal video camera) resulting from the use of the Renuvion/J-Plasma® technology for soft tissue coagulation and to determine the effect of multiple variables on the tissue temperatures. These temperatures were recorded after performing six consecutive passes of the Renuvion/J-Plasma® technology under the same area of tissue to represent a "worst case" scenario. However, even in this "worst case" scenario, the epidermal surface temperature remained below 41°C and within safe limits (below 47°C) *. The results of this testing demonstrate that safe skin temperatures are maintained with the Renuvion/J-Plasma® Technology and skin temperature monitoring is not indicated due to this unique mechanism of action. This is different from devices such as the Reference Device (Thermi Temperature Controlled Radiofrequency (RF) System, K173582 & Thermi Injectable RF Electrodes, K170116) that work on the principle of bulk tissue heating in order to achieve coagulation of soft tissue and where monopolar energy is primarily directed into the dermis thus necessitating skin temperature monitoring.

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Image /page/8/Picture/2 description: The image shows the logo for Apyx Medical. The logo is orange and features the company name in a stylized font. The word "MEDICAL" is written in blue below the company name.

K191542

c. Tissue Thermal Effect Equivalency Test for Apyx Plasma RF Device An ex-vivo study was conducted on several tissue types (i.e., muscle, liver, kidney) to compare the tissue thermal effect of the Apyx Plasma/RF Handpiece and the predicate device. The quantitative results of this testing demonstrated that the tissue effects of all the subject device models (APYX-27-TP, APYX-15-TP and APYX-15-SP) are equivalent to the predicate device's effect over a range of power and flow settings that are clinically relevant.

Test	Objective	Result
TissueTemperatureProfileEquivalency	Compare the tissue temperatureprofiles of the devices owned byApyx Medical and that share theRenuvion/J-Plasma® technology(subject device & primary predicatedevices, ) via device activation onporcine skin while capturing theskin temperatures using a thermalvideo camera.	The subject device (Apyx Plasma/RFHandpiece) and predicate devices(Renuvion/J-Plasma® Precise OpenHandpiece & Renuvion/J-Plasma®Precise Handpiece) all heat tissue inan equivalent manner and aresubstantially equivalent in in terms oftissue effect for the coagulation ofsoft tissue.
MaximumInternal &ExternalTemperatureStudy	Quantify the internal and externaltissue temperatures (via a thermalvideo camera) resulting from theuse of the Renuvion/J-Plasma®technology for soft tissuecoagulation in a worst-casescenario and to determine theeffect of multiple variables on thetissue temperatures in a liveporcine model.	The porcine skin epidermal surfacetemperature remained below 41°Cand within safe limits (below 47°C) *even with 6 passes in the same area.The results of this testingdemonstrate that safe skintemperatures are maintained with theRenuvion/J-Plasma® Technology andskin temperature monitoring is notindicated due to this uniquemechanism of action.
ThermalTissue EffectComparison	Verify that the Apyx Plasma/RFHandpiece produces equivalent ex-vivo tissue effect when comparedto the Predicate Device.	The depth and lateral spread (i.e.,average of length and width) ofthermal effect measured for the ApyxPlasma/RF handpiece wereequivalent to the predicate device'sthermal effect as measured over arange of power and flow settingswhich include worst-case clinicalscenarios.

The pre-clinical and ex-vivo testing discussed above is summarized in the table below:

Chen SS, Wright NT, Humphrey JD. Heat-induced changes in the mechanics of a collagenous tissue: isothermal free shrinkage. Journal of Biomechanical Engineering 1997:109:372-378.

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Image /page/9/Picture/2 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in a combination of blue and orange colors, with a small blue triangle replacing the dot over the "i". Below the word "Apyx", the word "MEDICAL" is written in blue, in a smaller, bolder font.

K191542

7. Substantial Equivalence:

Feature/Characteristic	Subject DeviceApyx Plasma/RF HP	Primary Predicate DeviceRenuvion/J-Plasma Precise Open HP (K183610 & K170188)
Indications forUse	The Apyx Plasma/RF 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 Apyx RF/Plasma Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P owned by Apyx Medical	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 Handpiece is compatible with electrosurgical Generators BVX-200H and BVX-200P.
EnergySource	RF Generator; Only with Generators owned by Apyx Medical	RF Generator; Only Generators owned by Apyx Medical
Energy Type	Helium gas plasma;	Helium gas plasma; Monopolar coagulation
ElectricalCurrentsTransmitted	150mA – 250mA	150mA – 250mA
Output	Monopolar	Monopolar
DeviceActivation	Hand activation button or optional footswitch	Hand activation button or optional footswitch
SystemComponents	The Apyx Plasma/RF System consists of:RF GeneratorDisposable HPFoot pedalPower cordGas regulatorGas cylinder	The Renuvion/J-Plasma Precise Open System consists of:RF GeneratorDisposable HPFoot pedalPower cordGas regulatorGas cylinder
User Interface	Straight	Straight
Shaft Design& EnergyDeliveryConfiguration	15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft	15cm and 4.4cm long with a distal port delivery configuration
Feature/Characteristic	Subject DeviceApyx Plasma/RF HP	Primary Predicate DeviceRenuvion/J-Plasma Precise Open HP (K183610 & K170188)
Shaft OuterDiameter	3mm	5mm
ElectrodeConfiguration	Non-extendable	Extendable
PlasmaSettings	Maximum 40 watts, 1-5 L/min gas flow	Maximum 40 watts, 1-5 L/min gas flow
Compatibility	Only with Electrosurgical Generators BVX-200H and BVX-200P owned by Apyx Medical	Only with Electrosurgical Generators BVX-200H and BVX-200P owned by Apyx Medical
Connector	Company Proprietary – per design change reflected in K183610 that establishes both pneumatic seal and electrical connection	Company Proprietary - per design change reflected in K183610 that establishes both pneumatic seal and electrical connection

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Image /page/10/Picture/1 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the word "Apyx" in a stylized font. A blue triangle is incorporated into the "A" of "Apyx." Below "Apyx," the word "MEDICAL" is written in blue, indicating the company's focus on the medical field.

K191542

Since the predicate devices were cleared with the results of non-clinical testing, non-clinical testing was also used to support substantial equivalence for the subject Apyx Plasma/RF System. The subject device has the same indications for use, operational principle and very similar technological characteristics as the predicate devices that were cleared in K183610 & K170188 (Renuvion®J-Plasma® Precise & Precise Open Handpieces). The conclusions drawn from the bench and pre-clinical testing demonstrate that the Apyx Plasma/RF is at least as safe and effective as the legally marketed predicate device for the same indications. Functional and mechanical verification testing demonstrate that the Apyx Plasma/RF System should perform as intended in the specified use conditions. The results of the bench, pre-clinical and ex-vivo tissue studies demonstrate that the Apyx Plasma/RF Handpiece performs comparably to the predicate device.

8. Conclusion:

The Apyx Plasma/RF Handpiece is a modification to the primary predicate device that was cleared in K183610 & K170188 (Renuvion/J-Plasma® Precise Open Handpiece). There are no changes to indications for use, principle of operation, mechanism of action or sterilization methods. The subject device (Apyx Plasma/RF Handpiece) like the primary predicate device (Renuvion J-Plasma® Precise Open Handpiece, K183610 & K170188) is intended for cutting, coagulation, and ablation of soft tissue and both devices utilize the same energy source (Electrosurgical Generators BVX-200H and BVX-200P) with no changes to the principle of operation.

Technological differences between the Apyx Plasma/RF Handpiece (subject device), the Renuvion/J-Plasma® Precise Open Handpiece (predicate device cleared in K183610 & K170188), and the Renuvion/J-Plasma® Precise Handpiece (predicate device cleared in

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Image /page/11/Picture/2 description: The image shows the logo for Apyx Medical. The logo is orange and blue. The word "Apyx" is in orange, with a blue triangle in place of the "A". Below the word "Apyx" is the word "MEDICAL" in blue.

K183610) that all share the Renuvion/J-Plasma® technology, do not raise any new concerns of safety or efficacy as:

1. Bench testing demonstrated that all three devices owned by Apyx Medical will deliver the same amount of enerqy to tissue at equivalent generator settings.
1. Testing utilizing porcine skin demonstrated that there is no difference in the external skin temperature profiles of these 3 devices owned by Apyx Medical.
Pre-clinical testing demonstrated safe internal and external tissue temperatures 3. for the Renuvion/J-Plasma® Technology.
1. Since the energy delivered to the tissue has been demonstrated to be equivalent, it can be concluded that the histologic effect of the energy on the tissue will be equivalent between all 3 devices owned by Apyx Medical.
1. Ex-vivo tissue testing for thermal equivalency demonstrated that depth and lateral spread (i.e., average of length and width) of thermal effect measured for the Apyx Plasma/RF handpiece are equivalent to the predicate device over a range of power and flow settings which include worst-case clinical scenarios.

The subject device's safety and performance have been confirmed by results of the performance bench, ex-vivo tissue, and animal testing and the design change has gone through the design controls process to 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 tissue effects of all the subject device models (APYX-27-TP, APYX-15-TP and APYX-15-SP) are equivalent to the predicate device's effect over a range of power and flow settings that are clinically relevant.

Results of bench and animal testing demonstrate that the Apyx Plasma/RF Handpiece is as and effective as the predicate devices (Renuvion/J-Plasma® Precise Open safe Handpiece (K183610 & K170188) & Renuvion/J-Plasma® Precise Handpiece (K183610).

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.