The Apyx Helium Plasma Generators (owned by Apyx Medical) are indicated for delivery of radiofrequency energy and/ or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/ J-Plasma handpieces.

Device Description

The Apyx Helium Plasma Generator is an electrosurqical device that delivers radiofrequency (RF) energy to cut and coaqulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. Like the predicate, the Apyx Helium Plasma Generator provides standard electrosurgical energy and Helium Plasma energy, and there are no changes to the intended use, performance specifications, electrosurgical modes, output power waveforms or maximum power settings. Essentially, the Apyx Helium Plasma Generator is a combination of a standard electrosurgical generator and a Helium Plasma generator.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Objective)	Reported Device Performance (Result)
Electrical Safety	Complies with: - ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and A1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance) - AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) - AAMI/ANSI/IEC-60601-2-2:2017 (Medical electrical equipment - Part 2-2: Particular requirements of basic safety and essential performance of high-frequency surgical equipment)
Electromagnetic Compatibility (EMC)	Complies with: - AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) - IEC60601-1-2 (electromagnetic compatibility)
Electrical Performance	The electrical functionality of the generator was verified to meet performance specification requirements.
Software Functionality	The system and Field Programmable Gate Array (FPGA) perform as intended and according to the product specifications.
Mechanical Design	The mechanical design meets the product and performance requirements.

Summary of the Study:

The provided document describes a 510(k) premarket notification for the Apyx Helium Plasma Generator. This notification seeks to demonstrate substantial equivalence to a previously cleared predicate device (K170188, Bovie Ultimate® Gen 2 Electrosurgical Generator). The study involved bench and software verification and validation testing to confirm the modified device's safety and effectiveness.

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

The document does not specify a numerical sample size for the test set. The tests describe "Electrical Verification," "Software Verification & Validation," and "Mechanical Verification," which are typically performed on a limited number of manufactured units or system components, rather than a large clinical "test set" in the sense of patient data.

The data provenance is retrospective, as the study primarily compares the modified device to a previously cleared predicate and leverages existing regulatory standards. The testing itself would have been conducted in a controlled laboratory or engineering environment, rather than using patient data from a specific country of origin.

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. The type of testing described (electrical, software, mechanical verification) typically relies on engineering and regulatory standards rather than expert clinical consensus to establish "ground truth" for the device's functional and safety characteristics.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the type of testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic decisions. Here, the "truth" is determined by adherence to established engineering and safety standards.

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

No, an MRMC comparative effectiveness study was not done. The study described is not a clinical trial evaluating human reader performance with or without AI assistance. It's a regulatory submission demonstrating the substantial equivalence of an electrosurgical device through engineering and software verification.

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

This concept is not directly applicable to this device. The Apyx Helium Plasma Generator is a physical medical device that delivers energy for surgical procedures. It does not operate as an "algorithm only" or an AI system that provides diagnostic output without human intervention in the loop. Its performance is evaluated based on its technical specifications and safety conformity, regardless of human interaction methods.

7. Type of Ground Truth Used

The "ground truth" used in this submission is implicitly based on established international and national standards for medical electrical equipment (e.g., IEC 60601 series). Compliance with these standards, along with the device's documented performance against its own product specifications, forms the basis of its "truth" for safety and effectiveness in the context of substantial equivalence. There is no mention of pathology, expert consensus (in a clinical sense), or outcomes data being used to establish ground truth for the device itself in this specific regulatory context.

8. Sample Size for the Training Set

This information is not applicable/not provided. The device in question is an electrosurgical generator, which is a hardware device with embedded software. It is not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a "training set" of data in the conventional sense. The software verification and validation are against predefined specifications, not learned from a dataset.

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

This information is not applicable/not provided for the same reasons mentioned in point 8.

Summary

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October 31, 2019

Apyx Medical Corporation (formerly Bovie Medical) % Dave Yungvirt Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K192867

Trade/Device Name: Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 3, 2019 Received: October 7, 2019

Dear Dave Yungvirt:

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) K192867

Device Name

Apyx Helium Plasma Generators (APYX-200H, APYX-200P, APYX-JS3, APYX-RS3)

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 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" is the word "MEDICAL" in a bold, dark blue font.

510(k) Summary

I. General InformationSubmitted by:	Apyx Medical Corporation (formerly Bovie Medical)5115 Ulmerton RoadClearwater, Florida 33760-4004United States of America
Establishment Registration #:Submitter FAX Number:	3007593903(727) 322-4465
Contact Person:	Dr. Libet Garber, Global Director of Regulatory Affairs5115 Ulmerton RoadClearwater, Florida 33760-4004United States of AmericaPhone: (727) 803-8512Email: Libet.Garber@apyxmedical.com
Date Prepared:	September 23, 2019
Trade Names (Model Number):	Apyx Helium Plasma Generator(APYX-200H/P, APYX-JS3/RS3)
Common Name:	Electrosurgical Generator
Classification:Predicate Device(s):	Class II per 21CFR 878.4400 - ElectrosurgicalCutting and Coagulation Device and AccessoriesProduct Code: GEIPredicate Device

2. Indications for Use

The Apyx Helium Plasma Generators (owned by Apyx Medical) are indicated for delivery of radiofrequency energy and/or helium plasma to cut, coaqulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/ J-Plasma handpieces.

3. Device Description

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Image /page/4/Picture/2 description: The image shows the logo for Apyx Medical. The logo is orange and features the word "Apyx" in a stylized font. The "A" in "Apyx" is partially replaced by a blue triangle. Below the word "Apyx" is the word "MEDICAL" in blue, block letters.

510(k) Summary

4. Technological Characteristics and Performance Specifications

The Apyx Helium Plasma Generators is a modified version of the primary predicate device that was cleared under K170188 (Bovie Ultimate® Gen 2 Electrosurgical Generator). There are no changes to intended use or principles of operation.

The Apyx Helium Plasma Generator was modified to enhance the user interface and to comply with the new revision of the IEC 60601-2-2:2017 standard. Additionally, the gas pressure regulation was upgraded for better gas control.

5. Performance Data

Electrical safety and electromagnetic compatibility (EMC) testing were conducted, and the results demonstrated that the Apyx Helium Plasma Generator performance is in accordance with the following standards:

International Standard	Description
ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and A1:2012	Medical Electrical Equipment - Part 1: Generalrequirements for basic safety and essential performance
AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition)	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances -Requirements and tests
AAMI/ANSI/IEC-60601-2-2:2017	Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essentialperformance of high frequency surgical equipment andhigh frequency surgical accessories

Bench and Software verification and validation testing were completed according to a moderate level of concern to demonstrate substantial equivalence of the subject device to the predicate device (K170188):

Test	Objective	Results
ElectricalVerification	To verify electrical productand performancespecification requirements.	The electrical functionality of thegenerator was verified to meetperformance specificationrequirements.
SoftwareVerification &Validation forMain, Display andGas Boards	To validate the fieldprogrammable gate array(FPGA) procedure and thelogic design used in thegenerator.	The results demonstrated thatthe system and FPGA performas intended and according to theproduct specifications.
MechanicalVerification	To verify mechanical productand performancespecification requirements.	The results verified that themechanical design meets theproduct and performancerequirements.

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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 "A". Below "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, with a focus on the company name.

510(k) Summary

Results of the bench and software testing demonstrate that the Apyx Helium Plasma Generators are equivalent to the predicate device in terms of safety and effectiveness.

6. Substantial Equivalence

	Predicate Device	Subject Device
Feature/Characteristic	Bovie Ultimate Gen 2Electrosurgical Generator(K170188)	Apyx Helium PlasmaGenerator	SE Rationale
Indicationsfor Use	The Bovie Ultimate®Electrosurgical Generatorsare indicated for delivery ofradiofrequency energy and/orhelium gas plasma to cut,coagulate and ablate softtissue during open andlaparoscopic surgicalprocedures. The J-plasmaportion of the generator canbe used only with dedicatedBovie J-Plasma handpieces.	The Apyx Helium PlasmaGenerators (owned by ApyxMedical) are indicated fordelivery of radiofrequencyenergy and/or helium plasmato cut, coagulate and ablatesoft tissue during open andlaparoscopic surgicalprocedures. The heliumplasma portion of thegenerator can be used onlywith dedicated Renuvion/ J-Plasma handpieces.	The intendeduse is thesame, withsomelanguagedifferencesdue to thecompanyname changeand branding(i.e., BovieMedical toApyx Medical).
Technology /Energy Used,Delivered	Uses High FrequencyRadiofrequency (RF) energyto create clinical effect. Theelectrical properties of thewaveform (frequency, peak,and duration) produce theclinical effect (i.e. coagulationand cutting).For soft tissue coagulationusing Helium gas, the flowrate produces clinical effect(i.e. coagulation andablation).	Uses High FrequencyRadiofrequency (RF) energy tocreate clinical effect. Theelectrical properties of thewaveform (frequency, peak,and duration) produce theclinical effect (i.e. coagulationand cutting).For soft tissue coagulationusing Helium gas, the flow rateproduces clinical effect (i.e.coagulation and ablation).	Same
User Interface	Push buttons, Sevensegment display and LEDs.	Push buttons, Seven segmentdisplay and LEDs.	Same
AvailableModes	Cut (2), Blend (3),Coagulation (3: pinpoint,spray, gentle), Bipolar (3:Macro, Micro, Standard), andJ-Plasma (2 -with Activeaccessory and with Passiveaccessory)	Cut (2), Blend (3), Coagulation(3: pinpoint, spray, gentle),Bipolar (3: Macro, Micro,Standard) with auto bipolaroption, and J-Plasma (2 -withActive accessory and withPassive accessory)	Same modeswith the optionofan auto-bipolarfeature thatwas cleared inK134054
	Predicate Device	Subject Device
Feature/Characteristic	Bovie Ultimate Gen 2Electrosurgical Generator(K170188)	Apyx Helium PlasmaGenerator	SE Rationale
ElectricalSafetyStandards	Complies with ES60601-1(third edition), IEC60601-1-2(electromagneticcompatibility), and IEC60601-2-2 standard for the safety ofelectrosurgical equipment.	Complies with ES60601-1(third edition), IEC60601-1-2(electromagneticcompatibility), and IEC60601-2-2 (2017) standard for thesafety of electrosurgicalequipment.	Equivalent

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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 embedded within the "A" of "Apyx." Below the word "Apyx" is the word "MEDICAL" in blue, with a thin blue line underneath.

510(k) Summary

7. Conclusion

The Apyx Helium Plasma Generator is a modification to the predicate device that was cleared in K170188 (Bovie Ultimate® Gen 2 Electrosurgical Generator). There are no changes to the intended use, principle of operation or mechanism of action. The subject device, like the predicate device, is intended for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures.

Technological differences between the Apyx Plasma Generator and the predicate do not raise any new concerns of safety or effectiveness and the performance testing demonstrated that the device performs as intended because:

Electrical safety and EMC testing demonstrated that the Apyx Helium Plasma Generator complies with the applicable FDA recognized IEC-60601 standards.
트 Electrical Verification testing demonstrated that the product and performance specification requirements were met.
그 Software verification and validation demonstrated that the generator performs as intended and according to the product specifications.
Mechanical Verification confirmed that the mechanical design meets the product and performance requirements.

Therefore, the device has the same technological characteristics as the predicate and can be determined to be substantially equivalent in term of safety and effectiveness.

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.