The Apyx One Console is 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 One Console is an electrosurgical generator that delivers radiofrequency (RF) energy to cut and coagulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. Like the predicate, the Apyx One Console provides standard electrosurgical energy and Helium Plasma energy, with no changes to the intended use, electrosurgical modes, output power waveforms, or maximum power settings. The Apyx One Console is a modified version of the primary predicate device that was cleared under K192867 (Apyx Helium Plasma Generator), with a no change to the intended use.

The Apyx One Console has a Graphical User Interface (GUI). Remote Services will be available using an attached cellular module to assist in troubleshooting the generator in the field, a helium Gas Pressure Transmitter, and two monopolar ports.

The Remote Service module will also provide non-HIPPA data to a cloud data system which will log the various settings of the generator throughout its use.

AI/ML Overview

The Apyx One Console is an electrosurgical generator intended for the 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 only be used with dedicated Renuvion/J-Plasma handpieces.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

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

Acceptance Criteria (Standards Met)	Reported Device Performance (Results)
Electrical Safety Standards:
ANSI/AAMI/IEC ES60601-1:2005/(R2012)+A1:2012 (General requirements for basic safety and essential performance)	The electrical functionality of the generator was verified to meet performance specification requirements.
AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) (Electromagnetic disturbances - Requirements and tests)	Complies with the standard.
AAMI/ANSI/IEC-60601-2-2:2017 (6th Edition) (Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and accessories)	Complies with the standard.
Usability Standard:
IEC 62366-1:2015+AMD1:2020 (Application of usability engineering to medical devices)
Software/Firmware Performance:
Field Programmable Gate Array (FPGA) Procedure and Logic Design Validation	The results demonstrated that the system and FPGA perform as intended and according to the product specifications.
Mechanical Performance:
Mechanical Product and Performance Specification Requirements	The results verified that the mechanical design meets the product and performance requirements.

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. Instead, the performance testing described focuses on engineering verification and validation. Therefore, information regarding sample size and data provenance for a test set (e.g., patient data) is not applicable here as it is not a clinical study in that sense.

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

Not applicable. This evaluation focuses on engineering performance rather than clinical endpoints requiring expert ground truth establishment.

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

Not applicable. This was not a study requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an electrosurgical generator, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone algorithm performance" is not relevant. The performance evaluation focuses on the engineering safety and effectiveness of the hardware and software in its intended operational context.

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

The "ground truth" for this device's acceptance criteria primarily involved:

Compliance with established international electrical safety, electromagnetic compatibility, and usability standards.
Verification against product and performance specifications for electrical functionality, software/firmware operation, and mechanical design.

8. The sample size for the training set

Not applicable. This device, being an electrosurgical generator, does not utilize a "training set" in the context of machine learning.

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

Not applicable, as there is no training set for this type of medical device evaluation.

Summary

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October 11, 2022

Apyx Medical Corporation David Ceretti 5115 Ulmerton Road Clearwater, Florida 33760-4004

Re: K221830

Trade/Device Name: Apyx One Console Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 9, 2022 Received: September 12, 2022

Dear David Ceretti:

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 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

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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,

for

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)

K221830

Device Name Apyx One Console (APYX-ONE)

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 consists of the word "Apyx" in orange, with a blue triangle replacing 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.

510K Summary

General InformationSubmitted by:	Apyx Medical Corporation5115 Ulmerton RoadClearwater, FL 33760-4004
Establishment Registration #:	3007593903
Submitter FAX Number:	(727) 322-4465
Contact Person:	David Ceretti, Pre-Market RegulatoryAffairs Manager5115 Ulmerton RoadClearwater, FL 33760-4004Phone: (727) 803-8508Email: David.Ceretti@Apyxmedical.com
Date Prepared:	June 21, 2022
Trade Names (Model Number):	Apyx One Console(APYX-ONE)
Common Name:	Electrosurgical Generator
Classification:	Class II per 21 CFR 878.4400 -Electrosurgical Cutting andCoagulation Device andAccessoriesProduct Code: GEI
Predicate Device(s):	Predicate DeviceApyx Helium Plasma Generator(K192867)

Indications for Use 2.

The Apyx One Console is indicated for the 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.

ടം 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 blue, with the word "Apyx" in large, bold letters. The word "MEDICAL" is written in blue, smaller letters below the word "Apyx". There is a blue triangle on the left side of the logo.

510K Summary

maximum power settings. The Apyx One Console is a modified version of the primary predicate device that was cleared under K192867 (Apyx Helium Plasma Generator), with a no change to the intended use.

The Remote Service module will also provide non-HIPPA data to a cloud data system which will log the various settings of the generator throughout its use.

Performance Data 4.

a. 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/(R2012)+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 (6th Edition)	Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essentialperformance of high frequency surgical equipment andhigh frequency surgical accessories
IEC 62366-1:2015+AMD1:2020	Medical devices – Application of usabilityengineering to medical devices IEC62366:2007

b. Performance testing was completed to demonstrate substantial equivalence of the subject device to the predicate device (K192867) and in accordance with the FDA Guidance Documents:

Test	Objective	Results
Electrical Safety	To verify electrical productand performancespecification requirements.	The electrical functionality ofthe generator was verified tomeet performance specificationrequirements.

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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 in place 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.

510K Summary

Software /FirmwareVerification & Validation	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 tothe product specifications.
MechanicalVerification	To verify mechanical productand performancespecification requirements.	The results verified that themechanical design meets theproduct and performancerequirements.

Results of the bench and software/Firmware testing demonstrate that the Apyx One Console is equivalent to the predicate device in terms of safety and effectiveness.

Substantial Equivalence ട്.

Feature/	Subject Device	Predicate Device
Characteristic	Apyx One Console	Apyx Helium Plasma Generator(K192867)
Intended Use /Indications forUse	The Apyx One Console is indicated forthe delivery of radiofrequency energyand/or helium plasma to cut, coagulateand ablate soft tissue during open andlaparoscopic surgical procedures. Thehelium plasma portion of the generatorcan be used only with dedicatedRenuvion/ J-Plasma handpieces.	The Apyx Helium Plasma Generators(owned by Apyx Medical) are indicatedfor delivery of radiofrequency energyand/or helium plasma to cut, coagulateand ablate soft tissue during open andlaparoscopic surgical procedures. Thehelium plasma portion of the generatorcan be used only with dedicatedRenuvion/ J-Plasma handpieces.
Technology /Energy Used,Delivered	Uses High Frequency Radiofrequency(RF) energy to create clinical effect. Theelectrical properties of the waveform(frequency, peak, and duration) producethe clinical effect (i.e. coagulation andcutting).For soft tissue coagulation using Heliumgas, the flow rate produces clinicaleffect (i.e. coagulation and ablation).	Uses High Frequency Radiofrequency(RF) energy to create clinical effect. Theelectrical properties of the waveform(frequency, peak, and duration) producethe clinical effect (i.e. coagulation andcutting).For soft tissue coagulation using Heliumgas, the flow rate produces clinicaleffect (i.e. coagulation and ablation).
User Interface	Touch Screen display and LEDs	Push buttons, Seven segment displayand LEDs.

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Image /page/6/Picture/1 description: The image shows the logo for Apyx Medical. The logo is comprised of the word "Apyx" in orange, with a blue triangle in place of the dot over the "i". Below the word "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, and the colors are bright and eye-catching.

510K Summary

AvailableModes	Cut (2), Blend (3), Coagulation (3:pinpoint, spray, gentle), Bipolar (3:Macro, Micro, Standard) with autobipolar option, and J-Plasma (2 -withActive accessory and with Passiveaccessory)	Cut (2), Blend (3), Coagulation (3:pinpoint, spray, gentle), Bipolar (3:Macro, Micro, Standard) with autobipolar option, and J-Plasma (2 -withActive accessory and with Passiveaccessory)
ElectricalSafetyStandards/	Complies with ANSI/AAMI ES60601-1:2005 (R2012), IEC60601-1-2(electromagnetic compatibility), andIEC60601-2-2:2017 standard for thesafety of electrosurgical equipment.	Complies with ES60601-1 (third edition),IEC60601-1-2 (electromagneticcompatibility), and IEC60601-2-2 (fourthedition) standard for the safety ofelectrosurgical equipment.

Conclusion 6

The Apyx One Console is a modification to the predicate device that was cleared in K192867 (Apyx Helium Plasma Generator) There are no changes to the intended use, principle of operation, or mechanism of action. Like the predicate, the subject device is intended for the delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during laparoscopic surgical procedures.

Technological differences between the Apyx One Console and the predicate do not raise any new concerns of safety or effectiveness and the performance testing demonstrated that the device performs as intended.

Based upon the intended use, comparison of technical characteristics and performance testing provided in this pre-market notification, the Apyx One is substantially equivalent to the predicate device and does not raise new or different questions 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.