The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma (J-Plasma energy) for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.

The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.

Device Description

The J-Plasma Precise® Flex Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the delivery of radiofrequency ("RF") energy and/or helium gas plasma for electrosurgical cutting, coaqulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The handpiece has one configuration, model # APYX-500BF. The compatible Generators operate at an adjustable power of up to 40 W (expressed as 0-100% where 100% is 40 W) 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 J-Plasma Precise® Flex Handpiece has an extendable electrode (blade) in the tip to generate helium plasma. The tip is controlled by the user via graspers to actuate (extend and retract) the blade. The handpiece comes with an Introducer that allows for more control of the tip when introducing and removing the distal end to and from the cannula. The handpiece has a flexible, seamless cable that can be advanced with graspers through the cannula during minimally invasive surgical procedures. The handpiece is activated by the footswitch.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the J-Plasma Precise® FLEX Handpiece. The core of the submission is to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., a specific percentage or value to be met). Instead, the studies aim to demonstrate equivalence to the predicate device. The performance is reported qualitatively as "equivalent" or that requirements were "met."

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Functionality: Device must demonstrate proper mechanical operation.	"Mechanical functionality requirements were all met."
Tissue Thermal Effect (Plasma Activation): Tissue effects (depth and lateral spread of thermal effects) must be similar to the predicate device across different tissue types and energy settings.	"The depth and lateral spread (i.e. average length and width) of thermal tissue effects were demonstrated to be equivalent between the subject device and Predicate device across all tissue types and J-Plasma energy settings."
Tissue Thermal Effect (Monopolar Coagulation): Tissue effects (depth and lateral spread of thermal effects) must be similar to the predicate device across different tissue types and energy settings.	"The depth and lateral spread (i.e. average length and width) of thermal tissue effects were demonstrated to be equivalent between the subject device and Predicate device across all tissue types and Monopolar Coagulation energy settings."
Electrical Safety and EMC: Compliance with relevant electrical safety and electromagnetic compatibility standards.	"The handpiece complies with the ANSI/AAMI/IEC 60601-1:2005/(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 J-Plasma Precise® Flex was determined to be in conformance with these standards."
Biocompatibility: Device materials must be biocompatible for indirect blood path contact 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."

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

Sample Size for Test Set: The document states that an "ex-vivo study was conducted on several tissue types (i.e., muscle, liver, kidney)" for the tissue thermal effect equivalency testing. However, the specific number of samples or replicates for each tissue type is not provided.
Data Provenance: The study was "ex-vivo," meaning performed on tissue outside of a living organism. The country of origin for the tissue or the testing location is not specified, but the applicant is Apyx Medical Corporation, located in Clearwater, Florida, USA. The study design appears to be retrospective in the sense that it's comparing a modified device to an existing predicate, rather than a prospective clinical trial.

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

This document describes bench testing and ex-vivo studies. There is no mention of human experts establishing ground truth for a test set in the context of diagnostic performance or interpretation. The "ground truth" for the performance tests (e.g., tissue effect, electrical safety) would be established by the physical measurements and compliance with engineering standards by qualified technical personnel.

4. Adjudication Method for the Test Set

As there's no mention of a human expert-based assessment or diagnostic interpretation requiring adjudication, there is no adjudication method described. The tests are directly measuring physical and electrical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an electrosurgical handpiece, not an AI diagnostic tool. The performance evaluation focuses on the safety and effectiveness of the device itself and its equivalence to a predicate, not on how it assists human readers in making diagnoses.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of this device. The J-Plasma Precise® FLEX Handpiece is a physical surgical tool, not an algorithm. Its "performance" is its ability to cut, coagulate, and ablate tissue, and to meet safety standards. The ex-vivo tissue effect studies are "standalone" in the sense that they assess the device's direct effect on tissue, independent of a human operator's skill, but it's not an algorithm's performance.

7. The Type of Ground Truth Used

The ground truth for the performance studies is based on:

Physical Measurements and Engineering Standards: For electrical safety and mechanical functionality, the ground truth is defined by compliance with established international standards (e.g., IEC 60601 series, ISO 14971) and meeting predefined operational requirements.
Quantitative Tissue Effect Data: For tissue thermal effect, the ground truth is derived from measurements of depth and lateral spread of thermal effects in the ex-vivo tissue samples. The "truth" is established by direct scientific measurement and comparison to the predicate device's measured effects.
ISO Standards for Biocompatibility: For biocompatibility, the ground truth is established by demonstrating compliance with ISO 10993 guidelines.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI/ML algorithm. Therefore, there is no concept of a "training set" as would be used for machine learning. The device's design, manufacturing, and testing follow established engineering and quality system procedures.

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

As there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's development and verification relies on engineering specifications, risk assessments (ISO 14971), and established laboratory testing protocols in compliance with design and development procedures (21 CFR 820.30).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".

January 4, 2021

Apyx Medical Corporation (formerly Bovie Medical Corporation) Topaz Kirlew Vice President, Quality Assurance & Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004

Re: K202880

Trade/Device Name: J-Plasma Precise FLEX Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 25, 2020 Received: September 28, 2020

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/cdrl/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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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 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/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 (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202880

Device Name J-Plasma Precise® FLEX (APYX-500BF)

Indications for Use (Describe)

The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma energy) for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.

The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.

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 incorporated into the "A" of "Apyx." Below "Apyx" is the word "MEDICAL" in blue, smaller, block letters.

K202880

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
	Applicant Contact:	Lauren Tiller, Senior Regulatory Affairs Specialist III5115 Ulmerton RoadClearwater, Florida 33760-4004United States of AmericaPhone: (727) 803-8550Email: Lauren.Tiller@apyxmedical.com
	Correspondent Contact:	Dr. Topaz Kirlew, MBA, Vice President, QualityAssurance & Regulatory Affairs5115 Ulmerton RoadClearwater, Florida 33760-4004United States of AmericaPhone: (727) 803-8617Email: Topaz.Kirlew@apyxmedical.com
	Date Prepared:	December 4, 2020
	Trade Names (Model Number):	J-Plasma Precise® FLEX Handpiece(APYX-500BF)
	Common Name:	Electrosurgical Handpiece
	Classification:	Class II per 21CFR 878.4400 - ElectrosurgicalCutting and Coagulation Device and AccessoriesProduct Code: GEI
	Predicate Device(s):	Predicate DeviceBovie J-Plasma Precise® Flex (K170777)

2. Indications for Use

The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma (J-Plasma energy) for electrosurgical cutting, coagulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.

The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.

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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. The "A" in "Apyx" has a small, dark blue triangle in the lower-left corner. Below "Apyx" is the word "MEDICAL" in a bold, dark blue font, with a thin, dark blue line underneath.

K202880

3. Device Description

Image /page/4/Picture/8 description: The image shows a medical device called J-Plasma. The device consists of a generator (ESU), a helium tank with a regulator, a footswitch, a grounding pad, and a handpiece with an introducer and cable. The generator has a display showing the numbers 8, 20, and 40.

Figure 1: J-Plasma Precise® FLEX System

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Image /page/5/Picture/2 description: The image shows the logo for Aryx Medical. The logo features the word "Aryx" in orange, with a small blue triangle replacing the "A". Below the word "Aryx" is the word "MEDICAL" in blue. The logo is simple and modern, and the colors are eye-catching.

K202880

4. Technological Characteristics

The J-Plasma Precise® Flex Handpiece is a modification to the predicate device that was cleared in K170777 (Bovie J-Plasma Precise® Flex Handpiece). There are no changes to intended use, indications for use, operational principles, energy type, tissue treatment effects, performance specifications, electrosurgical modes, output power waveforms, maximum power settings, and plasma settings that change the energy delivered to the tissue.

The J-Plasma Precise® Flex Handpiece, as compared to the predicate device (K170777), has only the following differences in technological characteristics:

. Blade actuation, extension, and retraction is now in the distal end of the device
Blade configuration will now extend a maximum of 5 mm .
Seamless, working length of the cable
. Addition of the Introducer, as a tip gasping aid/accessory
. Updated One-Wire Programmability for compatibility with the upgraded APYX-JS3/RS3 (Upgrades cleared under K192867)

The J-Plasma Precise® Flex Handpiece with its components is pictured below in Figures 2 and 3:

Image /page/5/Figure/14 description: The image shows a medical device with several labeled parts. The device includes a cable connected to a plug, which leads to an introducer. At the end of the introducer, there is a blade and a tip with grasping features, indicating its use in surgical or medical procedures.

Figure 2: J-Plasma Precise® FLEX (Subject Device)

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Image /page/6/Picture/0 description: The image shows the logo for Apyx Medical. The logo is comprised of the word "Apyx" in orange, with a blue triangle replacing the "A". Below the word "Apyx" is the word "MEDICAL" in blue. The "TM" symbol is in the upper right corner of the logo.

Image /page/6/Picture/5 description: The image shows a medical device with labels pointing to different parts. The top part of the device is labeled as the "Introducer" and the "Tip". The bottom part of the device is labeled as the "Secondary Grasping Location", "Blade", and "Operative Grasping Location".

Figure 3: J-Plasma Precise® FLEX Introducer, Tip Configuration, and Grasping Features (Subject Device)

Results of verification and validation testing demonstrate that the J-Plasma Precise® Flex Handpiece is equivalent in safety and effectiveness to the predicate device, as described below.

5. Performance Data

a. Bench Testing

All testing protocols performed on the subject device, J-Plasma Precise® Flex Handpiece, were derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness of the design modification in accordance with Apyx Medical's design and development procedures. Both the predicate and the modified subject device are designed by the same manufacturer, Apyx Medical (formerly Bovie Medical). The test methodology and acceptance criteria were developed from the same standards and following Apyx Medical's Design and Development procedures, in compliance with the Design and Development requirements of 21 CFR 820.30. The testing performed are summarized in table below.

b. Tissue Thermal Effect Equivalency Test

An ex-vivo study was conducted on several tissue types (i.e., muscle, liver, kidney) to compare the tissue thermal effect of the J-Plasma Precise® Flex and the predicate device. The quantitative results of this testing demonstrated that the tissue effects the subject device is equivalent to the predicate device's effect over a range of power and flow settings that are clinically relevant. This ex-vivo testing is summarized in the table below.

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Image /page/7/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, dark blue triangle is positioned to the left of the "A" in "Apyx." Below "Apyx," the word "MEDICAL" is written in a bold, dark blue font.

K202880

Test	Objective	Result
MechanicalVerification &Functionality	Verify Mechanical functionality of the J-Plasma Precise® Flex	Mechanical functionalityrequirements were all met.
Tissue Effect(PlasmaActivation)	Verify that the tissue effects for PlasmaActivation are similar between thesubject device and the Predicate device(K170777) using 3 different tissue types(Muscle, Kidney & Liver)	The depth and lateral spread(i.e. average length and width)of thermal tissue effects weredemonstrated to be equivalentbetween the subject deviceand Predicate device acrossall tissue types and J-Plasmaenergy settings.
Tissue Effect(MonopolarCoagulation)	Verify that the tissue effects of thesubject device and the Predicate device(K170777) are the same for MonopolarCoagulation using 3 different tissuetypes (Muscle, Kidney & Liver)	The depth and lateral spread(i.e. average length and width)of thermal tissue effects weredemonstrated to be equivalentbetween the subject deviceand Predicate device acrossall tissue types and MonopolarCoagulation energy settings.

c. Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the J-Plasma Precise® Flex. The handpiece complies with the ANSI/AAMI/IEC 60601-1:2005/(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 J-Plasma Precise® Flex was determined to be in conformance with these standards.

6. Biocompatibility Testing

The biocompatibility evaluation for the J-Plasma Precise® Flex 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 ISO 10993-1 Fifth edition 2018-08 standard. "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process".

The J-Plasma Precise® Flex 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.

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Image /page/8/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 letter "A". Below the word "Apyx" is the word "MEDICAL" in blue.

K202880

7. Substantial Equivalence

Feature /Characteristic	Bovie J-Plasma Precise Flex(Predicate Device)K170777	J-Plasma Precise FLEX(Subject Device)
Indications for Use	The Bovie J-Plasma Precise® FlexHandpiece is used for the deliveryof radiofrequency energy and/or ahelium gas plasma forelectrosurgical cutting, coagulation,and ablation of soft tissue. It isintended for use with graspinginstruments during minimallyinvasive surgical procedures.The Bovie J-Plasma Precise FlexHandpiece is compatible withBovie Ultimate Generators BVX-	The J-Plasma Precise® FLEX isused for the of radiofrequencyenergy and/or helium gasplasma (J-Plasma energy) forelectrosurgical cutting,coagulation, and ablation of softtissue. It is intended for use witha grasper during minimallyinvasive surgical procedures.The J-Plasma Precise® FLEX iscompatible with Apyx Medicalelectrosurgical generators.
Procedures	200H and BVX-200P.Laparoscopic or minimally invasivesurgical procedures	Same
Energy Source	Apyx Generator	Same
Energy Type	Monopolar RF energy via HeliumPlasma (helium facilitates the useof low current RF waveform)	Same
Output	Monopolar	Same
Plasma settings	Maximum 40 watts, 1-5 lpm gasflow	Same
Plasma ActivationTissue Effect	Same	Same
Monopolar CoagulationMode	Yes	Same
Monopolar CoagulationSettings	Maximum 120 watts, 1-5 lpm gasflow	Same
Monopolar CoagulationTissue Effect	Same	Same
System Components	The Bovie J-Plasma Precise FlexSystem consists of:- Apyx Medical (formerly BovieMedical) Generator- Disposable handpiece- Foot pedal- Power cord- Gas regulator- Gas cylinder	Same
User Interface	Footswitch activation andgenerator buttons and displays.	Same
Connector	Company Proprietary PlugConnector involving 6 electrical	Same
Feature /Characteristic	Bovie J-Plasma Precise Flex(Predicate Device)K170777	J-Plasma Precise FLEX(Subject Device)
	pins and 1 pneumatic connectionin the center to provide helium gas
Shaft Design	Flexible	Same
Shaft Outer Diameter	8 mm	Same
Total Distance from Tipto Plug	3,251.2 mm total distance from tipto the plug	Same
Tip Configuration	Extendable Blade or Needle	Extendable Blade
Blade Extension	Maximum 10 mm	Maximum 5 mm
Blade Width x Thickness	1.6 mm x 0.4 mm	1.8 mm x 0.4 mm
Tip Protector	Ceramic nozzle	Same
Blade Actuation	Proximal Actuation	Distal Actuation
Device Activation	Footswitch activation only,no hand activation	Same
Grasping Feature	Yes	Same
Tip graspingaid/accessory	None	Introducer
Generator Compatibility	Compatible Bovie MedicalElectrosurgical Generators	Compatible Apyx Medical(formerly Bovie Medical)Electrosurgical Generators
One-Wire Proximal Chip	ETO Sterilizable	Same
BiocompatibilityMaterials	All patient contacting materials arebiocompatible	Same
Sterility	Single-use disposable sterilehandpieces	Same
Electrical Safety	Complies with IEC Electrical SafetyStandards:IEC 60601-1IEC 60601-1-2IEC 60601-2-2	Same

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K202880

The subject device has the same indications for use, operational principle, and technological characteristics as the predicate device. The conclusions drawn from the bench and pre-clinical testing demonstrate that the J-Plasma Precise® Flex Handpiece is substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device for the same indications. Functional and mechanical verification testing demonstrate that the J-Plasma Precise® Flex Handpiece performs as intended in the specified use conditions.

8. Conclusion

The subject device, J-Plasma Precise® FLEX, has the same intended use, indications for use, operational principles, energy type, tissue treatment effects, performance specifications, electrosurgical modes, output power waveforms, maximum power settings, and plasma settings as the originally designed predicate device (Bovie J-Plasma Precise® Flex, K170777).

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Image /page/10/Picture/2 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 letter "A". Below the word "Apyx" is the word "MEDICAL" in blue. There is a thin blue line below the word "MEDICAL".

K202880

The technological differences between the subject and predicate device are the transfer of the blade actuation to the tip to create a seamless design of the cable, a reduction of the maximum blade length from 10 mm to 5 mm, the addition of an introducer as a tip grasping aid, and an updated one-wire programmability for compatibility with the upgraded APYX-JS3/RS3 (these generator upgrades were cleared under K192867). The subject device and the predicate device operate in a similar manner with the same range of energy settings; the modifications explained above accommodates the users' preferences and enhances the stability of the device. There are no differences that would raise new or different questions regarding safety or effectiveness, as the subject device and the predicate device operate in a similar manner with the same range of tissue treatment energy parameters.

The subject device's safety and performance have been confirmed by the results of the performance bench testing and the design change has gone through the design controls process and verification and validation testing to demonstrate that the device is as safe and effective as the predicate device (Bovie J-Plasma Precise® Flex, K170777).

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.