Apyx One Console

K221830 · Apyx Medical Corporation · GEI · Oct 11, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221830
• Device Name: Apyx One Console
• Applicant: Apyx Medical Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Electrosurgical generator delivering radiofrequency (RF) energy and helium plasma; used for cutting, coagulation, and ablation of soft tissue in open and laparoscopic surgery. Device features graphical user interface (GUI), two monopolar ports, and helium gas pressure transmitter. Includes remote service module with cellular connectivity for field troubleshooting and cloud-based logging of non-HIPAA generator settings. Operated by surgical staff in clinical settings. Provides standard electrosurgical energy and helium plasma energy; output power waveforms and maximum settings identical to predicate. Benefits include precise tissue management via RF and helium plasma delivery.

Clinical Evidence

Bench testing only. Testing included electrical safety (ANSI/AAMI/IEC ES60601-1), electromagnetic compatibility (AAMI/ANSI/IEC 60601-1-2), high-frequency surgical equipment safety (AAMI/ANSI/IEC 60601-2-2), and usability engineering (IEC 62366-1). Software/firmware verification and validation confirmed FPGA logic design and system performance meet specifications. Mechanical verification confirmed design requirements.

Technological Characteristics

Electrosurgical generator; RF and helium plasma energy source. Features touch screen GUI, two monopolar ports, helium gas pressure transmitter, and cellular remote service module. Complies with ANSI/AAMI/IEC ES60601-1, IEC 60601-1-2, and IEC 60601-2-2. Software/firmware includes FPGA-based logic design.

Indications for Use

Indicated for soft tissue cutting, coagulation, and ablation during open and laparoscopic surgical procedures. Requires use of dedicated Renuvion/J-Plasma handpieces for helium plasma delivery.

Regulatory Classification

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.

Predicate Devices

• Apyx Helium Plasma Generator (K192867)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </div> | <div> <span> <span style="font-size: 10pt;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </div> |

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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.

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## 510K Summary

| General Information<br>Submitted by: | Apyx Medical Corporation<br>5115 Ulmerton Road<br>Clearwater, FL 33760-4004 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration #: | 3007593903 |
| Submitter FAX Number: | [phone] |
| Contact Person: | David Ceretti, Pre-Market Regulatory<br>Affairs Manager<br>5115 Ulmerton Road<br>Clearwater, FL 33760-4004<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | June 21, 2022 |
| Trade Names (Model Number): | Apyx One Console<br>(APYX-ONE) |
| Common Name: | Electrosurgical Generator |
| Classification: | Class II per 21 CFR 878.4400 -<br>Electrosurgical Cutting and<br>Coagulation Device and<br>Accessories<br>Product Code: GEI |
| Predicate Device(s): | Predicate Device<br>Apyx Helium Plasma Generator<br>(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

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

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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 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.

#### 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-<br>1:2005/(R2012)+A1:2012 | Medical Electrical Equipment - Part 1: General<br>requirements for basic safety and essential performance |
| AAMI/ANSI/IEC 60601-1-<br>2:2014 (4th Edition) | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance<br>- Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests |
| AAMI/ANSI/IEC-60601-2-<br>2:2017 (6th Edition) | Medical electrical equipment - Part 2-2: Particular<br>requirements for the basic safety and essential<br>performance of high frequency surgical equipment and<br>high frequency surgical accessories |
| IEC 62366-<br>1:2015+AMD1:2020 | Medical devices – Application of usability<br>engineering to medical devices IEC<br>62366:2007 |

- 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 product<br>and performance<br>specification requirements. | The electrical functionality of<br>the generator was verified to<br>meet performance specification<br>requirements. |

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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 /<br>FirmwareVerificatio<br>n & Validation | To validate the field<br>programmable gate array<br>(FPGA) procedure and the<br>logic design used in the<br>generator. | The results demonstrated that<br>the system and FPGA perform<br>as intended and according to<br>the product specifications. |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Mechanical<br>Verification | To verify mechanical product<br>and performance<br>specification requirements. | The results verified that the<br>mechanical design meets the<br>product and performance<br>requirements. |

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<br>(K192867) |
| Intended Use /<br>Indications for<br>Use | The Apyx One Console is indicated for<br>the delivery of radiofrequency energy<br>and/or helium plasma to cut, coagulate<br>and ablate soft tissue during open and<br>laparoscopic surgical procedures. The<br>helium plasma portion of the generator<br>can be used only with dedicated<br>Renuvion/ J-Plasma handpieces. | The Apyx Helium Plasma Generators<br>(owned by Apyx Medical) are indicated<br>for delivery of radiofrequency energy<br>and/or helium plasma to cut, coagulate<br>and ablate soft tissue during open and<br>laparoscopic surgical procedures. The<br>helium plasma portion of the generator<br>can be used only with dedicated<br>Renuvion/ J-Plasma handpieces. |
| Technology /<br>Energy Used,<br>Delivered | Uses High Frequency Radiofrequency<br>(RF) energy to create clinical effect. The<br>electrical properties of the waveform<br>(frequency, peak, and duration) produce<br>the clinical effect (i.e. coagulation and<br>cutting).<br>For soft tissue coagulation using Helium<br>gas, the flow rate produces clinical<br>effect (i.e. coagulation and ablation). | Uses High Frequency Radiofrequency<br>(RF) energy to create clinical effect. The<br>electrical properties of the waveform<br>(frequency, peak, and duration) produce<br>the clinical effect (i.e. coagulation and<br>cutting).<br>For soft tissue coagulation using Helium<br>gas, the flow rate produces clinical<br>effect (i.e. coagulation and ablation). |
| User Interface | Touch Screen display and LEDs | Push buttons, Seven segment display<br>and 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

| Available<br>Modes | Cut (2), Blend (3), Coagulation (3:<br>pinpoint, spray, gentle), Bipolar (3:<br>Macro, Micro, Standard) with auto<br>bipolar option, and J-Plasma (2 -with<br>Active accessory and with Passive<br>accessory) | Cut (2), Blend (3), Coagulation (3:<br>pinpoint, spray, gentle), Bipolar (3:<br>Macro, Micro, Standard) with auto<br>bipolar option, and J-Plasma (2 -with<br>Active accessory and with Passive<br>accessory) |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical<br>Safety<br>Standards/ | Complies with ANSI/AAMI ES60601-<br>1:2005 (R2012), IEC60601-1-2<br>(electromagnetic compatibility), and<br>IEC60601-2-2:2017 standard for the<br>safety of electrosurgical equipment. | Complies with ES60601-1 (third edition),<br>IEC60601-1-2 (electromagnetic<br>compatibility), and IEC60601-2-2 (fourth<br>edition) standard for the safety of<br>electrosurgical 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.