(110 days)
No
The summary describes a standard electrosurgical generator with remote service capabilities for troubleshooting and logging settings, but there is no mention of AI or ML being used for decision-making, analysis, or control of the device's function.
Yes
The device is indicated for medical procedures (cutting, coagulating, and ablating soft tissue during surgical procedures) to treat a condition or for diagnosis, which aligns with the definition of a therapeutic device.
No
The Apyx One Console is described as an electrosurgical generator designed to cut, coagulate, and ablate soft tissue using radiofrequency energy and/or helium plasma during surgical procedures. Its function is to perform therapeutic actions, not to diagnose medical conditions.
No
The device description clearly states it is an electrosurgical generator that delivers RF and Helium plasma energy, and mentions hardware components like a cellular module, gas pressure transmitter, and monopolar ports. It also includes mechanical verification testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The device is described as an "electrosurgical generator" that delivers energy for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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:
- ANSI/AAMI/IEC ES60601-1:2005/(R2012)+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 (6th Edition), Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 62366-1:2015+AMD1:2020, Medical devices – Application of usability engineering to medical devices IEC 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:
- Electrical Safety: To verify electrical product and performance specification requirements. Results: The electrical functionality of the generator was verified to meet performance specification requirements.
- Software/Firmware Verification & Validation: To validate the field programmable gate array (FPGA) procedure and the logic design used in the generator. Results: The results demonstrated that the system and FPGA perform as intended and according to the product specifications.
- Mechanical Verification: To verify mechanical product and performance specification requirements. Results: The results verified that the mechanical design meets the product and performance 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
1-
510K Summary
| General Information
Submitted by: | Apyx Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760-4004 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration #: | 3007593903 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | David Ceretti, Pre-Market Regulatory
Affairs Manager
5115 Ulmerton Road
Clearwater, FL 33760-4004
Phone: (727) 803-8508
Email: 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 and
Coagulation Device and
Accessories
Product Code: GEI |
| Predicate Device(s): | Predicate Device
Apyx 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
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
4
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- | |
| 1:2005/(R2012)+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 (6th Edition) | Medical electrical equipment - Part 2-2: Particular
requirements for the basic safety and essential
performance of high frequency surgical equipment and
high frequency surgical accessories |
| IEC 62366-
1:2015+AMD1:2020 | Medical devices – Application of usability
engineering to medical devices IEC
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 | |
| and performance | ||
| specification requirements. | The electrical functionality of | |
| the generator was verified to | ||
| meet performance specification | ||
| requirements. |
5
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 /
FirmwareVerificatio
n & Validation | To validate the field
programmable gate array
(FPGA) procedure and the
logic design used in the
generator. | The results demonstrated that
the system and FPGA perform
as intended and according to
the product specifications. |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Mechanical
Verification | To verify mechanical product
and performance
specification requirements. | The results verified that the
mechanical design meets the
product and performance
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 |
| (K192867) | ||
| Intended Use / | ||
| Indications for | ||
| Use | The Apyx One Console is indicated 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 be used only with dedicated | ||
| Renuvion/ J-Plasma handpieces. | 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. | ||
| Technology / | ||
| Energy Used, | ||
| Delivered | Uses High Frequency Radiofrequency | |
| (RF) energy to create clinical effect. The | ||
| electrical properties of the waveform | ||
| (frequency, peak, and duration) produce | ||
| the clinical effect (i.e. coagulation and | ||
| cutting). | ||
| For soft tissue coagulation using Helium | ||
| gas, the flow rate produces clinical | ||
| effect (i.e. coagulation and ablation). | Uses High Frequency Radiofrequency | |
| (RF) energy to create clinical effect. The | ||
| electrical properties of the waveform | ||
| (frequency, peak, and duration) produce | ||
| the clinical effect (i.e. coagulation and | ||
| cutting). | ||
| For soft tissue coagulation using Helium | ||
| gas, the flow rate produces clinical | ||
| effect (i.e. coagulation and ablation). | ||
| User Interface | Touch Screen display and LEDs | Push buttons, Seven segment display |
| and LEDs. |
6
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
Modes | Cut (2), Blend (3), Coagulation (3:
pinpoint, spray, gentle), Bipolar (3:
Macro, Micro, Standard) with auto
bipolar option, and J-Plasma (2 -with
Active accessory and with Passive
accessory) | Cut (2), Blend (3), Coagulation (3:
pinpoint, spray, gentle), Bipolar (3:
Macro, Micro, Standard) with auto
bipolar option, and J-Plasma (2 -with
Active accessory and with Passive
accessory) |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical
Safety
Standards/ | Complies with ANSI/AAMI ES60601-
1:2005 (R2012), IEC60601-1-2
(electromagnetic compatibility), and
IEC60601-2-2:2017 standard for the
safety of electrosurgical equipment. | Complies with ES60601-1 (third edition),
IEC60601-1-2 (electromagnetic
compatibility), and IEC60601-2-2 (fourth
edition) standard for the safety of
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.