(24 days)
No
The summary describes a standard electrosurgical and helium plasma generator with no mention of AI or ML capabilities. The performance studies focus on electrical safety, EMC, and software verification, not AI/ML model performance.
Yes.
The device is used to cut, coagulate, and ablate soft tissue during surgical procedures, which are therapeutic interventions.
No
The device is described as an electrosurgical device that delivers radiofrequency energy and/or helium plasma to cut, coagulate, and ablate soft tissue, which are therapeutic actions, not diagnostic.
No
The device description explicitly states it is an "electrosurqical device" and a "combination of a standard electrosurgical generator and a Helium Plasma generator," indicating it is a hardware device that delivers energy. The performance studies also include electrical and mechanical verification, further confirming it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "delivery of radiofrequency energy and/ or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures." This describes a surgical tool used directly on the patient's tissue.
- Device Description: The description confirms it's an "electrosurqical device" that delivers energy for cutting, coagulation, and ablation of soft tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The device is clearly intended for direct surgical intervention on the patient's body, which is the domain of surgical devices, not IVDs.
N/A
Intended Use / 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, 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
GEI
Device Description
The Apyx Helium Plasma Generator is an electrosurgical device 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 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.
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
open and laparoscopic surgical procedures. (Implies surgical setting, performed by surgeons/medical professionals)
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)
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/(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 for the basic safety and essential performance of high frequency surgical equipment and high 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):
- Electrical Verification: To verify electrical product and performance specification requirements. Results: "The electrical functionality of the generator was verified to meet performance specification requirements."
- Software Verification & Validation for Main, Display and Gas Boards: 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."
Key Results: "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." and "Electrical safety and EMC testing demonstrated that the Apyx Helium Plasma Generator complies with the applicable FDA recognized IEC-60601 standards. Electrical Verification testing demonstrated that the product and performance specification requirements were met. 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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
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.
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510(k) Summary
| I. General Information
Submitted by: | Apyx Medical Corporation (formerly Bovie Medical)
5115 Ulmerton Road
Clearwater, Florida 33760-4004
United States of America |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration #:
Submitter FAX Number: | 3007593903
(727) 322-4465 |
| Contact Person: | Dr. Libet Garber, Global Director of Regulatory Affairs
5115 Ulmerton Road
Clearwater, Florida 33760-4004
United States of America
Phone: (727) 803-8512
Email: 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 - Electrosurgical
Cutting and Coagulation Device and Accessories
Product Code: GEI
Predicate 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
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.
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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: 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 for the basic safety and essential
performance of high frequency surgical equipment and
high 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 |
|---|---|---|
| Electrical | ||
| Verification | To verify electrical product | |
| and performance | ||
| specification requirements. | The electrical functionality of the | |
| generator was verified to meet | ||
| performance specification | ||
| requirements. | ||
| Software | ||
| Verification & | ||
| Validation for | ||
| Main, Display and | ||
| Gas Boards | 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. |
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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 2 | ||
| Electrosurgical Generator | |||
| (K170188) | Apyx Helium Plasma | ||
| Generator | SE Rationale | ||
| Indications | |||
| for Use | The Bovie Ultimate® | ||
| Electrosurgical Generators | |||
| are indicated for delivery of | |||
| radiofrequency energy and/or | |||
| helium gas plasma to cut, | |||
| coagulate and ablate soft | |||
| tissue during open and | |||
| laparoscopic surgical | |||
| procedures. The J-plasma | |||
| portion of the generator can | |||
| be used only with dedicated | |||
| Bovie 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. | The intended | ||
| use is the | |||
| same, with | |||
| some | |||
| language | |||
| differences | |||
| due to the | |||
| company | |||
| name change | |||
| and branding | |||
| (i.e., Bovie | |||
| Medical to | |||
| Apyx Medical). | |||
| 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). | Same | ||
| User Interface | Push buttons, Seven | ||
| segment display and LEDs. | Push buttons, Seven segment | ||
| display and LEDs. | Same | ||
| Available | |||
| Modes | Cut (2), Blend (3), | ||
| Coagulation (3: pinpoint, | |||
| spray, gentle), Bipolar (3: | |||
| Macro, Micro, Standard), 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) | Same modes | ||
| with the option | |||
| of | |||
| an auto-bipolar | |||
| feature that | |||
| was cleared in | |||
| K134054 | |||
| Predicate Device | Subject Device | ||
| Feature/ | |||
| Characteristic | Bovie Ultimate Gen 2 | ||
| Electrosurgical Generator | |||
| (K170188) | Apyx Helium Plasma | ||
| Generator | SE Rationale | ||
| Electrical | |||
| Safety | |||
| Standards | Complies with ES60601-1 | ||
| (third edition), IEC60601-1- | |||
| 2(electromagnetic | |||
| compatibility), and IEC60601- | |||
| 2-2 standard for the safety of | |||
| electrosurgical equipment. | Complies with ES60601-1 | ||
| (third edition), IEC60601-1-2 | |||
| (electromagnetic | |||
| compatibility), and IEC60601- | |||
| 2-2 (2017) standard for the | |||
| safety of electrosurgical | |||
| equipment. | 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.