(122 days)
The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.
The Renuvion® APR Handpiece is a sterile, single-use electrosurgical (monopolar) device intended to be used in conjunction with compatible electrosurgical generators. The compatible generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) 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 passes over the energized electrode, a helium plasma is generated which delivers thermal energy to soft tissue for the purposes of cutting, coagulation/contraction, or ablation.
The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).
This document is an FDA 510(k) premarket notification for the Renuvion® APR Handpiece. It discusses the device's substantial equivalence to previously cleared devices based on bench testing, electrical safety, biocompatibility, and pre-clinical/ex-vivo studies. Crucially, it states that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." Therefore, there is no information in this document regarding acceptance criteria, human reader studies (MRMC), or specific expert consensus for establishing ground truth as these types of studies were not conducted for this specific submission to demonstrate substantial equivalence.
However, the document does contain information about performance testing to support expanded indications for use. I will address the relevant points based on the provided text.
Acceptance Criteria and Device Performance (as inferred from the pre-clinical/ex-vivo studies to support expanded indications)
Since the submission did not rely on clinical performance data for substantial equivalence, formal acceptance criteria in the typical sense for a clinical study are not provided. Instead, the document describes the types of pre-clinical and ex-vivo studies conducted and the data they demonstrated to support the expanded indications.
The expanded indication required demonstrating the ability of the device to achieve "coagulation/contraction of soft tissue" including "subcutaneous tissue."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from study purpose) | Reported Device Performance (as described in the document) |
|---|---|
| Demonstrate coagulative effect on various tissues (liver, kidney, muscle) via ex vivo testing, similar to a reference device. | Apyx Medical conducted the "same ex vivo tissue testing using the Renuvion APR handpiece on liver, kidney, and muscle tissues at 20%, 50%, and 100% power and 1, 3, and 5 Lpm gas flow rate." Measurements of lateral spread and depth of thermal effect were characterized under histological examination. The results supported the addition of "coagulation/contraction of soft tissue" to the indications for use. |
| Demonstrate thermal effects (e.g., depth of thermal effect) in subcutaneous tissue suitable for contraction via in vivo porcine study. | A GLP Acute Porcine Study was conducted to assess thermal effects of the device on subcutaneous and connective tissue. The handpiece was moved continuously at 1 cm/sec at 60-80% power and 1.5 Lpm gas flow rate. "Depth of thermal effect in subcutaneous tissue was measured and analyzed via histology." The data "demonstrated the thermal effects of the device on subcutaneous soft tissues," supporting "contraction" and "subcutaneous tissue" in the indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Ex-Vivo Tissue Testing: The document mentions "liver, kidney, and muscle tissues" were used. A specific sample size (number of tissue samples or replicates) is not provided.
- In-Vivo Acute Porcine Study: The document refers to "an in vivo acute porcine study" but does not specify the number of animals used.
- Data Provenance: The document does not explicitly state the country of origin for the data. The studies were conducted by Apyx Medical, a US-based company. The nature of the studies (ex-vivo and acute in-vivo) suggests they are prospective laboratory and animal studies, not retrospective or prospective human clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Ground Truth for Ex-Vivo and In-Vivo Studies: Ground truth for these studies was established through "histological examination" to characterize lateral spread and depth of thermal effect. The document does not specify the number of experts or their exact qualifications (e.g., pathologist with X years of experience) who performed this histological analysis. It's implied this was done by qualified personnel in a lab setting, but specifics are missing from this FDA letter.
4. Adjudication Method for the Test Set
- Given the nature of the ground truth (histological examination), a multi-reader adjudication method like "2+1" or "3+1" is typically not applicable in the same way as for diagnostic imaging studies. Histological analysis would involve expert pathological review. The document does not describe any specific adjudication method, such as multiple pathologists reviewing and finding consensus, for the histological examinations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." An MRMC human reader study would fall under clinical performance data. Therefore, no information on human reader improvement with or without AI assistance is provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- Not applicable. This device is an electrosurgical handpiece, not an AI algorithm. Its performance is measured by its physical effect on tissue, not by an algorithm's diagnostic capabilities.
7. The Type of Ground Truth Used
- For the ex-vivo and in-vivo studies supporting the expanded indications, the ground truth was established through histological examination of treated tissues (liver, kidney, muscle, and subcutaneous tissue) to measure thermal effects, specifically lateral spread and depth of thermal effect. This is a form of pathology-based ground truth.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device (electrosurgical handpiece), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
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February 23, 2023
Apyx Medical Corporation Mark Evans Sr. Premarket Regulatory Affairs Specialist (formerly Bovie Medical Corporation) 5115 Ulmerton Road Clearwater, Florida 33760-4004
Re: K223262
Trade/Device Name: Renuvion® APR Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: January 27, 2023 Received: January 27, 2023
Dear Mark Evans:
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
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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,
Image /page/1/Picture/5 description: The image shows the name "Jessica Carr-S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223262
Device Name Renuvion® APR Handpiece
Indications for Use (Describe)
The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/2 description: The image shows the logo for Apyx Medical. The logo is orange and blue. The word "Apyx" is in orange, and the word "Medical" is in blue.
-
- General Information:
| Submitted by: | Apyx Medical Corporation5115 Ulmerton Road Clearwater, Florida 33760-4004United States of America |
|---|---|
| Establishment Registration #: | 3007593903 |
| Contact Person: | Mark D. Evans, Sr. Premarket Regulatory AffairsSpecialist5115 Ulmerton RoadClearwater, Florida 33760-4004United States of AmericaPhone: (856) 524-5037Email: mark.evans@apyxmedical.com |
| Date Prepared: | October 21st, 2022 |
| Trade Names (Model Numbers): | Renuvion® APR Handpiece(APYX-15-SP, APYX-15-TP, APYX-27-TP) |
| Common Name: | Electrosurgical Handpiece |
| Classification: | Class II per 21CFR 878.4400 - ElectrosurgicalCutting and Coagulation Device and AccessoriesProduct Code GEI |
| Predicate and Reference Devices: | Predicate DeviceRenuvion® APR Handpiece (K220970)Reference Device |
Ellusa Bipolar Wands (K202558)
Proposed Indications for Use:
Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
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Image /page/4/Picture/2 description: The image shows the logo for Apyx Medical. The logo is in orange and blue. The word "Apyx" is in orange, with a blue triangle in the "A". The word "MEDICAL" is in blue and is located below the word "Apyx".
The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical qenerators owned by Apyx Medical.
2. Device Description and Technological Characteristics:
The Renuvion® APR System with all components and accessories is shown in the picture below. The system is comprised of a compatible electrosurgical generator, a sterile, single use handpiece, and a supply of helium gas. Additional accessories include a gas regulator, grounding pad and optional footswitch.
Image /page/4/Figure/7 description: The image shows a medical setup with several components labeled. A red helium tank is connected to a regulator via a valve. A blue tube runs from the regulator to a generator (ESU), which also has a handpiece and cable attached. A foot switch and grounding pad are also part of the setup.
The Renuvion® APR Handpiece is a sterile, single-use electrosurgical (monopolar) device intended to be used in conjunction with compatible electrosurgical generators. The compatible generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) 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 passes over the energized electrode, a helium plasma is generated which delivers thermal energy to soft tissue for the purposes of cutting, coagulation/contraction, or ablation.
The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).
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Image /page/5/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. The logo is simple and modern, and the colors are bright and eye-catching.
The Renuvion APR Handpiece is pictured below.
Image /page/5/Figure/5 description: The image shows a medical device with several labeled parts. The device has a long, thin, flexible shaft with energy exit portals and tip distance indicators at the end. The device also has a handle with an activation button, a plug connector, and a cable.
3. Performance Data:
a. Bench Testing
N/A; no design modifications were made to the commercially available Handpiece cleared under K220970.
b. Electrical Safety and Electromagnetic Compatibility (EMC)
N/A; no design modifications were made to the commercially available Handpiece cleared under K220970.
c. Biocompatibility Testing
N/A; no design modifications were made to the commercially available Handpiece cleared under K220970.
4. Pre-Clinical & Ex-Vivo Studies:
Ex vivo tissue testing that included liver, kidney, and muscle tissues to measure the coagulative effect of the device on tissue was previously provided in 510(k) submission K191542 is presented below in summary format. Apyx Medical conducted a GLP Acute Porcine Study to assess thermal effects of the subject device use in subcutaneous and connective tissue. The data demonstrated the thermal effects of the device on subcutaneous soft tissues.
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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 blue triangle is incorporated into the "A" of "Apyx." Below "Apyx" is the word "MEDICAL" in blue, block letters. The "®" symbol is located to the right of the "X" in "Apyx."
5. Clinical Studies:
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
6. Substantial Equivalence:
| Feature/ | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Characteristic | Renuvion® APRHandpiece1 | Apyx Plasma/RFHandpiece (K220970) | Ellusa Bipolar Wands(K202558) |
| Classification | Class II | Class II | Class II |
| Regulation Nameand ProductCode: | Electrosurgical cutting &coagulation device andaccessories, GEI | Electrosurgical cutting &coagulation device andaccessories, GEI | Electrosurgical cutting &coagulation device andaccessories, GEI |
| Indications forUse Statement | Renuvion® APRHandpiece is intended forthe delivery ofradiofrequency energyand/or helium plasmawherecoagulation/contractionof soft tissue is needed.Soft tissue includessubcutaneous tissue.The Renuvion® APRHandpiece is indicated foruse in subcutaneousdermatological andaesthetic procedures toimprove the appearance oflax (loose) skin in the neckand submental region. | The Renuvion® APRHandpiece is intended forthe delivery ofradiofrequency energyand/or helium plasma forcutting, coagulation andablation of soft tissueduring open surgicalprocedures.The Renuvion® APRHandpiece is indicated foruse in subcutaneousdermatological andaesthetic procedures toimprove the appearanceof lax (loose) skin in theneck and submentalregion. | The Ellusa BipolarWands are intended foruse by a physicianfamiliar with bipolarcoagulation withelectrosurgery wherecoagulation/contractionof soft tissue is needed. |
| Feature/Characteristic | Subject Device | Predicate Device | Reference Device |
| Renuvion® APRHandpiece1 | Apyx Plasma/RFHandpiece (K220970) | Ellusa Bipolar Wands(K202558) | |
| The Renuvion® APRHandpiece is intended tobe used with compatibleelectrosurgical generatorsowned by Apyx Medical. | The Renuvion® APRHandpiece is intended tobe used with compatibleelectrosurgical generatorsowned by Apyx Medical(specifically BVX-200H,BVX-200P, APYX-200H,APYX-200P, APYX-RS3,and APYX-JS3). | ||
| Energy Source | RF Generator, onlyGenerators owned byApyx Medical | RF Generator, onlyGenerators owned byApyx Medical | RF Generator |
| Energy Type | Radio frequency (RF)Energy and Helium Gas | Radio frequency (RF)Energy and Helium Gas | Radio frequency (RF)Energy |
| SystemComponents | The Apyx Plasma/RFSystem consists of:RF GeneratorDisposable HPFoot pedalPower cordGas regulatorGas cylinder | The Apyx Plasma/RFSystem consists of:RF GeneratorDisposable HPFoot pedalPower cordGas regulatorGas cylinder | The Ellusa RF Systemconsists of:RF GeneratorDisposable HPFoot pedalPower cord |
| Design & EnergyDeliveryConfiguration | 15cm and 27cm long shaftwith a side portconfiguration (single ortwin) and indicator lines onthe shaft | 15cm and 27cm long shaftwith a side portconfiguration (single ortwin) and indicator lines onthe shaft | 11cm to 40cm long,with Ball Tip, Standard,or Hex Blade Tipconfiguration |
| Shaft OuterDiameter | 3mm | 3mm | 1.2mm to 6mm |
1 The Bold text represents the modified wording.
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Image /page/7/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 left side of the "A". Below "Apyx" is the word "MEDICAL" in blue, in a smaller font. The logo is simple and modern, with a focus on the company name.
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Image /page/8/Picture/2 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the letters "Apyx" displayed in a stylized font. A small, dark blue triangle is incorporated into the "A" of the logo. Below the main logo, the word "MEDICAL" is written in blue, block letters.
7. Substantial Equivalence Determination
The subject and predicate devices are identical. No design modifications were made to the predicate for this new 510(k) submission. The only change is to modify the indications for use of the subject device to include "where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue."
The reference device received FDA clearance for the coagulation/contraction of soft tissue by performing ex vivo tissue testing that included liver, kidney, and muscle tissues to measure the coagulative effect of the device on tissue. Apyx Medical conducted the same ex vivo tissue testing using the Renuvion APR handpiece on liver, kidney, and muscle tissues at 20%, 50%, and 100% power and 1, 3, and 5 Lpm gas flow rate. Measurements of lateral spread and depth of thermal effect were characterized under histological examination.
Additionally, to support use in subcutaneous tissue, the subject device was tested in an in vivo acute porcine study at 60-80% power and 1.5 Lpm gas flow rate. The handpiece was moved continuously at a rate of 1 cm/sec while depositing the energy subcutaneously in the flank region of the animal. Depth of thermal effect in subcutaneous tissue was measured and analyzed via histology. The results of this testing supports the addition of "contraction" and "subcutaneous tissue" to the indication for use statement of the subject device.
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Image /page/9/Picture/2 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a blue triangle in the upper left corner of the "A". The word "MEDICAL" is written in blue below the word "Apyx". There is a registered trademark symbol to the right of the "x" in "Apyx".
Conclusion:
The subject of this submission is the modifications to the general intended use for the Renuvion APR Handpiece. The proposed changes to the indications for use are supported by ex vivo and in vivo tissue testing that demonstrates the coagulative tissue effects. The commercially available Renuvion® APR handpiece is safe and effective, and the modifications to the indications for use do not raise any new questions of safety or effectiveness compared to the predicate device.
§ 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.