Renuvion® APR Handpiece

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, while the text on the right is in blue and is arranged in three lines. May 8, 2023 Apyx Medical Corporation Angela Huber Global Director of Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004 Re: K230272 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 Dear Angela Huber: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 27, 2021. Specifically, FDA is updating this SE Letter due to a formatting error in which the K-number appears as 2K230272 in the header of page 2 as an administrative correction. Please note that the 510(k) sub mission was not re-reviewed. For questions regarding this letter please contact Long Chen, OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, or Long. Chen@fda.hhs.gov. Sincerely, Mark Trumbore, Ph.D. Mark Trumbore Digitally signed by Mark Trumbore -S Date: 2023.05.08 08:19:04 -04'00' For Long Chen, Ph.D. Acting 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 27, 2023 Apyx Medical Corporation Angela Huber Global Director of Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004 Re: K230272 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: March 31, 2023 Received: March 31, 2023 Dear Angela Huber: 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 {2}------------------------------------------------ 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.04.27 13:00:33 -04'00' Mark Trumbore, 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) Device Name Renuvion® APR Handpiece #### Indications for Use (Describe) 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 intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. 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 for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. 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) | <div> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--------------------------------------------------------------------------------| | <div> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {4}------------------------------------------------ ## 510(k) SUMMARY # 1. General Information | Submitted by: | Apyx Medical Corporation<br>5115 Ulmerton Road<br>Clearwater, Florida 33760-4004<br>United States of America | |--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Establishment Registration #: | 3007593903 | | Contact Person: | Angela Huber, PhD, RAC, | | | Global Director of Regulatory Affairs<br>Phone: 218-343-4881<br>Email: angela.huber@apyxmedical.com | | Date Prepared: | March 30th, 2023 | | Trade Name (Model Numbers): | Renuvion® APR Handpiece<br>(APYX-15-SP, APYX-15-TP, APYX-27-TP) | | Common Name: | Electrosurgical Handpiece | | Classification: | Class II per 21CFR 878.4400 - Electrosurgical<br>Cutting and Coagulation Device and<br>Accessories<br>Product Code GEI | | Predicate Device:<br>Secondary Predicate Device: | Renuvion® APR Handpiece (K220970)<br>Renuvion® APR Handpiece (K223262) | ## 2. 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 intended for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological {5}------------------------------------------------ and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region. The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical. #### 3. Device Description The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. 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 cutting, coagulation or ablation of soft tissue during open surgical procedures. 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 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15 cm and 27 cm. The 15 cm 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). The device can also be used for percutaneous delivery of radiofrequency and helium plasma energy to coagulate subcutaneous soft tissue. The recommended settings for subcutaneous soft tissue coagulation are provided in detail in Section C.1 RECOMMENDED SETTINGS & TREATMENT PARAMETERS of the Instructions for Use. The Renuvion® APR System with all components and accessories is shown in the picture below. Image /page/5/Figure/8 description: This image shows a medical device setup with several components labeled. A red helium tank is connected to a gas regulator via a valve. The setup also includes a generator, a handpiece and cable, a foot switch, and a grounding pad, all arranged on a white surface. 10-2 {6}------------------------------------------------ #### 4. Technological Characteristics The Renuvion APR Handpiece with its components is pictured below. Image /page/6/Figure/3 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". Plug Connector #### 5. Performance Data #### a. Bench Testing N/A: no modifications were made to the commercially available handpiece cleared under K220970. #### b. Electrical Safety and Electromagnetic Compatibility (EMC) N/A; no modifications were made to the commercially available handpiece cleared under K220970 or generator cleared under K192867. #### c. Biocompatibility Testing N/A; no modifications were made to the commercially available handpiece cleared under K220970. #### 6. Pre-Clinical & Animal Studies No modifications were made to the commercially available handpiece cleared under K220970 and K223262. 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 and K223262. Apyx Medical conducted a GLP Acute Porcine Study to assess thermal effects of the subject device use in subcutaneous tissue. The data demonstrated the thermal effects of the device on subcutaneous soft tissues and was previously provided in 510(k) submission K191542 and K223262. #### 7. Clinical Performance The Renuvion APR handpiece safety and effectiveness in the neck and submental region was assessed in IDE, G190152 (VP-1902, A Prospective Multi-Center, {7}------------------------------------------------ Evaluator-Blinded Study evaluating the Safety and Effectiveness of the Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region). Apyx analyzed real-world evidence gathered from 6 studies in which all procedures used Renuvion APR following liposuction. This data set includes retrospective chart reviews in 1,184 body areas (across 483 subjects in the following body areas: abdomen, arms, back, buttocks, breast/axilla, face, hips/flanks, legs, neck) followed by coagulation of the subcutaneous soft tissues with Renuvion following liposuction. These data were then compared to the adverse event rates for liposuction alone established in a published meta-analysis. This data supports the safe use of the device for its proposed indications for use. ## 8. Substantial Equivalence The Renuvion APR handpiece is the predicate device; therefore all technological and performance characteristics are the same. The only difference is the addition to the indications for use. | Feature/<br>Characteristic | Subject Device | Predicate Device | Secondary Predicate<br>Device | Comments | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Renuvion® APR<br>Handpiece<br>(K230272) | Renuvion®<br>APR Handpiece<br>(K220970) | Renuvion® APR<br>Handpiece (K223262) | | | Classification | Class II | Class II | Class II | Identical | | Regulation<br>Name and<br>Product Code: | Electrosurgical cutting &<br>coagulation device and<br>accessories, GEI | Electrosurgical cutting<br>& coagulation device<br>and accessories, GEI | Electrosurgical cutting &<br>coagulation device and<br>accessories, GEI | Identical | | Indications for<br>Use | Renuvion® APR<br>Handpiece is intended<br>for the delivery of<br>radiofrequency energy<br>and/or helium plasma<br>where<br>coagulation/contractio<br>n of soft tissue is<br>needed. Soft tissue<br>includes subcutaneous<br>tissue.<br><br>The Renuvion® APR<br>Handpiece is intended<br>for the coagulation of<br>subcutaneous soft | The Renuvion® APR<br>Handpiece is intended<br>for the delivery of<br>radiofrequency<br>energy and/or helium<br>plasma for cutting,<br>coagulation and<br>ablation of soft tissue<br>during open surgical<br>procedures.<br><br>The Renuvion® APR<br>Handpiece is<br>indicated for use in<br>subcutaneous<br>dermatological and<br>aesthetic procedures | The Renuvion® APR<br>Handpiece is intended for<br>the delivery of<br>radiofrequency energy<br>and/or helium plasma<br>where<br>coagulation/contraction<br>of soft tissue is needed.<br>Soft tissue includes<br>subcutaneous tissue.<br><br>The Renuvion® APR<br>Handpiece is indicated<br>for use in subcutaneous<br>dermatological and<br>aesthetic procedures to<br>improve the appearance<br>of lax (loose) skin in the | Generally, the<br>predicate is<br>indicated for<br>use during<br>open surgical<br>procedure or<br>percutaneous<br>procedures<br>and associated<br>surgical<br>equipment.<br>The<br>modification<br>to the<br>intended use<br>is to specify | | | tissues following<br>liposuction for<br>aesthetic body<br>contouring.<br><br>The Renuvion® APR<br>Handpiece is indicated<br>for use in<br>subcutaneous<br>dermatological and<br>aesthetic procedures<br>to improve the<br>appearance of lax<br>(loose) skin in the<br>neck and submental<br>region.<br><br>The Renuvion®<br>APR Handpiece is<br>intended for the<br>delivery of<br>radiofrequency<br>energy and/or<br>helium plasma for | to improve the<br>appearance of lax<br>(loose) skin in the<br>neck and submental<br>region.<br><br>The Renuvion®<br>APR Handpiece is<br>intended to be used<br>with compatible<br>electrosurgical<br>generators owned by<br>Apyx Medical<br>(specifically BVX-<br>200H, BVX-200P,<br>APYX-200H,<br>APYX-200P, APYX-<br>RS3, and APYX-<br>JS3). | neck and submental<br>region.<br><br>The Renuvion® APR<br>Handpiece is intended to<br>be used with compatible<br>electrosurgical generators<br>owned by Apyx Medical. | that the<br>handpiece is<br>intended for<br>the<br>coagulation of<br>subcutaneous<br>soft tissues<br>following<br>liposuction for<br>aesthetic body<br>contouring. | | | cutting, coagulation<br>and ablation of soft<br>tissue during open<br>surgical procedures.<br><br>The Renuvion® APR<br>Handpiece is<br>intended to be used<br>with compatible<br>electrosurgical<br>generators owned by<br>Apyx Medical. | | | | | Energy Type | Helium gas plasma | Helium gas plasma | Helium gas plasma | Identical | | Electrical<br>Currents<br>Transmitted | 150mA - 250mA | 150mA - 250mA | 150mA - 250mA | Identical | | EnergyType<br>Delivered | Monopolar RF energy<br>via Helium Plasma<br>(helium facilitates the<br>use of low | Monopolar RF energy<br>via Helium Plasma<br>(helium facilitates the<br>use of low | Monopolar RF energy<br>via Helium Plasma<br>(helium facilitates the<br>use of low | Identical | | System<br>Components | The Apyx<br>Plasma/RF<br>System consists of:<br>- RF Generator<br>- Disposable HP<br>- Foot pedal<br>- Power cord<br>- Gas regulator<br>- Gas cylinder | The Apyx<br>Plasma/RF<br>System consists of:<br>- RF Generator<br>- Disposable HP<br>- Foot pedal<br>- Power cord<br>- Gas regulator<br>- Gas cylinder | The Apyx<br>Plasma/RF<br>System consists of:<br>- RF Generator<br>- Disposable HP<br>- Foot pedal<br>- Power cord<br>- Gas regulator<br>- Gas cylinder | Identical | | User Interface | Straight | Straight | Straight | Identical | | Shaft Design &<br>Energy Delivery<br>Configuration | 15cm and 27cm long<br>with a side port<br>configuration (single<br>or twin) and<br>indicator lines on the<br>shaft | 15cm and 27cm long<br>with a side port<br>configuration (single<br>or twin) and<br>indicator lines on the<br>shaft | 15cm and 27cm long<br>with a side port<br>configuration (single<br>or twin) and<br>indicator lines on the<br>shaft | Identical | | Shaft Outer<br>Diameter | 3mm | 3mm | 3mm | Identical | | Electrode<br>Configuration | Non-extendable | Non-extendable | Non-extendable | Identical | | Plasma Settings | Maximum 40 watts,<br>1-5<br>L/min gas flow | Maximum 40 watts,<br>1-5<br>L/min gas flow | Maximum 40 watts,<br>1-5<br>L/min gas flow | Identical | | Compatibility | Only with<br>Electrosurgical<br>Generators owned by<br>Apyx Medical | Only with<br>Electrosurgical<br>Generators owned by<br>Apyx Medical | Only with<br>Electrosurgical<br>Generators owned by<br>Apyx Medical | Identical | {8}------------------------------------------------ {9}------------------------------------------------ #### 9. Substantial Equivalence Determination The subject device and predicate device are identical with the exception of the modification to the intended use statement to specify that the Renuvion® APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. Apyx was able to assess the device based on a large set of retrospective chart reviews. No new risks were identified in the risk analysis or real-world evidence and published literature analysis. Renuvion treatment adverse events (AEs) compared to the realworld evidence gathered for the liposuction treatments in the literature review demonstrated there are no new or increased risks for Renuvion procedures following liposuction procedures compared to liposuction alone. These findings support the proposed indications for use. {10}------------------------------------------------ #### 10. Conclusion The Renuvion APR is identical in terms of principle of operation, mechanism of action and sterilization methods to the predicate device, Renuvion APR (K220970 and K223262). The only difference between the subject and predicate devices is the indications for use statement. The clinical data presented in this 510(k) supports the substantial equivalence of safety and effectiveness of the subject device for the proposed indications for use. Therefore, the subject device is as safe and effective as the predicate, and the data presented supports a substantially equivalent decision.