Who is the manufacturer of Renuvion APR Handpiece?

Apyx Medical Corporation(Formerly Bovie Medical Corporation) filed the 510(k) submission for Renuvion APR Handpiece (K220970).

What is the FDA product code for Renuvion APR Handpiece?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Renuvion APR Handpiece?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Renuvion APR Handpiece?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Renuvion APR Handpiece

K220970 · Apyx Medical Corporation(Formerly Bovie Medical Corporation) · GEI · Jul 15, 2022 · General, Plastic Surgery

Device Facts

Record ID	K220970
Device Name	Renuvion APR Handpiece
Applicant	Apyx Medical Corporation(Formerly Bovie Medical Corporation)
Product Code	GEI · General, Plastic Surgery
Decision Date	Jul 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Renuvior® 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 (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).

Device Story

Monopolar electrosurgical handpiece; delivers radiofrequency energy and helium gas to generate plasma for soft tissue cutting, coagulation, and ablation. Used in open surgical procedures; specifically indicated for neck and submental skin laxity. Operated by physicians in clinical settings. System includes handpiece, compatible Apyx electrosurgical generator, foot switch, grounding pad, and helium gas supply. Physician activates device via hand button or foot switch; energy/plasma output applied to subcutaneous tissue via cannula tunneling. Output effect: tissue heating/contraction to improve skin appearance. Benefits: non-surgical aesthetic improvement of lax skin.

Clinical Evidence

Prospective, multi-center, evaluator-blinded study (IDE G190152) of 65 adults (35-65 years). Primary effectiveness: 82.5% responder rate at 180 days (2/3 blinded reviewers). Primary safety: 96.9% of subjects reported none-to-moderate pain at 7 days (NRS). Adverse events included edema, temporary nerve injury, ecchymoses, erythema, crepitus, pain, nodules, and pruritus.

Technological Characteristics

Monopolar electrosurgical handpiece; 15cm or 27cm lengths; single or twin port configurations. Non-extendable electrode. Energy source: RF generator (up to 40W). Helium gas flow: 1-5 LPM. Connectivity: Proprietary connector for Apyx generators. Sterile, single-use.

Indications for Use

Indicated for adults aged 35-65 years undergoing subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Apyx Plasma/RF Handpiece (K191542)

Related Devices

K223262 — Renuvion® APR Handpiece · Apyx Medical Corporation · Feb 23, 2023
K230272 — Renuvion® APR Handpiece · Apyx Medical Corporation · Apr 27, 2023
K211652 — Renuvion Dermal Handpiece, Renuvion Dermal System · Apyx Medical Corporation (Formerly Bovie Medical Corporation · May 25, 2022
K230586 — Renuvion® Micro Handpiece · Apyx Medical Corporation · Jun 9, 2023
K191542 — Apyx Plasma/RF Handpiece · Bovie Medical Corporation Dba Apyx Medical Corporation · Oct 11, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ July 15, 2022 Image /page/0/Picture/1 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 & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The logo is simple and professional, conveying the agency's authority and mission. Apyx Medical Corporation(formerly Bovie Medical Corporation) Priscilla Herpai Global Director of Regulatory 5115 Ulmerton Road Clearwater, Florida 33760-4004 #### Re: K220970 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: June 10, 2022 Received: June 13, 2022 #### Dear Priscilla Herpai: 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 {1}------------------------------------------------ 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 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, 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 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K220970 Device Name Renuvion® APR Handpiece Indications for Use (Describe) 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 Renuvior® 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 (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3). | 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. 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 is orange and blue. The word "Apyx" is in orange, with a blue triangle in place of the "A". Below the word "Apyx" is the word "MEDICAL" in blue. ### 1. General Information: | Submitted by: | Apyx Medical Corporation 5115 Ulmerton Road Clearwater, Florida 33760 -4004 United States of America | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration #: | 3007593903 | | Submitter FAX Number: | (727) 322-4465 | | Contact Person: | Priscilla Herpai, Global Regulatory Affairs Director 5115 Ulmerton Road Clearwater, Florida 33760 -4004 United States of America Phone: (610) 533-7984 Email: priscilla.herpai@apyxmedical.com | | Date Prepared: | April 1, 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 - Electrosurgical Cutting and Coagulation Device and Accessories Product Code GEI | | Predicate Devices: | Predicate Device Apyx Plasma/RF Handpiece (K191542) | ### 2. Proposed Indications for Use: 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 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 (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3). {4}------------------------------------------------ Image /page/4/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". The word "MEDICAL" is written in blue below the word "Apyx". There is a thin blue line underneath the word "MEDICAL". ### 3. Device Description: 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 for soft tissue cutting, coaqulation or ablation. The Renuvion® APR Handpiece has a non-extendable electrode to generate helium plasma. 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). The Renuvion® APR System with all components and accessories is show in the picture below. Image /page/4/Figure/8 description: The image shows a medical setup with several components. A red helium tank stands on the left, connected to a regulator with a pressure gauge. A blue hose runs from the regulator to a generator (ESU), which is labeled as such. Other components include a foot switch and a grounding pad, both connected to the generator. {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for Apyx Medical. The logo is orange and blue, with the word "Apyx" in a stylized font. The word "MEDICAL" is written in blue below the word "Apyx". There is a horizontal line below the word "MEDICAL". ## 4. Technological Characteristics: The Renuvion APR Handpiece with its components is pictured below. Image /page/5/Figure/6 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. ### 5. Performance Data: #### a. Bench Testing N/A; no modifications were made to the commercially available Handpiece cleared under K191542. #### b. Electrical Safety and Electromaqnetic Compatibility (EMC) N/A; no modifications were made to the commercially available Handpiece cleared under K191542. #### c. Biocompatibility Testing N/A; no modifications were made to the commercially available Handpiece cleared under K191542. #### 6. Pre-Clinical & Ex-Vivo Studies: N/A; no modifications were made to the commercially available product cleared under K191542. ### 7. Clinical Studies: Performance was assessed in a prospective, multi-center, evaluator-blinded study of 65 adults, age 35-65 years. The bilateral treatment area included the tissue of the neck (to the posterior border of the sternocleidomastoid muscle) and the submental area. After infusion of tumescent anesthesia, three incisions (2 periauricular and 1 submental) were used to allow tunneling/undermining with a cannula followed by treatment with Renuvion APR handpiece, using 4-6 treatment passes at settings of 70% power, 1.5 LPM of helium flow, and an average movement speed of approximately 5.5 cm/s. {6}------------------------------------------------ Image /page/6/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". The word "MEDICAL" is written in blue below the word "Apyx". There is a thin blue line below the word "MEDICAL". The primary effectiveness endpoint was response rate at Day 180, where a responder was defined as correct identification of the "after" images by at least 2 of 3 blinded Independent Photographic Reviewers. The responder rate was 82.5%. The most common adverse events were edema, temporary sensory nerve injury, ecchymoses, erythema, crepitus, pain/tenderness, nodules, temporary motor nerve injury, and pruritus. Primary Effectiveness Endpoint: The primary effectiveness endpoint was improvement in the appearance of lax tissue in the neck and submental region at 180-days as determined by 2 out of 3 blinded Independent Photographic Reviewers through assessment of 2D photography images The observed proportion of subjects achieving the primary effectiveness endpoint and demonstrating an improvement in the appearance of lax skin in the neck and submental region was 82.5% (52/63) (97.5% one-sided lower CL=70.9% p<.0001). Primary Safety Endpoint: The primary safety endpoint was the proportion of subjects with none-to-moderate pain at 7 days, on a Numeric Rating Scale (NRS) through the 7-day followup visit. The baseline NRS score was 0 in 100% of subjects. The observed proportion of subjects achieving the primary safety endpoint was 96.9% (62/64) (97.5% one-sided lower CL=89.2% p<.0001). Conclusion: The totality of the data demonstrates benefit to subjects in the improvement of the appearance of lax tissue in the neck and submental region. The primary effectiveness endpoint for this study was achieved at 82.5%. The primary safety endpoint was achieved at 96.9%. {7}------------------------------------------------ Image /page/7/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 incorporated into the "A" of "Apyx." Below "Apyx," the word "MEDICAL" is written in blue, in a sans-serif font. A thin blue line is located underneath the word "MEDICAL." ## 8. Substantial Equivalence: | Feature/ Characteristic | Subject Device Renuvion® APR Handpiece | Predicate Device Apyx Plasma/RF Handpiece (K191542) | Comments | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Classification | Class II | Class II | Identical | | Regulation Name and Product Code: | Electrosurgical cutting & coagulation device and accessories, GEI | Electrosurgical cutting & coagulation device and accessories, GEI | Identical | | Indications for Use | 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 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 (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3). | Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Apyx RF/Plasma Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P owned by Apyx Medical | Expanded indication to support additional claim. See Substantial Equivalence Discussion. | | Feature/ Characteristic | Subject Device Renuvion® APR Handpiece | Predicate Device Apyx Plasma/RF Handpiece (K191542) | Comments | | Energy Source | RF Generator, only Generators owned by Apyx Medical | RF Generator, only Generators owned by Apyx Medical | Identical | | Energy Type | Helium gas plasma | Helium gas plasma | Identical | | Electrical Currents Transmitted | 150mA – 250mA | 150mA – 250mA | Identical | | Output | Monopolar | Monopolar | Identical | | Device Activation | Hand activation button or optional footswitch | Hand activation button or optional footswitch | Identical | | System Components | The Apyx Plasma/RF System consists of: • RF Generator • Disposable HP • Foot pedal • Power cord • Gas regulator • Gas cylinder | The Apyx Plasma/RF System consists of: • RF Generator • Disposable HP • Foot pedal • Power cord • Gas regulator • Gas cylinder | Identical | | User Interface | Straight | Straight | Identical | | Shaft Design & Energy Delivery Configuration | 15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft | 15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft | Identical | | Shaft Outer Diameter | 3mm | 3mm | Identical | | Electrode Configuration | Non-extendable | Non-extendable | Identical | | Feature/ Characteristic | Subject Device | Predicate Device | Comments | | | Renuvion® APR Handpiece | Apyx Plasma/RF Handpiece (K191542) | | | Plasma Settings | Maximum 40 watts, 1-5 L/min gas flow | Maximum 40 watts, 1-5 L/min gas flow | Identical | | Compatibility | Only with Electrosurgical Generators owned by Apyx Medical | Only with Electrosurgical Generators owned by Apyx Medical | Identical | | Connector | Company Proprietary - per design change reflected in K183610 that establishes both pneumatic seal and electrical connection | Company Proprietary - per design change reflected in K183610 that establishes both pneumatic seal and electrical connection | Identical | {8}------------------------------------------------ Image /page/8/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 incorporated into the "A" of "Apyx." Below "Apyx" is the word "MEDICAL" in blue, and there is a thin blue line underneath the word "MEDICAL." {9}------------------------------------------------ Image /page/9/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 incorporated into the letter "A". Below "Apyx", the word "MEDICAL" is written in blue, in a smaller, sans-serif font. #### Substantial Equivalence Determination Because the subject device is the predicate device and no modifications were made to the subject device for this new 510(k) submission, there is no question of substantial equivalence in technological performance or material characterization. The only change is to expand the indication for use to add a specific claim related to the treatment of lax skin. Data to support this expanded indication was generated through a prospective IDE Clinical study approved by FDA (G190152). The results of the clinical trial support the expanded Indications for Use. The clinical study VP-1902, a prospective, multi-center, evaluator-blinded study evaluating the safety and effectiveness of the Renuvion APR Handpiece to improve the appearance of lax tissue in the neck and submental region, was conducted to support efficacy of the treatment and to demonstrate substantial equivalence in safety compared to the predicate device. As such, the results provide evidence to demonstrate that the expanded indication does not raise any new safety questions. The efficacy results support the claim of improvement in the appearance of lax skin. #### 9. Conclusion: The Renuvion® APR Handpiece is identical in terms mechanism of action and sterilization methods to the predicate device, Apyx Plasma/RF Handpiece (K191542). {10}------------------------------------------------ Image /page/10/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" is shaped like a triangle with a smaller blue triangle inside. The word "MEDICAL" is written in blue below the word "Apyx". - The only difference between the subject and predicate devices is the addition of a 1. specific indication for use. - 2. The Renuvion APR Handpiece's safety and performance in the indications for use have been confirmed by results of the clinical study, IDE Study G190152. - 3. There are no issues that would raise new or different questions of safety or effectiveness and the benefits of the Renuvion APR handpiece outweigh the risks of its intended use. - The clinical data presented in this 510(k) supports the safety of the subject device. 4. Additionally, the clinical data further supports the subject device performs as intended and in accordance with its specifications. The Renuvion® APR handpiece is as safe and effective and is substantially equivalent to the predicate device.