(102 days)
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).
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 provided document describes the K220970 Premarket Notification for the Renuvion APR Handpiece. The focus of this submission is not on a new device but on an expanded indication for use for an existing, previously cleared device (Renuvion APR Handpiece, cleared under K191542). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are specifically related to proving the safety and effectiveness of the device for this new indication, rather than the core functionality of the electrosurgical device itself, as no modifications were made to the hardware.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are effectively the primary and safety endpoints defined for the clinical study.
| Acceptance Criterion (Endpoint) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: 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. | 82.5% (52/63 subjects demonstrated improvement, with a 97.5% one-sided lower CL=70.9%, p<.0001) |
| Primary Safety Endpoint: Proportion of subjects with none-to-moderate pain at 7 days, on a Numeric Rating Scale (NRS) through the 7-day follow-up visit. (Baseline NRS score was 0 in 100% of subjects). | 96.9% (62/64 subjects, with a 97.5% one-sided lower CL=89.2%, p<.0001) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 65 adults. The effectiveness endpoint was assessed on 63 subjects, and the safety endpoint on 64 subjects.
- Data Provenance: The study was a "prospective, multi-center, evaluator-blinded study." The document does not explicitly state the country of origin, but given the FDA submission, it implicitly refers to data from a US-based or FDA-compliant clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: 3 blinded Independent Photographic Reviewers.
- Qualifications of Experts: The document does not explicitly state the qualifications of these reviewers (e.g., radiologist with X years of experience). They are referred to as "Independent Photographic Reviewers," implying expertise in assessing aesthetic outcomes from photographs.
4. Adjudication Method for the Test Set
- Adjudication Method: "Correct identification of the 'after' images by at least 2 of 3 blinded Independent Photographic Reviewers." This is a 2-out-of-3 majority consensus method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- Was an MRMC study done? No, this was not an MRMC study comparing human readers with and without AI assistance. The study assessed the clinical effectiveness of the device itself by human evaluators of photographic outcomes. The device is not an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable as the Renuvion APR Handpiece is a physical medical device that delivers energy and plasma for treatment, not an AI algorithm. Its performance is directly observed in patient outcomes or through human assessment of those outcomes. The "performance data" sections (Bench Testing, Electrical Safety, Biocompatibility, Pre-Clinical & Ex-Vivo) were all "N/A" for new testing because no modifications were made to the commercially available Handpiece cleared under K191542, indicating that these aspects were previously evaluated for the predicate device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for effectiveness was established by expert consensus based on the visual assessment of 2D photography images by 3 blinded Independent photographic reviewers. For safety, the ground truth was patient-reported outcomes (pain levels via Numeric Rating Scale).
8. The Sample Size for the Training Set
- Training Set Sample Size: This information is not applicable and not provided. The device isn't an AI model that requires a "training set" in the conventional sense. The entire clinical study (n=65) serves as the "test set" to prove the device's performance for its expanded indication.
9. How the Ground Truth for the Training Set was Established
- This is not applicable, as there is no "training set" for this device in the context of an algorithm or AI. The clinical trial data is the performance data used to support the claim.
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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
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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
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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.
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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, 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 Corporation5115 Ulmerton Road Clearwater, Florida 33760 -4004United States of America |
|---|---|
| Establishment Registration #: | 3007593903 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | Priscilla Herpai, Global Regulatory Affairs Director5115 Ulmerton RoadClearwater, Florida 33760 -4004United States of AmericaPhone: (610) 533-7984Email: 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 - ElectrosurgicalCutting and Coagulation Device and AccessoriesProduct Code GEI |
| Predicate Devices: | Predicate DeviceApyx 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).
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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.
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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.
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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%.
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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 DeviceRenuvion® APRHandpiece | Predicate DeviceApyx Plasma/RFHandpiece (K191542) | Comments |
|---|---|---|---|
| Classification | Class II | Class II | Identical |
| RegulationName andProduct Code: | Electrosurgical cutting &coagulation device andaccessories, GEI | Electrosurgical cutting &coagulation device andaccessories, GEI | Identical |
| Indications forUse | 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 appearance oflax (loose) skin in the neckand submental region.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). | Handpiece is intended tobe used with compatibleelectrosurgical generatorsfor the delivery ofradiofrequency energyand/or helium plasma forcutting, coagulation andablation of soft tissueduring open surgicalprocedures.The Apyx RF/PlasmaHandpiece is compatiblewith the ElectrosurgicalGenerators BVX-200Hand BVX-200P owned byApyx Medical | Expanded indicationto support additionalclaim. SeeSubstantialEquivalenceDiscussion. |
| Feature/Characteristic | Subject DeviceRenuvion® APRHandpiece | Predicate DeviceApyx Plasma/RFHandpiece (K191542) | Comments |
| Energy Source | RF Generator, onlyGenerators owned byApyx Medical | RF Generator, onlyGenerators owned byApyx Medical | Identical |
| Energy Type | Helium gas plasma | Helium gas plasma | Identical |
| ElectricalCurrentsTransmitted | 150mA – 250mA | 150mA – 250mA | Identical |
| Output | Monopolar | Monopolar | Identical |
| DeviceActivation | Hand activation button oroptional footswitch | Hand activation button oroptional footswitch | Identical |
| SystemComponents | The Apyx Plasma/RFSystem consists of:• RF Generator• Disposable HP• Foot pedal• Power cord• Gas regulator• Gas cylinder | The Apyx Plasma/RFSystem consists of:• RF Generator• Disposable HP• Foot pedal• Power cord• Gas regulator• Gas cylinder | Identical |
| User Interface | Straight | Straight | Identical |
| Shaft Design &Energy DeliveryConfiguration | 15cm and 27cm long with aside port configuration(single or twin) andindicator lines on the shaft | 15cm and 27cm long with aside port configuration(single or twin) andindicator lines on the shaft | Identical |
| Shaft OuterDiameter | 3mm | 3mm | Identical |
| ElectrodeConfiguration | Non-extendable | Non-extendable | Identical |
| Feature/Characteristic | Subject Device | Predicate Device | Comments |
| Renuvion® APRHandpiece | Apyx Plasma/RFHandpiece (K191542) | ||
| PlasmaSettings | Maximum 40 watts, 1-5L/min gas flow | Maximum 40 watts, 1-5L/min gas flow | Identical |
| Compatibility | Only with ElectrosurgicalGenerators owned by ApyxMedical | Only with ElectrosurgicalGenerators owned byApyx Medical | Identical |
| Connector | Company Proprietary - perdesign change reflected inK183610 that establishesboth pneumatic seal andelectrical connection | Company Proprietary - perdesign change reflected inK183610 that establishesboth pneumatic seal andelectrical connection | Identical |
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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 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."
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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).
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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.
-
- 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.
-
- 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.
§ 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.