(102 days)
Not Found
No
The summary describes a hardware device that delivers radiofrequency energy and helium plasma for tissue modification. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance study focuses on clinical outcomes and safety, not the performance of an AI/ML algorithm.
Yes
The device is intended for "subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin," which is a therapeutic purpose. It uses radiofrequency energy and helium plasma for "cutting, coagulation and ablation of soft tissue," directly impacting and modifying the body for a medical/aesthetic benefit.
No
The device is described as an electrosurgical device for cutting, coagulation, and ablation of soft tissue, primarily to improve the appearance of lax skin. Its function is to deliver energy to tissue, not to diagnose medical conditions.
No
The device description clearly states it is a sterile, single-use electrosurgical handpiece, which is a physical hardware component. It is used in conjunction with compatible electrosurgical generators, also hardware.
Based on the provided information, the Renuvion® APR Handpiece is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures" and for "subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region." This describes a device used on the body for surgical and aesthetic purposes.
- Device Description: The description details an electrosurgical device that generates plasma for tissue manipulation. This is consistent with a surgical/aesthetic tool, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVD devices are designed for testing in vitro (in glass, or outside the living organism).
Therefore, the Renuvion® APR Handpiece is a surgical/aesthetic device, not an IVD.
N/A
Intended Use / 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 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).
Product codes
GEI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck and submental region
Indicated Patient Age Range
Adults, age 35-65 years
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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%.
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
§ 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.
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