(122 days)
Renuvion® APR Handpiece (K220970)
Ellusa Bipolar Wands (K202558)
No
The summary describes a standard electrosurgical device that uses radiofrequency energy and helium plasma for tissue coagulation and contraction. There is no mention of AI or ML in the intended use, device description, or performance studies. The studies focus on the thermal effects of the device on tissue, not on any algorithmic analysis or decision-making.
Yes
The device is described as treating lax skin to improve appearance, which is a therapeutic purpose. It uses energy to cause coagulation/contraction of soft tissue, indicating a function beyond diagnostic or assistive.
No
The device is intended for soft tissue coagulation/contraction through radiofrequency energy and helium plasma, used in aesthetic procedures to improve the appearance of lax skin. It does not perform any diagnostic function.
No
The device description clearly details a physical handpiece that delivers radiofrequency energy and helium plasma, which are hardware components. It also mentions being used with compatible electrosurgical generators.
Based on the provided text, the Renuvion® APR Handpiece is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The Renuvion® APR Handpiece is a surgical device that directly applies energy to soft tissue within the body for therapeutic purposes (coagulation/contraction).
- The intended use and device description clearly state its function is to deliver radiofrequency energy and/or helium plasma for coagulation/contraction of soft tissue in the neck and submental region. This is a direct treatment application, not an in vitro diagnostic test.
- The performance studies described involve ex vivo tissue testing and in vivo animal studies to assess the device's effect on tissue, not to analyze patient samples for diagnostic information.
Therefore, the Renuvion® APR Handpiece is a therapeutic surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Renuvion® APR System with all components and accessories is shown in the picture below. The system is comprised of a compatible electrosurgical generator, a sterile, single use handpiece, and a supply of helium gas. Additional accessories include a gas regulator, grounding pad and optional footswitch.
The Renuvion® APR Handpiece is a sterile, single-use electrosurgical (monopolar) device intended to be used in conjunction with compatible electrosurgical generators. The compatible generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas passes over the energized electrode, a helium plasma is generated which delivers thermal energy to soft tissue for the purposes of cutting, coagulation/contraction, or ablation.
The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).
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
Not Found
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)
Ex vivo tissue testing that included liver, kidney, and muscle tissues to measure the coagulative effect of the device on tissue was previously provided in 510(k) submission K191542 is presented below in summary format. Apyx Medical conducted a GLP Acute Porcine Study to assess thermal effects of the subject device use in subcutaneous and connective tissue. The data demonstrated the thermal effects of the device on subcutaneous soft tissues.
The reference device received FDA clearance for the coagulation/contraction of soft tissue by performing ex vivo tissue testing that included liver, kidney, and muscle tissues to measure the coagulative effect of the device on tissue. Apyx Medical conducted the same ex vivo tissue testing using the Renuvion APR handpiece on liver, kidney, and muscle tissues at 20%, 50%, and 100% power and 1, 3, and 5 Lpm gas flow rate. Measurements of lateral spread and depth of thermal effect were characterized under histological examination.
Additionally, to support use in subcutaneous tissue, the subject device was tested in an in vivo acute porcine study at 60-80% power and 1.5 Lpm gas flow rate. The handpiece was moved continuously at a rate of 1 cm/sec while depositing the energy subcutaneously in the flank region of the animal. Depth of thermal effect in subcutaneous tissue was measured and analyzed via histology. The results of this testing supports the addition of "contraction" and "subcutaneous tissue" to the indication for use statement of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Renuvion® APR Handpiece (K220970)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Ellusa Bipolar Wands (K202558)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 23, 2023
Apyx Medical Corporation Mark Evans Sr. Premarket Regulatory Affairs Specialist (formerly Bovie Medical Corporation) 5115 Ulmerton Road Clearwater, Florida 33760-4004
Re: K223262
Trade/Device Name: Renuvion® APR Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: January 27, 2023 Received: January 27, 2023
Dear Mark Evans:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Jessica Carr-S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223262
Device Name Renuvion® APR Handpiece
Indications for Use (Describe)
The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
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Image /page/3/Picture/2 description: The image shows the logo for Apyx Medical. The logo is orange and blue. The word "Apyx" is in orange, and the word "Medical" is in blue.
-
- General Information:
| Submitted by: | Apyx Medical Corporation
5115 Ulmerton Road Clearwater, Florida 33760-4004
United States of America |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration #: | 3007593903 |
| Contact Person: | Mark D. Evans, Sr. Premarket Regulatory Affairs
Specialist
5115 Ulmerton Road
Clearwater, Florida 33760-4004
United States of America
Phone: (856) 524-5037
Email: mark.evans@apyxmedical.com |
| Date Prepared: | October 21st, 2022 |
| Trade Names (Model Numbers): | Renuvion® APR Handpiece
(APYX-15-SP, APYX-15-TP, APYX-27-TP) |
| Common Name: | Electrosurgical Handpiece |
| Classification: | Class II per 21CFR 878.4400 - Electrosurgical
Cutting and Coagulation Device and Accessories
Product Code GEI |
| Predicate and Reference Devices: | Predicate Device
Renuvion® APR Handpiece (K220970)
Reference Device |
Ellusa Bipolar Wands (K202558)
Proposed Indications for Use:
Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
4
Image /page/4/Picture/2 description: The image shows the logo for Apyx Medical. The logo is in orange and blue. The word "Apyx" is in orange, with a blue triangle in the "A". The word "MEDICAL" is in blue and is located below the word "Apyx".
The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical qenerators owned by Apyx Medical.
2. Device Description and Technological Characteristics:
The Renuvion® APR System with all components and accessories is shown in the picture below. The system is comprised of a compatible electrosurgical generator, a sterile, single use handpiece, and a supply of helium gas. Additional accessories include a gas regulator, grounding pad and optional footswitch.
Image /page/4/Figure/7 description: The image shows a medical setup with several components labeled. A red helium tank is connected to a regulator via a valve. A blue tube runs from the regulator to a generator (ESU), which also has a handpiece and cable attached. A foot switch and grounding pad are also part of the setup.
The Renuvion® APR Handpiece is a sterile, single-use electrosurgical (monopolar) device intended to be used in conjunction with compatible electrosurgical generators. The compatible generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas passes over the energized electrode, a helium plasma is generated which delivers thermal energy to soft tissue for the purposes of cutting, coagulation/contraction, or ablation.
The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).
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Image /page/5/Picture/2 description: The image shows the logo for Apyx Medical. The logo is comprised of the word "Apyx" in orange, with a blue triangle in place of the letter "A". Below the word "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, and the colors are bright and eye-catching.
The Renuvion APR Handpiece is pictured below.
Image /page/5/Figure/5 description: The image shows a medical device with several labeled parts. The device has a long, thin, flexible shaft with energy exit portals and tip distance indicators at the end. The device also has a handle with an activation button, a plug connector, and a cable.
3. Performance Data:
a. Bench Testing
N/A; no design modifications were made to the commercially available Handpiece cleared under K220970.
b. Electrical Safety and Electromagnetic Compatibility (EMC)
N/A; no design modifications were made to the commercially available Handpiece cleared under K220970.
c. Biocompatibility Testing
N/A; no design modifications were made to the commercially available Handpiece cleared under K220970.
4. Pre-Clinical & Ex-Vivo Studies:
Ex vivo tissue testing that included liver, kidney, and muscle tissues to measure the coagulative effect of the device on tissue was previously provided in 510(k) submission K191542 is presented below in summary format. Apyx Medical conducted a GLP Acute Porcine Study to assess thermal effects of the subject device use in subcutaneous and connective tissue. The data demonstrated the thermal effects of the device on subcutaneous soft tissues.
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Image /page/6/Picture/2 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the word "Apyx" in a stylized font. A blue triangle is incorporated into the "A" of "Apyx." Below "Apyx" is the word "MEDICAL" in blue, block letters. The "®" symbol is located to the right of the "X" in "Apyx."
5. Clinical Studies:
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
6. Substantial Equivalence:
| Feature/ | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Characteristic | Renuvion® APR | ||
| Handpiece1 | Apyx Plasma/RF | ||
| Handpiece (K220970) | Ellusa Bipolar Wands | ||
| (K202558) | |||
| Classification | Class II | Class II | Class II |
| Regulation Name | |||
| and Product | |||
| Code: | Electrosurgical cutting & | ||
| coagulation device and | |||
| accessories, GEI | Electrosurgical cutting & | ||
| coagulation device and | |||
| accessories, GEI | Electrosurgical cutting & | ||
| coagulation device and | |||
| accessories, GEI | |||
| Indications for | |||
| Use Statement | Renuvion® APR | ||
| Handpiece is intended for | |||
| the delivery of | |||
| radiofrequency energy | |||
| and/or helium plasma | |||
| where | |||
| coagulation/contraction | |||
| of soft tissue is needed. | |||
| Soft tissue includes | |||
| subcutaneous tissue. | |||
| The Renuvion® APR | |||
| Handpiece is indicated for | |||
| use in subcutaneous | |||
| dermatological and | |||
| aesthetic procedures to | |||
| improve the appearance of | |||
| lax (loose) skin in the neck | |||
| and submental region. | The Renuvion® APR | ||
| Handpiece is intended 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 Ellusa Bipolar | ||
| Wands are intended for | |||
| use by a physician | |||
| familiar with bipolar | |||
| coagulation with | |||
| electrosurgery where | |||
| coagulation/contraction | |||
| of soft tissue is needed. | |||
| Feature/ | |||
| Characteristic | Subject Device | Predicate Device | Reference Device |
| Renuvion® APR | |||
| Handpiece1 | Apyx Plasma/RF | ||
| Handpiece (K220970) | Ellusa Bipolar Wands | ||
| (K202558) | |||
| The Renuvion® APR | |||
| Handpiece is intended to | |||
| be used with compatible | |||
| electrosurgical generators | |||
| owned by Apyx Medical. | 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). | |||
| Energy Source | RF Generator, only | ||
| Generators owned by | |||
| Apyx Medical | RF Generator, only | ||
| Generators owned by | |||
| Apyx Medical | RF Generator | ||
| Energy Type | Radio frequency (RF) | ||
| Energy and Helium Gas | Radio frequency (RF) | ||
| Energy and Helium Gas | Radio frequency (RF) | ||
| Energy | |||
| System | |||
| Components | The Apyx Plasma/RF | ||
| System consists of: | |||
| RF GeneratorDisposable HPFoot pedalPower cordGas regulatorGas cylinder | The Apyx Plasma/RF | ||
| System consists of: | |||
| RF GeneratorDisposable HPFoot pedalPower cordGas regulatorGas cylinder | The Ellusa RF System | ||
| consists of: | |||
| RF GeneratorDisposable HPFoot pedalPower cord | |||
| Design & Energy | |||
| Delivery | |||
| Configuration | 15cm and 27cm long shaft | ||
| with a side port | |||
| configuration (single or | |||
| twin) and indicator lines on | |||
| the shaft | 15cm and 27cm long shaft | ||
| with a side port | |||
| configuration (single or | |||
| twin) and indicator lines on | |||
| the shaft | 11cm to 40cm long, | ||
| with Ball Tip, Standard, | |||
| or Hex Blade Tip | |||
| configuration | |||
| Shaft Outer | |||
| Diameter | 3mm | 3mm | 1.2mm to 6mm |
1 The Bold text represents the modified wording.
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Image /page/7/Picture/2 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a blue triangle replacing the left side of the "A". Below "Apyx" is the word "MEDICAL" in blue, in a smaller font. The logo is simple and modern, with a focus on the company name.
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Image /page/8/Picture/2 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the letters "Apyx" displayed in a stylized font. A small, dark blue triangle is incorporated into the "A" of the logo. Below the main logo, the word "MEDICAL" is written in blue, block letters.
7. Substantial Equivalence Determination
The subject and predicate devices are identical. No design modifications were made to the predicate for this new 510(k) submission. The only change is to modify the indications for use of the subject device to include "where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue."
The reference device received FDA clearance for the coagulation/contraction of soft tissue by performing ex vivo tissue testing that included liver, kidney, and muscle tissues to measure the coagulative effect of the device on tissue. Apyx Medical conducted the same ex vivo tissue testing using the Renuvion APR handpiece on liver, kidney, and muscle tissues at 20%, 50%, and 100% power and 1, 3, and 5 Lpm gas flow rate. Measurements of lateral spread and depth of thermal effect were characterized under histological examination.
Additionally, to support use in subcutaneous tissue, the subject device was tested in an in vivo acute porcine study at 60-80% power and 1.5 Lpm gas flow rate. The handpiece was moved continuously at a rate of 1 cm/sec while depositing the energy subcutaneously in the flank region of the animal. Depth of thermal effect in subcutaneous tissue was measured and analyzed via histology. The results of this testing supports the addition of "contraction" and "subcutaneous tissue" to the indication for use statement of the subject device.
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Image /page/9/Picture/2 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a blue triangle in the upper left corner of the "A". The word "MEDICAL" is written in blue below the word "Apyx". There is a registered trademark symbol to the right of the "x" in "Apyx".
Conclusion:
The subject of this submission is the modifications to the general intended use for the Renuvion APR Handpiece. The proposed changes to the indications for use are supported by ex vivo and in vivo tissue testing that demonstrates the coagulative tissue effects. The commercially available Renuvion® APR handpiece is safe and effective, and the modifications to the indications for use do not raise any new questions of safety or effectiveness compared to the predicate device.