(99 days)
No
The summary describes a device that uses radiofrequency energy and helium plasma for tissue coagulation/contraction. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
Yes
The device is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed, which indicates therapeutic use.
No.
This device is intended for therapeutic purposes (coagulation/contraction of soft tissue) by delivering radiofrequency energy and/or helium plasma, not for diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a handpiece, generator, gas supply, regulator, grounding pad, and optional footswitch. The performance studies also focus on hardware-related testing like mechanical verification, electrical safety, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed." This describes a surgical or therapeutic procedure performed directly on the patient's body.
- Device Description: The description details an electrosurgical device that generates plasma for tissue coagulation. This is a physical intervention on living tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health. The Renuvion® Micro Handpiece does not perform any analysis of biological samples.
Therefore, the Renuvion® Micro Handpiece is a surgical/therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Renuvion® Micro 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® Micro Handpiece is compatible with the Apyx One Console Generator, owned by Apyx Medical.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Renuvion® Micro System with all components and accessories is show in the picture below. The system is comprised of a compatible electrosurgical generator (Apyx One Console)¹, a sterile, single use handpiece, and a supply of helium gas. Additional accessories include a digital gas regulator2, grounding pad3 and optional footswitch4.
The Renuvion® Micro handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with the Apyx One Console Electrosurgical Generator for the percutaneous delivery of radiofrequency and helium plasma energy to soft tissue. When connected to the Apyx One Generator, the device operates at an adjustable power of up to 12 W (expressed as 0 - 30% where 30% is 12 W) and an adjustable helium gas flow of 1 -1.5 L/Min. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue coagulation/contraction.
The handpiece has a non-extendable electrode to generate helium plasma. The handpiece features a low-profile shaft that is 10cm in length. The distal end of the shaft and tip has a 2mm outer diameter that tapers down to 1.5mm for the remaining length of the shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, subcutaneous tissue
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)
a. Bench Testing
Study Type: Mechanical Verification & Functionality, System Compatibility, Inspectional Verification, Packaging Validation
Objective:
- Mechanical Verification & Functionality: Verify Mechanical functionality of the Renuvion® Micro Handpiece
- System Compatibility Testing: Verify the device, when connected to the generators (with all the components and accessories working together as a system), are working as intended and are compatible with all system components.
- Inspectional Verification: Document parameters that can be verified through inspection of the Micro Handpiece Labeling and IFU.
- Packaging Validation: Evaluate simulated (and/or real-time) aging and associated package integrity and shelf-life claims. Assess the potential for damage to the device (e.g., drop tests of the instrument in its packaging).
Key Results: - Mechanical functionality requirements met.
- System compatibility requirements met.
- Inspectional requirements met.
- Packaging requirements met.
b. Electrical Safety and Electromagnetic Compatibility (EMC)
Study Type: Electrical Safety and EMC testing
Key Results: The handpiece complies with the ANSI/AAMI/IEC 60601-1:2015/(R)2012 and A1:2012, and AAMI/ANSI/IEC 60601-2-2:2017 standards for safety and the AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) standard for EMC. The Renuvion® Micro System was determined to be in conformance with these standards.
c. Biocompatibility Testing
Study Type: Biocompatibility evaluation
Key Results:
- Cytotoxicity: Non-cytotoxic
- Sensitization: No sensitization reaction
- Irritation: Non-irritant
- Acute Systemic Toxicity: Non-toxic
- Material Mediated Pyrogen/Pyrogenicity: Non-pyrogenic
The materials used in the manufacture of the device met biocompatibility test requirements for external communicating device, Tissue/Bone/Dentin, limited duration devices.
5. Pre-Clinical & Ex-Vivo Studies:
Study Type: Ex-vivo tissue testing - Thermal Tissue Effect
Objective: Evaluate the thermal effect between Renuvion Micro Handpiece (APYX-10-MICRO) against its predicate device (Renuvion APR Handpiece, 15 cm, Twin Port, APYX-15-TP).
Key Results: The test device (APYX-10-MICRO) was subjected to tissue thermal testing and demonstrated an equal or less tissue thermal effect when compared to the predicate device (APYX-15-TP) on five different tissue types at different Renuvion settings.
Study Type: Ex-vivo tissue testing - Tissue Temperature Over 85 Degrees Celsius Comparison
Objective: Evaluate the tissue time over 85 degrees Celsius between the Renuvion Micro Handpiece (APYX-10-MICRO) and its predicate device (Renuvion APR Handpiece, 15 cm, Twin Port, APYX-15-TP) when used at the recommended setting per the IFU for coagulation/contraction of soft tissue such as subcutaneous tissues.
Key Results: The test device (APYX-10-MICRO) met the acceptance criteria demonstrating that on average the device is at or above 85 degrees for greater than 45 msec. The predicate device showed similar results as a control.
6. Clinical Studies:
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
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.
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.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2023
Apyx Medical Corporation Mark Evans Sr. Premarket Regulatory Affairs Specialist (formerly Bovie Medical Corporation) 5115 Ulmerton Road Clearwater, Florida 33760-4004
Re: K230586
Trade/Device Name: Renuvion® Micro Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 15, 2023 Received: May 15, 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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.06.09 15:33:07 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Renuvion® Micro Handpiece
Indications for Use (Describe)
Renuvion® Micro 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® Micro Handpiece is compatible with the Apyx One Console Generator, owned by Apyx Medical.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/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 "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.
-
- 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: | March 2, 2023 |
| Trade Names (Model Numbers): | Renuvion® Micro Handpiece
(APYX-10-Micro) |
| Common Name: | Electrosurgical Handpiece |
| Classification: | Class II per 21CFR 878.4400 - Electrosurgical
Cutting and Coagulation Device and Accessories
Product Code GEI |
| Primary Predicate Device:
Secondary Predicate Device: | Renuvion® APR Handpiece (K223262)
Renuvion® APR Handpiece (K230272) |
2. Proposed Indications for Use:
Renuvion® Micro 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® Micro Handpiece is compatible with the Apyx One Console Generator, owned by Apyx Medical.
-
- Device Description and Technological Characteristics:
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Image /page/4/Picture/2 description: The image shows the logo for Apyx Medical. 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 logo is simple and modern.
The Renuvion® Micro System with all components and accessories is show in the picture below. The system is comprised of a compatible electrosurgical generator (Apyx One Console)¹, a sterile, single use handpiece, and a supply of helium gas. Additional accessories include a digital gas regulator2, grounding pad3 and optional footswitch4.
The front view of the entire system with all components and accessories is depicted in Figure 1 below.
Image /page/4/Picture/6 description: The image shows a medical device setup. The main component is a white generator (ESU) with a black screen. Connected to it are a handpiece and cable, a digital regulator attached to a helium tank, foot switches labeled "J-PLASMA" and "COOL COAG", and a grounding pad.
Figure 1: Front View of System
1 510(K) Number: K221830
2 510(K) Number: K221830
3 510(k) Number: K092761
4 510(K) Number: K170188
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Image /page/5/Picture/2 description: The image shows the logo for Apyx Medical. The logo consists of the word "Apyx" in orange, with a blue triangle in the "A". The word "MEDICAL" is written in blue below the word "Apyx".
The Renuvion® Micro handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with the Apyx One Console Electrosurgical Generator for the percutaneous delivery of radiofrequency and helium plasma energy to soft tissue. When connected to the Apyx One Generator, the device operates at an adjustable power of up to 12 W (expressed as 0 - 30% where 30% is 12 W) and an adjustable helium gas flow of 1 -1.5 L/Min. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue coagulation/contraction.
The handpiece has a non-extendable electrode to generate helium plasma. The handpiece features a low-profile shaft that is 10cm in length. The distal end of the shaft and tip has a 2mm outer diameter that tapers down to 1.5mm for the remaining length of the shaft.
Image /page/5/Figure/6 description: The image shows a Renuvion device with its various components labeled. The device consists of a handle with an activation button, a stainless steel shaft with an energy exit port and tip distance indicators, and a flush port. Additionally, there is a plug connector and a cable attached to the device.
The Renuvion® Micro Handpiece is pictured in Figure 2 below.
Figure 2: Renuvion® Micro Handpiece Major Components
The Renuvion® Micro Handpiece is a modification to the primary predicate device that was cleared in K223262 (Renuvion® APR Handpiece). There are no changes to the principle of operation or mechanism of action.
The Renuvion® Micro Handpiece as compared to the predicate devices has the following differences in technological characteristics to enable overall dimensional profile:
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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". Below the word "Apyx" is the word "MEDICAL" in blue. The "®" symbol is located to the right of the "X" in "Apyx".
- front-port ceramic nozzle/tip, rather than predicate side-port configuration ●
- introduces a sterile saline flush port to assist in removing coagulum build up on the ceramic tip.
- The subject devices shaft material is stainless steel with an outer polymer layer, ● whereas the predicate used a polymer-based material throughout.
- o The subject device maximum allowable power setting will lowered compared to the predicate, 30% power and maximum helium flow will be 1.5 L/min
4. Performance Data:
a. Bench Testing
All testing performed on the Renuvion® Micro Handpiece, hereinafter referred to as Micro Handpiece, was derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness of the design with Apyx Medical's Design and Development procedures. The test methodology and acceptance criteria were developed from the same standards and internal Design and Development procedures used for clearance of the primary predicate device.
A risk analysis was conducted using the Design Risk Analysis and Control (DRAC) for the subject device (Micro Handpiece). The risk analysis concluded that no new failure modes or risk hazards were identified as a result of the design modifications.
Performance testing to assure that the subject device met performance requirements was conducted in accordance with protocols to verify design specifications. The testing performed is summarized in the following table:
| Test | Objective | Result |
|---|---|---|
| Mechanical | ||
| Verification | ||
| & | ||
| Functionality | Verify Mechanical functionality of | |
| the Renuvion® Micro Handpiece | Mechanical functionality | |
| requirements met | ||
| System | ||
| compatibility | ||
| Testing | Verify the device, when connected | |
| to the generators (with all the | ||
| components and accessories | ||
| working together as a system), are | ||
| working as intended and are | ||
| compatible with all system | ||
| components. | System compatibility requirements | |
| met | ||
| Inspectional | ||
| Verification | Document parameters that can be | |
| verified through inspection of the | ||
| Micro Handpiece Labeling and IFU. | Inspectional requirements met |
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Image /page/7/Picture/2 description: The image shows the logo for Apyx Medical. The logo consists of the word "Apyx" in orange, with a blue triangle in the negative space of the "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.
| Test | Objective | Result |
|---|---|---|
| Packaging | ||
| Validation | Evaluate simulated (and/or real- | |
| time) aging and associated | ||
| package integrity and shelf-life | ||
| claims. Assess the potential for | ||
| damage to the device (e.g., drop | ||
| tests of the instrument in its | ||
| packaging). | Packaging requirements met |
b. Electrical Safety and Electromaqnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the Renuvion® Micro System. The handpiece complies with the ANSI/AAMI/IEC 60601-1:2015/(R)2012 and A1:2012, and AAMI/ANSI/IEC 60601-2-2:2017 standards for safety and the AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) standard for EMC. The Renuvion® Micro System was determined to be in conformance with these standards.
c. Biocompatibility Testing
The biocompatibility evaluation for the Micro Handpiece was conducted in accordance with the June 16, 2016 FDA Guidance, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the AAMI/ANSI/ISO 10993-1:2018 standard, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". A Biological Evaluation Plan within Apyx Medical's risk management process was developed for the Micro Handpiece to determine the testing and risk assessment for the device and to develop a plan for the mitigation of risks identified.
Biocompatibility testing performed is summarized below:
Category: External Communicating Device Contact: Tissue / Bone / Dentin Duration of Contact: Limited