(99 days)
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.
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), a sterile, single use handpiece, and a supply of helium gas. Additional accessories include a digital gas regulator, grounding pad and optional footswitch.
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.
The Renuvion® Micro Handpiece is cleared based on demonstrating substantial equivalence to a predicate device, the Renuvion® APR Handpiece (K223262 and K230272). This type of submission (510(k)) focuses on comparing a new device to an already legally marketed device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" are primarily based on demonstrating that the new device is as safe and effective as the predicate device by showing similar technological characteristics and performance.
Here's a breakdown of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a separate section with specific numerical targets. Instead, it presents various tests performed and states whether the device "met requirements" or demonstrated equivalent/lesser effects compared to the predicate. The overall acceptance criterion is demonstrating that the Renuvion® Micro Handpiece is as safe and effective as the predicate device.
| Test Type | Objective | Reported Device Performance (Result) |
|---|---|---|
| Bench Testing | ||
| 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. |
| 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. |
| Electrical Safety & EMC | Compliance with ANSI/AAMI/IEC 60601-1:2015/(R)2012 and A1:2012, AAMI/ANSI/IEC 60601-2-2:2017, and AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) standards. | The Renuvion® Micro System was determined to be in conformance with these standards. |
| Biocompatibility Testing | Compliance with 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 AAMI/ANSI/ISO 10993-1:2018 standard. | |
| Cytotoxicity | Evaluate cytotoxicty. | Non-cytotoxic. |
| Sensitization | Evaluate sensitization reaction. | No sensitization reaction. |
| Irritation | Evaluate irritation. | Non-irritant. |
| Acute Systemic Toxicity | Evaluate acute systemic toxicity. | Non-toxic. |
| Material Mediated Pyrogen/Pyrogenicity | Evaluate pyrogenicity. | Non-pyrogenic. |
| Pre-Clinical & Ex-Vivo Studies | ||
| Thermal Tissue Effect | Evaluate the thermal effect of the Renuvion Micro Handpiece against its predicate device on different tissue types at different Renuvion settings. | The test device (APYX-10-MICRO) 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. |
| Tissue Temperature Over 85 Degrees Celsius Comparison | Evaluate the tissue time over 85 degrees Celsius between the Renuvion Micro Handpiece and its predicate device when used at recommended settings for coagulation/contraction of soft tissue. | 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. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify numerical sample sizes for the bench, electrical safety, biocompatibility, or ex-vivo tests. It states that tests were conducted according to protocols.
- Data Provenance:
- All summarized tests appear to be pre-clinical/bench-top studies and ex-vivo (tissue) tests conducted by the manufacturer, Apyx Medical Corporation.
- The "Ex-vivo tissue testing" section implies that animal or cadaveric tissue was used, but the specific origin (e.g., species, country) is not mentioned.
- There is no mention of human subjects or clinical data in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Since these are primarily bench and ex-vivo tests for a 510(k) submission, the "ground truth" is established by engineering and scientific measurements/observations against predefined specifications and industry standards.
- The document does not mention the involvement of external medical experts (e.g., radiologists) for establishing ground truth in these specific tests. The experts involved would likely be engineers, scientists, and quality assurance personnel from Apyx Medical performing the tests and comparing results to established criteria. There is no mention of "ground truth" in the context of clinical interpretation, as clinical studies were not performed.
4. Adjudication Method for the Test Set:
- Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation by multiple readers.
- Given that this submission relies on bench and ex-vivo testing, such adjudication methods are not applicable and are not mentioned in the document. Performance is measured against physical or biological criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." (Section 6: Clinical Studies).
- Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. The device is not an AI-based diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable as the Renuvion® Micro Handpiece is an electrosurgical device, not an algorithm or AI-based system. It does not perform diagnostic tasks independently.
7. The Type of Ground Truth Used:
- For the bench and ex-vivo tests, the "ground truth" is based on:
- Defined engineering specifications (e.g., mechanical functionality, system compatibility, electrical safety, packaging integrity).
- Biological responses to known stimuli (e.g., non-cytotoxic, no sensitization reaction for biocompatibility tests).
- Physical measurements and comparisons (e.g., thermal effect and tissue temperature measurements in ex-vivo tissue).
- The ground truth is established by the test protocols against established standards and internal design requirements, often compared to the performance of the predicate device.
- No pathology or outcomes data is mentioned as forming the ground truth for this set of studies.
8. The Sample Size for the Training Set:
- This question is not applicable for this device. Training sets are relevant for machine learning or AI-based devices. The Renuvion® Micro Handpiece is a physical surgical tool, and its development involves engineering design and testing, not algorithm training.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no training set for this 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.