(86 days)
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 intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.
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 intended to be used with compatible electrosurgical generators owned by Apyx Medical.
The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. 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 cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15 cm and 27 cm. The 15 cm 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 device can also be used for percutaneous delivery of radiofrequency and helium plasma energy to coagulate subcutaneous soft tissue.
The provided document is a 510(k) summary for the Renuvion® APR Handpiece. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The primary change for this submission is an addition to the indications for use.
Crucially, this document describes a determination of substantial equivalence, not a study proving adherence to specific acceptance criteria for performance, particularly not for an AI/algorithm-based device as the prompt's structure implies. The device in question is an electrosurgical handpiece, a hardware device, not an AI/software device.
Therefore, many of the requested fields related to AI/algorithm performance (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable in the context of this 510(k) submission. The "Performance Data" section explicitly states "N/A" for bench testing, electrical safety, EMC, and biocompatibility because "no modifications were made to the commercially available handpiece cleared under K220970."
However, I can extract information related to the clinical justification for the expanded indications for use.
Here's an analysis based on the provided text, addressing the prompt's points where applicable, and stating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:
Device Name: Renuvion® APR Handpiece
Regulation Name: Electrosurgical cutting and coagulation device and accessories
Product Code: GEI
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in the format one would typically see for an AI performance study (e.g., minimum AUC, sensitivity, specificity). Instead, the assessment for substantial equivalence relies on:
- Technological equivalence to predicate devices.
- Demonstration of safety and effectiveness for the additional proposed indication.
The "performance" is assessed in terms of comparable safety profiles rather than specific quantitative metrics against a defined threshold.
| Criterion/Characteristic | Subject Device (Renuvion® APR Handpiece - K230272) | Predicate Device (Renuvion® APR Handpiece - K220970) | Secondary Predicate Device (Renuvion® APR Handpiece - K223262) | Comments/Performance |
|---|---|---|---|---|
| Classification | Class II | Class II | Class II | Identical |
| Regulation Name & Product Code | Electrosurgical cutting & coagulation device and accessories, GEI | Electrosurgical cutting & coagulation device and accessories, GEI | Electrosurgical cutting & coagulation device and accessories, GEI | Identical |
| Energy Type | Helium gas plasma | Helium gas plasma | Helium gas plasma | Identical |
| Electrical Currents Transmitted | 150mA - 250mA | 150mA - 250mA | 150mA - 250mA | Identical |
| Energy Type Delivered | Monopolar RF energy via Helium Plasma | Monopolar RF energy via Helium Plasma | Monopolar RF energy via Helium Plasma | Identical |
| System Components | RF Generator, Disposable HP, Foot pedal, Power cord, Gas regulator, Gas cylinder | RF Generator, Disposable HP, Foot pedal, Power cord, Gas regulator, Gas cylinder | RF Generator, Disposable HP, Foot pedal, Power cord, Gas regulator, Gas cylinder | Identical |
| Shaft Design & Energy Delivery Configuration | 15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft | 15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft | 15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft | Identical |
| Shaft Outer Diameter | 3mm | 3mm | 3mm | Identical |
| Electrode Configuration | Non-extendable | Non-extendable | Non-extendable | Identical |
| Plasma Settings | Maximum 40 watts, 1-5 L/min gas flow | Maximum 40 watts, 1-5 L/min gas flow | Maximum 40 watts, 1-5 L/min gas flow | Identical |
| Compatibility | Only with Electrosurgical Generators owned by Apyx Medical | Only with Electrosurgical Generators owned by Apyx Medical | Only with Electrosurgical Generators owned by Apyx Medical | Identical |
| New Indication Safety Assessment | No new or increased risks for Renuvion procedures following liposuction compared to liposuction alone. | N/A (did not have this expanded indication) | N/A (did not have this expanded indication) | Assessed through real-world evidence and meta-analysis. |
2. Sample size used for the test set and the data provenance
- Test Set (for the new indication): The document refers to "real-world evidence gathered from 6 studies in which all procedures used Renuvion APR following liposuction."
- This data set includes retrospective chart reviews in 1,184 body areas across 483 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the retrospective chart reviews. It is implied to be clinical data, likely from the US, given the FDA submission.
- Retrospective or Prospective: Primarily retrospective chart reviews for the liposuction indication. There is also a mention of an IDE study (G190152, VP-1902) for the neck and submental region (which was already an indicated use for the predicate device, not new for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable in the context of an AI ground truth. For this device (an electrosurgical handpiece), "ground truth" relates to clinical outcomes and safety profiles, typically established by treating physicians and follow-up. The data relies on clinical records and published meta-analyses. No specific "experts" were convened to "establish ground truth" for a test set in the way one would for an AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is not an AI performance study requiring image or data annotation adjudication. Clinical outcomes are typically recorded by the treating physician or study staff, and adverse events are reported as per standard clinical practice.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI device. The study described compares adverse event rates of Renuvion APR following liposuction to liposuction alone, based on a meta-analysis. It does not involve human readers interpreting images, assisted or unassisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is clinical outcomes and adverse event rates derived from:
- Retrospective chart reviews (for the new liposuction-related indication).
- Data from a previously conducted IDE study (for the neck and submental region indication, which was already on the predicate).
- Comparative data from a published meta-analysis (for liposuction alone adverse event rates).
8. The sample size for the training set
- Not Applicable. This is not an AI device that requires a training set. The clinical data mentioned (1,184 body areas across 483 subjects) serves as the evidence for safety and effectiveness for the new indication.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set" in the context of machine learning. Clinical data collection follows established medical record-keeping and study protocols.
§ 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.