(89 days)
The RF-Relief is an over the counter hand held device intended to emit energy in RF spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
The RF-Relief is an OTC, home use device, designed to deliver RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a non-invasive, non-ablative device and it is supplied as non-sterile.
The RF-Relief device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes four Bi-polar (2 pairs) electrodes, two redundant temperature sensors and a vibration motor. The PLC (on the PCBA) is especially configured software combined with hardware circuits that provides the operational and safety function of the system.
The RF-Relief device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the RF energy together with mechanical massage over the entire treatment area.
The RF-Relief device is an over-the-counter handheld device intended to emit radio frequency (RF) energy for topical heating to temporarily relieve minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasms, temporarily increase local blood circulation, and temporarily relax muscles.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety - Overheating Protection | The two redundant temperature sensors embedded in the device constantly measure skin temperature and deactivate RF delivery when temperature exceeds 41ºC/ 105.8ºF. This temperature was determined to be acceptable based on published information that human skin begins to feel pain at 44°C and may start to develop burns at 48°C. |
| Power Accuracy | The device was validated for different power levels (6±1, 8±1 and 10±1 Watt) on a 150 Ω load (appropriate reference for average user load) and other impedance values in relevant environmental conditions. The measured total power was within the predefined error margin. |
| Parameter Validation | The device was tested for varied parameters including radio frequency (1±0.05 MHz), pulse cycle, waveform, and pulse duration. All results were within the acceptance criteria. |
| Electrical Safety and EMC Compliance | Complies with IEC 60601-1:2012/EN 60601-1:2013 (General safety), IEC 60601-1-2:2014 (EMC), IEC 60601-2-2:2009 (High-frequency surgical equipment), and IEC 60601-1-11:2015 (Home healthcare environment). |
| Software Verification and Validation | Documentation provided as recommended by FDA guidance for "moderate" level of concern software. |
| Temperature during Treatment (Effectiveness) | Temperature measurement of the skin during treatment showed that when operated according to instructions for use and in all treatment modes, a safe and effective temperature around 41°C is reached and maintained over 10-20 minutes on all skin types. |
| Labeling Comprehension/Self-Selection | Demonstrated that intended OTC users can understand the package labeling and correctly choose this device for themselves for the indicated aesthetic use. |
| Usability/User Interface | Evaluated usability performance for intended use. |
| Biocompatibility | Body contact materials are biocompatible per ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization) for "Surface device, Skin Contact for limited contact duration" ( |
§ 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.