(130 days)
The Indiba Diathermia Radiofrequency Devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
The Indiba Diathermia Radiofrequency Device is a therapeutic device for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: stainless steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes. The electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a 2-metre cable.
In resistive mode the system delivers a high-frequency current of 448 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current to pass. The high frequency current ranges between 400 kHz and 449 kHz and is automatically tuned by the equipment according to the patient's impedance. Current returns through the neutral return electrode. The Indiba Diathermia Radiofrequency Device is provided with an electroconductive media which is applied to the patients' skin prior to each treatment session.
The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue.
The temperature on the skin is measured using a separate IR (Infra-red) thermometer and there is an integrated massage device that can be used to massage the skin during cellulite treatment.
This document is a 510(k) summary for the Indiba Diathermia Radiofrequency Devices. It describes the device, its intended use, and provides evidence of substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the typical format of a clinical study. However, it details the performance characteristics tested and confirms they were met. The primary performance characteristic demonstrated by the in-house study is the ability of the device to elevate and maintain skin surface temperature.
| Characteristic Tested | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Temperature Elevation | Raise and maintain skin surface temperature to 40-45 °C | Individual volunteers' maximum temperatures on capacitive treatment were 41-44 °C and on combined capacitive and resistive were 41-43 °C. This was achieved and maintained after a minimum of 5 minutes. |
| Electrical Output (Output frequency, voltage, power) | Within stated performance characteristics specification | "The results for each tested output characteristic for all the Indiba Diathermia Radiofrequency Devices passed the acceptance criteria." (Specific numerical values for acceptance are not provided.) |
| Biocompatibility | Materials must be biocompatible for intended use | Patient contacting materials confirmed to be biocompatible for their intended use as per ISO10993-1:2009. |
| Device Safety & Software | Compliance with relevant IEC standards (60601-1, 60601-1-2, 60601-2-2) and FDA software guidance | Devices are in compliance with IEC/EN 60601-1:2005+ Corr. 2006, IEC/EN60601-1-2:2007+AC:2010, and applicable sections of IEC 60601-2-2: 2009. Software verification and validation conducted to IEC 62304: 2006. |
2. Sample size used for the test set and data provenance
- Sample Size (for temperature elevation study): 9 healthy volunteers.
- Data Provenance: The study was an "in-house study" on healthy volunteers. The country of origin is not explicitly stated, but the applicant and C/O applicant addresses are in the USA and Spain, respectively. It was a prospective study, as it involved actively treating volunteers and recording data.
3. Number of experts used to establish the ground truth for the test set and their qualifications
The document does not mention the use of experts to establish a "ground truth" for the temperature elevation study. The ground truth for this study was directly measured skin surface temperature using an Infrared Thermometer.
4. Adjudication method for the test set
Not applicable. The study involved direct measurement of physical parameters (temperature) rather than subjective interpretation requiring adjudication.
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 a medical device for therapeutic heating, not an AI-assisted diagnostic device. The document does not describe an MRMC study or AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm. The device is a radiofrequency energy delivery system. The temperature elevation study assessed the standalone performance of the device in achieving its intended therapeutic effect (raising tissue temperature).
7. The type of ground truth used
For the temperature elevation study, the "ground truth" was measured skin surface temperature using an Infrared Thermometer. This is an objective, directly measured physiological parameter.
8. The sample size for the training set
Not applicable. This is a medical device that delivers radiofrequency energy, not a machine learning model requiring a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.