(277 days)
The Indiba Diathermia Radiofrequency Deep Care/Activ 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 Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current.
The device models consist 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 (RES), and thin layer insulated capacitive electrodes (CAP). The electrodes are inserted into a handle, and the handle is connected to the console by a designated cable, the generated current flows through the patient and returns to the device through the neutral return electrode.
The Activ CT9 device model is equipped with additional massage applicators which provide mechanical massage for the temporary reduction in the appearance of cellulite.
The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model comprise a user interface (touchscreen) to facilitate the user device operation and to enable the user to predefine the device treatment settings.
The INDIBA Diathermia Radiofrequency Deep Care device model device incorporates smart handles and smart electrodes, which enables the device to automatically identify the connected applicators and enables their operation via the control options on the touchscreen.
The EVONY device provides a new temperature tracking tool enabling the user to track the patient skin temperature during the treatment time.
Improvements were performed in both device models in the console design and in the graphical user interface (GUI).
New applicators were introduced for the INDIBA Diathermia Radiofrequency Activ device model - the Fascia and Target electrodes and for the INDIBA Diathermia Radiofrequency Deep Care device model - the Sculpture electrodes. The new electrodes behave and operate in the same manner as the already FDA cleared RES and CAP electrodes.
The provided text describes a 510(k) premarket notification for two medical devices: the Indiba Diathermia Radiofrequency Deep Care Device and the Indiba Diathermia Radiofrequency Activ Device. This submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing performance against specific, quantifiable clinical acceptance criteria for effectiveness.
Therefore, the information typically found in a study proving device meets acceptance criteria for a novel device (e.g., diagnostic accuracy metrics, sensitivity, specificity, statistically significant improvement over a comparator) is not present in this document. This is common for 510(k) submissions, especially for devices undergoing modifications or being introduced as substantially equivalent to existing ones.
Instead, the acceptance criteria revolve around safety, electrical performance, and substantial equivalence to a predicate device. The study proving the device meets these "acceptance criteria" consists of non-clinical (bench) performance data, demonstrating adherence to recognized standards and consistency with the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are compliance with recognized standards and demonstration that the changes do not raise new safety or effectiveness concerns compared to the predicate devices. The "reported device performance" is successful completion of these non-clinical tests and the maintenance of the predicate device's technological characteristics.
| Acceptance Criteria (Demonstrated through) | Reported Device Performance |
|---|---|
| Compliance with ES60601-1 (Basic Safety & Essential Performance) | Tested and complies. |
| Compliance with IEC 60601-1-2 (EMC Requirements & Tests) | Tested and complies. |
| Compliance with IEC 60601-2-2 (High Frequency Surgical Equipment) (for Deep Care device) | Tested and complies. |
| Software Verification and Validation Testing | All validation activities performed; successfully passed. |
| Electrical Safety and EMC testing | Successfully passed. |
| Power control and RF accuracy testing | Successfully passed. |
| Labeling Verification and Validation Testing | Successfully passed. |
| Biocompatibility of patient-contacting materials | Materials are biocompatible and identical to predicate devices. |
| No new risks to device safety and effectiveness due to improvements/modifications | Concluded by manufacturer based on testing. |
| Substantial Equivalence to predicate devices (K161458) | Demonstrated through comparison of intended use and technological characteristics; same underlying RF technology, mechanism of action, and operational principles. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable for clinical data. The "test set" here refers to the physical devices themselves and their components undergoing bench testing. The document implies that the "subject device models" (Activ CT9 and EVONY) were tested. The specific number of individual units tested is not provided, but it's understood that representative units were used for the non-clinical tests.
- Data Provenance: The data is described as "Non-Clinical (Bench) Performance Data." It would have been generated in a controlled laboratory or testing facility environment, presumably by the manufacturer (INDIBA S.A.U.) or a contracted testing lab. Country of origin not explicitly stated, but the manufacturer is based in Spain. The data is prospective in the sense that tests were conducted on the newly designed devices per predefined protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For non-clinical bench testing and safety standards compliance, "ground truth" is established by the specifications in the recognized standards and validated engineering principles, not by expert medical opinion in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers review and resolve discrepancies in interpretations (e.g., medical images). This submission pertains to device engineering and safety performance, not clinical interpretation.
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 device is a radiofrequency therapy device, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not feature an algorithm for standalone performance evaluation in the usual sense (e.g., an AI algorithm for diagnosis). Its functionality is a therapeutic radiofrequency delivery system, where the "performance" is its ability to generate specific RF fields and temperatures, and the "human-in-the-loop" is the medical professional operating the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" is defined by:
- Recognized Standards: e.g., AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-2 for electrical safety, EMC, and specific RF surgical equipment requirements.
- Device Specifications: The manufacturer's defined technical specifications for power output, frequency, temperature ranges, etc.
- Biocompatibility Standards: Standards for materials that contact the patient's skin.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of algorithm development.
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.