(29 days)
The NuEra Tight RF Family is intended for:
- to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
- to provide, with a massage device, a temporary reduction in the appearance of cellulite.
NuEra Tight RF Family is a family of devices designed to:
- develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient.
Specifically, there are two devices in the family: - -NuEra Tight RF - radiofrequency generator with single RF electrode connector
- -NuEra Tight RF Plus - radiofrequency generator with single RF electrode connector. The device has a different design, in particular for larger size, than the NuEra Tight RF, for the presence of an additional electronic part that is cleared under K201239.
The purpose of the treatment based on the radiofrequency system (NuEra Tight) is to raise the temperature inside the tissues up to maximum of 45℃. Therefore, depending on the treatment and intended use, different parts of the body can be treated.
The devices use RF electrodes of the capacitive (or monopolar) and resistive (or bipolar) types. Capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts.
The small area handpiece tip is provided sterile and disposable. The tip is Eto sterilized, the sterilization process was verified and validated using FDA-recognized standards UNI EN ISO 11138-1, UNI EN ISO 11138-2 and UNI EN ISO 11138-7. Also, the package integrity and shelf-life for this change have been evaluated through accelerated aging using American Society for Testing and Materials (ASTM) F1980.
Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates can be reusable or disposable, with specific connectors on the front tray. One resistive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. The resistive electrode, being bipolar, is not meant to work with the return plate. One massage handpiece is provided to be used to add a mechanical treatment to the heat emission. All the handpieces are used with a small amount (approximately 1 mm layer) of cream, that is Parker Redux cream K782055. The cream purpose is to provide aid to transfer the heat.
A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button.
The pause handpiece can be used to pause the treatment without using the GUI.
The provided text describes a 510(k) premarket notification for a medical device called the "NuEra Tight RF Family." This submission seeks to demonstrate substantial equivalence to a legally marketed predicate device (K200359), with the only significant change being the introduction of a sterile, disposable tip for the small area handpiece.
Therefore, the acceptance criteria and study described here are focused on demonstrating that this change does not negatively impact the device's safety or effectiveness, and that the sterilization process itself is valid.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performance (maintaining set skin temperature) is not impacted by the sterilization process for the small area handpiece tip. | Tips, after the sterilization process, maintained the set skin temperature at 40°C and 42°C (minimum and maximum set points) within an interval of ±2°C for 15 minutes. This was tested for all RF frequencies used with the small area handpiece (470 kHz, 1 MHz, 2 MHz, 4 MHz, and 6 MHz). The same protocol used for the predicate device (K200359) was employed. |
| Compliance with Sterilization Standard ISO 11607 (Packaging for terminally sterilized medical devices). | Testing results demonstrate compliance with ISO 11607. |
| Compliance with Sterilization Standard ISO 11135-1 (Ethylene oxide sterilization for medical devices). | Testing results demonstrate compliance with ISO 11135-1. |
| Compliance with Biocompatibility Standard ISO 10993-7 (Ethylene oxide sterilization residuals). | Testing results demonstrate compliance with ISO 10993-7. |
| Package integrity and shelf-life validated for the new disposable configuration. | Package integrity and shelf-life for the small area handpiece tip were evaluated through accelerated aging using ASTM F1980. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific numerical sample size for the functional testing of the small area handpiece tips. It indicates "Tips, after sterilization process, have been tested." It also mentions that "Ethylene Oxide sterilization and Shelf-life validation activities for the new disposable configuration of the small area handpiece tip were conducted by external laboratories," implying these tests followed established protocols which would involve specific sample sizes, though they are not detailed in this summary.
The data provenance is not specified (e.g., country of origin, retrospective/prospective). The applicant is listed as "Bios s.r.l." from Italy.
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)
This section is not applicable to the provided document. The studies described are for functional performance and sterilization validation of the device components, not for diagnostic or interpretive tasks where expert ground truth would be required (e.g., image analysis, clinical diagnosis). The "ground truth" here is objective measurement (e.g., temperature, sterility, package integrity) against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the studies are technical performance and sterilization validations, not involving human interpretation or adjudication for clinical outcomes.
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
This is not applicable. The device is an RF energy delivery system for therapeutic purposes (topical heating, cellulite reduction), not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical RF energy system, not a standalone algorithm. Its performance is evaluated through functional testing and adherence to physical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the functional testing, the "ground truth" is based on objective physical measurements against predefined parameters (e.g., maintaining skin temperature within a specific range, over a specific duration, at specified RF frequencies).
For sterilization and shelf-life validation, the "ground truth" is defined by compliance with recognized international standards (ISO 11607, ISO 11135-1, ISO 10993-7, ASTM F1980).
8. The sample size for the training set
This is not applicable. The device is not based on a machine learning model that requires a "training set." The testing performed is for validating physical and sterilization performance.
9. How the ground truth for the training set was established
This is 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.