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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

April 21, 2021

BIOS s.r.l. Eliana Russo Quality Assurance Manager Via Guido Rossa 10/12 Vimodrone, MI 20090 Italy

Re: K210867

Trade/Device Name: NuEra Tight RF, NuEra Tight RF Plus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: March 19, 2021 Received: March 23, 2021

Dear Eliana Russo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approv al of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements,

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including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and. if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations. please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210867

Device Name NUERA Tight RF Family

Indications for Use (Describe) 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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) Summary

Contact Details

510(k) Number	K210867
510(k) Type	Special
Applicant Information	Bios s.r.l.Via Guido Rossa, 10/1220055 Vimodrone (MI) - Italy
Contact	Dr Eliana Russo
Date Prepared	April 21th, 2021
Device Name(s):	NuEra Tight RF Family
Model Refs	APMD145-1ch.US, APMD151-1ch.US
Common Name	Radiofrequency System
Regulatory Class	Class II
Product Codes	PBX
Regulation Names	Massager, vacuum, radio frequency induced heat

Predicate and Reference Devices

510(k) Ref	Pro Code/Reg No	Trade Name	Applicant
Predicate Device
K200359	PBX, 878.4400	NuEra Tight RF Family	Bios s.r.l.

Device Description

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.

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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.

Indications for Use

The NuEra Tight RF Family is intended:

. 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.

Predicate Device Comparison

The product specification, functionality, indications for use, and treatment parameters of the NuEra Tight RF Family are the same or very similar to the legally marketed predicate device.

The technological similarities and differences between the NuEra Tight RF Family, model NuEra Tight, and the predicate device are described in comparison Table 1.

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Table 1: Predicate device comparison table - NuEra Tight RF Family - Radiofrequency
Feature	Subject device	Predicate device	Similarity
Device name	NuEra Tight RF Family	NuEra Tight RF Family	Same
DeviceManufacturer	Bios s.r.l.	Bios s.r.1.	Same
510(K) Number	K210867	K200359	N/A
Product Code	PBX - Massager, Vacuum,Radio Frequency InducedHeat	PBX - Massager, Vacuum,Radio Frequency InducedHeat	Same
Regulation	21 CFR 878.4400	21 CFR 878.4400	Same
Indications for Use	The NuEra Tight RFFamily is intended:· to provide topical heatingfor the purpose ofelevating tissuetemperature for thetreatment of selectedmedical conditions suchas temporary relief ofpain, muscle spasms, andincrease local circulation;· to provide, with a massagedevice, a temporaryreduction in theappearance of cellulite.	The NuEra Tight RFFamily is intended:· to provide topical heatingfor the purpose ofelevating tissuetemperature for thetreatment of selectedmedical conditions suchas temporary relief ofpain, muscle spasms, andincrease local circulation;· to provide, with a massagedevice, a temporaryreduction in theappearance of cellulite.	Same
Principle of action	Electromagnetic wavespenetrate in exposed tissueand produce heat,increasing the temperatureon a certain part of thebody for therapeuticpurposes.	Electromagnetic wavespenetrate in exposed tissueand produce heat,increasing the temperatureon a certain part of thebody for therapeuticpurposes.	Same
Clinical use	Prescription Use	Prescription Use	Same
Electrical Protection	Class I type BF	Class I type BF	Same
User Interface	Touch Screen	Touch Screen	Same
FirmwareControlled	Yes	Yes	Same
Type of energy	Radiofrequency waves	Radiofrequency waves	Same
TemperatureControl	Yes	Yes	Same
Frequency	470 kHz; 1 MHz; 2 MHz; 4MHz; 6 MHz	470 kHz; 1 MHz; 2 MHz; 4MHz; 6 MHz	Same
Output RF Power	Max 250 W	Max 250 W	Same
Table 1: Predicate device comparison table – NuEra Tight RF Family - Radiofrequency
Feature	Subject device	Predicate device	Similarity
Voltage	100 - 240 V	100 – 240 V	Same
Handpiece	Body, pen, small areacomposed of an handlingpart and the tip sterile anddisposable	Body, pen, small areacomposed of an handlingpart and the tip reusableand provided non sterileand cleaned by the user	Same with theexception of thesmall areahandpiece tipprovided EtOsterile for singleuse

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The difference is the introduction of a sterile and disposable configuration for the small area handpiece tip instead of the already cleared multiuse tip. The introduction of a sterile single use tip in place of the previous reusable tip to the cleared small area handpiece is to avoid to be carrier of bacteria and virus in sensitive and vulnerable areas of the body.

The indications for use and materials of construction remain unchanged from the cleared device. this difference does not, therefore, raise any new types of safety or effectiveness questions.

Performance Data and Bench Test

Functional Testing

Functional test has been performed to confirm that the performance of the NuEra Tight RF Family device. using the small area handpiece, is not impacted from the introduction of the sterilization process. Tips, after sterilization process, have been tested in order to demonstrate that the device can maintain the set skin temperature at 2 set point (minimum: 40°C and maximum: 42°C) and it can maintain the skin temperature inside that interval of + 2°C for 15 minutes.

The test is executed for all RF frequencies used with the small area handpiece (470 kHz, 1 Mhz, 2 Mhz, 4 MHz and 6 MHz).

Sterilization validation and shelf-life

Ethylene Oxide sterilization and Shelf-life validation activities for the new disposable configuration of the small area handpiece tip were conducted by external laboratories. Testing results demonstrate compliance with the following recognized FDA Standards:

ISO 11607, FDA standards recognition # 14-530

ISO 11135-1, FDA standards recognition # 14-529

ISO 10993-7, FDA standards recognition # 2-275

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A summary of all the verification and validation activities performed on the NuEra Tight RF family are listed in Table 2 below.

Test name	Test Description
Functional testing	The temperature stability in all operative status (multifrequency) and with all available electrodes provided with the devices was fully verified, validated and submitted under the NuEra Tight RF family submission K200359. The same protocol has been used to verify the performance of the small area handpiece tip, before and after the sterilization process.
Sterilization	Sterilization process validation of the small area handpiece tip was completed using an established method (EO). Package integrity testing and shelf-life validation has been performed. Testing results demonstrate compliance with ISO 11607, ISO 11135-1, and ISO 10993.

Table 2 - Verification and validation activities on NuEra Tight RF family

Conclusion

Based upon the indications for use, the known technical information and the performed tests listed above based on well-established methods and standards, the NuEra Tight RF Family device has been shown to be substantially equivalent to currently marketed predicate device. The only difference which is the introduction of the small area handpiece tip sterile and disposable in place of the previous not sterile and reusable one is considered minor and do not raise new issues of the safety and effectiveness of the NuEra Tight RF Family devices when compared to the predicate device.

Regulation Number and Section

§ 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.