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. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX.
The treatment performed by the NuEra Tight RF Family consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.
The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts.
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 are available as reusable or single use, with specific connectors on the panel below the front tray of the main control unit.
One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a 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 a lubricious coating to allow the user to glide the electrode over the treated area and to ensure conduction with the return element on the bipolar electrode.
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.
A new accessory, proposed in this submission, is the Handsfree Accessory. The Handsfree will enable the same treatment without requiring the operator to manually move the handpiece and connected electrode over the entire treatment area. This is because the Handsfree electrodes (up to 8) can be connected together in a row with a belt, and also used with a double-sided adhesive tape, to better attach to the entire treatment area.

AI/ML Overview

The provided text is a 510(k) Summary for the NuEra Tight RF Model APMD145.M70-US. It describes a medical device, which is an electrosurgical cutting and coagulation device. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria, especially in the context of device performance metrics like sensitivity, specificity, accuracy, or any clinical trial results typically associated with establishing device effectiveness against specific endpoints.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K210867) by introducing a "Handsfree Accessory." The "Performance Data and Bench Test" section briefly mentions verification and validation were performed on the Handsfree accessory using methods established by the predecessor device and in accordance with several standards (EN 60601-1, EN 60601-1-2, IEC 62304, ISO 14971). It concludes that "Testing confirms that the Handsfree operates in accordance with the same principles as the cleared electrodes in the predicate, which is to maintain the selected temperature at the treated site."

This level of detail is insufficient to answer the questions posed, as it does not present:

A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., in terms of temperature accuracy, duration of elevated temperature, or reduction in cellulite appearance quantified with specific measurements) are provided, nor are numerical acceptance criteria discussed.
Sample size and data provenance: No information is given about sample sizes for any tests, nor the provenance of any data (e.g., country of origin, retrospective/prospective).
Number and qualifications of experts for ground truth: No experts are mentioned in relation to establishing ground truth, as there are no clinical performance measures reported.
Adjudication method: Not applicable as no ground truth establishment is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device treats patients directly and does not involve human readers interpreting AI output.
Standalone performance: While the device acts in a standalone manner, the document doesn't provide detailed performance data typically associated with a standalone study. The "performance data" mentioned refers to bench testing for safety and functional equivalence.
Type of ground truth: No specific ground truth (pathology, outcomes data, expert consensus) is discussed regarding device performance, as the primary focus is on safety and functional equivalence to the predicate, specifically for the new accessory. The statement "maintain the selected temperature at the treated site" implies a functional goal, but not how "ground truth" for this was established beyond physical measurement.
Sample size for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.
How ground truth for training set was established: Not applicable.

In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical medical device and its new accessory, emphasizing safety and functional similarity to a predicate. It does not contain the kind of detailed performance criteria, study data, or ground truth establishment typically found in studies for diagnostic or AI-powered devices measuring specific efficacy or accuracy outcomes.

Summary

{0}------------------------------------------------

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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 2, 2023

BIOS s.r.l. Martina Iturbe RA Associate Via Guido Rossa 10/12 Vimodrone, MI 20055 Italy

Re: K223907

Trade/Device Name: NuEra Tight RF Model APMD145.M70-US Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: December 28, 2022 Received: December 28, 2022

Dear Martina Iturbe:

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 approval 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 (OS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.05.02 16:08:49 -04'00'

Mark Trumbore, 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K223907

Device Name NUERA Tight RF Model APMD145.M70-US

Indications for Use (Describe) The NuEra Tight RF Model APMD145.M70-US 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Bios s.r.l.

Special 510(k) Premarket Notification NuEra Tight RF Family

510 (k) Summary

Contact Details

510(k) Number	TBD
510(k) Type	Special
Applicant Information	Bios s.r.l.Via Guido Rossa, 10/1220055 Vimodrone (MI) - Italy
Contact	Dr Martina De Iturbe
Date Prepared	December 22, 2022
Device Name(s):	NuEra Tight RF Model APMD145.M70-US
Common Name	Massager, vacuum, radio frequency induced heat
Regulatory Class	Class II (21CFR§878.4400)
Product Codes	PBX
Regulation Names	Electrosurgical cutting and coagulation device and accessories

Predicate and Reference Devices

510(k) Ref	Pro Code/Reg No	Trade Name	Applicant
Predicate Device
K210867	PBX, 878.4400	APMD145.M70 US	Bios s.r.l.

Device Description

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. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX.

The treatment performed by the NuEra Tight RF Family consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.

The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts.

{4}------------------------------------------------

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 are available as reusable or single use, with specific connectors on the panel below the front tray of the main control unit.

One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a 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 a lubricious coating to allow the user to glide the electrode over the treated area and to ensure conduction with the return element on the bipolar electrode.

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.

A new accessory, proposed in this submission, is the Handsfree Accessory. The Handsfree will enable the same treatment without requiring the operator to manually move the handpiece and connected electrode over the entire treatment area. This is because the Handsfree electrodes (up to 8) can be connected together in a row with a belt, and also used with a double-sided adhesive tape, to better attach to the entire treatment area.

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 purpose of the Special 510(k) submission is to add the new model, APMD145.M70-US ("subject device"), to the NuEra Tight RF Family. The new model contains all the previously cleared features and functions of the predicate, predecessor model (K210867) and the additional Handsfree Accessory, as shown in Table 1 below.

Feature	Predicate device:	Subject device:
Device Manufacturer	Bios s.r.l.	Bios s.r.l.
510(K) Number	K210867	TBD
Product Code	PBX - Massager, Vacuum,Radio Frequency InducedHeat	PBX - Massager, Vacuum,Radio Frequency InducedHeat
	NuEra Tight RF model(#APMD145-1ch.US)-(K210867)	APMD145.M70-US
Feature	Predicate device:	Subject device:
	NuEra Tight RF model(#APMD145-1ch.US)-(K210867)	APMD145.M70-US

Regulation	21 CFR 878.4400	21 CFR 878.4400
	The NuEra Tight RFFamily is intended:	The NuEra Tight RFFamily is intended:
Indications for Use	• to provide topical heating forthe purpose of elevatingtissue temperature for thetreatment of selectedmedical conditions such astemporary relief of pain,muscle spasms, and increaselocal circulation.• to provide, with a massagedevice, a temporaryreduction in the appearanceof cellulite.	• to provide topical heating forthe purpose of elevatingtissue temperature for thetreatment of selectedmedical conditions such astemporary relief of pain,muscle spasms, and increaselocal circulation.• to provide, with a massagedevice, a temporaryreduction in the appearanceof cellulite.
Principle of action	RF energy increases thetemperature in the tissues fortherapeutic purposes.	Identical to predicate
Clinical use	Prescription Use	Identical to predicate
User Interface	Touch Screen	Identical to predicate
Firmware Controlled	Yes	Similar to predicate
Type of energy	Radiofrequency waves	Identical to predicate
Max Temperature at Skin	45°C	Identical to predicate
Frequency	470 kHz; 1 MHz; 2 MHz; 4MHz; 6 MHz	Identical to predicate
	Body handpiece
	Pen handpiece
	Bipolar handpiece
	Massage accessory
Accessories	RF monopolar electrodes ofsizes 20mm, 30mm, 40mm,Massage with 40 mm, 60mm,80mm, 100mm	Identical to predicate
	Disposable Return Plate
	Reusable Return Plate
	Foot Pedal
	Small Area handpiece
Feature	Predicate device:	Subject device:
	NuEra Tight RF model(#APMD145-1ch.US)-(K210867)	APMD145.M70-US
	Pause Handpiece
		Handsfree
Output RF Power	Max 250 W	Max 250 W
	Parker Cream	Parker Cream
User-Supplied Items		Double-sided MedicalAdhesive Tape of 2-3 mmthickness

{5}------------------------------------------------

{6}------------------------------------------------

Bios s.r.l.

Special 510(k) Premarket Notification NuEra Tight RF Family

Performance Data and Bench Test

Verification and validation were performed on the Handsfree using methods established by the predecessor, predicate device. The tests were conducted in accordance with the following standards:

EN 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
EN 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62304: Medical device software Software life cycle processes -
-ISO 14971: Medical devices - Application of risk management to medical devices

Conclusion

As designed. the subject device is essentially the predicate with the newly added Handsfree Accessory that provides another option for heating a larger area without requiring the user to continuously move the RF electrode. Testing confirms that the Handsfree operates in accordance with the same principles as the cleared electrodes in the predicate, which is to maintain the selected temperature at the treated site. The subject device therefore does not raise a different question of safety or effective and is substantially equivalent to its predecessor, predicate NuEra RF Tight model.

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.