to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face.
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 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.

The labeling changes proposed in this submission are to clarify that the use of the device to provide topical heating to increase local circulation is not limited to the body but can also include the face with the exception being within the orbital rim and on the neck.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (NuEra Tight RF Model OptiStream), which focuses on establishing substantial equivalence to a predicate device. It does not describe a study involving an AI algorithm or a device that meets acceptance criteria through AI performance metrics. Therefore, I cannot generate the requested information about acceptance criteria and study proving AI device performance.

The document discusses:

Device Name: NuEra Tight RF Model OptiStream
Intended Use: Topical heating for pain relief, muscle spasms, increased local circulation (body and face), and temporary reduction of cellulite.
Comparison to Predicate: The submission is primarily to update the indication statement to include use on the face and to introduce an additional 10mm electrode.
Performance Data: Refers to literature, bench testing, and clinical testing on the face to support the proposed labeling changes, and testing of the 10mm electrode. It states that the device is able to "induce and maintain such a temperature on the face" (referring to 42°C for face, as opposed to 45°C for body).

There is no mention of:

Acceptance criteria for an AI algorithm
Performance metrics like sensitivity, specificity, accuracy, or AUC
Sample sizes for a test set or training set for AI
Expert annotation or ground truth adjudication for AI
MRMC studies or standalone AI performance

Therefore, I am unable to fulfill your request as it pertains to AI device performance.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 30, 2023

BIOS s.r.1. Martina Iturbe RA Associate Via Guido Rossa 10/12 Vimodrone, MI 20055 Italy

Re: K230755

Trade/Device Name: NuEra Tight RF Model OptiStream Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: August 3, 2023 Received: August 4, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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, 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
MarkTrumbore -S		Digitally signed by MarkTrumbore -SDate: 2023.10.3011:48:24 -04'00'
Mark Trumbore, Ph.D.Assistant Director
DHT4A: Division of General Surgery DeviceOHT4: Office of Surgicaland Infection Control DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

Device Name NUERA Tight RF Model OptiStream

Indications for Use (Describe) The NuEra Tight RF Model OptiStream is intended:

to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face.
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."

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Traditional 510(k) Premarket Notification NuEra Tight RF Family 006 510 (k) Summary

Bios s.r.l.

006 510 (k) Summary

Contact Details
510(k) Number	K230755
510(k) Type	Traditional
Applicant Information	Bios s.r.l.Via Guido Rossa, 10/1220055 Vimodrone (MI) - Italy
Contact	Dr. Martina De Iturbe
Date Prepared	August 2, 2023
Device Name(s):	NuEra Tight RF Model OptiStream
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	NuEra Tight RF Model 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.

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Traditional 510(k) Premarket Notification NuEra Tight RF Family 006 510 (k) Summary

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.

Indications for Use

The NuEra Tight RF Family is intended:

= to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face.
to provide, with a massage device, a temporary reduction in the appearance of cellulite. .

Predicate Device Comparison

The purpose of the 510(k) submission is to update the indication statement with regards to the use of the device for the face and the related labeling statements regarding use on the face. The subject device, OptiStream, in Full Configuration, contains all the previously cleared features and functions of the predicate, predecessor model (K210867) and the additional 10 mm electrode, as shown in the table below. In its Basic Configuration, the OptiStream is provided with only the 10 mm and 20 mm electrodes.

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Traditional 510(k) Premarket Notification
NuEra Tight RF Family
006_510 (k) Summary

Bios s.r.l.

Feature	Predicate device:NuEra Tight RF model(#APMD145-1ch.US)-	Reference device:Surgitron RF Generatorwith Pellevé Handpiece	Subject device:NuEra Tight RF ModelOptiStream
DeviceManufacturer	Bios s.r.l.	Cynosure, Inc.(formerly, EllmanInternational, Inc.)	Bios s.r.l.
510(K) Number	K210867	K132665	TBD
Product Code	PBX - Massager,Vacuum, RadioFrequency Induced Heat	GEI - Electrosurgical,Cutting & Coagulation& Accessories	PBX - Massager,Vacuum, RadioFrequency InducedHeat
Regulation	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
Indications for Use	The NuEra Tight RFFamily is intended:• to provide topical heatingfor the purpose of elevatingtissue temperature for thetreatment of selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease local circulation.• to provide, with a massagedevice, a temporaryreduction in the appearanceof cellulite	The Pellevé Non-Ablative WrinkleTreatment System isindicated for the non-ablative treatment ofmild to moderate facialwrinkles and rhytids.	The NuEra Tight RFFamily is intended:• to provide topical heatingto treat selected medicalconditions such as fortemporary relief of pain ormuscle spasms and toincrease local circulationon body and face.• to provide, with amassage device, atemporary reduction inthe appearance ofcellulite.
Principle of action	RF energy increases thetemperature in thetissues for therapeuticpurposes.	RF energy increasesthe temperature in thetissues for therapeuticpurposes.	Identical to predicate
Clinical use	Prescription Use	Prescription Use	Identical to predicate
User Interface	Touch Screen	Touch Screen	Identical to predicate
FirmwareControlled	Yes	Yes	Similar to predicate
Type of energy	Radiofrequency waves	Radiofrequency waves	Identical to predicate
Max Temperatureat Skin	45°C	45°C for face	45°C(42°C for face)
Frequency	470 kHz; 1 MHz; 2MHz; 4 MHz; 6 MHz	4 MHz	Identical to predicate
Accessories	Body handpiecePen handpieceBipolar handpiece		The Full Configurationincludes the identicalaccessories as the
Feature	Predicate device:	Reference device:	Subject device:
	NuEra Tight RF model(#APMD145-1ch.US)-	Surgitron RF Generatorwith Pellevé Handpiece	NuEra Tight RF ModelOptiStream
	Massage accessory
	RF monopolar electrodes ofsizes 20mm, 30mm, 40mm,Massage with 40 mm, 60mm,80mm, 100mm	RF monopolar electrodes ofsizes 7.5mm, 10mm, 15mm,20mm	predicate, and a RFmonopolar electrode ofsize 10 mm.Basic Configurationcomes with the 10 mmand 20 mm electrodes.
	Disposable Return Plate
	Foot Pedal
	Small Area handpiece
	Pause Handpiece
User-SuppliedItems	Parker Cream	Parker	Parker Cream

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Traditional 510(k) Premarket Notification NuEra Tight RF Family 006 510 (k) Summary

Bios s.r.l.

Performance Data and Bench Test

To support the proposed labeling changes, data reported in the literature and from bench and clinical testing of the subject device on the face were provided. Further, testing conducted on the 10 mm electrodes, using the methods and criteria that were established for the predicate electrodes, also showed that the 10 mm electrode performed as intended.

Conclusion

As designed, the subject device is essentially the predicate with the additional 10 mm electrode for heating small areas. The proposed addition to the indication statements to clarify the use of the subject device for heating the face does not pose a different safety or effectiveness question given that the FDA has cleared devices for heating the face to the same temperature as the subject device. Further, testing of the subject device on the face demonstrates that the subject device is able to induce and maintain such a temperature on the face. Here is not a different safety or effectiveness question for the clarification that the subject device can also be used "on body and face" for topical heating to increase local circulation, or for the related labeling changes clarifying the use on the face. The subject device therefore 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.