(227 days)
No
The summary describes a radiofrequency generator and associated handpieces for topical heating and cellulite reduction. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to treat selected medical conditions such as temporary relief of pain or muscle spasms and to increase local circulation, which are therapeutic uses. It also provides a temporary reduction in the appearance of cellulite.
No
The device is intended for therapeutic purposes, such as providing topical heating for pain relief, muscle spasms, increased local circulation, and temporary reduction in the appearance of cellulite. It does not perform any diagnostic functions.
No
The device description clearly outlines hardware components including a radiofrequency generator, electrodes, handpieces, and a return plate, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NuEra Tight RF Model OptiStream is described as a device that uses radio frequency energy to provide topical heating to the body and face. Its intended uses are for temporary relief of pain or muscle spasms, increasing local circulation, and temporary reduction in the appearance of cellulite.
- Lack of Sample Analysis: The device description and intended uses do not involve the analysis of any biological samples taken from the patient. The treatment is applied externally to the body.
Therefore, the NuEra Tight RF Model OptiStream falls under the category of therapeutic or aesthetic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
PBX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body and face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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).
1
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, | ||
|---|---|---|
| Mark | ||
| Trumbore -S | Digitally signed by Mark | |
| Trumbore -S | ||
| Date: 2023.10.30 | ||
| 11:48:24 -04'00' | ||
| Mark Trumbore, Ph.D. | ||
| Assistant Director | ||
| DHT4A: Division of General Surgery Device | ||
| 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
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.
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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:
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3
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, 10/12 | |
| 20055 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
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.
4
Traditional 510(k) Premarket Notification NuEra Tight RF Family 006 510 (k) Summary
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.
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.
5
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 Generator
with Pellevé Handpiece | Subject device:
NuEra Tight RF Model
OptiStream |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Manufacturer | Bios s.r.l. | Cynosure, Inc.
(formerly, Ellman
International, Inc.) | Bios s.r.l. |
| 510(K) Number | K210867 | K132665 | TBD |
| Product Code | PBX - Massager,
Vacuum, Radio
Frequency Induced Heat | GEI - Electrosurgical,
Cutting & Coagulation
& Accessories | PBX - Massager,
Vacuum, Radio
Frequency Induced
Heat |
| Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| 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 local circulation.
• to provide, with a massage
device, a temporary
reduction in the appearance
of cellulite | The Pellevé Non-
Ablative Wrinkle
Treatment System is
indicated for the non-
ablative treatment of
mild to moderate facial
wrinkles and rhytids. | 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. |
| Principle of action | RF energy increases the
temperature in the
tissues for therapeutic
purposes. | RF energy increases
the temperature in the
tissues for therapeutic
purposes. | Identical to predicate |
| Clinical use | Prescription Use | Prescription Use | Identical to predicate |
| User Interface | Touch Screen | Touch Screen | Identical to predicate |
| Firmware
Controlled | Yes | Yes | Similar to predicate |
| Type of energy | Radiofrequency waves | Radiofrequency waves | Identical to predicate |
| Max Temperature
at Skin | 45°C | 45°C for face | 45°C
(42°C for face) |
| Frequency | 470 kHz; 1 MHz; 2
MHz; 4 MHz; 6 MHz | 4 MHz | Identical to predicate |
| Accessories | Body handpiece
Pen handpiece
Bipolar handpiece | | The Full Configuration
includes the identical
accessories as the |
| Feature | Predicate device: | Reference device: | Subject device: |
| | NuEra Tight RF model
(#APMD145-1ch.US)- | Surgitron RF Generator
with Pellevé Handpiece | NuEra Tight RF Model
OptiStream |
| | Massage accessory | | |
| | RF monopolar electrodes of
sizes 20mm, 30mm, 40mm,
Massage with 40 mm, 60mm,
80mm, 100mm | RF monopolar electrodes of
sizes 7.5mm, 10mm, 15mm,
20mm | predicate, and a RF
monopolar electrode of
size 10 mm.
Basic Configuration
comes with the 10 mm
and 20 mm electrodes. |
| | Disposable Return Plate | | |
| | Foot Pedal | | |
| | Small Area handpiece | | |
| | Pause Handpiece | | |
| User-Supplied
Items | Parker Cream | Parker | Parker Cream |
6
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.