(29 days)
No
The summary describes a radiofrequency device for heating tissue and reducing cellulite. There is no mention of AI or ML in the device description, intended use, or performance studies. The device relies on user-controlled settings and physical contact for treatment.
Yes
The device is intended for "temporary relief of pain, muscle spasms, and increase in local circulation," which are therapeutic applications. It also provides a temporary reduction in the appearance of cellulite, which is also a form of treatment.
No
The device is intended for therapeutic purposes, specifically topical heating to elevate tissue temperature for conditions like pain relief, muscle spasm, and improved circulation, and for temporary reduction of cellulite appearance. It does not perform any diagnostic functions.
No
The device description clearly outlines hardware components including a radiofrequency generator, electrodes, handpieces, a return plate, and a footswitch. It is a physical device that delivers energy to the patient.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions" and "a temporary reduction in the appearance of cellulite." These are therapeutic and aesthetic applications, not diagnostic testing performed in vitro (outside the body) on biological samples.
- Device Description: The device description details a radio frequency generator and electrodes that deliver energy to the patient's body to heat tissue. This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device does not perform tests to diagnose diseases or conditions based on the analysis of these samples.
Therefore, the NuEra Tight RF Family is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
different parts of the body can be treated.
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)
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).
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
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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,
1
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
2
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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3
510 (k) Summary
Contact Details
| 510(k) Number | K210867 |
|---|---|
| 510(k) Type | Special |
| Applicant Information | Bios s.r.l. |
| Via Guido Rossa, 10/12 | |
| 20055 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.
4
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.
5
| 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 |
| Device | |||
| Manufacturer | Bios s.r.l. | Bios s.r.1. | Same |
| 510(K) Number | K210867 | K200359 | N/A |
| Product Code | PBX - Massager, Vacuum, | ||
| Radio Frequency Induced | |||
| Heat | PBX - Massager, Vacuum, | ||
| Radio Frequency Induced | |||
| Heat | Same | ||
| Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| 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 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. | Same | ||
| Principle of action | Electromagnetic waves | ||
| penetrate in exposed tissue | |||
| and produce heat, | |||
| increasing the temperature | |||
| on a certain part of the | |||
| body for therapeutic | |||
| purposes. | Electromagnetic waves | ||
| penetrate in exposed tissue | |||
| and produce heat, | |||
| increasing the temperature | |||
| on a certain part of the | |||
| body for therapeutic | |||
| purposes. | 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 |
| Firmware | |||
| Controlled | Yes | Yes | Same |
| Type of energy | Radiofrequency waves | Radiofrequency waves | Same |
| Temperature | |||
| Control | Yes | Yes | Same |
| Frequency | 470 kHz; 1 MHz; 2 MHz; 4 | ||
| MHz; 6 MHz | 470 kHz; 1 MHz; 2 MHz; 4 | ||
| MHz; 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 area | ||
| composed of an handling | |||
| part and the tip sterile and | |||
| disposable | Body, pen, small area | ||
| composed of an handling | |||
| part and the tip reusable | |||
| and provided non sterile | |||
| and cleaned by the user | Same with the | ||
| exception of the | |||
| small area | |||
| handpiece tip | |||
| provided EtO | |||
| sterile for single | |||
| use |
6
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
7
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.