(125 days)
Not Found
No
The document describes a radiofrequency device for heating tissue and reducing cellulite. It details the hardware components, intended uses, and testing against established standards. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or device control beyond basic temperature regulation.
Yes
The device is described as treating "selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation," and reducing "the appearance of cellulite," which are therapeutic applications.
No
This device is intended for therapeutic purposes (topical heating, temporary pain relief, muscle spasm treatment, circulation increase, and temporary cellulite reduction), not for diagnosis.
No
The device description clearly outlines hardware components such as RF generators, electrodes, handpieces, return plates, and a footswitch. The verification and validation section also references testing related to hardware standards (EN 60601-1, EN 60601-1-2).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for topical heating to treat pain, muscle spasms, increase circulation, and temporarily reduce the appearance of cellulite. These are all therapeutic or aesthetic applications performed directly on the patient's body.
- Device Description: The device description details how the device delivers radio frequency energy to heat subcutaneous tissue through electrodes in contact with the patient. It also mentions a massage handpiece. These are all external applications.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device operates in vivo (on the body).
N/A
Intended Use / Indications for Use
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.
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
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.
Not Found
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 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)
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, 10/12 | |
| 20055 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
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.
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 Induced | ||
| Heat | PBX - Massager, Vacuum, | |
| Radio Frequency Induced | ||
| Heat | ||
| 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 RF | ||
| Family is intended: | The NuEra Tight RF | |
| Family is intended: | ||
| Indications for Use | • 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. | • 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. | ||
| Principle of action | RF energy increases the | |
| temperature in the tissues for | ||
| therapeutic 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; 4 | |
| MHz; 6 MHz | Identical to predicate | |
| Body handpiece | ||
| Pen handpiece | ||
| Bipolar handpiece | ||
| Massage accessory | ||
| Accessories | RF monopolar electrodes of | |
| sizes 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 Medical | |
| Adhesive Tape of 2-3 mm | ||
| thickness |
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.