(425 days)
Tua Face Fitness / Tua Trend Face is a device intended for facial stimulation and is indicated for Over-the-Counter cosmetic use.
Tua Face Fitness /Tua Trend Face is a two-channel, battery-operated cosmetic device which is intended for use on the face. The device comprises a rechargeable electronic device which connects to an applicator wand that delivers electrical impulses to the face. The device operates by applying Transcutaneous Electrical Nerve Stimulation to the facial area. It means that the electrodes that are positioned on the skin must be wet with tap water to be conductive to generate of the electric pulses. The pads are made of pure cellulose backed by PVC. It is a surface device which comes in contact with skin. The duration of contact is less than or equal to 24 hours.
This document is a 510(k) Premarket Notification for the Tua Face Fitness / Tua Trend Face device. It aims to demonstrate substantial equivalence to a legally marketed predicate device (BMR Face) and is not a report of a study proving the device meets specific performance acceptance criteria for an AI-powered diagnostic or similar type of device.
The document discusses the regulatory classification, intended use, and technological characteristics of a Transcutaneous Electrical Nerve Stimulator (TENS) for cosmetic facial stimulation. It focuses on demonstrating that the new device is as safe and effective as the predicate device by comparing their technical specifications and compliance with relevant electrical and safety standards.
Therefore, the requested information about acceptance criteria, detailed study design with sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI-driven performance cannot be extracted from this document, as it does not describe such a study.
Specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. This document is not performing comparative testing against specific performance metrics for an AI algorithm. It's comparing technical and safety specifications of a TENS device to a predicate.
- Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the context of an AI performance study is described. The document relies on comparisons of device specifications and compliance with safety standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established or discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a TENS unit, not an AI-powered diagnostic tool, so MRMC studies are irrelevant to its regulatory submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. Ground truth for AI performance is not established.
- The sample size for the training set: Not applicable. No AI training set is mentioned or relevant.
- How the ground truth for the training set was established: Not applicable. No AI training is mentioned or relevant.
The document states "No new clinical studies have been submitted as part of this Premarket Notification," indicating that the substantial equivalence argument is based on non-clinical tests (electrical safety, EMC, biocompatibility, mechanical, thermal, and software safety/classification) and comparison of technical specifications to the predicate device.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
September 30, 2020
Vupiesse S.R.L % Chuck Mograbi Regulatory Affairs - Director Silicus Technologies 2700 Post Oak Blvd #1625 Houston, Texas 77056
Re: K192077
Trade/Device Name: Tua Face Fitness / Tua Trend Face Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: September 17, 2020 Received: September 17, 2020
Dear Chuck Mograbi:
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.
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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 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 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.
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192077
Device Name Tua Face Fitness / Tua Trend Face
Indications for Use (Describe)
Tua Face Fitness / Tua Trend Face is a device intended for facial stimulation and is indicated for Over-the-Counter cosmetic use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for VuPEsse Bodyplanet. The logo is in black and blue. The word "Vu" is in black, followed by a blue curved line with a white dot on top. The word "Esse" is in black, and below it, the word "Bodyplanet" is in smaller black letters.
510(K) SUMMARY - K192077
for Tua Face Fitness / Tua Trend Face
This 510k Summary is being submitted by the requirements of 21 CFR 807.92
1. Submitter
| Name: | Vupiesse S.r.l. |
|---|---|
| Address: | Via della Lontra, 49 |
| 47923 Rimini RN, Italy | |
| Contact person: | Marco Paolizzi (President) |
| Telephone: | +39 0541 753020 |
| Fax: | +39 0541 753171 |
| E-Mail: | info@vupiesse.com |
2. Contact Details for Correspondence in the USA
| Name: | Silicus Technologies |
|---|---|
| Address: | 2700 Post Oak Blvd #1625Houston, TX 77056 |
| Contact Person: | Chuck H. Mograbi (Regulatory Affairs Director) |
| Telephone: | (954) 682-3529 |
| Fax: | (713) 353-7480 |
| chuck.mograbi@silicus.com | |
| Prepared On: | September 28, 2020 |
3. Device Name
Trade Name of Device: Common Name: Regulation Number: Regulation Description: Product Code: Device Class:
Tua Face Fitness /Tua Trend Face Facial Stimulator 21CFR 882.5890 Transcutaneous Electrical Nerve Stimulator for Pain Relief NFO 2
4. Identification of Equivalent Legally Marketed Device
| 510(k) Number: | K103031 |
|---|---|
| Clearance Date: | 11/10/2011 |
| Regulation Number: | 21CFR 882.5890 |
| Manufacturer: | Bio-Medical Research, LTD |
| Trade Name: | BMR Face |
| Product Code: | NFO |
| Device Class: | 2 |
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5. Description of Device
Tua Face Fitness /Tua Trend Face *:
*Tua Face Fitness is the same device and has the same label as the "Tua Trend Face. Tua Face Fitness name was added for marketing purpose to designate it for the distribution in the USA.
Tua Face Fitness /Tua Trend Face is a two-channel, battery-operated cosmetic device which is intended for use on the face. The device comprises a rechargeable electronic device which connects to an applicator wand that delivers electrical impulses to the face.
The device operates by applying Transcutaneous Electrical Nerve Stimulation to the facial area. It means that the electrodes that are positioned on the skin must be wet with tap water to be conductive to generate of the electric pulses. The pads are made of pure cellulose backed by PVC. It is a surface device which comes in contact with skin. The duration of contact is less than or equal to 24 hours.
Description of Device Software.
The software of the Tua Face Fitness / Tua Trend Face use five programs or 5 zone locations with a total time of 10 minutes on one side of the face skin, this represent twenty minutes total when the client operate the device on the two sides of the face location. (ten minutes for the right side of the face sken and additional ten minutes for the left side ). The client would choose the program of the specific zone (1 to 5) and the intensity of the program based on their preferences.
Tua Face Fitness / Tua Trend Face shows these five zones/ programs on high definition display, as you can see in the attached device's description document that the five programs and its location are pre-programmed in the CPU Circuit board with specific parameters such as stimulation frequency, pulse width, contraction times and recovery times: The pre- programmed characteristic are part of the CPU circuit board and it cannot be changed or controlled by the client. The client can only control the zone location, and the stimulation intensity of the micro-current through an up and down buttons, below the display of the device.
When the device is activated. The high definition displays Program 1. the time of two minutes is stated on the right upper corner, the client choice of the adjustable intensity (20-60) is stated on the left lower corner as 20, and the area of program one is the left upper cheek. The client can start this program by pressing "OK"
The total time for the five-program is 10 minutes for one side of the face (2 minutes each). When the intensity of the micro-current has been adjusted up or down during the application, the intensity is recorded in the program's memory for each program. The client then can repeat the same five programs on the other side of the face for 10 minutes and the right side and use the same recorded/save intensity. This feature will provide a visual direction and consistent operation on both sides of the face, making no other change.
The total duration for a full application is 20 minutes: (5 programs X 2:00 minutes each) X 2 sides of the face = 20 minutes. The same as the BMR predicate device.
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The device recommended operating time is ranged from two minutes for one zone to 20 minutes for both sides of the face skin zones.
Description of the Operation Voltage
The Tua Face Fitness /Tua Trend Face uses a low voltage 4.8 V researchable battery to operate the device. The device/s charger will not recharge the battery while the device is in an operating mode.. The battery & rechargeable component specifications were submitted to the FDA "K192077".
6. Statement of Intended Use/Indications for Use
Tua Face Fitness/Tua Trend Face is intended for facial stimulation and is indicated for Over the Counter Cosmetic Use.
7. Summary of Technological Characteristics
We have demonstrated the new device Tua Face Fitness/Tua Trend Face substantially Equivalent to the legally marketed predicate device BMR as part of this 510k submission. Table 5.1 below provides a summary comparison of technological characteristics of Tua Trend Face (Tua Face Fitness) versus that of the predicate "BMR Face." There are no new technological characteristics that could affect the safety or effectiveness of Tua Trend Face / Tua Face Fitness.
8. Basic unit characteristics
Table 5.1 Summary comparison of Technological features of Tua Face Fitness/Tua Trend Face versus BMR Face (predicate device)
| Tua Trend Face (Tua FaceFitness)- (new device) | BMR Face (predicate device) | |
|---|---|---|
| Intended use | Tua Face Fitness/Tua Trend Face isintended for facial stimulation. | BMR Face is intended for facialstimulation. |
| Device Class | Class II | Class II |
| Indications for use | Tua Face Fitness/Tua Trend Faceis intended for facial stimulationand is indicated for Over theCounter Cosmetic Use. | BMR Face is intended for facialstimulation and is indicated for Overthe Counter Cosmetic Use. |
| Target population | Healthy Adults | Healthy adults |
| Treatment area | Facial skin | Facial skin |
| Location used | Portable-used at home | Portable-used at home |
| Operating Power | 4,8V DC rechargeable battery | 3,6V rechargeable batteries |
| Materials | Same for a plastic case, electrodescaps constructed of PVC and wetpure cellulose for skin conduction. | Plastic case built of abs, electrodes ofskin conductive through adhesivehydrogel layer. |
| Number of output modes | Five programs/zones delivered:10.0 Minutes for 5 zone/ one side.20.0 Minutes for 5 zone/both | 3 programs delivered:20.0 Minutes10.0 Minutes. |
| Number of outputchannels | Two Chanels | Two Chanels |
| Silent Use Mode | Yes | Yes |
| Automatic ShutOff | Yes | Yes |
| Intencity ControlScale | 0.0 to 60 | 0.0 to 100 |
| Biocompatibility | Facial Wand comply with ISO10993-1 "Biological evaluation ofmedical devices" ISO 10993-5:Tests for in vitro cytotoxicity, ISO10993-10: Tests for irritationIntracutaneous; Skin sensitization;Cytotoxicity-Elution method. | Gel pads comply with ISO 10993-5and ISO 10993-10. |
| Regulated currentor regulatedvoltage | Rechargeable Battery is regulatedthrough intensity control. | Rechargeable Battery is regulatedthrough intensity control. |
| Compatibilitywith Electrical.Environmentaland GeneralRequirement. | Complies to IEC 60601-1-2Medical electrical equipment -Part I-2: General requirements forsafety—Collateral standard:Electromagnetic compatibility -Requirements and tests. | Complies to IEC 60601-1-2 Medicalelectrical equipment - Part I-2:General requirements for safety—Collateral standard: Electromagneticcompatibility -Requirements andtests. |
| Sterility | Non-Sterile | Non-Sterile |
| Electrical safety | Complies to IEC 60601-1 Medicalelectrical equipment-Part 1General requirements for safety &IEC 60601-2-10 Medicalelectrical equipment-Part 2:10;Particular requirements for thesafety of nerve and musclestimulators. | Complies to IEC 60601-1 Medicalelectrical equipment-Part 1 Generalrequirements for safety & IEC60601-2-10 Medical electricalequipment-Part 2:10; Particularrequirements for the safety of nerveand muscle stimulators. |
| Compliance* with21 CFR 898 | Yes | Yes |
| Mechanical safety | Complies to IEC 60601-1 &IEC60601-2-10 | Complies to IEC 60601-1 &IEC60601-2-10 |
| Thermal safety | Complies to IEC 60601-1 &IEC60601-2-10 | Complies to IEC 60601-1 &IEC60601-2-10 |
| Radiation safety | Non-applicable | Non-applicable |
| Electrical Charger | IEC 60601-1, IEC 60601-1-2, IEC60601-2-10 charger IEC 60950 | IEC 60601-1, IEC 60601-1-2, IEC60601-2-10 charger IEC 60950 |
| Software | Class A low risk designation.Completed based on the"Guidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices." | Completed based on the "Guidancefor the Content of PremarketSubmissions for Software Containedin Medical Devices." |
| SoftwarePrograms | 5 program/zones. 20 , 10 minutesand 2 minutes. | 3 programs 20, 10 and 5 minutes. |
| Program Control | Intensity, Time, and Silent mode. | Intensity, time, and Silent mode. |
| Program Memory | Yes, Memory Function | Yes, Memory Function |
| Design | Device contains a control unit, anapplicator, spare parts electrodescaps, charger, instructions for use. | The device contains a control unit, anapplicator, gel pads, charger andinstruction for use. |
| User interface | The user interfaces with the hand-held electrodes wand. The useralso interacts with the control unit- On/off/pause button, and thechoice of program mode such asincrease or decrease intensity onthe device. | The user interfaces with the controlunit, applicator, and gel pads. Theuser interacts will the control unit -On/off/pause button, increase ordecrease intensity on the left andright-hand sides of the device. |
| IndicatorDisplay? | Yes | Yes |
| Patient Overridecontrol? | Yes | Yes |
| ON/Off Status | Yes | Yes |
| Low BatteryIndicator | Yes | Yes |
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9. Device Output specifications (related to Prog. #1)
| Tua Trend Face / TuaFace Fitness (newdevice) | BMR Face (predicatedevice) | |
|---|---|---|
| Mode or program names | Programs N°1, 2, 3, 4, 5 | P1, P2, P3 |
| Waveform | biphasic symmetrical | biphasic symmetrical |
| Shape (output voltage – resistive load) | Sinusoidal | Rectangular |
| Maximum output voltage (V) (+/- 10%) | 19,1 @500 Ω36,8 @2 KΩ69,5 @10 KΩ | 15 @500 Ω60 @2 KΩ32 @10 KΩ |
| Maximum output current (mA) (+/-10%) | 38,2 @500 Ω18,4 @2 KΩ6,95 @10 KΩ | 30 @500 Ω30 @2 KΩ3,2 @10 KΩ |
| Duration of primary phase (depolarizing) (μS) | 75uS | 100uS |
| Pulse duration (positive+ negative) (μς) | 150uS | 160-200uS |
| Frequency of modulation (Hz) | 20-40-80 | 70-80 |
| Net charge (per pulse) | Zero (biphasic symmetrical) | Zero (biphasic symmetrical) |
| Max phase charge @500Ω (μC) | 5,73 | 6 |
| Max current density (mA/cm², r.m.s.) @500Ω | 1,31 | 1 |
| Max average current (mA) @500Ω | 5,95mA | 4,1mA |
| Max average Power Density (W/cm²) | 3,91 W/ cm² | 3,91 W/ cm² |
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The carrier frequency, its shape and waveform are the same for all the programs. (see waveform Specification on table below; The same for the max values of voltage, current, net charge, max phase charge, max current density, max average current, max average power density). These are pre-programed into the device's Central Process, except the intensity which is control by the client to reduce or increase the intensity through upper or lower arrow button (The intensity represents the duty cycle/frequency and the contraction/recovery time.)
| Programs (isto be treated) | Time(Min) | working Phase | ||||||
|---|---|---|---|---|---|---|---|---|
| t (sec.) | PulseON | PulseOFF | Dutycycle % | Frequency(Hz) | Contraction time(sec.) | Recoverytime (sec.) | ||
| 1Zygomaticarea | 2 | 120 | 6mS | 44mS | 12 | 20 | 4 | 1 |
| 2 (cheek) | 2 | 120 | 2.5mS | 22.5mS | 10 | 40 | 4 | 2 |
| 3(forehead) | 2 | 120 | 3mS | 9.5mS | 24 | 80 | 2 | 1 |
| 4 (chin andjaw) | 2 | 120 | 2.5mS | 22.5mS | 10 | 40 | 3 | 1 |
| 5 (eyebags) | 2 | 120 | 6mS | 44mS | 12 | 20 | 3 | 1 |
ON time (contraction) is 2-4, 5 seconds and OFF time (recovery) is 1- 0.5 second.
As the data above show the similarity of the values measured., the main minor difference is because of the different shape of the voltage wave (sinusoidal/rectangular) seen on a resistive load, but as the real impedance load of the face is not resistive, but resistive/capacitive, the shape of the current becomes very similar (almost sinusoidal). As showed by the tables, there are no new technological characteristics and no significant differences between Tua Face Fitness/Tua Trend Face device and BMR Face that could affect the safety or effectiveness of the device. Our device has been on the market in Europe since year 2002 with no adverse effect that affects the safety of the users.
10. Clinical and Non-Clinical Tests
Clinical Tests:
No new clinical studies have been submitted as part of this Premarket Notification. Non-Clinical Tests: Tua Trend Face (Tua Face Fitness) has been designed and independently tested to the following requirements:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety. ●
- IEC 60601-1-2 General requirements for basic safety and essential performance -● Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-10: Requirements for the safety of nerve and muscle stimulators Also, the power supply unit complies with:
- UL 60950 Information Technology Equipment Safety Part 1: General Requirements ●
- A risk management plan was carried out per ISO 14971.
- The software is classified as a low-risk class A, as defined per the FDA guidance and the ● recognized ISO 62304.
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11. Safety and Effectiveness
Vupiesse S.R. L complied with 21 CFR 820 and was certified by TUV Rheinland in compliance to ISO 13485 Medical Device Quality Management System for the design, manufacture, and distribution of electro-medical devices.
A risk management plan was carried out per ISO 14971.
The software is classified as a low-risk class A, per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
12. Conclusions
Based on the preceding, Vupiesse S.R.L. Believe that Tua Face Fitness/Tua Trend Face device is substantially equivalent to the legally marketed predicate of BMR Face Device.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).