T-PLUS

K181893 · Wintecare SA · PBX · Jan 29, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K181893
• Device Name: T-PLUS
• Applicant: Wintecare SA
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Jan 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T~PLUS is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

Device Story

T~PLUS is a diathermy/Tecar therapy device; generates 447 kHz radiofrequency (RF) current. System includes control unit, 2-meter cable, and two handpieces (one for stainless steel resistive electrodes, one for thin-layer insulated capacitive electrodes). In resistive mode, current flows directly to skin; in capacitive mode, electrode coating acts as a capacitor. Device automatically tunes current based on patient impedance; current returns via indifferent return electrode. Conductive A+ cream applied to skin prior to treatment. Used in clinical settings by healthcare providers to generate subcutaneous heating. Output is controlled via 5.7-inch TFT display. Heating profile aims to elevate tissue temperature to 40°C–45°C for therapeutic benefit.

Clinical Evidence

Clinical testing demonstrated the device's ability to maintain therapeutic subcutaneous tissue temperatures between 40°C and 45°C for at least 10 minutes without exceeding 45°C.

Technological Characteristics

Diathermy/Tecar therapy device; 447 kHz RF output. Materials: stainless steel electrodes, insulated capacitive electrodes. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (HF surgical equipment), ISO 10993-5/10 (biocompatibility). Interface: 5.7-inch TFT color display (320x240 pixels). Power: 100-240V, 50/60Hz. Connectivity: wired handpiece connection.

Indications for Use

Indicated for patients requiring topical heating for pain relief, muscle spasms, or increased local circulation, and for temporary reduction in the appearance of cellulite.

Regulatory Classification

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.

Predicate Devices

• Indiba Diathermia Radiofrequency Device Activ; Indiba Diathermia Radiofrequency Device - Deep Care (K161458)

Submission Summary (Full Text)

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January 29, 2019

Wintecare SA Mr. Claudio Freti Director Via Livio 12 6830 Chiasso Switzerland

Re: K181893

Trade/Device Name: T-plus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: January 10, 2019 Received: January 16, 2019

Dear Mr. Freti:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Image /page/1/Picture/6 description: The image shows a signature block. The signature is for Long H. Chen, and it was digitally signed on January 29, 2019, at 08:51:50 -05'00'. The signature is for Binita S. Ashar, M.D., M.B.A., F.A.C.S., who is the Director of the Division of Surgical Devices.

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K181893

Device Name T~PLUS

Indications for Use (Describe)

The T~PLUS is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide 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) |

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Image /page/3/Picture/1 description: The image contains the logo for Wintecare. The logo consists of a circular design with three overlapping arcs in red, black, and gray. Below the logo, the word "WINTECARE" is written in a serif font, with "WINTE" in black and "CARE" in red.

# 510(k) Summary

#### 1. Sponsor/ Applicant

Wintecare SA Via Livio 12, 6830 Chiasso Switzerland

Mr. Claudio Freti Position: CEO/Director Phone: [phone] Fax: [phone] Email: [e-mail]

Summary Preparation Date: January 24, 2019

#### 2. Device

| Trade Name | T~PLUS |
|-------------------|---------------------------|
| Classification | Class II |
| Product Code | PBX |
| Regulation Number | 21 CFR 878.4400 |
| Review Panel | General & Plastic Surgery |

#### 3 . Predicate Device

- · Indiba Diathermia Radiofrequency Device Activ; Indiba Diathermia Radiofrequency Device - Deep Care (K161458)
#### 4 . Device Description

The Wintecare T~PLUS is a device for diathermy / Tecar therapy. It consists of a control unit which generates a radiofrequency current which is delivered to the patient, through two different types of electrodes: stainless steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a smart handle/handpiece, one handpiece for each kind of electrode, and the handpiece is connected to the control unit by means of a 2-metre cable.

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In resistive mode the system delivers a high-frequency current of 447 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current to pass. The high frequency current is automatically tuned by the equipment according to the patient's impedance. Current returns through the indifferent return electrode. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue.

The use of Wintecare Conductive A+ Cream is recommended on the patients' skin prior to each treatment session with the T~PLUS. The cream is offered with the T~PLUS and is part of this 510(k) submission.

#### 5. Indications for Use

The T~PLUS is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

#### 6. Technological Characteristics and Substantial Equivalence

The proposed T~PLUS is substantially equivalent to the referenced predicate device in regard to the intended use, fundamental scientific technology, and technological characteristics, as outlined in the following table:

### Table 1: Substantial Equivalence Comparison between T~PLUS and the Predicate Device

| Characteristic | Subject Device | Predicate Device |
|----------------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Trade Name | T~PLUS | Indiba Diathermia Radiofrequency<br>Device - Activ; Indiba Diathermia<br>Radiofrequency Device - Deep Care |
| Submitter | Wintecare, SA | Indiba USA Inc. |
| Classification | Device Class: 2<br>Product Code: PBX<br>21 CFR 878.4400 | Device Class: 2<br>Product Code: PBX<br>21 CFR 878.4400 |

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| Indications for Use | The T~PLUS is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite. | The Indiba Diathermia Radiofrequency Devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.<br>The massage device provided is intended to provide a temporary reduction in the appearance of cellulite |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Characteristic | Subject Device | Predicate Device |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | T-PLUS | Indiba Diathermia Radiofrequency<br>Device - Activ; Indiba Diathermia<br>Radiofrequency Device - Deep Care |
| | | |
| Prescription /<br>Over-<br>TheCounter<br>(OTC) Use | Prescription Use | Prescription Use |
| Device<br>Description | The Wintecare T~PLUS is a<br>device for diathermy / Tecar<br>therapy. It consists of a control<br>unit which generates a<br>radiofrequency current which is<br>delivered to the patient, through<br>two different types of electrodes:<br>stainless steel conductive<br>resistive electrodes, and thin layer<br>insulated capacitive electrodes.<br>The electrodes are inserted into a<br>smart handle/handpiece, one<br>handpiece for each kind of<br>electrode, and the handpiece is<br>connected to the control unit by<br>means of a 2metre cable.<br><br>In resistive mode the system<br>delivers a high-frequency current<br>of 447 kHz directly to the patient's<br>skin surface. In capacitive mode,<br>the electrode coating creates a<br>layer between the electrode and<br>the human tissue, forming a<br>capacitor that allows a high<br>frequency current to pass. The<br>high frequency current is<br>automatically tuned by the<br>equipment according to the<br>patient's impedance. Current<br>returns through the indifferent<br>return electrode. The RF energy<br>generates a heating profile that<br>produces a moderate temperature<br>rise in the subcutaneous tissue.<br>The Wintecare Conductive A+<br>Cream is recommended to be<br>used on the patients' skin prior to<br>each treatment session. | The Indiba Diathermia Radiofrequency<br>Device is a therapeutic device for deep,<br>non-invasive diathermy. The device<br>consists of a console which generates a<br>radiofrequency current which is delivered to<br>the patient, in monopolar form, through two<br>different types of electrodes: stainless steel<br>conductive resistive electrodes, and thin-<br>layer insulated capacitive electrodes. The<br>electrodes are inserted into a<br>handle/handpiece, one handle for each<br>kind of electrode, and the handle is<br>connected to the console by means of a<br>2metre cable.<br><br>In resistive mode the system delivers a<br>high-frequency current of 448 kHz directly<br>to the patient's skin surface. In capacitive<br>mode, the electrode coating creates a layer<br>between the electrode and the human<br>tissue, forming a capacitor that allows a<br>high-frequency current to pass. The high<br>frequency current ranges between 400 kHz<br>and 449 kHz and is automatically tuned by<br>the equipment according to the patient's<br>impedance. Current returns through the<br>neutral return electrode. The Indiba<br>Diathermia Radiofrequency Device is<br>provided with an electroconductive media<br>which is applied to the patients' skin prior to<br>each treatment session.<br>The RF energy generates a heating profile<br>that produces a moderate temperature rise<br>in the subcutaneous tissue.<br><br>The temperature on the skin is measured<br>using a separate IR (Infra-red)<br>thermometer and there is an integrated<br>massage device that can be used to<br>massage the skin during cellulite treatment. |
| Characteristic | Subject Device | Predicate Device |
| Trade Name | T~PLUS | Indiba Diathermia Radiofrequency<br>Device - Activ; Indiba Diathermia<br>Radiofrequency Device - Deep Care |
| Display/ User<br>Interface | 5.7 inch TFT color 320 x 240<br>pixels | 5.7 inch TFT color 320 x 240 pixels |
| Technical<br>Specifications | | |

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| Timer range | 3 – 90 minutes | 0 – 99 minutes | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Output<br>Frequency | 447 kHz | 448 ± 1 kHz | | | | | | | | | | | | | | | | | | | | | | | | |
| Input voltage<br>supply | 100 - 240 V, 50/60 Hz | 100 – 130 V, 50/60 Hz | | | | | | | | | | | | | | | | | | | | | | | | |
| Output Power<br>Rating | RES: 300W CAP:<br>450VA | Indiba Devices | | | | | | | | | | | | | | | | | | | | | | | | |
| | | activ 7 activ CT8 active CT9 RES 65 W 100 W 200 W CAP 250 VA 350 VA 450 VA Deep are<br>ELITE Deep Care<br>ELITE NS Deep Care<br>RGN RES 200 W 200 W 65 W CAP 450 VA 450 VA 250 VA | | | | | | | | | | | | | | | | | | | | | | | | |
| Operating<br>temperature | +10°C to +40°C | +10°C to +40°C | | | | | | | | | | | | | | | | | | | | | | | | |
| Storage and<br>Transport<br>temperature | -40°C to +70°C | -20°C to +50°C | | | | | | | | | | | | | | | | | | | | | | | | |
| Conformity to<br>Standards | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Electrical Safety | 60601-1<br>60601-2-2: Medical electrical<br>equipment. Particular<br>requirements for the basic safety<br>and essential performance of high<br>frequency surgical equipment and<br>high frequency surgical<br>accessories. | 60601-1 | | | | | | | | | | | | | | | | | | | | | | | | |
| EMC | 60601-1-2 | 60601-1-2 | | | | | | | | | | | | | | | | | | | | | | | | |

#### 7. Non-clinical Bench (Performance) testing

The Electrical Safety and Electromagnetic Compatibility of the T~PLUS is demonstrated through testing conducted in compliance with standards IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2, respectively.

In addition, the Biocompatibility of the electrodes and conductive cream used with the T~PLUS is demonstrated through testing conducted per standards ISO 10993-5 and ISO 10993-10.

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With regard to the conductive cream, evidences of ingredients' correspondence between the INCI UE classification and INCI US classification as well as IUPAC nomenclature have been demonstrated.

#### 8. Clinical Testing

The submission also contains data from clinical testing, demonstrating the ability of the T~PLUS to maintain therapeutic temperature for at least 10 minutes on patients, between 40° and 45° C, never exceeding 45° C.

#### 9. Conclusion:

Based on the intended use, design, technological characteristics and performance data provided in the submission, clinical and non-clinical testing the T~PLUS device is substantially equivalent to the referenced predicate devices.