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 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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called T~PLUS, which is a diathermy/Tecar therapy device. The document focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical and clinical testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria in the sense of predefined thresholds for performance metrics. Instead, it details that the device underwent testing to demonstrate certain aspects. For the clinical testing, the "performance" can be inferred from the stated outcome.

Performance Aspect	Acceptance Criteria (inferred/demonstrated)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-2-2	Demonstrated compliance through testing.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Demonstrated compliance through testing.
Biocompatibility (electrodes/cream)	Compliance with ISO 10993-5 and ISO 10993-10	Demonstrated compliance through testing. Additionally, correspondence of conductive cream ingredients between INCI UE and INCI US classification, and IUPAC nomenclature, was demonstrated.
Therapeutic Temperature Maintenance	Ability to maintain therapeutic temperature between 40° and 45°C for at least 10 minutes, never exceeding 45°C.	Clinical testing demonstrated 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.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document states that clinical testing was performed but does not specify the sample size (number of patients) involved in this testing.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's "clinical testing" for a device seeking market clearance, it is generally assumed to be prospective clinical data, but this is not explicitly confirmed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number of experts or their qualifications used to establish ground truth for the clinical testing. The objective of the clinical testing was to demonstrate the device's ability to maintain a specific temperature range, which likely relies on direct measurement rather than expert interpretation of an outcome.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. Given the nature of the clinical test (temperature maintenance), it's unlikely a formal adjudication process (like 2+1 review) for primary endpoints would be necessary, as the measurement of temperature is typically objective.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study focuses on the device's ability to perform its intended function (temperature maintenance) rather than comparing performance with and without AI assistance (as this is not an AI device based on the description).

6. Standalone Performance Study

The clinical testing described is effectively a standalone performance study for the device. It demonstrates the T~PLUS's ability to maintain a therapeutic temperature without human intervention in the temperature delivery mechanism itself, although a human operator would apply the device. The reported performance details the device's outputs (temperature range and duration) when used on patients.

7. Type of Ground Truth Used

For the clinical testing of therapeutic temperature maintenance, the "ground truth" was established by direct measurement of the tissue temperature on patients, ensuring it remained within the specified range (40° to 45°C for at least 10 minutes and never exceeding 45°C). This is an objective, quantitative ground truth.

8. Sample Size for the Training Set

The document does not mention a training set as this device does not appear to involve machine learning or artificial intelligence that would typically require a training data set. The device operates based on radiofrequency physics and controls, not learned algorithms.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set or AI/ML components, this question is not applicable based on the provided text.

Summary

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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 and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: +41 (0)91 2255229 Fax: +41 (0)91 6472147 Email: claudio.freti@wintecare.ch

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

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5. Indications for Use

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 RadiofrequencyDevice - Activ; Indiba DiathermiaRadiofrequency Device - Deep Care
Submitter	Wintecare, SA	Indiba USA Inc.
Classification	Device Class: 2Product Code: PBX21 CFR 878.4400	Device Class: 2Product Code: PBX21 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.The massage device provided is intended to provide a temporary reduction in the appearance of cellulite
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Characteristic	Subject Device	Predicate Device
Trade Name	T-PLUS	Indiba Diathermia RadiofrequencyDevice - Activ; Indiba DiathermiaRadiofrequency Device - Deep Care

Prescription /Over-TheCounter(OTC) Use	Prescription Use	Prescription Use
DeviceDescription	The Wintecare T~PLUS is adevice for diathermy / Tecartherapy. It consists of a controlunit which generates aradiofrequency current which isdelivered to the patient, throughtwo different types of electrodes:stainless steel conductiveresistive electrodes, and thin layerinsulated capacitive electrodes.The electrodes are inserted into asmart handle/handpiece, onehandpiece for each kind ofelectrode, and the handpiece isconnected to the control unit bymeans of a 2metre cable.In resistive mode the systemdelivers a high-frequency currentof 447 kHz directly to the patient'sskin surface. In capacitive mode,the electrode coating creates alayer between the electrode andthe human tissue, forming acapacitor that allows a highfrequency current to pass. Thehigh frequency current isautomatically tuned by theequipment according to thepatient's impedance. Currentreturns through the indifferentreturn electrode. The RF energygenerates a heating profile thatproduces a moderate temperaturerise in the subcutaneous tissue.The Wintecare Conductive A+Cream is recommended to beused on the patients' skin prior toeach treatment session.	The Indiba Diathermia RadiofrequencyDevice is a therapeutic device for deep,non-invasive diathermy. The deviceconsists of a console which generates aradiofrequency current which is delivered tothe patient, in monopolar form, through twodifferent types of electrodes: stainless steelconductive resistive electrodes, and thin-layer insulated capacitive electrodes. Theelectrodes are inserted into ahandle/handpiece, one handle for eachkind of electrode, and the handle isconnected to the console by means of a2metre cable.In resistive mode the system delivers ahigh-frequency current of 448 kHz directlyto the patient's skin surface. In capacitivemode, the electrode coating creates a layerbetween the electrode and the humantissue, forming a capacitor that allows ahigh-frequency current to pass. The highfrequency current ranges between 400 kHzand 449 kHz and is automatically tuned bythe equipment according to the patient'simpedance. Current returns through theneutral return electrode. The IndibaDiathermia Radiofrequency Device isprovided with an electroconductive mediawhich is applied to the patients' skin prior toeach treatment session.The RF energy generates a heating profilethat produces a moderate temperature risein the subcutaneous tissue.The temperature on the skin is measuredusing a separate IR (Infra-red)thermometer and there is an integratedmassage device that can be used tomassage the skin during cellulite treatment.
Characteristic	Subject Device	Predicate Device
Trade Name	T~PLUS	Indiba Diathermia RadiofrequencyDevice - Activ; Indiba DiathermiaRadiofrequency Device - Deep Care
Display/ UserInterface	5.7 inch TFT color 320 x 240pixels	5.7 inch TFT color 320 x 240 pixels
TechnicalSpecifications

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Timer range	3 – 90 minutes	0 – 99 minutes
OutputFrequency	447 kHz	448 ± 1 kHz
Input voltagesupply	100 - 240 V, 50/60 Hz	100 – 130 V, 50/60 Hz
Output PowerRating	RES: 300W CAP:450VA	Indiba Devices
		activ 7 activ CT8 active CT9 RES 65 W 100 W 200 W CAP 250 VA 350 VA 450 VA Deep areELITE Deep CareELITE NS Deep CareRGN RES 200 W 200 W 65 W CAP 450 VA 450 VA 250 VA
Operatingtemperature	+10°C to +40°C	+10°C to +40°C
Storage andTransporttemperature	-40°C to +70°C	-20°C to +50°C
Conformity toStandards
Electrical Safety	60601-160601-2-2: Medical electricalequipment. Particularrequirements for the basic safetyand essential performance of highfrequency surgical equipment andhigh frequency surgicalaccessories.	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.

Regulation Number and Section

§ 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.