(200 days)
Not Found
No
The document describes a standard radiofrequency diathermy device with automatic impedance tuning, which is a common engineering feature and does not indicate the presence of AI or ML. There are no mentions of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as providing "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," and includes a "massage device provided is intended to provide a temporary reduction in the appearance of cellulite," all of which are therapeutic indications.
No
The device is intended for therapeutic purposes like pain relief, muscle spasm reduction, and increasing local circulation, rather than for diagnosing medical conditions.
No
The device description clearly outlines hardware components including a control unit, electrodes, handpieces, and cables, which are integral to its function of delivering radiofrequency current for therapeutic heating.
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 treatment of selected medical conditions" and "temporary reduction in the appearance of cellulite." These are therapeutic applications, not diagnostic ones.
- Device Description: The description details how the device generates and delivers radiofrequency current to the patient's tissue for heating. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
In summary, the T~PLUS is a therapeutic device that uses radiofrequency energy for heating and massage, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PBX
Device Description
The Wintecare TPLUS 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 TPLUS. The cream is offered with the T~PLUS and is part of this 510(k) submission.
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)
Non-clinical Bench (Performance) testing: The Electrical Safety and Electromagnetic Compatibility of the TPLUS 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 TPLUS is demonstrated through testing conducted per standards ISO 10993-5 and ISO 10993-10. 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.
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.
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
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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.
1
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
2
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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3
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
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.
4
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 TPLUS. The cream is offered with the TPLUS 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 |
| Device - Activ; Indiba Diathermia | ||
| Radiofrequency Device - Deep Care | ||
| Submitter | Wintecare, SA | Indiba USA Inc. |
| Classification | Device Class: 2 | |
| Product Code: PBX | ||
| 21 CFR 878.4400 | Device Class: 2 | |
| Product Code: PBX | ||
| 21 CFR 878.4400 |
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. | 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 |
| --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Trade Name | T-PLUS | Indiba Diathermia Radiofrequency |
| Device - Activ; Indiba Diathermia | ||
| Radiofrequency Device - Deep Care | ||
| Prescription / | ||
| Over- | ||
| TheCounter | ||
| (OTC) Use | Prescription Use | Prescription Use |
| 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. | ||
| The 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 2metre 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 Wintecare Conductive A+
Cream is recommended to be
used on the patients' skin prior to
each treatment session. | The Indiba Diathermia Radiofrequency
Device is a therapeutic device for deep,
non-invasive diathermy. The device
consists of a console which generates a
radiofrequency current which is delivered to
the patient, in monopolar form, through two
different types of electrodes: stainless steel
conductive resistive electrodes, and thin-
layer insulated capacitive electrodes. The
electrodes are inserted into a
handle/handpiece, one handle for each
kind of electrode, and the handle is
connected to the console by means of a
2metre cable.
In resistive mode the system delivers a
high-frequency current of 448 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 ranges between 400 kHz
and 449 kHz and is automatically tuned by
the equipment according to the patient's
impedance. Current returns through the
neutral return electrode. The Indiba
Diathermia Radiofrequency Device is
provided with an electroconductive media
which is applied to the patients' skin prior to
each treatment session.
The RF energy generates a heating profile
that produces a moderate temperature rise
in the subcutaneous tissue.
The temperature on the skin is measured
using a separate IR (Infra-red)
thermometer and there is an integrated
massage device that can be used to
massage the skin during cellulite treatment. |
| Characteristic | Subject Device | Predicate Device |
| Trade Name | T~PLUS | Indiba Diathermia Radiofrequency
Device - Activ; Indiba Diathermia
Radiofrequency Device - Deep Care |
| Display/ User
Interface | 5.7 inch TFT color 320 x 240
pixels | 5.7 inch TFT color 320 x 240 pixels |
| Technical
Specifications | | |
6
7
| Timer range | 3 – 90 minutes | 0 – 99 minutes | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Output | ||||||||||||||||||||||||||
| Frequency | 447 kHz | 448 ± 1 kHz | ||||||||||||||||||||||||
| Input voltage | ||||||||||||||||||||||||||
| supply | 100 - 240 V, 50/60 Hz | 100 – 130 V, 50/60 Hz | ||||||||||||||||||||||||
| Output Power | ||||||||||||||||||||||||||
| Rating | 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 are | ||||||||||||||||||||||||||
| ELITE Deep Care | ||||||||||||||||||||||||||
| ELITE NS Deep Care | ||||||||||||||||||||||||||
| RGN RES 200 W 200 W 65 W CAP 450 VA 450 VA 250 VA | ||||||||||||||||||||||||||
| Operating | ||||||||||||||||||||||||||
| temperature | +10°C to +40°C | +10°C to +40°C | ||||||||||||||||||||||||
| Storage and | ||||||||||||||||||||||||||
| Transport | ||||||||||||||||||||||||||
| temperature | -40°C to +70°C | -20°C to +50°C | ||||||||||||||||||||||||
| Conformity to | ||||||||||||||||||||||||||
| Standards | ||||||||||||||||||||||||||
| Electrical Safety | 60601-1 | |||||||||||||||||||||||||
| 60601-2-2: Medical electrical | ||||||||||||||||||||||||||
| equipment. Particular | ||||||||||||||||||||||||||
| requirements for the basic safety | ||||||||||||||||||||||||||
| and essential performance of high | ||||||||||||||||||||||||||
| frequency surgical equipment and | ||||||||||||||||||||||||||
| high frequency surgical | ||||||||||||||||||||||||||
| 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.
8
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.