(315 days)
Not Found
No
The summary describes a diathermy device that uses electrical current to generate heat. There is no mention of AI, ML, image processing, or any data-driven decision-making or learning capabilities. The "automatic mode" mentioned in the test description appears to refer to a pre-set or controlled mode of operation, not an AI/ML driven one.
Yes
The device is described as "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," which aligns with the definition of a therapeutic device.
No
The device is intended to provide topical heating for therapeutic purposes, such as pain relief and muscle spasm reduction, and does not perform any diagnostic functions.
No
The device description explicitly states it is composed of hardware components such as a touch screen, Multi-Function knob, plate, handpiece for radiofrequency energy delivery, and an on/off button, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide topical heating for therapeutic purposes (pain relief, muscle spasms, increased circulation). This is a treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a diathermy device that uses electrical current to increase tissue temperature. This is a physical therapy modality.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
The Doctor Tecar Plus and Doctor Tecar Smart 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.
Product codes (comma separated list FDA assigned to the subject device)
PBX
Device Description
Doctor Tecar Plus and Doctor Tecar Smart are devices for diathermy. This therapy develops an increase in temperature in the area of the body which is treated through the passage of a particular electrical current. Through twin delivering modes, capacitive and resistive, the operator can set a specific treatment. The purpose of the treatment is to raise the temperature inside the tissue at a value maximum to 45 °C. The device is composed by a touch screen and a Multi-Function knob (only Plus model) for managing all the device's functions, a plate, an handpiece for the delivery of radiofrequency energy, software and an on/off button to activate and deactivate the energy emission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The devices are developed as portable devices indicated in therapy for muscular & skeletal pathologies.
Indicated Patient Age Range
Whole population
Intended User / Care Setting
Prescription Use (21 CFR 801, Subpart D)
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
A test was performed to in order to to demonstrate the capability of Doctor Tecar Smart/Plus to maintain the temperature on the surface of the human skin. Based on the treatment recommendations, the test report demonstrates that Doctor Tecar Plus is capable of maintaining a skin surface temperature of 40℃ - 45℃ for 10-20 minutes after the temperature of the skin has reached 40℃. The test recorded actual skin temperature data to demonstrate safety when using the device as intended. The temperature test was done evaluating the device on 3 different people and for each people it was done the test on three different place on the body that are consistent with our instructions and indication for use. In this test we have included people with light and dark skin and people with different somatotype. For each person and for each place the test was performed in automatic mode, using electrodes and in manual mode with nine different applicators: small flat applicator, small rounded applicator, medium flat applicator, medium rounded applicator, big flat applicator, big rounded applicator, medium capacitive applicator, small bipolar applicator and big bipolar applicator. The temperature of the skin was measured every minutes for a treatment period of 12 minutes after the temperature of the skin has reached the 40°C. No discrepancies were found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Test: A test was performed to demonstrate the capability of Doctor Tecar Smart/Plus to maintain the temperature on the surface of the human skin. The test was done evaluating the device on 3 different people on three different places on the body, including people with light and dark skin and different somatotypes. The test demonstrated that Doctor Tecar Plus is capable of maintaining a skin surface temperature of 40℃ - 45℃ for 10-20 minutes after the temperature of the skin has reached 40℃. The temperature of the skin was measured every minute for a treatment period of 12 minutes after the temperature of the skin reached 40°C. No discrepancies were found.
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
February 17, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Mectronic Medicale S.r.l. Gloria Aloisini Quality Manager Via Orio al Serio 15 Grassobbio, BG 24050 Italy
Re: K221043
Trade/Device Name: Doctor Tecar Plus, Doctor Tecar Smart Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: January 16, 2023 Received: January 18, 2023
Dear Gloria Aloisini:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 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,
Colin K. Chen -S
for
Long Chen, 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
Indications for Use
510(k) Number (if known) K221043
Device Name Doctor Tecar Plus Doctor Tecar Smart
Indications for Use (Describe)
The Doctor Tecar Plus and Doctor Tecar Smart 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.
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/2 description: The image shows a logo for a company called "Electronic Medicale". The logo features a blue star on the left side, followed by the word "Electronic" in a stylized font. Below "Electronic", the word "Medicale" is written in a smaller, sans-serif font, also in blue. The overall design has a slightly three-dimensional effect, with subtle shading and depth.
510(K) SUMMARY
510(k) Number K221043 510(k) Application Traditional
CONTACT DETAILS
Mectronic Medicale S.r.l. Via Orio al Serio, 15 24050 Grassobbio (BG) ITALY Phone: +39 035 656080, FAX: +39 035 65736 Official Correspondent Gloria Aloisini Mectronic Medicale S.r.l. gloriaaloisini@mectronicmedicale.it Phone: +39 035 656080, FAX: +39 035 65736
TRADE NAME
Doctor Tecar Plus Doctor Tecar Smart Common Name Device Common name: Radiofrequency Device Classification name Classification name: Electrosurgical, cutting and coagulation accessories Classification: Class II Regulation Nos .: 21 CFR 878.4400 Product Codes: 79 PBX - Massager, Vacuum, Radio Frequency Induced Heat
PREDICATE DEVICE
The device under submission is substantially equivalent to the predicate devices:
- NuEra Tight RF Family, K200359, Bios S.r.l.
DEVICE DESCRIPTION
Doctor Tecar Plus and Doctor Tecar Smart are devices for diathermy. This therapy develops an increase in temperature in the area of the body which is treated through the passage of a particular electrical current. Through twin delivering modes, capacitive and resistive, the operator can set a specific treatment. The purpose of the treatment is to raise the temperature inside the tissue at a value maximum to 45 °C. The device is composed by a touch screen and a Multi-
4
K221043 510(k) Summary
Image /page/4/Picture/2 description: The image shows a logo for a company called "Electronic Medicale". The logo features a stylized star shape in dark blue, positioned to the left of the company name. The text "ELECTRONIC" is in a stylized font, with the letters connected and a horizontal line above them. Below "ELECTRONIC" is the word "MEDICALE" in a smaller font.
Function knob (only Plus model) for managing all the device's functions, a plate, an handpiece for the delivery of radiofrequency energy, software and an on/off button to activate and deactivate the energy emission.
DEVICE INTENDED USE
The Doctor Tecar Plus and Doctor Tecar Smart 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.
PREDICATE DEVICE COMPARISON
The product specification, functionality, indications for use, and treatment parameters of the Doctor Tecar Smart and Doctor Tecar Plus are the same or very similar to the legally marketed predicate and reference devices. The technological similarities and differences between the doctor Tecar Smart/Plus and the predicate devices are described in the following table.
| Feature | Predicate Device | Doctor Tecar Device | Comments |
|---|---|---|---|
| Regulation and product | |||
| Classification Code | 21 CFR 878.4400 | ||
| PBX | 21 CFR 878.4400 | ||
| PBX | - | ||
| Intended Use / Indication | |||
| For Use | The device is is intended to | ||
| provide topical heating for the | |||
| purpose of elevating tissue | |||
| temperature for the | |||
| treatment of selected medical | |||
| conditions such as relief of | |||
| pain, muscle spasms, and | |||
| increase in local circulation. | Same | - | |
| Type of use | Prescription Use (21 CFR 801, | ||
| Subpart D) | Same | - | |
| Target Population | Whole population | Same | - |
| Anatomical Site | The devices are developed as | ||
| portable devices indicated in | |||
| therapy for muscular & | |||
| skeletal pathologies. | Same | - | |
| Clinical use | Prescription type | Same | - |
| Energy Used And/Or | |||
| Delivered | 250 W | PLUS : 200 VA | |
| SMART: 70 VA | No significant | ||
| difference | |||
| Frequencies | 470 kHz; 1 MHz; 2 MHz; 4 | ||
| MHz ; 6 MHz | PLUS : 300 kHz - 448 kHz - 500 | ||
| kHz - 750 kHz - 1 MHz - 1.2 MHz |
- 1.5 MHz | No significant
difference |
5
Image /page/5/Picture/0 description: The image shows a logo for a company called "Electronic Medicale". The logo features a blue star on the left side, followed by the company name in a stylized font. The word "Electronic" is larger and more prominent, while the word "Medicale" is smaller and positioned below it.
K221043 510(k) Summary
| Feature | Predicate Device | Doctor Tecar Device | Comments |
|---|---|---|---|
| SMART : 448 kHz - 750 kHz | No significant | ||
| difference | |||
| Type of energy | Radiofrequency Waves | Radiofrequency Waves | - |
| Active Electrode | Round shape | Same | - |
| Neutral Electrode | Rectangular shape | Same | - |
| Design | Radiofrequency Energy with | ||
| intensity adjustment from 0% | |||
| to 100% | Same | - | |
| Patient Safety Switch | Available | Same | - |
| Human Factors | Graphical user interface | ||
| allows a better user | |||
| experience and proper | |||
| therapy selection | Same | ||
| IEC 60601-1-6 | - | ||
| Standards Met | IEC 60601-1; | ||
| IEC 60601-1- 2 | |||
| IEC 60601-2-2 | |||
| IEC 60601-1- 6 | |||
| IEC 62304 | |||
| ISO 14971 | CEI EN 60601-1 | ||
| CEI EN 60601-1-2 | |||
| IEC 60601-2-2 | |||
| IEC 60601-1-6 | |||
| IEC 62304 | |||
| IEC 62366 | |||
| UNI EN ISO 14971 | No significant | ||
| differences | |||
| Biocompatibility | IEC 60601 - 1 | ||
| ISO 10993 | IEC 60601 - 1 | ||
| ISO 10993 | - | ||
| Compatibility With The | |||
| Environment And Other | |||
| Devices | IEC 60601-1-2 | IEC 60601-1-2 | - |
| Sterility | N.A. | N.A. | - |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | - |
| Mechanical Safety | IEC 60601-1 | IEC 60601-1 | - |
| Chemical Safety | IEC 60601-1 | IEC 60601-1 | - |
| Thermal Safety | IEC 60601-1 | IEC 60601-1 | - |
SAFETY TEST
The device has been tested and found in compliance with the following standards
- CEI EN 60601-1 Electro-medical equipment – General requirements for safety.
- . CEI EN 60601-1-2 Electro-medical equipment - General requirements for safety – Secondary standard: Electromagnetic compatibility - Prescriptions and tests.
- . IEC 60601-2-2 Medical electrical equipment. Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
6
K221043 510(k) Summary
Image /page/6/Picture/2 description: The image shows a logo for a company called "Electronic Medicale". The logo features a blue star on the left side, followed by the word "Electronic" in blue, stylized font. Below "Electronic" is the word "Medicale" in a smaller, blue, stylized font. The logo has a slight shadow effect, giving it a three-dimensional appearance.
- IEC 60601-1-6 Medical electrical equipment- Part 1: General requirements for basic safety and essential Performance. Collateral standard: Usability.
- IEC 62304 Medical device software - Software life-cycle processes.
- IEC 62366 Medical devices -Application of usability engineering to medical devices .
- . UNI EN ISO 14971 Medical devices - Application of risk management to medical devices.
BENCH TEST
A test was performed to in order to to demonstrate the capability of Doctor Tecar Smart/Plus to maintain the temperature on the surface of the human skin. Based on the treatment recommendations, the test report demonstrates that Doctor Tecar Plus is capable of maintaining a skin surface temperature of 40℃ - 45℃ for 10-20 minutes after the temperature of the skin has reached 40℃. The test recorded actual skin temperature data to demonstrate safety when using the device as intended. The temperature test was done evaluating the device on 3 different people and for each people it was done the test on three different place on the body that are consistent with our instructions and indication for use. In this test we have included people with light and dark skin and people with different somatotype. For each person and for each place the test was performed in automatic mode, using electrodes and in manual mode with nine different applicators: small flat applicator, small rounded applicator, medium flat applicator, medium rounded applicator, big flat applicator, big rounded applicator, medium capacitive applicator, small bipolar applicator and big bipolar applicator. The temperature of the skin was measured every minutes for a treatment period of 12 minutes after the temperature of the skin has reached the 40°C. No discrepancies were found.
BIOCOMPATIBILITY
The Doctor Tecar Smart and Doctor Tecar Plus patient-contacting components have surfaces that, in accordance with the instructions for use, are categorized as 'surface devices', contacting 'intact skin', for a 'limited' time period (