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.

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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria in the typical sense of an AI/ML medical device submission. Instead, it describes a 510(k) submission for a non-AI medical device (radiofrequency device) and its general safety and performance testing.

The document primarily focuses on establishing substantial equivalence for the "Doctor Tecar Plus" and "Doctor Tecar Smart" devices to a predicate device (NuEra Tight RF Family, K200359). The "study" mentioned is a "Bench Test" to demonstrate the device's capability to maintain skin temperature.

Given the information, I will interpret the request within the context of the provided document, even though it doesn't involve AI/ML or comparative effectiveness studies with human readers.

Here's an attempt to extract and present the information based on the provided text:

Acceptance Criteria and Device Performance (Based on provided "Bench Test")

1. Table of Acceptance Criteria & Reported Device Performance

Acceptance Criteria (from "Bench Test" description)	Reported Device Performance (from "Bench Test" description)
Capability to maintain a skin surface temperature of 40℃ - 45℃ for 10-20 minutes after the temperature of the skin has reached 40℃.	"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℃." "No discrepancies were found."
Safety demonstration when using the device as intended.	"The test recorded actual skin temperature data to demonstrate safety when using the device as intended." "No discrepancies were found."

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

Sample Size: 3 different people.
Data Provenance: The document does not specify the country of origin of the data. The test was conducted for each person in three different places on the body. It included participants with light and dark skin, and different somatotypes. The test was performed in automatic mode (using electrodes) and in manual mode (with nine different applicators) for each person and each body place. The nature of the study appears to be a prospective bench test, as it describes actively performing measurements.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable (N/A): This type of information is not relevant to the described "Bench Test." The test focuses on physical measurements (temperature) directly from the device and human skin, not on subjective expert interpretation of output (like image diagnosis with AI). There's no mention of experts establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not Applicable (N/A): No adjudication method is mentioned or required for this type of quantitative bench test. The temperature measurements are objective.

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

No: A MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a radiofrequency medical device, not an AI/ML diagnostic aid. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Not Applicable (N/A): This is a physical medical device, not an algorithm. The "Bench Test" describes the device's direct physical performance; thus, the concept of "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used

Physical Measurements/Observed Performance: The "ground truth" in this context is the actual temperature measured on the skin and the device's ability to maintain that temperature within a specified range, as observed directly during the bench test. It's not a diagnostic "ground truth" derived from expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not Applicable (N/A): This document describes testing of a physical medical device, not the development or training of an AI algorithm. Therefore, there is no concept of a "training set" in this submission.

9. How Ground Truth for Training Set Was Established

Not Applicable (N/A): As there is no training set, this question is not applicable to the provided document.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K221043

Device Name Doctor Tecar Plus Doctor Tecar Smart

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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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

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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

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 productClassification Code	21 CFR 878.4400PBX	21 CFR 878.4400PBX	-
Intended Use / IndicationFor Use	The device is is intended toprovide topical heating for thepurpose of elevating tissuetemperature for thetreatment of selected medicalconditions such as relief ofpain, muscle spasms, andincrease 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 asportable devices indicated intherapy for muscular &skeletal pathologies.	Same	-
Clinical use	Prescription type	Same	-
Energy Used And/OrDelivered	250 W	PLUS : 200 VASMART: 70 VA	No significantdifference
Frequencies	470 kHz; 1 MHz; 2 MHz; 4MHz ; 6 MHz	PLUS : 300 kHz - 448 kHz - 500kHz - 750 kHz - 1 MHz - 1.2 MHz- 1.5 MHz	No significantdifference

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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 significantdifference
Type of energy	Radiofrequency Waves	Radiofrequency Waves	-
Active Electrode	Round shape	Same	-
Neutral Electrode	Rectangular shape	Same	-
Design	Radiofrequency Energy withintensity adjustment from 0%to 100%	Same	-
Patient Safety Switch	Available	Same	-
Human Factors	Graphical user interfaceallows a better userexperience and propertherapy selection	SameIEC 60601-1-6	-
Standards Met	IEC 60601-1;IEC 60601-1- 2IEC 60601-2-2IEC 60601-1- 6IEC 62304ISO 14971	CEI EN 60601-1CEI EN 60601-1-2IEC 60601-2-2IEC 60601-1-6IEC 62304IEC 62366UNI EN ISO 14971	No significantdifferences
Biocompatibility	IEC 60601 - 1ISO 10993	IEC 60601 - 1ISO 10993	-
Compatibility With TheEnvironment And OtherDevices	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

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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 (< 24 h), resulting in biocompatibility evaluation as follows, in accordance with Table A.1 of ISO 10993-1 and FDA guidance:

Cytotoxicity: ISO 10993-5
. Sensitization: ISO 10993-10
. Irritation: ISO 10993-10

These patient-contacting components have all previously been cleared by FDA by means of successful 510(k) submissions. No further biocompatibility data is therefore included within this submission.

CONCLUSIONS

Doctor Tecar Plus and Doctor Tecar Smart generate radio frequency for treatment of selected tissues. They share the same basic characteristics and the same intended use as the predicate device. Moreover the safety and bench tests demonstrate that the the device is safe and performs as intended, and do not raise any concern about safety and effectiveness. There are no substantial differences between the product defined in this 510(k) submission and the predicate device that is,

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Image /page/7/Picture/1 description: The image shows a logo for a company called "Electronic Medical". The logo features a large, dark blue star on the left side, with the company name written in a stylized font to the right of the star. The text is also in dark blue, and the word "MEDICAL" is stacked below "ELECTRONIC".

K221043 510(k) Summary

they are essentially equivalents for the requested intended use. Therefore, the proposed device is substantially equivalent to the NuEra Tight RF Radiofrequency Device, cleared under 510(k) registration K200359.

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.