The Doctor Tecar device 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.

Device Description

The Doctor Tecar generates a high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a hand held electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitor resistive monopolar mode. The product consists of a power console on a moveable trolley, LCD monitor, and accessories including capacitive resistive electrodes and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 460 KHz to 600 KHz.

AI/ML Overview

The provided FDA 510(k) summary for the "Doctor Tecar" device focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and a detailed study proving the device meets those criteria. The submission is for a Radiofrequency Induced Heat device, which is an electrosurgical cutting and coagulation device.

Here's an analysis of the available information in response to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for device performance. Instead, it relies on demonstrating that the Doctor Tecar device performs comparably to its predicate device, the Winback 3SE (K162828), and meets general safety and performance standards. The "Explanation of Differences" column in the Predicate Device Comparison Table (page 5) serves as an indirect way of stating performance equivalence rather than specific acceptance metrics.

Criteria Category (Implied)	Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (Doctor Tecar)
Regulation & Product Classification	Same as Predicate (21 CFR 878.4400, PBX)	Met: 21 CFR 878.4400, PBX
Indications for Use	Comparable to Predicate (topical heating for pain relief, muscle spasms, increased local circulation)	Met: "The Doctor Tecar device 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." (Note: Predicate also included "temporary reduction in the appearance of cellulite" which Doctor Tecar does not, but this was deemed "No significant difference for radiofrequency device").
Electrode Shapes	Comparable to Predicate (Square and circular)	Met: Square and circular
Infrared Light	Absence of Infrared Light (Identical to Predicate)	Met: No
Vacuum (suction)	Absence of Vacuum (Identical to Predicate)	Met: No
Treatment Activation	Comparable to Predicate (Finger selection on console)	Met: Finger selection on console
RF Type	Unipolar or Multipolar/Unipolar (Comparable to Predicate)	Met: Unipolar
RF Frequency	Within a comparable range to Predicate (460 KHz - 600 KHz vs. 300kHz - 1 MHz)	Met: 460 KHz - 600 KHz ("No significant difference")
Max RF Power	Within a comparable range to Predicate (120 W vs. 300 W)	Met: 120 W ("Max RF Power NO significant difference")
Intensity Adjustment	Identical to Predicate (0-100%)	Met: 0-100%
Configuration	Identical to Predicate (Cart mounted console with accessories)	Met: Cart mounted console with accessories
Patient Safety Switch	Identical to Predicate (Presence of switch)	Met: Yes
Standards Compliance	Compliance with relevant electrical safety, EMC, and biocompatibility standards (e.g., ISO10993, IEC60601-1, IEC60601-1-2)	Met: ISO10993, IEC60601-1, IEC60601-1-2 Compliant & IEC 60601-2-2: 2017 (6.0 Ed.) for use in conjunction with IEC 60601-1: 2005 AM1:2012
Tissue Temperature Elevation	Satisfactory safe therapeutic increases in tissue temperature.	Met: Studies indicated satisfactory safe therapeutic increases in tissue temperature. (Page 6)
Usability & Risk Management	Satisfactory verification of user interface, safety features, and performance.	Met: Assessments done using worst-case assumptions to verify user interface, safety features and satisfactory performance. (Page 6)
Biocompatibility	No cytotoxicity, sensitization, or intracutaneous reactivity.	Met: Samples of the tissue contacting probes were tested for cytotoxicity, sensitization and intracutaneous reactivity. (Results implied as satisfactory) (Page 6)
Software Assessment	Compliance with FDA software validation guidelines for Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing.	Met: All addressed and assessed. (Page 6)

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

The document mentions "Studies were done in Italy using volunteers of varying skin colors to assess the capacity of the device to elevate tissue temperature in the treatment areas." (page 6).

Sample Size: Not specified. The term "volunteers" is used, but no number is given.
Data Provenance: Italy.
Retrospective or Prospective: Implied to be prospective as studies were "done" using volunteers.

For other tests (electrical safety, EMC, biocompatibility, usability, software) which are typically conducted in a laboratory or simulated environment, specific "test sets" in the sense of patient data are not applicable. These tests use engineering samples or components of the device.

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

This type of information is generally not applicable for the tests described for this device.

Tissue Temperature Elevation Assessment: The ground truth for safe therapeutic temperature increase would be based on established medical and physiological understanding, not expert consensus in the typical sense of reading medical images. The "ground truth" here is the objective measurement of temperature and its comparison to known physiological thresholds for safety and efficacy.
Other Tests (e.g., electrical safety, EMC, biocompatibility): Ground truth is established by compliance with international standards and validated testing methodologies, not by expert interpretation in the medical sense.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers assess medical images or clinical outcomes, and their disagreements need to be resolved to establish ground truth for algorithm performance evaluation.

This information is not applicable to the type of studies presented here, which are primarily engineering and bench testing, as well as a volunteer study for temperature elevation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The Doctor Tecar device is a treatment device (Radiofrequency Induced Heat) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study assessing human reader improvement with or without AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The Doctor Tecar device is a physical treatment device, not an algorithm. Its performance is evaluated through its physical characteristics, safety, and physiological effects, not as a standalone algorithm.

7. The Type of Ground Truth Used

Tissue Temperature Elevation: The ground truth is the objective measurement of tissue temperature elevation in volunteers, compared against established physiological thresholds for safe and therapeutic heating.
Electrical Safety & EMC: The ground truth is compliance with specific international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
Biocompatibility: The ground truth is the absence of cytotoxic, sensitizing, or reactive responses to the device materials as defined by ISO 10993 standards.
Usability & Risk Management: The ground truth is the successful verification of user interface and safety features against predetermined functional requirements and risk assessments.
Software Assessment: The ground truth is compliance with FDA software validation guidelines, ensuring proper functionality, hazard analysis, and validation against specified requirements.

8. The Sample Size for the Training Set

This information is not applicable. The Doctor Tecar device is not an AI/ML algorithm that requires a training set. Its development involves engineering design and testing, not machine learning model training.

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

This information is not applicable as there is no training set for this type of device.

Summary

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February 22, 2019

Mectronic Medicale S.r.l. Ms. Gloria Aloisini Quality Manager Via Orio al Serio, 15 24050 Grassobbio (BG), ITALY

Re: K183693

Trade/Device Name: Doctor Tecar Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: December 19, 2018 Received: December 31, 2018

Dear Ms. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 medical devices and radiation-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,

David Krause - Digitally signed by David David Krause -s Date: 2019.02.22 08:29:41 ട -05'00' for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (ifknown)

-K183693

Device Name

Doctor Tecar

Indications for Use (Describe)

Type of Use (Select one or both, as applicable }

[X] Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Pursuant to 21 CFR 807.92

Date: February 18, 2019 K183693

1.	Submitted By:	Mectronic Medicale S.r.l.Via Orio al Serio, 1524050 Grassobbio (BG)ITALYennioaloisini@mectronicmedicale.itPhone: +39 035 656080, FAX: +39035 65736
2.	Contact:	Mrs. Gloria AloisiniQuality ManagerMectronic Medicale S.r.l.gloriaaloisini@mectronicmedicale.itPhone: +39 035 656080, FAX: +39035 65736
3.	US Agent:	Mr. Guilliermo LaureiroPresidentLuna America LLC751 Willard AveJefferson, PA, 18436Cell 570-840-2225Fax 570-955-3783e-mail gil@lunaamerica.com
4.	Product:	Doctor Tecar(21CFR§878.4400) Class IIDoctor TecarProduct code PBX
5.	Common/Trade Name:	Radiofrequency Induced Heat

Doctor Tecar

Description:

The product consists of a power console on a moveable trolley, LCD monitor, and accessories including capacitive resistive electrodes and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 460 KHz to 600 KHz.

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Intended Use:

Substantial Equivalence/Technological Characteristics:

The Doctor Tecar device is substantially equivalent to the following device:

•Predicate device clearance: K162828
•Trade Name: Winback 3SE
•Company: WINBACK USA Corp

Both devices are cart mounted consoles with electrode accessories capable of operation in monopolar modes in the range of 460 kHz to 600 KHz radiofrequency.

Both devices operate in the same treatment range and voltage and feature intensity adjustments from 0 to 100%. Electrical safety and biocompatibility have been established for both devices. No direct comparison was made since there are no significant differences in operation and test results indicate identical safety.

The table below summarizes the equivalence of the devices.

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Predicate Device Comparison Table

Element of Comparison	510(k) Device:	Predicate Device:	Explanation of Differences
	Doctor Tecar	Winback 3SE K162828
Regulation and ProductClassification Code	21 CFR 878.4400PBX	21 CFR 878.4400PBX	None
Indications for Use	The Doctor Tecar device isintended to provide topicalheating for the purpose ofelevating tissue temperature forthe treatment of selectedmedical conditions such asrelief of pain, muscle spasms,and increase in localcirculation.	The Winback Back 3SE devise isintended to provide topical heatingfor the purpose of elevating tissuetemperature for the treatment ofselected medical conditions such asrelief of pain, muscle spasms, andincrease in local circulation.The Winback 3SE massage deviceis intended to provide a temporaryreduction in the appearance ofcellulite.	No significantdifference forradiofrequencydevice.
Electrode Shapes	Square and circular	Square and circular	Electrode shape isnot a significantdifference
Infrared Light	No	No	Identical
Vacuum (suction)	No	No	Identical
Treatment Activation	Finger selection on console	Finger selection on console	No significantdifference
RF Type	Unipolar	Multipolar/Unipolar	No significantdifference
RF Frequency	460 KHz - 600 KHz	300kHz - 1 MHz	No significantdifference
Max RF Power	120 W	300 W	Max RF Power NOsignificant difference
Intensity Adjustment	0-100%	0-100%	Identical
Configuration	Cart mounted console withaccessories	Cart mounted console withaccessories	Identical
Patient Safety Switch	Yes	Yes	Identical
Standards Compliance	ISO10993, IEC60601-1,IEC60601-1-2 Compliant & IEC60601-2-2: 2017 (6.0 Ed.) for usein conjunction withIEC 60601-1: 2005 AM1:2012	ISO10993, IEC60601-1 &IEC60601-1-2 Compliant	Identical

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Summary of Testing:

The technological characteristics of the Doctor Tecar System has been verified based on assessments of electrical safety, performance, biocompatibility, software and usability. In addition, an assessment was done to demonstrate that the device effectively raises tissue temperature in a safe and efficient manner.

The following testing has been conducted with satisfactory results:

Doctor Tecar Usability & Risk Management: Usability and Risk Management . assessments were done using worse-case assumptions to verify user interface, safety features and satisfactory performance.
Tissue Temperature Elevation Assessment: Studies were done in Italy using volunteers of varying skin colors to assess the capacity of the device to elevate tissue temperature in the treatment areas. The smallest and the largest electrodes were tested as well as the facial applicator electrode. Results indicated satisfactory safe therapeutic increases in tissue temperature.
Biocompatibility: Samples of the tissue contacting probes were tested for cytotoxicity, sensitization and intracutaneous reactivity.
Software Assessment: Software features were assessed in accordance with FDA software validation guidelines. Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing were all addressed.
. Electromagnetic compatibility: EMC testing was done to evaluate emissions and immunity to electromagnetic fields in accordance with IEC 60601-1-2.
Electrical safety: Full electrical safety testing was done in compliance with IEC 60601-1.
Additional Electrical Testing: Additional electrical testing was done in . compliance with IEC 60601-2-2: 2017 (6.0 Ed.) for use in conjunction with IEC 60601-1: 2005 AM1:2012

Substantial Equivalent Conclusion:

All testing has determined that Doctor Tecar is substantially equivalent to the predicate Winback 3SE device clearance: K162828. Both devices operate in the same treatment range and voltage and feature intensity adjustments from 0 to 100%. Electrical safety and biocompatibility have been established for both 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.