K Number

Device Name

Doctor Tecar

Manufacturer

Mectronic Medicale S.r.l.

Date Cleared

2019-02-22

(53 days)

Product Code

PBX

Regulation Number

878.4400

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K162828

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the electrical and mechanical aspects of the device and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

Yes
The device is described as intended for "the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation," which classifies it as a therapeutic device.

Diagnostic

No
The device description states its intended use is to provide topical heating for treatment, not for diagnosis. There is no mention of capabilities to identify, measure, or monitor a medical condition.

SaMD (Software as a Medical Device)

The device description clearly outlines physical hardware components including a power console, LCD monitor, electrodes, and a moveable trolley, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Doctor Tecar 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 the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation." This describes a therapeutic device used on the patient's body, not a device used to examine specimens taken from the body (which is the definition of an IVD).
Device Description: The description details a device that generates electrical current and uses electrodes applied to the patient. This aligns with a physical therapy or therapeutic device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

Therefore, the Doctor Tecar device is a therapeutic device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

PBX

Device 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.

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

Not Found

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

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.

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

Key Metrics

Not Found

Predicate Device(s)

K162828

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.

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

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

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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Image /page/3/Picture/1 description: The image shows a logo for a company called "ELECTRONIC MEDICALE". The logo features a stylized star on the left side, with the company name written in a stylized font to the right of the star. The word "MEDICALE" is written in smaller letters below the word "ELECTRONIC".

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, 15
24050 Grassobbio (BG)
ITALY
ennioaloisini@mectronicmedicale.it
Phone: +39 035 656080, FAX: +39
035 65736 |
|----|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Mrs. Gloria Aloisini
Quality Manager
Mectronic Medicale S.r.l.
gloriaaloisini@mectronicmedicale.it
Phone: +39 035 656080, FAX: +39
035 65736 |
| 3. | US Agent: | Mr. Guilliermo Laureiro
President
Luna America LLC
751 Willard Ave
Jefferson, PA, 18436
Cell 570-840-2225
Fax 570-955-3783
e-mail gil@lunaamerica.com |
| 4. | Product: | Doctor Tecar
(21CFR§878.4400) Class II
Doctor Tecar
Product code PBX |
| 5. | Common/Trade Name: | Radiofrequency Induced Heat |

Doctor Tecar

Description:

Image /page/4/Picture/1 description: The image shows a logo for a company called "Electronic Medicale". The logo features a blue star above the word "Electronic", with the word "Medicale" written in a smaller font size below "Electronic". The text and star are all in a blue color.

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.

Image /page/5/Picture/0 description: The image shows a logo for a company called "Mectronic Medicale". The logo features a blue star above the word "Mectronic", which is also in blue. Below "Mectronic" is the word "Medicale" in a smaller font size and also in blue. The logo has a slightly blurred or shadowed effect, giving it a three-dimensional appearance.

Predicate Device Comparison Table

Element of Comparison	510(k) Device:	Predicate Device:	Explanation of Differences
	Doctor Tecar	Winback 3SE K162828
Regulation and Product
Classification Code	21 CFR 878.4400
PBX	21 CFR 878.4400
PBX	None
Indications for Use	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.	The Winback Back 3SE devise 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.
The Winback 3SE massage device
is intended to provide a temporary
reduction in the appearance of
cellulite.	No significant
difference for
radiofrequency
device.
Electrode Shapes	Square and circular	Square and circular	Electrode shape is
not a significant
difference
Infrared Light	No	No	Identical
Vacuum (suction)	No	No	Identical
Treatment Activation	Finger selection on console	Finger selection on console	No significant
difference
RF Type	Unipolar	Multipolar/Unipolar	No significant
difference
RF Frequency	460 KHz - 600 KHz	300kHz - 1 MHz	No significant
difference
Max RF Power	120 W	300 W	Max RF Power NO
significant difference
Intensity Adjustment	0-100%	0-100%	Identical
Configuration	Cart mounted console with
accessories	Cart mounted console with
accessories	Identical
Patient Safety Switch	Yes	Yes	Identical
Standards Compliance	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	ISO10993, IEC60601-1 &
IEC60601-1-2 Compliant	Identical

Image /page/6/Picture/2 description: The image shows a logo for Electronic Medicale. The logo features a blue star-like shape on the left, followed by the text "ELECTRONIC" in a stylized, italicized font. Below "ELECTRONIC" is the word "MEDICALE" in a smaller, less stylized font. The overall design has a slightly blurred or shadowed effect, giving it a three-dimensional appearance.

Summary of Testing:

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.