Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

• K Number: K241107
• Device Name: Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
• Manufacturer: INDIBA S.A.U
• Date Cleared: 2025-01-24 ( 277 days)
• Product Code: PBX
• Regulation Number: 878.4400

Intended Use

The Indiba Diathermia Radiofrequency Deep Care/Activ 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.

Device Description

The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current. The device models consist 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 (RES), and thin layer insulated capacitive electrodes (CAP). The electrodes are inserted into a handle, and the handle is connected to the console by a designated cable, the generated current flows through the patient and returns to the device through the neutral return electrode. The Activ CT9 device model is equipped with additional massage applicators which provide mechanical massage for the temporary reduction in the appearance of cellulite. The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model comprise a user interface (touchscreen) to facilitate the user device operation and to enable the user to predefine the device treatment settings. The INDIBA Diathermia Radiofrequency Deep Care device model device incorporates smart handles and smart electrodes, which enables the device to automatically identify the connected applicators and enables their operation via the control options on the touchscreen. The EVONY device provides a new temperature tracking tool enabling the user to track the patient skin temperature during the treatment time. Improvements were performed in both device models in the console design and in the graphical user interface (GUI). New applicators were introduced for the INDIBA Diathermia Radiofrequency Activ device model - the Fascia and Target electrodes and for the INDIBA Diathermia Radiofrequency Deep Care device model - the Sculpture electrodes. The new electrodes behave and operate in the same manner as the already FDA cleared RES and CAP electrodes.

Predicate Devices

K161458

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard medical device functionalities like RF current generation, electrode types, user interface, and temperature tracking. The "smart handles and smart electrodes" feature is described as automatically identifying connected applicators, which is a form of automated recognition, but not necessarily indicative of AI/ML. There is no mention of learning, adaptation, or complex pattern recognition typically associated with AI/ML in the context of medical device operation or data analysis.

Therapeutic

Yes.
The device description explicitly states, "The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current." Furthermore, its intended use includes "relief of pain, muscle spasms, increase in local circulation," which are therapeutic benefits.

Diagnostic

No

Explanation: The device description states its purpose is to provide topical heating for treatment of medical conditions, not for diagnosing them. It is a therapeutic device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a console, electrodes, handles, cables, and massage applicators, in addition to the software user interface.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "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 "temporary reduction in the appearance of cellulite." These are therapeutic applications performed directly on the patient's body.
• Device Description: The description details a device that generates and delivers radiofrequency current to the patient through electrodes. This is a physical intervention on the body.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose or monitor a medical condition.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on applying energy to the body for therapeutic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Indiba Diathermia Radiofrequency Deep Care/Activ 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.

Product codes

PBX

Device Description

The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current.

The device models consist 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 (RES), and thin layer insulated capacitive electrodes (CAP). The electrodes are inserted into a handle, and the handle is connected to the console by a designated cable, the generated current flows through the patient and returns to the device through the neutral return electrode.

The Activ CT9 device model is equipped with additional massage applicators which provide mechanical massage for the temporary reduction in the appearance of cellulite.

The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model comprise a user interface (touchscreen) to facilitate the user device operation and to enable the user to predefine the device treatment settings.

The INDIBA Diathermia Radiofrequency Deep Care device model device incorporates smart handles and smart electrodes, which enables the device to automatically identify the connected applicators and enables their operation via the control options on the touchscreen.

The EVONY device provides a new temperature tracking tool enabling the user to track the patient skin temperature during the treatment time.

Improvements were performed in both device models in the console design and in the graphical user interface (GUI).

New applicators were introduced for the INDIBA Diathermia Radiofrequency Activ device model - the Fascia and Target electrodes and for the INDIBA Diathermia Radiofrequency Deep Care device model - the Sculpture electrodes. The new electrodes behave and operate in the same manner as the already FDA cleared RES and CAP electrodes.

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

Non-Clinical (Bench) Performance Data:
The following validation activities were performed:

• Software Verification and Validation Testing
• Electrical safety and EMC testing
• Power control and RF accuracy testing
• Labeling Verification and Validation Testing

All of the validation activities were performed using the same testing techniques and principles as performed using the predicate device models. The results of the above listed validation activities conclude that the INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model are safe and effective for their intended use and user population (both users and patients) and that the modified device models are substantially equivalent to their respective predicate devices.

Key Metrics

Not Found

Predicate Device(s)

K161458

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 24, 2025

Indiba S.A.U % Amit Goren Head of Regulatory Affairs A. stein Regulatory Affairs Consulting Company Ltd. 18 Hata'as St. Kfar Saba, 4442518 Israel

Re: K241107

Trade/Device Name: Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: October 28, 2024 Received: October 29, 2024

Dear Amit Goren:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

2

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Long H. Chen -S-s
Digitally signed by Long H. Chen
Date: 2025.01.24 15:20:56 -05'00'

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

Submission Number (if known)

K241107

Device Name

Indiba Diathermia Radiofrequency Deep Care Device

(IDC0409/EVONY);

Indiba Diathermia Radiofrequency Activ Device (ACT0309/Activ CT9)

Indications for Use (Describe)

The Indiba Diathermia Radiofrequency Deep Care/Activ 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.

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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INDIBA DIATHERMIA RADIOFREQUENCY ACTIV DEVICE, INDIBA DIATHERMIA RADIOFREQUENCY DEEP CARE DEVICE 510(K) SUMMARY

510(k) Number K241107

Applicant Name:

Company Name:	INDIBA S.A.U.
Address:	C/ Moianès, 13 – P.I. Can Casablanques
Sant Quirze del Vallès (Barcelona), 08192
Spain
	Tel: [phone]
	E-mail: [e-mail]

Contact Person:

Official Correspondent:	Amit Goren
Company Name:	A. Stein - Regulatory Affairs Consulting Ltd
Address:	18 Hata'as Str.
Kfar Saba 4442518
Israel
	Tel: [phone]
	Fax: [phone]
	E-mail: [e-mail]
Date Prepared:	October 28, 2024
Trade Name:	Activ CT9 device, EVONY device
Classification Name:	CFR Classification section 878.4400;
(Product code PBX)
Classification:	Class II Medical Device

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Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission – 510(K) Summary

Predicate Devices: The INDIBA Diathermia Radiofrequency Activ Device model (Activ CT9 device) and The INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device) are substantially equivalent to the following predicate devices;

Manufacturer	Device	510(k) No.
Indiba S.A.U.	Activ 902	K161458
Indiba S.A.U.	ELITE	K161458

Device Description:

The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current.

The device models consist 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 (RES), and thin layer insulated capacitive electrodes (CAP). The electrodes are inserted into a handle, and the handle is connected to the console by a designated cable, the generated current flows through the patient and returns to the device through the neutral return electrode.

The Activ CT9 device model is equipped with additional massage applicators which provide mechanical massage for the temporary reduction in the appearance of cellulite.

The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model comprise a user interface (touchscreen) to facilitate the user device operation and to enable the user to predefine the device treatment settings.

The INDIBA Diathermia Radiofrequency Deep Care device model device incorporates smart handles and smart electrodes, which enables the device to automatically identify the connected applicators and enables their operation via the control options on the touchscreen.

The EVONY device provides a new temperature tracking tool enabling the user to track the patient skin temperature during the treatment time.

Improvements were performed in both device models in the console design and in the graphical user interface (GUI).

New applicators were introduced for the INDIBA Diathermia Radiofrequency Activ device model - the Fascia and Target electrodes and for the INDIBA Diathermia Radiofrequency Deep Care device model - the Sculpture electrodes. The new electrodes behave and operate in the same manner as the already FDA cleared RES and CAP electrodes.

6

Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission - 510(K) Summary

All of the device improvements and modifications do not pose any new risks for the device safety and effectiveness.

The Activ CT9 and the EVONY device models, bearing the same technical specifications:

Feature	Subject device models
	Activ CT9	EVONY
Weight	9.5 kg	50 kg (includes trolley)
Size	400 mm (width)
530 mm (depth)
150 mm (height, with display folded)	670 mm (width)
530 mm (depth)
1370 mm (height)
Input Mains Supply	(100 - 240) VAC 50/60 Hz	(100 - 240) VAC 50/60 Hz
Display	8" color TFT
(800 x 480 pixels)	21.5" color TFT
(1920 x 1080 pixels)
User input interface	Touchscreen	Touchscreen
Output frequency in
RES mode	448 kHz	448 kHz
Output frequency
range in CAP mode	448 kHz	448 kHz
Maximum output
power in RES mode	200 W	200 W
Maximum output
power in CAP mode	450 VA	450 VA
Temperature range for
operation:	+10°C to +40°C	+10°C to +40°C
Temperature range for
storage and transport:	-20°C to +50°C	-20°C to +50°C
Timer range:	0 - 99 minutes	0 - 99 minutes

Intended Use/Indication for Use:

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.

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Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission – 510(K) Summary

Performance Standards:

The INDIBA Diathermia Radiofrequency Activ device model has been tested and complies with the following voluntary recognized standards:

• ES60601-1:2005/(R)2012 ● AAMI C1:2009/(R)2012 ANSI &A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

The INDIBA Diathermia Radiofrequency Deep Care device model has been tested and complies with the following voluntary recognized standards:

• AAMI ES60601-1:2005/(R)2012 C1:2009/(R)2012 ANSI &A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version Medical electrical equipment ● - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
• IEC 60601-2-2 Edition 6.0 2017-03 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

Non-Clinical (Bench) Performance Data:

The following validation activities were performed:

• Software Verification and Validation Testing
• Electrical safety and EMC testing
• Power control and RF accuracy testing ●
• Labeling Verification and Validation Testing ●

8

Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission – 510(K) Summary

All of the validation activities were performed using the same testing techniques and principles as performed using the predicate device models. The results of the above listed validation activities conclude that the INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model are safe and effective for their intended use and user population (both users and patients) and that the modified device models are substantially equivalent to their respective predicate devices.

Animal Performance Data / Histology Data:

Not Applicable

Clinical Performance Data:

Not Applicable

Biocompatibility

All of the modified device models' materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the manufacturing of the predicate device models all manufactured by INDIBA S.A.U.

Substantial Equivalence:

The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model are substantially equivalent to the INDIBA Diathermia Radiofrequency Activ 902 device model and to the INDIBA Diathermia Radiofrequency ELITE device model respectively, all manufactured by INDIBA S.A.U., and the subject of K161458. The subject device models and predicate device models share the same underlying technology of mono-polar RF, the same RF output specifications and same operational principles.

A comparison table is provided below comparing the intended use and basic technological characteristics of the subject device models to the intended use and basic technological characteristics of the predicate device models.

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| | ELITE
Predicate Device;
INDIBA S.A.U
K161458 | EVONY Device
Subject device;
INDIBA S.A.U | Activ 902
Predicate Device;
INDIBA S.A.U
K161458 | Activ CT9 Device
Subject device;
INDIBA S.A.U |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Technological Characteristics | | | | |
| Device description /
Design | The INDIBA Diathermia
Radiofrequency Device is a
therapeutic device for Deep,
non-invasive diathermy,
consists of a tabletop console
which generates a
radiofrequency current which
is delivered to the patient.
The device is line powered &
software controlled.
Mono-polar radiofrequency
(RF) current is generated in
the console and emitted to
the patient's skin by two
different RF electrode types:
RES & CAP.
The RF current returns to the
console through a neutral
return electrode.
The device comprises
additional massage pieces
that can be used to massage
the skin for cellulite
treatment. | The INDIBA Diathermia
Radiofrequency Device, is
a therapeutic device for
Deep, non-invasive
diathermy, consists of a
main body (console and a
touchscreen), and a CPU
unit that is also incorpor
ated in the main unit.
The device is line powered
& software controlled.
The touchscreen comprises
user interface and enables
the user to predefine the
device treatment settings
and facilitate the user
device operation.
Mono-polar radiofrequency
(RF) current is generated in
the console and emitted to
the patient's skin by two
different RF electrode
types: RES & CAP
installed on a smart handle. | The INDIBA Diathermia
Radiofrequency Device is a
therapeutic device for
Activ, non-invasive
diathermy, consists of a
tabletop console which
generates a radiofrequency
current which is delivered
to the patient.
The device is line powered
& software controlled.
Mono-polar radiofrequency
(RF) current is generated in
the console and emitted to
the patient's skin by two
different RF electrode
types: RES & CAP.
The RF current returns to
the console through a
neutral return electrode.
The device comprises
additional massage pieces
that can be used to massage | The INDIBA Diathermia
Radiofrequency Device,
is a therapeutic device
for Activ, non-invasive
diathermy, consists of a
tabletop console (console
and a touchscreen) which
generates a
radiofrequency current
which is delivered to the
patient.
The device is line
powered & software
controlled.
The touchscreen
comprises user interface
and enables the user to
predefine the device
treatment settings and
facilitate the user device
operation.
Mono-polar
radiofrequency (RF)
current is generated in |
| | ELITE
Predicate Device;
INDIBA S.A.U
K161458 | EVONY Device
Subject device;
INDIBA S.A.U | Activ 902
Predicate Device;
INDIBA S.A.U
K161458 | Activ CT9 Device
Subject device;
INDIBA S.A.U |
| | | The device comprises the
sculpture electrodes for
additional treatment
options.
The RF current returns to
the console through a
neutral return electrode. | the skin for cellulite
treatment. | the console and emitted
to the patient's skin by
two different RF
electrode types: RES &
CAP.
The device comprises the
fascia electrodes for
additional treatment
options.
The RF current returns to
the console through a
neutral return electrode.
The device comprises
additional massage
pieces that can be used to
massage the skin for
cellulite treatment. |
| Device components | The ELITE Device model
consists of the following
components:
Console, which
contains the following
components:
RF Generator Control unit (CPU) | The IDC0409 Device model
consists of the following
components:
Console, which
contains the
following
components:
RF Generator | The Activ 902 Device model
consists of the following
components:
Console, which
contains the following
components:
RF Generator Control unit (CPU) | The Activ CT9 Device
model consists of the
following components:
Console, which
contains the
following
components:
RF Generator |
| ELITE
Predicate Device;
INDIBA S.A.U
K161458 | EVONY Device
Subject device;
INDIBA S.A.U | Activ 902
Predicate Device;
INDIBA S.A.U
K161458 | Activ CT9 Device
Subject device;
INDIBA S.A.U | |
| o Device bottom panel
o Incorporated display
screen
o Outlets connectors for
treatment handles and
return electrode | o Control unit (CPU)
o Device bottom panel
o Touchscreen displays
with GUI
o Outlets connectors
for treatment handles
and return electrode | o Device bottom panel
o Incorporated display
screen
o Outlets connectors for
treatment handles and
return electrode | o Control unit (CPU)
o Incorporated flip
display screen
o Touchscreen
displays with GUI
o Outlets connectors
for treatment
handles and return
electrode | |
| The ELITE Device accessories:
• Handles
• Diathermia treatment
electrodes:
o Thin-layer insulated
electrodes (called
"Capacitive" or "CAP"
electrodes by INDIBA,
S.A.U). The insulated
material is polyamide | The IDC0409 Device
accessories:
• Smart Handle
• Diathermia treatment
electrodes with
indicative thermal
sensors imbedded in
them:
o Thin-layer insulated | The Activ 902 Device
accessories:
• Handles
• Diathermia treatment
electrodes:
o Thin-layer insulated
electrodes (called
"Capacitive" or "CAP"
electrodes by INDIBA
S.A.U). The insulated
material is polyamide | The Activ CT9 Device
accessories:
• Diathermia
treatment
electrodes:
o Thin-layer insulated
electrodes (called
"Capacitive" or
"CAP" electrodes by
INDIBA S.A.U).
The insulated
material is
polyamide #12.
Circular shape, sizes: | |
| #12. Circular shape,
sizes: 30, 40, 55, 65, 80
mm diameter.
o Stainless steel
conductive metal
electrodes (AISI 304L) | electrodes (called
"Capacitive" or
"CAP" electrodes by
INDIBA S.A.U). The
insulated material is
polyamide #12. | #12. Circular shape,
sizes: 30, 40, 55, 65, 80
mm diameter.
o Stainless steel
conductive metal | 12, 19, 25, 30, 40 | |
| ELITE
Predicate Device;
INDIBA S.A.U | EVONY Device
Subject device;
INDIBA S.A.U | Activ 902
Predicate Device;
INDIBA S.A.U | Activ CT9 Device
Subject device;
INDIBA S.A.U | |
| K161458 | | K161458 | | |
| (called "Resistive" or
"RES" electrodes by
INDIBA S.A.U),
circular shape, sizes:
35, 50, 65, 90 mm
diameter.
Return electrode (plate)
– stainless steel (AISI
304L) Massager piece IR thermometer Conductive gel Other Components Included
with Device: Power Supply
Cable Electrode Case
with Foam | Circular shape, sizes:
19, 30, 35, 40, 55, 65,
80 mm diameter and
35 mm diameter
curved.
Stainless steel
conductive metal
electrodes (AISI
304L) (called
"Resistive" or "RES"
electrodes by
INDIBA S.A.U),
circular shape, sizes:
19, 35, 50, 65, 90
mm diameter. Return electrode (plate)
with indicative thermal
sensors imbedded in it
made of stainless steel
(AISI 304L) Sculpture electrodes IR thermometer Conductive gel | electrodes (AISI 304L)
(called "Resistive" or
"RES" electrodes by
INDIBA S.A.U),
circular shape, sizes:
35, 50, 65, 90 mm
diameter. Return electrode
(plate) - stainless steel
(AISI 304L) Massager piece IR thermometer Conductive gel Other Components Included
with Device: Power Supply
Cable Electrode Case with
Foam | 55, 65, 80 mm
diameter. Stainless steel
conductive metal
electrodes (AISI
304L) (called
"Resistive" or
"RES" electrodes by
INDIBA S.A.U),
circular shape, sizes:
35, 50, 65, 90 mm
diameter. Return electrode
(plate) - stainless
steel (AISI 304L) Massager piece Fascia electrodes Target electrodes IR thermometer Conductive gel Other Components
Included with Device: | |
| | ELITE
Predicate Device;
INDIBA S.A.U
K161458 | EVONY Device
Subject device;
INDIBA S.A.U | Activ 902
Predicate Device;
INDIBA S.A.U
K161458 | Activ CT9 Device
Subject device;
INDIBA S.A.U |
| | | Other Components Included
with Device:
• Power Supply Cable
• Electrode Case with
foam | | • Power
Supply
Cable
• Electrode Case
with Foam |
| Input power | Input power:
220-240 VAC,
50-60 Hz | Input power:
100-240 VAC,
50-60 Hz | Input power:
220-240 VAC
50-60 Hz | Input power:
100-240 VAC,
50-60 Hz |
| Physical specifications | Dimensions:
458 mm W (width) x 440 mm D
(depth) x 170 mm H (height)
Weight: 14.1 kg | Cart Dimensions:
670 mm W (width) x 550 mm D
(depth) x 1,370 mm H (height)
Weight: 50 kg | Dimensions:
458 mm W (width) x 440 mm D
(depth) x 170 mm H (height)
Weight: 14.1 kg | Dimensions:
400 mm W (width) x 530 mm
D (depth) x 150 mm H (height
with display folded)
Weight: 8.6 kg |
| Output frequency in
RES mode | 448 kHz | Idem | 448 kHz | Idem |
| Output frequency in
CAP mode | 400-449 kHz | 448kHz | 400-449 kHz | 448kHz |
| Maximum output power
in RES mode | 200w | Idem | 200w | Idem |
| Maximum output power
in CAP mode | 450 VA | Idem | 450 VA | Idem |
| Maximal RF step in RES
mode | 1% ( $\geq$ 2 W) | 1% ( $\geq$ 2 W) | 1% ( $\geq$ 2 W) | 0.2 - 4: 0.2% ( $\geq$ 0.4 W)
2 - 40: 2% ( $\geq$ 4 W)
5 - 100: 5% ( $\geq$ 10 W) |
| ELITE
Predicate Device;
INDIBA S.A.U
K161458 | EVONY Device
Subject device;
INDIBA S.A.U | Activ 902
Predicate Device;
INDIBA S.A.U
K161458 | Activ CT9 Device
Subject device;
INDIBA S.A.U | |
| Maximal RF step in
CAP mode | 1% | 5% | 0.2% | |
| 5% | Display interface and
dimensions | 21.5" color TFT (1920 x 1080
pixels) | 5.7" color TFT (320 x 240
pixels) | 8" color TFT (800 x 480
pixels) |
| Timer range | 0-99 minutes | 0-90 minutes | 0-99 minutes | 0-99 minutes |
| Compatibility with
Environment and Other
Devices | The ELITE is compliant with the
IEC 60601-1-2 (EMC Safety)
standard | idem | The Activ 902 is compliant
with the IEC 60601-1-2 (EMC
Safety) standard | idem |
| Electrical Safety | Power Requirements:
220-240 VAC 50-60 Hz
The ELITE Device is compliant
with the IEC 60601-1 standard. | idem | Power Requirements:
220-240 VAC 50-60 Hz
The Activ 902 Device is
compliant with the IEC 60601-
1 standard. | idem |
| Mechanical Safety | The ELITE is compliant with
the IEC 60601-1 standard. | idem | The Activ 902 is compliant
with the IEC 60601-1
standard. | idem |
| Thermal Safety | The ELITE is compliant with
the IEC 60601-1 standard. | idem | The Activ 902 is compliant
with the IEC 60601-1
standard. | idem |
| Radiation Safety | The ELITE is compliant with
the IEC 60601-1-2 (EMC
Safety) standard. | idem | The Activ 902 is compliant
with the IEC 60601-1-2 (EMC
Safety) standard. | idem |
| Biocompatibility | All of the device materials that
come in direct contact with the
human skin are biocompatible. | idem | All of the device materials that
come in direct contact with the
human skin are biocompatible. | idem |

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Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission – 510(K) Summary

Comparison Discussion:

The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device) are portable, computerized, software-controlled device models comprising a console with a touchscreen, and equipped with several treatment handles and electrodes and intended for the purpose of elevating tissue temperature and provide a topical heating for treatment of selected medical conditions such as: relief of pain, muscle spasms and increase in local blood circulation.

The INDIBA Diathermia Radiofrequency Activ device model also comprises massage applicators intended to provide a temporary reduction in the appearance of cellulite by a mechanical massaging.

The indications for use and technological characteristics of the subject device models are substantially equivalent to the indications for use and technological characteristics of the predicate device models.

The subject device models are based on the same underlying RF technology as employed in the predicate device models. The mechanism of action and mechanism of operation are essentially identical to that of the predicate device models. The main modification in the subject device models do not raise new questions of safety or effectiveness therefore, the subject device models are substantially equivalent to the predicate device models.

The technological characteristics of the subject device models compared to the predicate device models do not raise new safety or effectiveness concerns. Furthermore, the subject device models underwent performance testing including software validation testing, electrical and mechanical safety testing, EMC testing, and specific bench testing, including RF output power testing.

All of the above-mentioned performance test protocols were designed and performed in the same manner as with the predicate device models and the test results demonstrated that the subject device models have successfully passed the tests and that all of the device requirements were fully met.

16

Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission – 510(K) Summary

Conclusion:

Conclusively, the subject device models, the INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device) are substantially equivalent to the predicate device models, the INDIBA Diathermia Radiofrequency Activ 902 device model and the INDIBA Diathermia Radiofrequency ELITE device model respectively, and therefore, may be legally marketed in the USA.