(277 days)
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.
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.
The provided text describes a 510(k) premarket notification for two medical devices: the Indiba Diathermia Radiofrequency Deep Care Device and the Indiba Diathermia Radiofrequency Activ Device. This submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing performance against specific, quantifiable clinical acceptance criteria for effectiveness.
Therefore, the information typically found in a study proving device meets acceptance criteria for a novel device (e.g., diagnostic accuracy metrics, sensitivity, specificity, statistically significant improvement over a comparator) is not present in this document. This is common for 510(k) submissions, especially for devices undergoing modifications or being introduced as substantially equivalent to existing ones.
Instead, the acceptance criteria revolve around safety, electrical performance, and substantial equivalence to a predicate device. The study proving the device meets these "acceptance criteria" consists of non-clinical (bench) performance data, demonstrating adherence to recognized standards and consistency with the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are compliance with recognized standards and demonstration that the changes do not raise new safety or effectiveness concerns compared to the predicate devices. The "reported device performance" is successful completion of these non-clinical tests and the maintenance of the predicate device's technological characteristics.
| Acceptance Criteria (Demonstrated through) | Reported Device Performance |
|---|---|
| Compliance with ES60601-1 (Basic Safety & Essential Performance) | Tested and complies. |
| Compliance with IEC 60601-1-2 (EMC Requirements & Tests) | Tested and complies. |
| Compliance with IEC 60601-2-2 (High Frequency Surgical Equipment) (for Deep Care device) | Tested and complies. |
| Software Verification and Validation Testing | All validation activities performed; successfully passed. |
| Electrical Safety and EMC testing | Successfully passed. |
| Power control and RF accuracy testing | Successfully passed. |
| Labeling Verification and Validation Testing | Successfully passed. |
| Biocompatibility of patient-contacting materials | Materials are biocompatible and identical to predicate devices. |
| No new risks to device safety and effectiveness due to improvements/modifications | Concluded by manufacturer based on testing. |
| Substantial Equivalence to predicate devices (K161458) | Demonstrated through comparison of intended use and technological characteristics; same underlying RF technology, mechanism of action, and operational principles. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable for clinical data. The "test set" here refers to the physical devices themselves and their components undergoing bench testing. The document implies that the "subject device models" (Activ CT9 and EVONY) were tested. The specific number of individual units tested is not provided, but it's understood that representative units were used for the non-clinical tests.
- Data Provenance: The data is described as "Non-Clinical (Bench) Performance Data." It would have been generated in a controlled laboratory or testing facility environment, presumably by the manufacturer (INDIBA S.A.U.) or a contracted testing lab. Country of origin not explicitly stated, but the manufacturer is based in Spain. The data is prospective in the sense that tests were conducted on the newly designed devices per predefined protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For non-clinical bench testing and safety standards compliance, "ground truth" is established by the specifications in the recognized standards and validated engineering principles, not by expert medical opinion in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers review and resolve discrepancies in interpretations (e.g., medical images). This submission pertains to device engineering and safety performance, not clinical interpretation.
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
Not applicable. This device is a radiofrequency therapy device, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not feature an algorithm for standalone performance evaluation in the usual sense (e.g., an AI algorithm for diagnosis). Its functionality is a therapeutic radiofrequency delivery system, where the "performance" is its ability to generate specific RF fields and temperatures, and the "human-in-the-loop" is the medical professional operating the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" is defined by:
- Recognized Standards: e.g., AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-2 for electrical safety, EMC, and specific RF surgical equipment requirements.
- Device Specifications: The manufacturer's defined technical specifications for power output, frequency, temperature ranges, etc.
- Biocompatibility Standards: Standards for materials that contact the patient's skin.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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
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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,
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)
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 CasablanquesSant Quirze del Vallès (Barcelona), 08192Spain |
| Tel: +34-932655522 | |
| E-mail: amit@asteinrac.com |
Contact Person:
| Official Correspondent: | Amit Goren |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd |
| Address: | 18 Hata'as Str.Kfar Saba 4442518Israel |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: amit@asteinrac.com | |
| 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.
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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 inRES mode | 448 kHz | 448 kHz |
| Output frequencyrange in CAP mode | 448 kHz | 448 kHz |
| Maximum outputpower in RES mode | 200 W | 200 W |
| Maximum outputpower in CAP mode | 450 VA | 450 VA |
| Temperature range foroperation: | +10°C to +40°C | +10°C to +40°C |
| Temperature range forstorage 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 ●
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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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| ELITEPredicate Device;INDIBA S.A.UK161458 | EVONY DeviceSubject device;INDIBA S.A.U | Activ 902Predicate Device;INDIBA S.A.UK161458 | Activ CT9 DeviceSubject device;INDIBA S.A.U | |
|---|---|---|---|---|
| Device Technological Characteristics | ||||
| Device description /Design | The INDIBA DiathermiaRadiofrequency Device is atherapeutic device for Deep,non-invasive diathermy,consists of a tabletop consolewhich generates aradiofrequency current whichis delivered to the patient.The device is line powered &software controlled.Mono-polar radiofrequency(RF) current is generated inthe console and emitted tothe patient's skin by twodifferent RF electrode types:RES & CAP.The RF current returns to theconsole through a neutralreturn electrode.The device comprisesadditional massage piecesthat can be used to massagethe skin for cellulitetreatment. | The INDIBA DiathermiaRadiofrequency Device, isa therapeutic device forDeep, non-invasivediathermy, consists of amain body (console and atouchscreen), and a CPUunit that is also incorporated in the main unit.The device is line powered& software controlled.The touchscreen comprisesuser interface and enablesthe user to predefine thedevice treatment settingsand facilitate the userdevice operation.Mono-polar radiofrequency(RF) current is generated inthe console and emitted tothe patient's skin by twodifferent RF electrodetypes: RES & CAPinstalled on a smart handle. | The INDIBA DiathermiaRadiofrequency Device is atherapeutic device forActiv, non-invasivediathermy, consists of atabletop console whichgenerates a radiofrequencycurrent which is deliveredto the patient.The device is line powered& software controlled.Mono-polar radiofrequency(RF) current is generated inthe console and emitted tothe patient's skin by twodifferent RF electrodetypes: RES & CAP.The RF current returns tothe console through aneutral return electrode.The device comprisesadditional massage piecesthat can be used to massage | The INDIBA DiathermiaRadiofrequency Device,is a therapeutic devicefor Activ, non-invasivediathermy, consists of atabletop console (consoleand a touchscreen) whichgenerates aradiofrequency currentwhich is delivered to thepatient.The device is linepowered & softwarecontrolled.The touchscreencomprises user interfaceand enables the user topredefine the devicetreatment settings andfacilitate the user deviceoperation.Mono-polarradiofrequency (RF)current is generated in |
| ELITEPredicate Device;INDIBA S.A.UK161458 | EVONY DeviceSubject device;INDIBA S.A.U | Activ 902Predicate Device;INDIBA S.A.UK161458 | Activ CT9 DeviceSubject device;INDIBA S.A.U | |
| The device comprises thesculpture electrodes foradditional treatmentoptions.The RF current returns tothe console through aneutral return electrode. | the skin for cellulitetreatment. | the console and emittedto the patient's skin bytwo different RFelectrode types: RES &CAP.The device comprises thefascia electrodes foradditional treatmentoptions.The RF current returns tothe console through aneutral return electrode.The device comprisesadditional massagepieces that can be used tomassage the skin forcellulite treatment. | ||
| Device components | The ELITE Device modelconsists of the followingcomponents:Console, whichcontains the followingcomponents:RF Generator Control unit (CPU) | The IDC0409 Device modelconsists of the followingcomponents:Console, whichcontains thefollowingcomponents:RF Generator | The Activ 902 Device modelconsists of the followingcomponents:Console, whichcontains the followingcomponents:RF Generator Control unit (CPU) | The Activ CT9 Devicemodel consists of thefollowing components:Console, whichcontains thefollowingcomponents:RF Generator |
| ELITEPredicate Device;INDIBA S.A.UK161458 | EVONY DeviceSubject device;INDIBA S.A.U | Activ 902Predicate Device;INDIBA S.A.UK161458 | Activ CT9 DeviceSubject device;INDIBA S.A.U | |
| o Device bottom panelo Incorporated displayscreeno Outlets connectors fortreatment handles andreturn electrode | o Control unit (CPU)o Device bottom panelo Touchscreen displayswith GUIo Outlets connectorsfor treatment handlesand return electrode | o Device bottom panelo Incorporated displayscreeno Outlets connectors fortreatment handles andreturn electrode | o Control unit (CPU)o Incorporated flipdisplay screeno Touchscreendisplays with GUIo Outlets connectorsfor treatmenthandles and returnelectrode | |
| The ELITE Device accessories:• Handles• Diathermia treatmentelectrodes:o Thin-layer insulatedelectrodes (called"Capacitive" or "CAP"electrodes by INDIBA,S.A.U). The insulatedmaterial is polyamide | The IDC0409 Deviceaccessories:• Smart Handle• Diathermia treatmentelectrodes withindicative thermalsensors imbedded inthem:o Thin-layer insulated | The Activ 902 Deviceaccessories:• Handles• Diathermia treatmentelectrodes:o Thin-layer insulatedelectrodes (called"Capacitive" or "CAP"electrodes by INDIBAS.A.U). The insulatedmaterial is polyamide | The Activ CT9 Deviceaccessories:• Diathermiatreatmentelectrodes:o Thin-layer insulatedelectrodes (called"Capacitive" or"CAP" electrodes byINDIBA S.A.U).The insulatedmaterial ispolyamide #12.Circular shape, sizes: | |
| #12. Circular shape,sizes: 30, 40, 55, 65, 80mm diameter.o Stainless steelconductive metalelectrodes (AISI 304L) | electrodes (called"Capacitive" or"CAP" electrodes byINDIBA S.A.U). Theinsulated material ispolyamide #12. | #12. Circular shape,sizes: 30, 40, 55, 65, 80mm diameter.o Stainless steelconductive metal | 12, 19, 25, 30, 40 | |
| ELITEPredicate Device;INDIBA S.A.U | EVONY DeviceSubject device;INDIBA S.A.U | Activ 902Predicate Device;INDIBA S.A.U | Activ CT9 DeviceSubject device;INDIBA S.A.U | |
| K161458 | K161458 | |||
| (called "Resistive" or"RES" electrodes byINDIBA S.A.U),circular shape, sizes:35, 50, 65, 90 mmdiameter.Return electrode (plate)– stainless steel (AISI304L) Massager piece IR thermometer Conductive gel Other Components Includedwith Device: Power SupplyCable Electrode Casewith Foam | Circular shape, sizes:19, 30, 35, 40, 55, 65,80 mm diameter and35 mm diametercurved.Stainless steelconductive metalelectrodes (AISI304L) (called"Resistive" or "RES"electrodes byINDIBA S.A.U),circular shape, sizes:19, 35, 50, 65, 90mm diameter. Return electrode (plate)with indicative thermalsensors imbedded in itmade of stainless steel(AISI 304L) Sculpture electrodes IR thermometer Conductive gel | electrodes (AISI 304L)(called "Resistive" or"RES" electrodes byINDIBA S.A.U),circular shape, sizes:35, 50, 65, 90 mmdiameter. Return electrode(plate) - stainless steel(AISI 304L) Massager piece IR thermometer Conductive gel Other Components Includedwith Device: Power SupplyCable Electrode Case withFoam | 55, 65, 80 mmdiameter. Stainless steelconductive metalelectrodes (AISI304L) (called"Resistive" or"RES" electrodes byINDIBA S.A.U),circular shape, sizes:35, 50, 65, 90 mmdiameter. Return electrode(plate) - stainlesssteel (AISI 304L) Massager piece Fascia electrodes Target electrodes IR thermometer Conductive gel Other ComponentsIncluded with Device: | |
| ELITEPredicate Device;INDIBA S.A.UK161458 | EVONY DeviceSubject device;INDIBA S.A.U | Activ 902Predicate Device;INDIBA S.A.UK161458 | Activ CT9 DeviceSubject device;INDIBA S.A.U | |
| Other Components Includedwith Device:• Power Supply Cable• Electrode Case withfoam | • PowerSupplyCable• Electrode Casewith Foam | |||
| Input power | Input power:220-240 VAC,50-60 Hz | Input power:100-240 VAC,50-60 Hz | Input power:220-240 VAC50-60 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 mmD (depth) x 150 mm H (heightwith display folded)Weight: 8.6 kg |
| Output frequency inRES mode | 448 kHz | Idem | 448 kHz | Idem |
| Output frequency inCAP mode | 400-449 kHz | 448kHz | 400-449 kHz | 448kHz |
| Maximum output powerin RES mode | 200w | Idem | 200w | Idem |
| Maximum output powerin CAP mode | 450 VA | Idem | 450 VA | Idem |
| Maximal RF step in RESmode | 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) |
| ELITEPredicate Device;INDIBA S.A.UK161458 | EVONY DeviceSubject device;INDIBA S.A.U | Activ 902Predicate Device;INDIBA S.A.UK161458 | Activ CT9 DeviceSubject device;INDIBA S.A.U | |
| Maximal RF step inCAP mode | 1% | 5% | 0.2% | |
| 5% | Display interface anddimensions | 21.5" color TFT (1920 x 1080pixels) | 5.7" color TFT (320 x 240pixels) | 8" color TFT (800 x 480pixels) |
| Timer range | 0-99 minutes | 0-90 minutes | 0-99 minutes | 0-99 minutes |
| Compatibility withEnvironment and OtherDevices | The ELITE is compliant with theIEC 60601-1-2 (EMC Safety)standard | idem | The Activ 902 is compliantwith the IEC 60601-1-2 (EMCSafety) standard | idem |
| Electrical Safety | Power Requirements:220-240 VAC 50-60 HzThe ELITE Device is compliantwith the IEC 60601-1 standard. | idem | Power Requirements:220-240 VAC 50-60 HzThe Activ 902 Device iscompliant with the IEC 60601-1 standard. | idem |
| Mechanical Safety | The ELITE is compliant withthe IEC 60601-1 standard. | idem | The Activ 902 is compliantwith the IEC 60601-1standard. | idem |
| Thermal Safety | The ELITE is compliant withthe IEC 60601-1 standard. | idem | The Activ 902 is compliantwith the IEC 60601-1standard. | idem |
| Radiation Safety | The ELITE is compliant withthe IEC 60601-1-2 (EMCSafety) standard. | idem | The Activ 902 is compliantwith the IEC 60601-1-2 (EMCSafety) standard. | idem |
| Biocompatibility | All of the device materials thatcome in direct contact with thehuman skin are biocompatible. | idem | All of the device materials thatcome in direct contact with thehuman 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.
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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.
§ 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.