(114 days)
The Reverso Pro System is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. The Reverso Pro System utilizing the Reverso Applicator is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin. The Reverso Pro System utilizing the Quadro RF Applicator is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.
The Reverso Pro System, positioned on a rolling cart, is a computerized system comprised of a console (main unit) and two Applicators: The Reverso Applicator with detachable single-use tips and the Quadro RF Applicator. The system using the Reverso Applicator delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin, or using the Quadro RF Applicator in a continuous wave manner to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Reverso Pro System provides individual adjustments of energy settings and treatment time, and, in the Reverso mode, it also enables the adjustment of tip pattern and pulse profile, to achieve appropriate efficiency and safety for each eligible patient. The system console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso Pro System Applicators are designed for use in dermatological procedures, they are hand-held and ergonomically designed for the treatment requirements. The applicators are connected to the system via a separate cable, each. When not in use, the applicators can be placed within the applicator holder, where the Reverso Applicator is positioned on the system console and the Quadro RF Applicator is positioned on the rolling cart. The Reverso Applicator is compatible with five types of fractional RF tip heads: 44, 80, 88, 160 pin tip head and 176 pin tip head. The Quadro RF Applicator is emitting continues RF energy through a set of two pairs of stainless steel, RF electrodes. The applicator is hand-held and ergonomically designed to induce heat of the skin and beneath tissues for topical heating sensation.
This document is a 510(k) summary for the Indiba S.A.U. Reverso Pro System (K243139). It details the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, the device in question is an electrosurgical cutting and coagulation device. The information provided outlines the non-clinical (bench) performance data for the device, and a qualitative assessment of its similarities to predicate devices to establish substantial equivalence. However, there is no detailed clinical study or acceptance criteria table in the format requested, nor is there information about AI/ML algorithm performance.
The document states:
- "Clinical Performance Data: Not Applicable" (Page 8)
- The "Non-Clinical (Bench) Performance Data" section primarily discusses the device's RF performance specifications and thermal effects. It does not describe a study involving human or expert evaluation for determining accuracy or clinical efficacy in the context of an AI/ML device.
- The entire submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and safety standards, rather than proving the device meets specific performance criteria through a rigorous clinical trial or AI/ML validation study.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets them, specifically for an AI/ML algorithm with human-in-the-loop performance, ground truth establishment, or sample sizes for test/training sets, because this submission is for a medical device that does not appear to involve an AI/ML component or a clinical performance study in the way typically required for AI/ML-driven devices.
The information provided relates to the physical device's electrical and mechanical safety, electromagnetic compatibility, and thermal performance.
Based on the provided text, the device is a radiofrequency aesthetic device, not an AI/ML-driven diagnostic or therapeutic device. As such, the types of studies and acceptance criteria you've asked about (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information presented in this 510(k) summary. The "study" mentioned for performance is a skin temperature test on 3 human volunteers for the Quadro RF Applicator, which is a very different type of study than an AI/ML validation.
Therefore, providing a specific table and detailed answers to your questions on AI/ML performance would be misleading as the document does not contain this information.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 22, 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: K243139
Trade/Device Name: Reverso Pro System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 16, 2024 Received: December 16, 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 Rule"). 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-udi-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 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-regulatory
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assistance/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,
Digitally signed by Long H. Chen
Long H. Chen -S -s
Date: 2025.01.22 08:52:50 -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
510(k) Number (if known) K243139
Device Name Reverso Pro System
Indications for Use (Describe)
The Reverso Pro System is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. The Reverso Pro System utilizing the Reverso Applicator is a non-invasive device intended for use in
dermatological procedures requiring ablation and resurfacing of the skin.
The Reverso Pro System utilizing the Quadro RF Applicator is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY REVERSO PRO SYSTEM
510(k) Number K243139
Applicant Name:
| Company Name: | Indiba S.A.U. |
|---|---|
| Address: | C/ Moianès, 13 – P.I. Can CasablanquesSant Quirze del Vallès (Barcelona), 08192Spain |
| Tel: | +972-528701672 |
| 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: | January 22, 2025 |
| Trade Name: | Reverso Pro System |
Classification Name: CFR Classification section 878.4400;
(Product codes GEI, PBX)
Classification: Class II Medical Device
Predicate Devices:
The Reverso Pro system is substantially equivalent to the following predicate devices;
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Intelis Instruments Ltd. | Reverso Device | K212107 |
| Venus Concept USA Inc. | Venus Viva MD | K201164 |
| InMode MD Ltd. | InMode PLUS System | K172302 |
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Device Description:
The Reverso Pro System, positioned on a rolling cart, is a computerized system comprised of a console (main unit) and two Applicators: The Reverso Applicator with detachable single-use tips and the Quadro RF Applicator. The system using the Reverso Applicator delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin, or using the Quadro RF Applicator in a continuous wave manner to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Reverso Pro System provides individual adjustments of energy settings and treatment time, and, in the Reverso mode, it also enables the adjustment of tip pattern and pulse profile, to achieve appropriate efficiency and safety for each eligible patient.
The system console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso Pro System Applicators are designed for use in dermatological procedures, they are hand-held and ergonomically designed for the treatment requirements. The applicators are connected to the system via a separate cable, each. When not in use, the applicators can be placed within the applicator holder, where the Reverso Applicator is positioned on the system console and the Quadro RF Applicator is positioned on the rolling cart. The Reverso Applicator is compatible with five types of fractional RF tip heads: 44, 80, 88, 160 pin tip head and 176 pin tip head.
The Quadro RF Applicator is emitting continues RF energy through a set of two pairs of stainless steel, RF electrodes. The applicator is hand-held and ergonomically designed to induce heat of the skin and beneath tissues for topical heating sensation.
Following are the Reverso Pro System specifications:
| Dimension: | 31.8cm W x 31.5cm D x 31.5cm H[12.4" W x 12.3" D x 12.3" H] |
|---|---|
| Weight: | 6 Kg (13.2 lbs.) |
| Main Line Frequency (nominal): | 50-60 Hz |
| Input Voltage (nominal): | 100-240 VAC |
| RF Max Output Power: | 10 Watt - Fractional Reverso50 Watt - Quadro RF |
| RF Output Frequency: | 640 KHz Fractional Reverso, 1 MHz Quadro RF |
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Intended Use/Indication for Use:
The Reverso Pro System is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists.
- · The Reverso Pro System utilizing the Reverso applicator is a noninvasive device intended for use in dermatologic procedures requiring ablation and resurfacing of the skin.
- . The Reverso Pro System utilizing the Quadro RF Applicator is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.
Performance Standards:
The Reverso Pro System has been tested and complies with the following voluntary recognized standards:
- . ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & 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.
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- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Non-Clinical (Bench) Performance Data:
Performance bench tests were conducted to evaluate and compare the Reverso Pro System RF performance specifications to the specific design requirements and to the RF performance specifications of the predicate device. The results of the bench test demonstrate that the Reverso device complies with the design requirements comprises similar RF output specifications as the predicate device and therefore, is substantially equivalent to the predicate devices.
The safety and effectiveness of the Reverso Pro System with the Quadro RF Applicator were further evaluated in a skin temperature test. The device was applied on 3 human volunteers, utilizing low and high RF power settings and skin temperatures were measured throughout the treatment time. The study results demonstrated that the Reverso Pro System with the Quadro RF Applicator is capable of maintaining a skin surface temperature of 40°-45°C for the entire treatment time.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The Reverso Pro System is substantially equivalent to the primary device, Reverso device (manufactured by Intelis Instruments Ltd., and the subject of K212107) when it is equipped with the microneedling heads. The Venus Viva MD Device (manufactured by Venus Concept USA Inc. and the subject of K201164) serves as the secondary predicate for the Quadro RF applicator, and
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K243139
Reverso Pro System 510(k) file 510(k) Summary
the InMode PLUS System (manufactured by InMode MD Ltd. and the subject of K172302) serves as a third predicate to justify the Quadro RF topical heating indication. The subject device and predicate devices share the same underlying technology of fractional and CW RF, same RF output specifications and same operational principles.
A comparison table is provided below comparing the intended use and basic technological characteristics of the Reverso Pro System to the intended use and basic technological characteristics of the predicate devices.
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| TechnologicalCharacteristic | Reverso Pro systemIndiba S.A.U.K234139(Subject Device) | Reverso DeviceIntelis InstrumentsLtd.K212107(Primary PredicateDevice) | Venus Viva MDTMVenus Concept USAInc.K201164(Secondary PredicateDevice) | InMode PLUS SystemInMode MD Ltd.K172302(Third PredicateDevice) |
|---|---|---|---|---|
| Product Code, Class | GEI, PBXClass II | GEIClass II | GEIClass II | PBX, ISAClass II |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400, 890.5660 |
| Indications for Use | The Reverso Pro System is anon-invasive device intendedto be used by aesthetic relatedphysicians or dermatologists.The Reverso Pro System, whenused with the Reversoapplicator, is indicated for usein dermatologic procedures,requiring ablation andresurfacing of the skin.The Reverso Pro Systemutilizing the Quadro RFApplicator is indicated toprovide topical heating for thepurpose of elevating tissuetemperature for the treatmentof selected medical conditionssuch as temporary relief ofpain, muscle spasms, andincrease in local circulation.The massage device isintended to provide atemporary reduction in theappearance of cellulite. | The Reverso device is a non-invasive device intended for usein dermatological proceduresrequiring ablation andresurfacing of the skin. | The Venus Viva MD is a non-invasive device intended to beused by aesthetic- relatedphysicians or dermatologists.The Venus Viva MD device whenused with the Diamondpolarapplicator, is intended for use indermatological and surgicalprocedures for females for thenon-invasive treatment ofmoderate to severe facialwrinkles and rhytides inFitzpatrick skin type I-IV.When used with the Viva MDapplicator, the Venus Viva MDDevice is intended for use indermatological proceduresrequiring ablation andresurfacing of the skin. | The InMode PLUS System withthe PLUS/PLUS90/PLUS-PLUSHand pieces is indicated for thetemporary relief of minor muscleaches and pain, temporary reliefof muscle spasm, and temporaryimprovement of local bloodcirculation |
| Anatomical Sites | Body parts requiringtreatment as specified in theindication for use | idem | idem | idem |
| TechnologicalCharacteristic | Reverso Pro systemIndiba S.A.U.K234139(Subject Device) | Reverso DeviceIntelis InstrumentsLtd.K212107(Primary PredicateDevice) | Venus Viva MDTMVenus Concept USAInc.K201164(Secondary PredicateDevice) | InMode PLUS SystemInMode MD Ltd.K172302(Third PredicateDevice) |
| Target Population | Adults requiring treatment asspecified in the indication foruse | idem | idem | idem |
| Environment Used | Hospital or Clinic setting | idem | idem | idem |
| Energy Used /Delivered | Fractional RF energyBi-polar RF energy | Fractional RF energy | Fractional RF energyBi-polar RF energy | Bi-polar RF energy |
| Design: | The Reverso Pro Systemcomprises a console, screen,connectors, designated cartand two treatment applicators:Reverso Fractional RF: Use ofRF energy delivered through amatrix of multiple pinelectrodes allocated on theapplicator tip.Quadro Bi-polar RF: Use oftwo sets of Bi-polar RFelectrodes for the delivery ofRF energy for local dermalheating. | The Reverso device comprises aconsole, screen, connectors, andthe Reverso Fractional RFapplicator.Reverso Fractional RF: Use ofRF energy delivered through amatrix of multiple pin electrodesallocated on the applicator tip. | The Venus Viva MD devicecomprises a console, screen,connectors and two treatmentapplicators:Viva MD Fractional RF: Use ofRF energy delivered through amatrix of multiple pin electrodesallocated on the applicator tip.Dimondpolar Bi-polar RF: Useof two sets of Bi-polar RFelectrodes for the delivery of RFenergy for local dermal heating. | The InMode PLUS Systemcomprises a console, screen,connectors and three treatmentapplicators:• InMode PLUS hand piece• InMode PLUS90 hand piece• InMode PLUS-PLUS handpiece |
| TechnologicalCharacteristic | Reverso Pro systemIndiba S.A.U.K234139(Subject Device) | Reverso DeviceIntelis InstrumentsLtd.K212107(Primary PredicateDevice) | Venus Viva MDTMVenus Concept USAInc.K201164(Secondary PredicateDevice) | InMode PLUS SystemInMode MD Ltd.K172302(Third PredicateDevice) |
| - Mechanism ofAction | Fractional RF treatments:Treatment is based onfractional sub- necroticheating of papillary andreticular dermis triggeringslow collagen remodeling.Bi-polar RF energy is beingemitted to the skin by two setsof RF electrodes, generatinglocal tissue heating forcollagen remodeling and tissueregeneration. | Fractional RF treatments:Treatment is based on fractionalsub- necrotic heating of papillaryand reticular dermis triggeringslow collagen remodeling. | Fractional RF treatments:Treatment is based on fractionalsub-necrotic heating of papillaryand reticular dermis triggeringslow collagen remodeling.Bi-polar RF energy is beingemitted to the skin by two sets ofRF electrodes, generating localtissue heating for collagenremodeling and tissueregeneration. | Bi-polar RF energy is beingemitted to the skin by two RFelectrodes, generating localtissue heating for topicalheating. |
| - Components | Tabletop/Cart positionedConsole including :Display panel Main CPU Power supply Applicator cradle RF generator Two optional applicators: | Tabletop Console including :Display panel Main CPU Power supply Applicator cradle | Tabletop Console including:Display panel Main CPU Power supply RF Generator Applicator cradle | Tabletop Console including:Display panel Main CPU Power supply RF Generator Applicator cradle |
| The Reverso Applicator. Theapplicator comprises theapplicator handle, trigger, RFgenerator, indication LEDsand detachable electrode tipheads (44, 80, 88, 160 or 176pins).The Quadro RF Applicator.The applicator comprises the | The Reverso applicator.The applicator comprises theapplicator handle, trigger, RFgenerator and detachableelectrode tip heads (160 pin or80 pin). | Two optional applicators:Viva MD applicator. Theapplicator comprises theapplicator handle, trigger, RFgenerator and detachableelectrode tip (80 pin or 160 pin). | Three optional applicators:InMode PLUS hand piece InMode PLUS90 hand piece InMode PLUS-PLUS hand piece | |
| TechnologicalCharacteristic | Reverso Pro systemIndiba S.A.U.K234139(Subject Device) | Reverso DeviceIntelis InstrumentsLtd.K212107(Primary PredicateDevice) | Venus Viva MD TMVenus Concept USAInc.K201164(Secondary PredicateDevice) | InMode PLUS SystemInMode MD Ltd.K172302(Third PredicateDevice) |
| applicator handle, trigger,indication LEDs and 2 sets ofRF electrodes. | Diamondpolar Applicator.The applicator comprises theapplicator handle, trigger, and 2sets of RF electrodes. | |||
| RF Performancespecifications | Reverso Applicator: 0.46 MHzQuadro RF Applicator: 1.0MHz | Reverso applicator: 0.46 MHz | Viva MD Applicator: 0.46 MHzDimondpolar applicator:1.0MHz | All PLUS Applicators: 1.0MHz |
| - System Dimensions | 31.8cm W x 31.5cm D x 31.5cmH[12.4" W x 12.3" D x 12.3" H] | idem | 38cm W x 40cm D x 40cm H[14.8" W x 15.6" D x 15.6" H] | Not Applicable |
| Cable Dimensions: | 170 cm | idem | idem | Not Applicable |
| Materials | Applicator Handle: PCMakrolon 2458Tip outer body: PC Makrolon2458RF pin electrodes: Stainlesssteel 302. | idem | idem | Not Applicable |
| Standards Met | AAMI/ANSI ES 60601-1IEC 60601-1-2IEC 60601-2-2IEC 60601-1-6 | idem | idem | idem |
| Biocompatibility | All materials arebiocompatible | idem | idem | idem |
| Compatibility withEnvironment and OtherDevices | Reverso Pro is compliant withthe IEC 60601-1-2 (EMCSafety) standard | idem | idem | idem |
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| TechnologicalCharacteristic | Reverso Pro systemIndiba S.A.U.K234139(Subject Device) | Reverso DeviceIntelis InstrumentsLtd.K212107(Primary PredicateDevice) | Venus Viva MDTMVenus Concept USAInc.K201164(Secondary PredicateDevice) | InMode PLUS SystemInMode MD Ltd.K172302(Third PredicateDevice) |
|---|---|---|---|---|
| Sterility | Provided non-sterile.The detachable, single use tiphead is to be sterilized by theuser close to treatment onset,using autoclaving sterilizationtechnique. | idem | idem | idem |
| Electrical Safety | Power Requirements:100-240 VAC 50-60 HzThe Reverso Pro is compliantwith the IEC 60601-1standard. | idem | idem | idem |
| Mechanical Safety | The Reverso Pro is compliantwith the IEC 60601-1standard. | idem | idem | idem |
| Chemical Safety | Not Applicable | Not Applicable | Not Applicable | Not Applicable |
| Thermal Safety | The Reverso Pro is compliantwith the IEC 60601-1standard. | idem | idem | idem |
| Radiation Safety | The Reverso Pro is compliantwith the IEC 60601-1-2 (EMCSafety) standard. | Idem | Idem | Idem |
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The indications for use and technological characteristics of the Reverso Pro System are substantially equivalent to the indications for use and technological characteristics of the predicate devices.
The design of and the components in the Reverso Pro System, including the console (with the power supply unit, controller and display user interface), screen, applicator cradles, applicator connectors and the applicator handle -The Reverso fractional RF applicator with detachable tip heads, is close to identical to the design of the Reverso device (FDA cleared Device, K212107) and the design of Quadro RF Applicator is similar to the design of the Dimondpolar applicator as in the secondary predicate device, the Venus Viva MD device, FDA cleared Device (510(k) document No. K201164).
The RF performance specifications (RF frequency, RF energy level) of the Reverso Pro System were shown to be identical to those of the predicate device as demonstrated in the bench performance testing. Furthermore, the Reverso Pro System with the Quadro RF Applicator demonstrated the ability to maintain therapeutic temperatures of the skin for topical heating purposes.
Therefore, it can be deduced that the Reverso Pro System is as safe and effective as the predicate devices, and that no new safety or effectiveness issues are raised in regard to the subject device functionality.
The safety features and compliance with safety standards in the subject device are similar to the safety features and compliance with safety standards found in the predicate devices.
Patient contact materials are the same between the subject device and its predicate devices. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns.
Furthermore, the Reverso Pro System underwent performance testing, including software validation testing, Electrical and Mechanical Safety testing according to IEC 60601-1, Electromagnetic Compatibility testing according to
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IEC 60601-1-2 and Usability according to IEC 60601-1-6, bench and human skin testing to evaluate and compare the RF performance specifications and the thermal effect of the device on target tissues to that of the predicate device. These performance tests demonstrated that the minor differences in the system design and specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the Reverso Pro System is substantially equivalent to the predicate devices 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.