(127 days)
The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
The Reverso device is a tabletop computerized system comprised a console (main unit) and Applicator with detachable single-use tips. The system delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin. The Reverso device provides individual adjustments of energy settings, tip pattern, pulse profile to achieve appropriate efficiency and safety for each eligible patient. The device console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso device Applicator is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. The applicator is hand- held and ergonomically designed for the treatment requiring ablation and resurfacing of the skin. The applicator is connected to the system via a cable. When not in use, the applicator can be placed within the applicator holder positioned on the system console. The Reverso Applicator is compatible with two types of fractional RF tip heads; 80 pin tip head and 160 pin tip head.
The provided text is a 510(k) summary for the Reverso device, which is an electrosurgical device for dermatological ablation and resurfacing. It aims to prove substantial equivalence to a predicate device, the Venus Viva MD.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Key Takeaway: This document is not about an AI/ML device where acceptance criteria would involve performance metrics like sensitivity, specificity, or AUC against a ground truth established by experts. Instead, it's a traditional medical device 510(k) focused on demonstrating substantial equivalence to an existing cleared device through engineering and performance testing, primarily with bench and ex-vivo studies. Therefore, many of the typical AI/ML-specific questions (number of experts, adjudication methods, MRMC studies, standalone performance metrics) are not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" in this context are not presented as a table of numerical thresholds for AI performance, but rather as meeting the design requirements and demonstrating similar performance characteristics to the predicate device. The primary goal is to show the Reverso device is "as safe and effective as the predicate device, and that no new safety or effectiveness issues are raised."
The document focuses on comparing the Reverso with the predicate device (Venus Viva MD) across various technical specifications and performance aspects.
Here's a table summarizing the "acceptance criteria" (implied equivalence to predicate) and the reported performance:
| Criterion/Characteristic | Implied Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (Reverso) |
|---|---|---|
| Operational Principle | Same underlying technology of fractional RF | Fractional RF: Use of RF energy delivered through a matrix of multiple pin electrodes allocated on the applicator tip. Treatment is based on fractional sub-necrotic heating of papillary and reticular dermis triggering slow collagen remodeling. |
| Intended Use | Non-invasive dermatological procedures requiring ablation and resurfacing of the skin | "The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin." (Identical to predicate's relevant indication) |
| RF Performance Specs | Identical/Equivalent RF output specifications (RF Frequency, Energy per pin) | RF Frequency: 0.46 MHz. Energy per pin: 62 mJ/pin (160 pin tip), 124 mJ/pin (80 pin tip). "The RF performance specifications... were shown to be identical to those of the predicate device as demonstrated in the bench performance testing." |
| Tissue Effect (Ex-vivo) | Similar ablation and coagulation characteristics / thermal effect on tissues | "The ex-vivo study results demonstrated that the Reverso device is safe for use and effective in achieving the specified indications of dermatological skin ablation and skin resurfacing. Furthermore, the histology results of the subject device tissue samples were compared with the histology results of the predicate device tissue samples. The comparison demonstrated an equivalency in ablation and coagulation characteristics." "similar thermal effect over ex-vivo human tissues following a single treatment performed under similar RF performance specifications and similar operation conditions." |
| Safety Features & Standards Compliance | Similar to predicate, compliance with relevant standards | Complies with ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6. "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 device." |
| Biocompatibility | All materials are biocompatible | "All materials are biocompatible" (identical to predicate) |
| Sterility | Provided non-sterile; single-use tip head to be sterilized by user | "Provided non-sterile. The detachable, single use tip head is to be sterilized by the user close to treatment onset, using autoclaving sterilization technique." (identical to predicate) |
| Hazards/Risks | Low risk, no new safety/effectiveness issues | "All of the identified device related hazards are of low risk and are mostly related with transient symptoms of erythema and edema which are resolved 24-72 hours post treatment." "no new safety or effectiveness issues are raised in regard to the subject device functionality." |
Study Details (Applicable to this type of device)
The studies conducted are primarily for engineering validation and comparison to a predicate device, not for typical AI/ML performance evaluation.
-
Sample Size and Data Provenance for Test Set:
- Bench Tests: No specific "sample size" for a data set in the AI sense is mentioned. These are engineering measurements.
- Ex-Vivo Tissue Testing: "The study was conducted on human abdomen tissues following an abdominoplasty surgery". A "single treatment" was performed. While it doesn't state the number of tissue samples or individual treatments, it implies a small, illustrative set rather than a large statistical sample.
- Data Provenance: Not specified, but standard for ex-vivo human tissue. Retrospective/Prospective is not applicable here as it's not a clinical study on living subjects. The tissues were obtained after abdominoplasty surgery.
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Number of Experts and Qualifications for Ground Truth:
- Experts: Not explicitly stated as "experts" for ground truth adjudication in the AI sense.
- Qualifications: The histology section mentions "biopsy sampling of slices trimmed along the pin's penetration path and collection immediately stained by H&E staining to visualize the tissue ablation and coagulation patterns." This implies histopathological analysis, which would typically be performed by trained personnel (e.g., pathologists or histotechnicians). There is no expert consensus or panel adjudication as would be common for subjective AI image analysis.
- Ground Truth Type: For the ex-vivo study, the ground truth was histology (H&E staining) to observe ablation and coagulation patterns. This is an objective measurement of tissue response.
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Adjudication Method for Test Set:
- Method: Not applicable. There was no expert panel or subjective assessment requiring adjudication. The comparison was based on objective histological findings.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Performed? No. This device is not an AI/ML diagnostic aid, so an MRMC study comparing human reader performance with and without AI assistance is not relevant or required.
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Standalone (Algorithm Only) Performance:
- Performed? Not applicable. This is a physical electrosurgical device, not a software algorithm providing diagnostic output.
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Type of Ground Truth Used:
- For the ex-vivo study, the ground truth was histology (H&E stained samples) to visually assess and compare tissue ablation and coagulation patterns between the subject and predicate devices.
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Sample Size for Training Set & How Ground Truth Was Established (for AI/ML):
- Not applicable. This document describes a traditional medical device, not an AI/ML algorithm that requires training data and ground truth labeling. The "training" here refers to the device's design, manufacturing, and internal testing, not machine learning model training.
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November 10, 2021
Intelis Instruments Ltd. % Amit Goren Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Suite 21 Kfar Saba, 4442518 Israel
Re: K212107
Trade/Device Name: Reverso Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 10, 2021 Received: October 13, 2021
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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-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,
for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Reverso
Indications for Use (Describe)
The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
| 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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510(K) SUMMARY REVERSO DEVICE
510(k) Number K212107
Applicant Name:
| Company Name: | Intelis Instruments Ltd. |
|---|---|
| Address: | HaOman 12Hadera, 3850172Israel |
| 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: | November 10, 2021 | |
| Trade Name: | Reverso | |
| Classification Name: | CFR Classification section 878.4400;(Product code GEI) |
Classification: Class II Medical Device
Predicate Device:
The Reverso device is substantially equivalent to the following predicate device;
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Venus ConceptUSA Inc. | Venus Viva MD | K201164 |
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Device Description:
The Reverso device is a tabletop computerized system comprised a console (main unit) and Applicator with detachable single-use tips. The system delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin. The Reverso device provides individual adjustments of energy settings, tip pattern, pulse profile to achieve appropriate efficiency and safety for each eligible patient.
The device console includes a power supply unit, controller card and LCD screen with touch panel.
The Reverso device Applicator is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. The applicator is hand- held and ergonomically designed for the treatment requiring ablation and resurfacing of the skin. The applicator is connected to the system via a cable. When not in use, the applicator can be placed within the applicator holder positioned on the system console.
The Reverso Applicator is compatible with two types of fractional RF tip heads; 80 pin tip head and 160 pin tip head.
Following are the Reverso device specifications:
| RF Max Output Power: | 10 Watt |
|---|---|
| RF Output Frequency: | 640[KHz] |
| 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 |
Intended Use/Indication for Use:
The Reverso device is a non-invasive device intended for use in dermatologic procedures requiring ablation and resurfacing of the skin.
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Performance Standards:
The Reverso device has been tested and complies with the following voluntary recognized standards:
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 . and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2 Edition 4.0 2014-02 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.
- . 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 device 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 comprise similar RF output specifications as the predicate devices and therefore, is substantially equivalent to the predicate devices.
The safety and effectiveness of the Reverso device were further evaluated in an ex-vivo tissue testing for dermatological procedures requiring skin ablation and skin resurfacing. The study was conducted on human abdomen tissues following an abdominoplasty surgery and included a single treatment utilizing the Reverso device in its final, finished version. The predicate device; the Venus Viva MD device (Subject of K201164) was used for comparison utilized in
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similar operation condition on similar ex-vivo tissues. Untreated tissue was used as a control. Treatment was followed by biopsy sampling of slices trimmed along the pin's penetration path and collection immediately stained by H&E staining to visualize the tissue ablation and coagulation patterns. The ex-vivo study results demonstrated that the Reverso device is safe for use and effective in achieving the specified indications of dermatological skin ablation and skin resurfacing. Furthermore, the histology results of the subject device tissue samples were compared with the histology results of the predicate device tissue samples. The comparison demonstrated an equivalency in ablation and coagulation characteristics.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The Reverso device is substantially equivalent to the Venus Viva MD Device (manufactured by Venus Concept USA Inc. and the subject of K201164). The subject device and predicate device share the same underlying technology of fractional RF, same RF output specifications and same operational principals. A comparison table is provided below comparing the intended use and basic technological characteristics of the Reverso device to the intended use and basic technological characteristics of the predicate device.
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| TechnologicalCharacteristic | Reverso DeviceIntelis InstrumentsLtd.(Subject Device) | Venus Viva MD TMVenus Concept USA Inc.K201164(Predicate Device) |
|---|---|---|
| Product Code,Class | GEIClass II | GEIClass II |
| RegulationNumber | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Indications forUse | The Reverso is a non-invasive device intendedfor use in dermatologicalprocedures requiringablation and resurfacingof the skin. | The Venus Viva MD is a non-invasive device intended to beused by aesthetic- relatedphysicians or dermatologists.When used with the Viva MDapplicator, the Venus Viva MDDevice is intended for use indermatological proceduresrequiring ablation and resurfacingof the skin. |
| Anatomical Sites | Body parts requiringtreatment as specified inthe indication for use | idem |
| TargetPopulation | Adults requiringtreatment as specified inthe indication for use | idem |
| EnvironmentUsed | Hospital or Clinic setting | idem |
| Energy Used /Delivered | RF energy | idem |
| Design: | Fractional RF: Use of RFenergy delivered through amatrix of multiple pinelectrodes allocated on theapplicator tip | idem |
| - Mechanism ofAction | Treatment is based onfractional sub- necroticheating of papillary andreticular dermis triggeringslow collagen remodeling. | idem |
| - Components | Tabletop Consoleincluding :Display panel Main CPU Power supplyReverso applicator. Theapplicator comprises theapplicator handle, trigger, | Tabletop Console including:Display panel Main CPU Power supply RF GeneratorTwo optional applicators:Viva MD applicator. Theapplicator comprises theapplicator handle, trigger, |
| TechnologicalCharacteristic | Reverso DeviceIntelis InstrumentsLtd. | Venus Viva MDTMVenus Concept USA Inc.K201164 |
| (Subject Device)detachable electrode tip(160 pin or 80 pin). | (Predicate Device)detachable electrode tip(160 pin or 80 pin).● Diamondpolar Applicator(irrelevant for this510(K) substantialequivalent discussion) | |
| RF Performancespecifications | RF Frequency: 0.46 MHz •Energy per pin:62 mJ/pin (160 pin tip)124 mJ/pin (80 pin tip) | idem |
| - SystemDimensions | 31.8cm W x 31.5cm D x31.5cm H[12.4" W x 12.3" D x 12.3"H] | 38cm W x 40cm D x 40cm H[14.8" W x 15.6" D x 15.6" H] |
| - WeightPlatform weightApplicator weight | 6 Kg (13.2 lbs.)Applicator - 0.3 Kg (0.66lbs.) | 8 Kg (17.6 lbs.)Applicator - N/A |
| Cable Dimensions: | 170 cm | idem |
| Materials | Applicator Handle: PCMakrolon 2458Tip outer body: PCMakrolon 2458RF pin electrodes:Stainless steel 302. | idem |
| Standards Met | AAMI/ANSI ES 60601-1IEC 60601-1-2IEC 60601-2-2IEC 60601-1-6 | idem |
| Biocompatibility | All materials arebiocompatible | idem |
| Compatibility withEnvironment andOther Devices | Reverso is compliant withthe IEC 60601-1-2 (EMCSafety) standard | idem |
| Sterility | Provided non-sterile.The detachable, single usetip head is to be sterilizedby the user close totreatment onset, usingautoclaving sterilizationtechnique. | idem |
| Electrical Safety | Power Requirements: | idem |
| TechnologicalCharacteristic | Reverso DeviceIntelis InstrumentsLtd.(Subject Device) | Venus Viva MDTMVenus Concept USA Inc.K201164(Predicate Device) |
| The Reverso is compliantwith the IEC 60601-1standard. | ||
| Mechanical Safety | The Reverso is compliantwith the IEC 60601-1standard. | idem |
| Chemical Safety | Not Applicable | Not Applicable |
| Thermal Safety | The Reverso is compliantwith the IEC 60601-1standard. | idem |
| Radiation Safety | The Reverso is compliantwith the IEC 60601-1-2(EMC Safety) standard. | Idem |
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The indications for use and technological characteristics of the Reverso device are substantially equivalent to the indications for use and technological characteristics of the predicate, the Venus Viva MD device (and the subject of K201164).
The design of and the components in the Reverso device, including the console (with the power supply unit, controller and display user interface) and the applicator (with cable, connector to console, handle and tip head) are identical to the design and components found in the predicate device, with similar to identical dimensions and weight.
The RF performance specifications (RF frequency, RF energy per pin, RF energy level) of the Reverso device were shown to be identical to those of the predicate device as demonstrated in the bench performance testing. Furthermore, the Reverso device and the predicate device demonstrated similar thermal effect over ex-vivo human tissues following a single treatment performed under similar RF performance specifications and similar operation conditions.
All of the identified device related hazards are of low risk and are mostly related with transient symptoms of erythema and edema which are resolved 24-72 hours post treatment.
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Therefore, it can be deduced that the Reverso device is as safe and effective as the predicate device, 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 device.
Patient contact materials are the same between the subject device and its predicate device. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns.
Furthermore, the Reverso device underwent performance testing, including software validation testing (provided in Section 16), Electrical and Mechanical Safety testing according to IEC 60601-1, Electromagnetic Compatibility testing according to IEC 60601-1-2 and Usability according to IEC 60601-1-6 (provided in Section 17), bench and ex-vivo 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 (provided in Section 18). These performance tests demonstrated that the minor differences in the device design and specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the Reverso device is substantially equivalent to the predicate device, the Venus Viva MD, FDA cleared under 510(k) K201164, 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.