(127 days)
Not Found
No
The summary describes a hardware device that delivers RF energy with adjustable settings. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which falls under the scope of therapeutic applications. It is used to treat the skin directly through RF energy.
No
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which are therapeutic rather than diagnostic actions.
No
The device description clearly outlines hardware components including a console, applicator, power supply unit, controller card, LCD screen, and detachable tips, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in dermatological procedures requiring ablation and resurfacing of the skin." This describes a procedure performed directly on the patient's body, not on a sample taken from the body.
- Device Description: The device delivers RF energy to the skin. This is a therapeutic or procedural device, not one that analyzes biological samples.
- No mention of analyzing samples: There is no indication that the device interacts with or analyzes any biological samples (like blood, urine, tissue biopsies, etc.).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body parts requiring treatment as specified in the indication for use
Indicated Patient Age Range
Adults requiring treatment as specified in the indication for use
Intended User / Care Setting
Hospital or Clinic setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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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3
510(K) SUMMARY REVERSO DEVICE
510(k) Number K212107
Applicant Name:
| Company Name: | Intelis Instruments Ltd. |
|---|---|
| Address: | HaOman 12 |
| Hadera, 3850172 | |
| Israel | |
| 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 4442518 | ||
| Israel | ||
| 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 Concept | ||
| USA Inc. | Venus Viva MD | K201164 |
4
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.
5
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
6
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.
7
| Technological
Characteristic | Reverso Device
Intelis Instruments
Ltd.
(Subject Device) | Venus Viva MD TM
Venus Concept USA Inc.
K201164
(Predicate Device) |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,
Class | GEI
Class II | GEI
Class II |
| Regulation
Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Indications for
Use | The Reverso is a non-
invasive device intended
for use in dermatological
procedures requiring
ablation and resurfacing
of the skin. | The Venus Viva MD is a non-
invasive device intended to be
used by aesthetic- related
physicians or dermatologists.
When used with the Viva MD
applicator, the Venus Viva MD
Device is intended for use in
dermatological procedures
requiring ablation and resurfacing
of the skin. |
| Anatomical Sites | Body parts requiring
treatment as specified in
the indication for use | idem |
| Target
Population | Adults requiring
treatment as specified in
the indication for use | idem |
| Environment
Used | Hospital or Clinic setting | idem |
| Energy Used /
Delivered | RF energy | idem |
| Design: | Fractional RF: Use of RF
energy delivered through a
matrix of multiple pin
electrodes allocated on the
applicator tip | idem |
| - Mechanism of
Action | Treatment is based on
fractional sub- necrotic
heating of papillary and
reticular dermis triggering
slow collagen remodeling. | idem |
| - Components | Tabletop Console
including :
Display panel Main CPU Power supply
Reverso applicator. The
applicator comprises the
applicator handle, trigger, | Tabletop Console including:
Display panel Main CPU Power supply RF Generator
Two optional applicators:
Viva MD applicator. The
applicator comprises the
applicator handle, trigger, |
| Technological
Characteristic | Reverso Device
Intelis Instruments
Ltd. | Venus Viva MDTM
Venus 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 this
510(K) substantial
equivalent discussion) |
| RF Performance
specifications | RF Frequency: 0.46 MHz •
Energy per pin:
62 mJ/pin (160 pin tip)
124 mJ/pin (80 pin tip) | idem |
| - System
Dimensions | 31.8cm W x 31.5cm D x
31.5cm 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] |
| - Weight
Platform weight
Applicator weight | 6 Kg (13.2 lbs.)
Applicator - 0.3 Kg (0.66
lbs.) | 8 Kg (17.6 lbs.)
Applicator - N/A |
| Cable Dimensions: | 170 cm | idem |
| Materials | Applicator Handle: PC
Makrolon 2458
Tip outer body: PC
Makrolon 2458
RF pin electrodes:
Stainless steel 302. | idem |
| Standards Met | AAMI/ANSI ES 60601-1
IEC 60601-1-2
IEC 60601-2-2
IEC 60601-1-6 | idem |
| Biocompatibility | All materials are
biocompatible | idem |
| Compatibility with
Environment and
Other Devices | Reverso is compliant with
the IEC 60601-1-2 (EMC
Safety) standard | idem |
| Sterility | Provided non-sterile.
The detachable, single use
tip head is to be sterilized
by the user close to
treatment onset, using
autoclaving sterilization
technique. | idem |
| Electrical Safety | Power Requirements: | idem |
| Technological
Characteristic | Reverso Device
Intelis Instruments
Ltd.
(Subject Device) | Venus Viva MDTM
Venus Concept USA Inc.
K201164
(Predicate Device) |
| | The Reverso is compliant
with the IEC 60601-1
standard. | |
| Mechanical Safety | The Reverso is compliant
with the IEC 60601-1
standard. | idem |
| Chemical Safety | Not Applicable | Not Applicable |
| Thermal Safety | The Reverso is compliant
with the IEC 60601-1
standard. | idem |
| Radiation Safety | The Reverso is compliant
with the IEC 60601-1-2
(EMC Safety) standard. | Idem |
8
9
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.
10
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.