(118 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard RF technology controlled by a programmable logic controller.
Yes
The device is intended for the "treatment" of mild to moderate facial wrinkles, which implies a therapeutic purpose, and it uses RF energy to heat tissue to improve the appearance of wrinkles and rhytides.
No
The device is intended for non-invasive treatment of facial wrinkles, not for diagnosing any condition.
No
The device description explicitly lists hardware components such as a hand-held device, RF power module, power supply, and RF electrodes, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- sensiLift Function: The sensiLift device uses radiofrequency energy applied externally to the skin to treat wrinkles. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use clearly states it's for "non-invasive treatment of mild to moderate facial wrinkles." This is a therapeutic or cosmetic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and how it generates and applies RF energy to the skin. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the sensiLift is a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
Product codes (comma separated list FDA assigned to the subject device)
PAY
Device Description
The sensiLift is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:
- User Interface
- Programmable logic controller (PLC, microcontroller) embedded in PCBA
- RF power module
- Power Supply
- RF electrodes
The user interface allows the selection of heating level: high, medium low or off, conjugated to movement speed level of the electrodes (also adjusted by the user): high or low. The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a sinusoidal signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.
Technical specifications:
- Maximal power output: 9±1 Watt.
- Skin level power: 3.5±1, 5±1 and 6.5±1 Watt (energy levels 1-3).
- Frequency: 1 MHz.
- Maximal temperature allowed: 40°C.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face: lower cheek (perioral), upper cheek (periorbital) and under the chin.
Indicated Patient Age Range
Adult women between the ages 40-64.
Intended User / Care Setting
Home Use, self-operation by an unprofessional user.
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
A human Factors Validation Testing was done to evaluate the HFE/ UE concerns, including label comprehension/ self-selection and usability/ user interface studies (one arm, simulated use and summative evaluation). In both studies, participants had received the labeling materials of the device, and given enough time to read it according to their own wish.
Labeling Comprehension/ Self Selection Study:
- A total of 43 participants, 2 men and 41 women, from age 18 to 65 years old (45 ± 13 years old) were enrolled to this study.
- Participants had different educational levels, as obtained by REALM testing with 20% below 9th grade level.
- All participants had met the inclusion/ exclusion criteria and signed ICF.
- 100% of the participants had reported correct answers, as further validated by the moderator («=1).
Usability/ User Interface Study:
- The study was focused on four use scenarios including 22 relevant tasks: "preparing and knowing the device" (7 tasks), "self-preparation" (4 tasks), "device usage" (7 tasks) and "after usage" (3 tasks).
- None of the participants had required assistance from the moderator while performing the tasks.
- All tasks were completed by 100% of the participants, and the success rate (pass criteria) was 100% per each task scenario.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Data:
- Study Type: Open label, prospective, interventional single arm study clinical study.
- Sample Size: 40 females between the ages 40-64, fulfilling the inclusion/ exclusion criteria, were enrolled. 35 participants (total of 87 treatment areas) completed the study.
- Key Results:
- No adverse events occurred during and after the study, meaning that the success criteria for primary safety endpoint have been met.
- After the completion of the active treatment regimen, 89%, 95% and 95% of the study participants (as assessed by 3 reviewers, respectively) have shown improvement in overall facial wrinkles appearance.
- Improvement was observed at the end of the Follow-up regimen, 3 months after the last treatment, for 97%, 100% and 100% of the participant by the three evaluators.
- All the participants were highly satisfied with the device at the end of the study. 89% reported on improvement in their skin's appearance.
- Performance Evaluation: Wrinkles appearance was assessed using the Fitzpatrick Wrinkles Severity Scale and improvement was defined as decrease of at least one score in the Scale. This assessment was conducted by 3 independent physicians (beside the PI, 3 board certified dermatologists or plastic surgeons).
Human Factors Validation Testing:
- Study Type: Human Factors Validation Testing to evaluate HFE/UE concerns, including label comprehension/self-selection and usability/user interface studies.
- Sample Size: 43 participants for label comprehension/self-selection study, and 20 participants for usability/user interface study.
- Key Results:
- Labeling Comprehension/Self Selection Study: 100% of participants reported correct answers regarding intended use, treatment areas, and contraindication.
- Usability/User Interface Study: 100% completion rate for all tasks across four use scenarios, with all tasks completed without moderator assistance. High user satisfaction (average 1.66 ± 0.25 on a 1-5 scale, 1 being best).
Bench Performance Data:
- Study Type: Non-clinical (bench) performance data, safety bench tests, and Verification & Validation (V&V).
- Tests Conducted:
- Over-heating safety: Two redundant thermistors embedded in the device constantly measure skin temperature and deactivate RF delivery when temperature exceeds 40℃.
- Power accuracy: Device validated for different power levels on a 200 Ω load, measured total power within error margin.
- Parameter validation: Tested radio frequency, pulse cycle, wave form and pulse duration; all within acceptance criteria.
- Electrical safety and electromagnetic compatibility (EMC) testing: Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-2.
- Software Verification and Validation Testing: Considered "moderate" level of concern.
Biocompatibility:
- Tests Conducted: Cytotoxicity, sensitization and irritation tests as categorized for "Surface device, Skin Contact for limited contact duration" per ISO 10993-5:2009 and ISO 10993-10:2010.
- Key Results: Body contact materials are biocompatible.
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.
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
§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.
(a)
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Instructions for cleaning the device must be validated.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include:
(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
El Global Trade Ltd Dr. Yael Liebes-Peer RA/ QA Manager 8 Tzoran St. P.O. Box 8242 Netanya, 4250608 Israel
Re: K170499
Trade/Device Name: sensiLift Regulation Number: 21 CFR 878.4420 Regulation Name: Electrosurgical Device for Over-The-Counter Aesthetic Use. Regulatory Class: Class II Product Code: PAY Dated: May 7, 2017 Received: May 12, 2017
Dear Dr. Yael Liebes-Peer:
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. The general controls provisions of the Actinclude 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 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 (reporting of medical device
1
related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/9 description: The image shows the text "Jennifer R. Stevenson -S3". The text is in a large, sans-serif font and is black. The background is white. The letters "FDA" are in the background in a light blue color.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170499
Device Name sensiLift
Indications for Use (Describe)
The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
| 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
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831 | |
|---------------------------|-------------------------------------------------------------------------------------------------|--|
| sensiLift – K170499/ S001 | RD- 11118 B2 | |
DATE PREPARED: APRIL 24TH, 2016
510(K) OWNER NAME 1.
EL Global Trade Ltd. Tzoran 8th st, P.O.Box 8242, Netanya 425608, Israel. Phone: +972-9-7889069, Fax: +972-9-7734831.
Contact person name: Dr. Yael Liebes-Peer, RA/ QA Manager
Phone: +972-9-7889069, Fax: +972-9-7734831, E mail: Yael@sensica.com
2. DEVICE NAME
Common/ Usual Name: OTC device for treatment of facial wrinkles based on RF Proprietary/Trade name: sensiLift
Classification: EL Global Trade Ltd.'s sensiLift device has been classified as Class II device under the following classification names:
| Classification Name | Product
Code | Regulation
Number | Panel |
|-----------------------------------------------------------------------|-----------------|----------------------|--------------------------------|
| Electrosurgical device
for over-the-counter
(OTC) aesthetic use | PAY | 878.4420 | General and Plastic
Surgery |
3. PREDICATE DEVICES
EL Global Trade Ltd.'s sensiLift device is substantially equivalent to the following Predicate Device:
3.1 EndyMed Medical Ltd.'s NEWA device,
cleared under De-Novo number DEN150005 at Dec 18th, 2016.
4. DEVICE DESCRIPTION
The sensiLift is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the
4
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 | | Fax: +972-9-7734831 |
|---------------------------|-----------------------------------------------------------------------------|--------------|---------------------|
| sensiLift – K170499/ S001 | | RD- 11118 B2 | |
tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:
- . User Interface
- Programmable logic controller (PLC, microcontroller) embedded in PCBA ●
- RF power module
- Power Supply ●
- RF electrodes ●
The user interface allows the selection of heating level: high, medium low or off, conjugated to movement speed level of the electrodes (also adjusted by the user): high or low. The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a sinusoidal signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.
Technical specifications:
- . Maximal power output: 9±1 Watt.
- . Skin level power: 3.5±1, 5±1 and 6.5±1 Watt (energy levels 1-3).
- . Frequency: 1 MHz.
- Maximal temperature allowed: 40°C. ●
ട. INTENDED USE/ INDICATIONS FOR USE
The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
5
| EL Global Trade Ltd | | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831 | |
|---------------------------|-------------|-------------------------------------------------------------------------------------------------|--|
| sensiLift – K170499/ S001 | RD-11118 B2 | | |
6. NON-CLINICAL (BENCH) PERFORMANCE DATA
The following performance data (bench tests) were provided in support of the performance and safety and efficacy of the sensiLift device as well as the substantial equivalence determination.
Safety Bench Tests and Verification & Validation (V&V) Summary
Bench testing was conducted per IEC standard 60601family to demonstrate that the sensiLift device performs as expected under anticipated conditions of use. This testing included safety performance verification (electrical and mechanical) according to IEC 60601-1, essential requirements according to IEC 60601-1-2 and particular requirements for home use medical device per IEC60601-1-11.
In addition, the following bench testing was conducted (among others) to demonstrate the device performance characteristics as part of the V&V:
- . Over-heating safety. The two redundant thermistors embedded in the device constantly measure the skin temperature and deactivate RF delivery when temperature exceeds 40℃. This temperature was determined to be acceptable based on published information from the National Institute for Standard and and Technology (http://www.nist.gov/fire/fire_behavior.cfm) which state that human skin begins to feel pain at 44°C and may start to develop skin burns at 48°C.
- . Power accuracy. The device was validated for the different power levels on a 200 Ω load, which is appropriate as the reference of the average load of the user. The measured total power was within the error margin, indicating that the device met the acceptance criteria.
6
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 | | Fax: +972-9-7734831 |
|---------------------------|-----------------------------------------------------------------------------|--|---------------------|
| sensiLift – K170499/ S001 | RD- 11118 B2 | | |
- Parameter validation. The device was tested for its varied parameters, . including radio frequency, pulse cycle, wave form and pulse duration. All results were within the acceptance criteria.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the sensiLift device. The device complies with:
- IEC 60601-1:2005/EN 60601-1:2006, General safety standard: safety . requirements for medical electrical systems.
- . IEC 60601-1-2:2007, IEC 60601-1-2:2009, Medical electrical equipment Part 1-2 - General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-1-11:2010. Medical electrical equipment Part 1-11 -. Requirements for the medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . IEC 60601-2-2: 2009, 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.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern because inadvertent software errors could result in skin burns to the user.
7
| K170499 | Page 5 of 1 |
|---|---|
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel |
| Tel: +972-9-7889069 | |
| Fax: +972-9-7734831 | |
| sensiLift – K170499/ S001 | RD- 11118 B2 |
Human Factors Validation Testing
A human Factors Validation Testing was done to evaluate the HFE/ UE concerns, including label comprehension/ self-selection and usability/ user interface studies (one arm, simulated use and summative evaluation). In both studies, participants had received the labeling materials of the device, and given enough time to read it according to their own wish.
Labeling Comprehension/ Self Selection Study was aimed at demonstrating potential user comprehension of the device labeling (mainly the outer package) in order to decide if device use is appropriate for her. It had included three main questions regarding the intended use of the device, treatment areas and possibility to usse the device according to the contraindication, with correct answers: ,,Yes" or "No", explenation and further validation by the moderator. A total of 43 participants, 2 men and 41 women, from age 18 to 65 years old (45 ± 13 years old) were enrolled to this study. Participants had different educational levels, as obtained by REALM testing with 20% below 9th grade level. All participants had met the inclusion/ exclusion criteria and signed ICF. 100% of the participants had reported correct answers, as further validated by the moderator («=1).
Usability/ User Interface Study was aimed at demonstrating the OTC user can correctly use the device, based on the labeling material for the intended aesthetic puspose. The study was focused on four use scenarios including 22 relevant tasks: "preparing and knowing the device" (7 tasks), "self-preparation" (4 tasks), "device usage" (7 tasks) and "after usage" (3 tasks). None of the participants had required assistance from the moderator while performing the tasks. Altogether, all tasks were completed by 100% of the participants, and the success rate (pass criteria) was 100% per each task scenario.
In addition, the vast majority of the participants (14 out of 20) had additionally commented that the device usage is easy and clear and they are curios and would
8
| EL Global Trade Ltd | | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831 | |
|---------------------------|--|-----------------------------------------------------------------------------------------------------|--|
| sensiLift – K170499/ S001 | | RD- 11118 B2 | |
be interested in using the device. Some participants (7 out of 20) had additionally commented (though succeeded in operation) regarding the comfort of using the buttons. Only few (4 out of 20 participants) were concerned about other elements of the device.
Furthermore, when participants were asked regarding their user experience and satisfaction after the usability and user interface study, high satisfaction was obtained, with an average result was 1.66 ± 0.25, using a 1-5 discrete scale (when 1 represent best and 5 worst).
These two demonstrates that the intended OTC users can understand the package labeling, correctly choose the device and use it for the indicated aesthetic use, based solely on reading the lableling materials.
7. PERFORMANCE TESTING - ANIMAL
No animal testing was performed with the subject device
CLEANING, STERILIZATION, SHELF LIFE AND BIOCOMPATIBILITY 8.
The sensiLift is a non-sterile, reusable device, intended for a single user. The device cleaning instructions are based on the cleaning instructions of the predicate device due to the fact that both devices are made from the same materials and used similarly.
The shelf life expectancy of the device is 5 years, similarly to the predicate device.
The biocompatibility evaluation for the sensiLift device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1
9
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831 |
|---------------------------|-------------------------------------------------------------------------------------------------|
| sensiLift – K170499/ S001 | RD- 11118 B2 |
"Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
EL Global has categorized its sensiLift device as: "Surface device, Skin Contact for limited contact duration", with contact duration of less than 24h ("A", up to 24 hours). Therefore, the battery of testing included the following tests: cytotoxicity, sensitization and irritation tests. The body contact materials are biocompatible per:
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: . Tests for in vitro cytotoxicity.
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: . Tests for irritation and skin sensitization.
The sensiLift device is made of similar materials that come into contact with user's body as already cleared for the predicate device (DEN150005) and for the auxiliary sensiLight mini device (K140527 and K161089).
9. CLINICAL PERFORMANCE DATA
The sensiLift safety and efficacy, when used at a home setting, for non-invasive treatment of mild to moderate facial wrinkles of adult women with Fitzpatrick Skin Types I-IV was examined in an open label, prospective, interventional single arm study clinical study.
40 females between the ages 40-64, fulfilling the inclusion/ exclusion criteria, were enrolled to the study by the Principle Investigator (PI) and treated 2-3 treatment regions (perioral, periorbital and chin regions), according to their preference and the physician approval. 35 participants (total of 87 treatment areas) had completed 8 treatments according to the instructions for use and appeared to the 3 months after treatments last follow-up (FU2). The wrinkles appearance was assessed using the Fitzpatrick Wrinkles Severity Scale and improvement was defined as decrease of at least one score in the Scale. This assessment was conducted by 3 independent physicians (beside the PI, 3 board certified
10
| EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
| Tel: +972-9-7889069 Fax: +972-9-7734831 | |
|---|---|
| sensiLift – K170499/ S001 | RD- 11118 B2 |
dermatologists or plastic surgeons) at the end of the active treatment regimen (T8), 1 and 3 months after the last treatment (follow-up regimen FU1 and FU2, respectively).
No adverse events occurred during and after the study, meaning that the success criteria for primary safety endpoint have been met. As for effectiveness, after the completion of the active treatment regimen, 89%, 95% and 95% of the study participants (as assessed by 3 reviewers, respectively) have shown improvement in overall facial wrinkles appearance. Similarly, improvement was observed at the end of the Follow-up regimen, 3 months after the last treatment, for 97%, 100% and 100% of the participant by the three evaluators. In addition, all the participants were highly satisfied with the device at the end of the study. 89% reported on improvement in their skin's appearance.
These results demonstrate that the device performs as intended under anticipated conditions of use (home environment) to achieve the intended aesthetic results.
10. SUBSTANTIAL EQUIVALENCE
The indications for use and technological characteristics of the sensiLift device are substantially equivalent to the indications for use and technological characteristics of the predicate device. A detailed comparison between the sensiLift by EL Global LTD. proposed device and the predicate device is presented at Table 1 below, including the similarities and differences and the related conclusion.
11
Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift – K170499/ S001
RD- 11118 B2
Table 1. Substantial Equivalence of EL Global's sensiLift with Predicate Device.
| Feature | EL Global
sensiLift
New Device | EndyMed
NewaTM
[DEN150005]
Predicate Device | Characteristics
comparison (similarity) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Regulatory information | | | |
| Device Class | Class II | Class II | Identical |
| Classification
Panel | General and Plastic
Surgery | General and Plastic
Surgery | Identical |
| Product code | PAY | PAY | Identical |
| Regulation
number | 21 CFR 878.4420 | 21 CFR 878.4420 | Identical |
| Device | Over-The-Counter
Radiofrequency
Coagulation Device For
Wrinkle Reduction | Over-The-Counter
Radiofrequency
Coagulation Device For
Wrinkle Reduction | Identical |
| Regulation
description | Electrosurgical device for
over-the-counter aesthetic
use | Electrosurgical device for
over-the-counter aesthetic
use | Identical |
| Intended use | The sensiLiftTM
is an over-the-counter
home use device intended
for non-invasive treatment
of mild to moderate facial
wrinkles for adult women
who have Fitzpatrick Skin
Types I-IV. | The EndyMed NewaTM is
an over-the-counter home
use device intended for
non-invasive treatment of
mild to moderate facial
wrinkles for adult women
who have Fitzpatrick Skin
Types I-IV. | Identical |
| Device characteristics | | | |
| Mode of
Operation | The device a home-use
hand-held device
generating pulses RF
energy that emitted into the
skin. RF energy heats the
tissue to improve the
appearance of wrinkles and
rhytides. It is non-invasive
and non-ablating device. | The device is a home-use
hand-held device
generating pulses of RF
energy that emitted into the
skin. RF energy heats the
tissue to improve the
appearance of wrinkles and
rhytides. It is non-invasive
and non-ablating device. | Identical |
| Energy
Source | 1 MHz RF (Bi-polar) | 1 MHz RF (Bi-polar) | Identical |
| Number of
electrodes | 2 electrodes (1 pair of Bi-
polar electrodes) | 6 electrodes (3 pairs of Bi-
polar electrodes) | Similar to Predicate
Device. See note No. 1 |
| | EL Global
sensiLift | EndyMed
Newa TM
[DEN150005] | Characteristics
comparison (similarity) |
| Feature | New Device | Predicate Device | |
| Treatment
areas | Face: lower cheek
(perioral), upper cheek
(periorbital) and under the
chin. | Face: lower cheek, upper
cheek and under the chin. | Identical |
| Treatment
regimen | 5 minute each area, 1 time
per week, for 8 consecutive
weeks (treatment area
about 4X4 cm2). | 4 minute each area, 5 times
per week, for 4 consecutive
weeks (treatment area
about 4X4 cm2). | Different. Treatment
regimen was validated via
clinical Trial.
See note No. 2. |
| Intended
population | Adult healthy women
(Fitzpatrick skin type I-IV)
who desire to reduce facial
wrinkles. | Adult healthy women
(Fitzpatrick skin type I-IV)
who desire to reduce facial
wrinkles. | Identical |
| Use
Environment | Home Use, self-operation
by an unprofessional user. | Home Use, self-operation
by an unprofessional user. | Identical |
| Device Features | | | |
| Hand piece
Dimensions,
(LXHXW)
[mm³] | 173 X 56.8 X 53 | 73 X 37 X 120 | Similar.
See note No. 3. |
| Weight [gr] | 122 | 70 | Similar.
See note No. 3. |
| Electrodes
treatment
area [mm²] | 176 | 178 | Identical |
| Body contact
materials | ABS plastic shell.
Chrome coated electrodes. | ABS plastic shell.
Chrome coated electrodes. | Identical |
| User
interface | 1 LED: device status
indicator (yellow-
green)1 LED panel (energy
level, green)1 LED panel (speed
level, green) | 1 LED, blue or green,
reflecting the device
statusKnob for energy level
selection | Similar.
See note No. 4. |
| Maximal
power by
hardware
[Watt] | $9 \pm 1$ | $10 \pm 2$ | Identical |
| User | 3 energy levels deliver skin | 2 energy levels, deliver | Similar. See note No. 1. |
| | EL Global | EndyMed | |
| Feature | sensiLift | Newa™ | Characteristics |
| | | [DEN150005] | comparison (similarity) |
| | New Device | Predicate Device | |
| energy levels
(time
modulation,
pulse) [%] | Level 3 - 72% Level 2 - 55% Level 1 - 38% | Level 2 - 60% Level 1 - 40% | |
| Safety
mechanism | Two redundant thermistors continuously monitoring skin temperature and automatically de-activate RF energy delivery when temperature of 40°C/ 104°F is detected, until temperature lowers enough. Moving electrodes to prevent local over-heating. A flickering or steady green LED light when the device is active. RF is delivered only when both electrodes are with body contact. | One Thermal sensor for skin temperature measurements. Automatically stop delivering RF when temperature of 42°C is detected, until temperature lowers enough. Built in moving sensor stop delivering RF when the device is stationary A steady LED when the device is active Vibratory signal alerts when treatment period completed. | Similar.
Usefulness of all safety mechanisms was validated in clinical trial and usability study.
See note No. 4. |
| | Performance Characteristics | | |
| Electrical
requirements | 100-240 V,
50-60 Hz
9 V, 1.5 A | 100-240 V
50-60 Hz
9 V, 2 A | Identical |
| Energy
consumption | Up to 10W | Up to 10W | Identical |
| Frequency
[MHz] | 1 | 1 | Identical |
| Safety standards | | | |
| Safety/EMC | IEC 60601-1:2005/EN
60601-1:2006, General
safety standard: safety | IEC 60601-1:2005/EN
60601-1:2006, General
safety standard: safety | Identical.
sensiLift has the same
safety/ EMC certifications |
| Feature | EL Global
sensiLift
New Device | EndyMed
NewaTM
[DEN150005]
Predicate Device | Characteristics
comparison (similarity) |
| | requirements for medical
electrical systems. | requirements for medical
electrical systems. | as the predicate device and
is certified for additional
standard. |
| | IEC 60601-1-2:2007, IEC
60601-1-2:2009, Medical
electrical equipment Part
1-2 - General requirements
for basic safety and
essential performance -
Collateral Standard:
Electromagnetic
Compatibility -
Requirements And Tests. | IEC 60601-1-2:2007,
Medical electrical
equipment Part 1-2 -
General requirements for
basic safety and essential
performance - Collateral
Standard: Electromagnetic
Compatibility -
Requirements And Tests. | |
| | IEC 60601-1-11:2010,
Medical electrical
equipment Part 1-11 -
Requirements for the
medical electrical
equipment and medical
electrical systems used in
the home healthcare
environment. | IEC 60601-1-11:2010,
Medical electrical
equipment Part 1-11 -
Requirements for the
medical electrical
equipment and medical
electrical systems used in
the home healthcare
environment. | |
| | IEC 60601-2-2: 2009,
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. | | |
| Biocompatibility | All parts that are in contact
with user comply with the
requirements for ISO-
10993-1: 2009, Biological | All parts that are in contact
with user comply with the
requirements for ISO-
10993-1: 2009, Biological | Identical
See note No. 5 |
| | | | |
| | EL Global | EndyMed | |
| | sensiLift | Newa™ | Characteristics |
| Feature | New Device | [DEN150005]
Predicate Device | comparison (similarity) |
| | devices - Part 1:
Evaluation and testing
within a risk management
process. | devices - Part 1:
Evaluation and testing
within a risk management
process. | |
| | ISO 10993-5:2009,
Biological evaluation of
medical devices - Part 5:
Tests for in vitro
cytotoxicity. | ISO 10993-5:2009,
Biological evaluation of
medical devices - Part 5:
Tests for in vitro
cytotoxicity. | |
| | ISO 10993-10:2010,
Biological evaluation of
medical devices - Part 10:
Tests for irritation and skin
sensitization. | ISO 10993-10:2010,
Biological evaluation of
medical devices - Part 10:
Tests for irritation and skin
sensitization. | |
| Software | The software was verified
and validated according to
the FDA guidance.
Moderate Level of
Concern | The software was verified
and validated according to
the FDA guidance.
Moderate Level of
Concern | Identical |
12
Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift – K170499/ S001
RD- 11118 B2
13
Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift – K170499/ S001
RD- 11118 B2
14
Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift – K170499/ S001
RD- 11118 B2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15
Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel Fax: +972-9-7734831 Tel: +972-9-7889069
sensiLift — K170499/ S001
RD- 11118 B2
Note No. 1. The energy delivered and electrodes architecture.
The method of RF delivery is the crucial factor, since it will dictate the penetration depth of the RF energy. Both sensiLift and predicate device are 1 MHz Bi-polar RF devices. The power energy output is an additional important factor for safe and effective treatment since it dictates the time required to achieve the desired heating. Both devices have similar maximal power consumption of up to 10 W and the effective delivered energy levels are set on time pulse basis (time modulation), with similar values for both devices.
The configuration of the electrodes affects the penetration depth of the RF energy as well as the treatment area and the current density. The differences in both devices configuration does not affect the safety and efficacy of the devices, as s
16
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831 | | |
|---------------------------|-------------------------------------------------------------------------------------------------|--------------|--|
| sensiLift – K170499/ S001 | | RD- 11118 B2 | |
was further demonstrated using varies EMC tests, in-vitro comparisons (Performance Testing - Bench) and a clinical trial (Performance Testing -Clinical).
Note No. 2. The treatment Regimen.
The treatment regimen of the sensiLift was especially planned to achieve its intended use in a safe and effective manner. Both sensiLift predicate devices are designed for the exact same anatomical site. Since the total exposure of the sensiLift device lower than of the predicate device, no safety issues are raised. Both the safety and efficacy of the sensiLift device for home-use environment for the intended use was validated in a clinical trial (Performance Testing - Clinical).
Note No. 3. Device size and weight.
The size and weight of the hand-held device are basic unit characteristics with no effect over the intended use nor the safety nor the efficacy of the device. The sensiLift device was designed to allow ergonomic and fatigue-free grip during several minutes of treatments by the naïve user.
Note No. 4. User interface and safety mechanism.
Both user interface elements and the safety mechanisms the sensiLift device were designed to meet the needs of the naïve user at home and to protect its user from any hazard (including several safety mechanisms). The added feature of the sensiLift electrodes to move along their axis does not alter the intended use nor affect neither the safety profile nor introducing new or additional risk factors. This movement ability of the electrodes is similar to devices classified as class 1 devices, exempt of 510K (Massager, Therapeutic, Electric; Product Code ISA; Regulation Number 890.5660). The suitability of sensiLift device for home-use environment and ability of the naïve lay user to use the device in a safe and effective manner was verified according to safety standards and further validated
17
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831 | | |
|---------------------------|-----------------------------------------------------------------------------------------------------|--------------|--|
| sensiLift – K170499/ S001 | | RD- 11118 B2 | |
in a Human Factors Test Validation (including self-screening) study and further validated in a clinical trial data (Performance Testing - Bench and Performance Testing - Clinical, respectively).
Note No. 5. Biocompatibility.
The sensiLift device is made of similar materials that come into contact with user's body as already cleared for the predicate device (DEN150005) and for the auxiliary device (K140527 and K161089).
11. CONCLUSIONS
Due to these identical clauses and high similarities, the sensiLift device is at least as safe and as effective as the predicate device, since they share the same intended use, technological characteristics, features, specifications and materials and anatomical site for use.
The differences between the sensiLift device and the predicate device do not raise new safety or effectiveness issues or questions, as detailed above.
Based on the performance testing and comparison to predicate devices, the sensiLift device is substantially equivalent to the previously cleared NEWA predicate device.