(118 days)
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.
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 provided document describes the SensiLift device, an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles. The document outlines the studies conducted to demonstrate its safety and effectiveness for FDA 510(k) clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SensiLift device are inferred from the safety and effectiveness endpoints of the clinical study, as well as the successful completion of various non-clinical bench tests and human factors studies.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from study objectives) | Reported Device Performance |
|---|---|---|
| Safety | - No adverse events | No adverse events occurred during and after the study. |
| - RF delivery deactivates when skin temperature exceeds 40°C | Two redundant thermistors continuously monitored skin temperature and automatically de-activated RF energy delivery when temperature of 40°C/104°F was detected. | |
| - Power accuracy within error margin | Measured total power was within the error margin. | |
| - Compliance with electrical safety and EMC standards (IEC 60601 family) | The device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-2. | |
| - Software verification and validation (for "moderate" level of concern) | Software verification and validation testing were conducted as recommended by FDA guidance, with a "moderate" level of concern. | |
| - Biocompatibility of body contact materials | All body contact materials are biocompatible per ISO 10993-5:2009 and ISO 10993-10:2010. | |
| Effectiveness | - Improvement in overall facial wrinkles appearance (at least one score decrease on Fitzpatrick Wrinkles Severity Scale) at end of active treatment (T8) | 89%, 95%, and 95% of participants (as assessed by 3 reviewers, respectively) showed improvement. |
| - Improvement in overall facial wrinkles appearance at 3 months after last treatment (FU2) | 97%, 100%, and 100% of participants (as assessed by 3 reviewers, respectively) showed improvement. | |
| - High user satisfaction | All participants were highly satisfied, with 89% reporting improvement in their skin's appearance. Average satisfaction: 1.66 ± 0.25 on a 1-5 discrete scale (1=best). | |
| Human Factors/Usability | - User comprehension of labeling and ability for self-selection | 100% of participants reported correct answers regarding intended use, treatment areas, and contraindications. |
| - OTC user can correctly use the device based on labeling | All tasks were completed by 100% of participants, with a 100% success rate per task scenario. |
Study Details
The document primarily describes a single-arm, prospective, interventional clinical study for effectiveness and safety, along with several non-clinical studies.
-
A table of acceptance criteria and the reported device performance: See table above.
-
Sample sizes used for the test set and the data provenance:
-
Clinical Study (Effectiveness & Safety):
- Enrollment: 40 female participants (ages 40-64).
- Completed Study: 35 participants (total of 87 treatment areas) completed 8 treatments and the 3-month follow-up.
- Provenance: Not explicitly stated, but presumable from the location of the submitting company (Israel) or where a clinical trial would be conducted. The study is described as "prospective" and "interventional."
-
Human Factors Validation Testing:
- Labeling Comprehension/Self-Selection Study: 43 participants (2 men, 41 women), ages 18-65 (45 ± 13 years old).
- Usability/User Interface Study: Not explicitly stated but implies a subset of the 43 participants or a similar number based on "14 out of 20" and "7 out of 20" comments. Assuming it's at least 20 participants for this part.
- Provenance: Not specified, but likely conducted in a simulated environment.
-
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Study (Effectiveness): 3 independent physicians (apart from the PI - Principal Investigator).
- Qualifications: "3 board certified dermatologists or plastic surgeons."
-
Adjudication method for the test set:
- Clinical Study (Effectiveness): Wrinkles appearance was assessed independently by the 3 physicians. There is no explicit mention of an adjudication process (e.g., 2+1 or 3+1 consensus). The percentages of improvement are reported for each reviewer separately (e.g., "89%, 95% and 95% of the study participants (as assessed by 3 reviewers, respectively)"). This implies independent assessment rather than a combined adjudicated score for each participant.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving AI assistance for human readers was conducted or described. This device is a direct-to-consumer physical device for wrinkle treatment, not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical electrosurgical aesthetic device, not an algorithm. Bench tests and a clinical trial evaluated the device's standalone performance in a human-in-the-loop setting (users operating the device).
-
The type of ground truth used:
- Clinical Study (Effectiveness): Expert assessment using the Fitzpatrick Wrinkles Severity Scale. Improvement was defined as a decrease of at least one score on this scale. This is a clinical outcome observed by qualified experts.
- Clinical Study (Safety): Observation of adverse events.
- Human Factors Study: Direct observation of task completion and user responses to questions.
-
The sample size for the training set:
- The document implies that the clinical study was conducted for final validation and performance assessment. There's no separate mention of a distinct "training set" for an algorithm, as this is a physical device submission. If the device's software had any machine learning components, details about a training set would typically be provided under software V&V. The software concern level is "moderate," indicating potential harm from errors, but it's not described as an AI/ML algorithm.
-
How the ground truth for the training set was established:
- Not applicable, as a discrete training set for an AI/ML algorithm is not described. The clinical study acts as the primary validation of the device's performance against ground truth established by expert consensus (dermatologists/plastic surgeons) using a recognized severity scale.
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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
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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,
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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
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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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| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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 | ProductCode | RegulationNumber | Panel |
|---|---|---|---|
| Electrosurgical devicefor over-the-counter(OTC) aesthetic use | PAY | 878.4420 | General and PlasticSurgery |
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
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| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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.
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| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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.
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| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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.
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| K170499 | Page 5 of 1 |
|---|---|
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069Fax: +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
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| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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
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| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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
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| EL Global Trade LtdTzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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.
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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 GlobalsensiLiftNew Device | EndyMedNewaTM[DEN150005]Predicate Device | Characteristicscomparison (similarity) |
|---|---|---|---|
| Regulatory information | |||
| Device Class | Class II | Class II | Identical |
| ClassificationPanel | General and PlasticSurgery | General and PlasticSurgery | Identical |
| Product code | PAY | PAY | Identical |
| Regulationnumber | 21 CFR 878.4420 | 21 CFR 878.4420 | Identical |
| Device | Over-The-CounterRadiofrequencyCoagulation Device ForWrinkle Reduction | Over-The-CounterRadiofrequencyCoagulation Device ForWrinkle Reduction | Identical |
| Regulationdescription | Electrosurgical device forover-the-counter aestheticuse | Electrosurgical device forover-the-counter aestheticuse | Identical |
| Intended use | The sensiLiftTMis an over-the-counterhome use device intendedfor non-invasive treatmentof mild to moderate facialwrinkles for adult womenwho have Fitzpatrick SkinTypes I-IV. | The EndyMed NewaTM isan over-the-counter homeuse device intended fornon-invasive treatment ofmild to moderate facialwrinkles for adult womenwho have Fitzpatrick SkinTypes I-IV. | Identical |
| Device characteristics | |||
| Mode ofOperation | The device a home-usehand-held devicegenerating pulses RFenergy that emitted into theskin. RF energy heats thetissue to improve theappearance of wrinkles andrhytides. It is non-invasiveand non-ablating device. | The device is a home-usehand-held devicegenerating pulses of RFenergy that emitted into theskin. RF energy heats thetissue to improve theappearance of wrinkles andrhytides. It is non-invasiveand non-ablating device. | Identical |
| EnergySource | 1 MHz RF (Bi-polar) | 1 MHz RF (Bi-polar) | Identical |
| Number ofelectrodes | 2 electrodes (1 pair of Bi-polar electrodes) | 6 electrodes (3 pairs of Bi-polar electrodes) | Similar to PredicateDevice. See note No. 1 |
| EL GlobalsensiLift | EndyMedNewa TM[DEN150005] | Characteristicscomparison (similarity) | |
| Feature | New Device | Predicate Device | |
| Treatmentareas | Face: lower cheek(perioral), upper cheek(periorbital) and under thechin. | Face: lower cheek, uppercheek and under the chin. | Identical |
| Treatmentregimen | 5 minute each area, 1 timeper week, for 8 consecutiveweeks (treatment areaabout 4X4 cm2). | 4 minute each area, 5 timesper week, for 4 consecutiveweeks (treatment areaabout 4X4 cm2). | Different. Treatmentregimen was validated viaclinical Trial.See note No. 2. |
| Intendedpopulation | Adult healthy women(Fitzpatrick skin type I-IV)who desire to reduce facialwrinkles. | Adult healthy women(Fitzpatrick skin type I-IV)who desire to reduce facialwrinkles. | Identical |
| UseEnvironment | Home Use, self-operationby an unprofessional user. | Home Use, self-operationby an unprofessional user. | Identical |
| Device Features | |||
| Hand pieceDimensions,(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. |
| Electrodestreatmentarea [mm²] | 176 | 178 | Identical |
| Body contactmaterials | ABS plastic shell.Chrome coated electrodes. | ABS plastic shell.Chrome coated electrodes. | Identical |
| Userinterface | 1 LED: device statusindicator (yellow-green)1 LED panel (energylevel, green)1 LED panel (speedlevel, green) | 1 LED, blue or green,reflecting the devicestatusKnob for energy levelselection | Similar.See note No. 4. |
| Maximalpower byhardware[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(timemodulation,pulse) [%] | Level 3 - 72% Level 2 - 55% Level 1 - 38% | Level 2 - 60% Level 1 - 40% | |
| Safetymechanism | 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 | |||
| Electricalrequirements | 100-240 V,50-60 Hz9 V, 1.5 A | 100-240 V50-60 Hz9 V, 2 A | Identical |
| Energyconsumption | Up to 10W | Up to 10W | Identical |
| Frequency[MHz] | 1 | 1 | Identical |
| Safety standards | |||
| Safety/EMC | IEC 60601-1:2005/EN60601-1:2006, Generalsafety standard: safety | IEC 60601-1:2005/EN60601-1:2006, Generalsafety standard: safety | Identical.sensiLift has the samesafety/ EMC certifications |
| Feature | EL GlobalsensiLiftNew Device | EndyMedNewaTM[DEN150005]Predicate Device | Characteristicscomparison (similarity) |
| requirements for medicalelectrical systems. | requirements for medicalelectrical systems. | as the predicate device andis certified for additionalstandard. | |
| IEC 60601-1-2:2007, IEC60601-1-2:2009, Medicalelectrical equipment Part1-2 - General requirementsfor basic safety andessential performance -Collateral Standard:ElectromagneticCompatibility -Requirements And Tests. | IEC 60601-1-2:2007,Medical electricalequipment Part 1-2 -General requirements forbasic safety and essentialperformance - CollateralStandard: ElectromagneticCompatibility -Requirements And Tests. | ||
| IEC 60601-1-11:2010,Medical electricalequipment Part 1-11 -Requirements for themedical electricalequipment and medicalelectrical systems used inthe home healthcareenvironment. | IEC 60601-1-11:2010,Medical electricalequipment Part 1-11 -Requirements for themedical electricalequipment and medicalelectrical systems used inthe home healthcareenvironment. | ||
| IEC 60601-2-2: 2009,Medical electricalequipment - Part 2-2:Particular requirements forthe basic safety andessential performance ofhigh frequency surgicalequipment and highfrequency surgicalaccessories. | |||
| Biocompatibility | All parts that are in contactwith user comply with therequirements for ISO-10993-1: 2009, Biological | All parts that are in contactwith user comply with therequirements for ISO-10993-1: 2009, Biological | IdenticalSee note No. 5 |
| EL Global | EndyMed | ||
| sensiLift | Newa™ | Characteristics | |
| Feature | New Device | [DEN150005]Predicate Device | comparison (similarity) |
| devices - Part 1:Evaluation and testingwithin a risk managementprocess. | devices - Part 1:Evaluation and testingwithin a risk managementprocess. | ||
| ISO 10993-5:2009,Biological evaluation ofmedical devices - Part 5:Tests for in vitrocytotoxicity. | ISO 10993-5:2009,Biological evaluation ofmedical devices - Part 5:Tests for in vitrocytotoxicity. | ||
| ISO 10993-10:2010,Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization. | ISO 10993-10:2010,Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization. | ||
| Software | The software was verifiedand validated according tothe FDA guidance.Moderate Level ofConcern | The software was verifiedand validated according tothe FDA guidance.Moderate Level ofConcern | Identical |
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Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift – K170499/ S001
RD- 11118 B2
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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
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| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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
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| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +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.
§ 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.