(134 days)
DEN 150005
No
The device description mentions a Programmable Logic Controller (PLC) and software for operational and safety functions, but there is no mention of AI, ML, or related concepts like training/test sets or image processing. The focus is on delivering RF energy and mechanical massage.
Yes
The device is intended for the "temporary reduction in the appearance of cellulite," which addresses a medical condition (cellulite is considered a medical condition by regulatory bodies, even if it's often viewed as cosmetic).
No
The device is intended for the temporary reduction in the appearance of cellulite, which is an aesthetic purpose, not for diagnosing a medical condition.
No
The device description explicitly states it is a hand-held device that delivers RF energy and mechanical massage, and includes hardware components such as a power supply, RF power generator, PCBA, vibration motor, electrodes, and temperature sensors. While it mentions a PLC with "specially configured software," this software is embedded within and controls the hardware, making it a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the sensiFirm device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "Temporary reduction in the appearance of cellulite" using non-thermal RF and massage. This is a cosmetic or aesthetic treatment applied directly to the body, not a test performed on biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The description details a device that applies energy and massage to the skin. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Detection or measurement of analytes.
- Providing information for diagnosis, monitoring, or screening of diseases.
The sensiFirm device is a therapeutic or aesthetic device used for physical treatment of the body.
N/A
Intended Use / Indications for Use
The sensiFirm device is intended for the following medical conditions using non thermal RF combined with massage: Temporary reduction in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
PBX, GEI
Device Description
The sensiFirm is an OTC, home use device, designed to deliver non-thermal RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the non-thermal RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a noninvasive, non-ablative device and it is supplied as non-sterile.
The sensiFirm device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes a vibration motor, four Bi-polar (2 pairs) electrodes and two redundant temperature sensors. The PLC (on the PCBA) is specially configured software combined with hardware circuits that provides the operational and safety function of the system.
The sensiFirm device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the non-thermal RF energy together with mechanical massage over the entire treatment area.
Device specifications:
- Maximal power output: 10±1 Watt. .
- . Skin level power: 6±1, 8±1 and 10±1 Watt (energy levels 1-3).
- Frequency: 1±0.05 MHz. .
- Maximal temperature allowed: 41℃/ 105.8ºF. ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cellulite areas (buttocks, thigh, upper legs)
Indicated Patient Age Range
Adult people
Intended User / Care Setting
Home Use, self-operation by an untrained 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sensiFirm safety and efficacy for non-invasive temporary reduction in cellulite appearance, was examined in an open label, prospective, interventional single arm clinical study, in a home use environment.
33 women, age ranging between 29 to 63 years (average age 46 ± 9 years), fulfilling the inclusion criteria, were enrolled to the study by the Principle Investigator (PI). Participants treated one to three treatment areas, according to participants own preference and the PI's approval: 27 participants chose to treat the cellulite (buttocks, including one participant treated the inner thigh area), and 8 and 4 chose to treat the abdomen and arms regions, respectively resulting in total of 39 areas that had completed 8 sensiFirm treatments according to the instructions for use and appeared to the 3 months after treatments last follow-up (FU2).
The cellulite appearance was assessed using the Modified Neurenberg-Muller Cellulite Grading Scale and improvement was defined as decrease of at least one score in the Scale. This assessment was conducted by 3 evaluators (3 board certified dermatologists and plastic surgeons) at the end of the active treatment regimen (T8), as well as one and three months after the last treatment (follow-up regimen FU1 and FU2, respectively). A participant was considered a success if at least 2 out of the 3 independent evaluators agreed that the participant had shown at least one degree of improvement in the cellulite appearance (one score reduction in the Modified Neurenberg-Muller Cellulite Grading Scale) when comparing the score obtained at each time point (T8, FU1 and FU2) to the baseline score ("subject as her own control"). In addition, a concurrent control was used, and only one side of the body (e.g. left buttocks) was treated to allow comparison to the other untreated side (e.g. right buttocks).
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, 93%, 96% and 100% of the study participants (according to agreement between at least 2 out of the 3 evaluators) have shown an improvement in overall cellulite appearance of the treated side at T8, FU1 and FU2, respectively. This improvement was manifested in an average reduction of -1.28. -1.59 and -1.78 in the Modified Neurenberg-Muller Cellulite Grading Scale, at T8, FU1 and FU2, respectively. In contrast, the untreated (control) side remained unchanged during the course of the study.
Effectiveness was also assessed according to the participants' satisfaction as recorded by the satisfaction questionnaire which was filled by all the participants at each follow-up visit. 95% of the participants (average value for after the last active treatment and follow-ups) were generally satisfied with the device. 94% had reported on improvement in their skin's appearance, 89% had reported on improvement in cellulite appearance and skin tightening and 90% had reported on skin texture improvement. In addition, the participants found the device easy to use, with 82% stating using sensiFirm was clear and simple, 93% and 89% stating that reaching the treatment areas and holding the device was comfortable, respectively, and 96% replied that a regime of total of 8 treatments was reasonable (all percentages refer to T8 visit). All participants found the device to be painless or discomfort less. At the last follow-up (FU2), participants were also asked whether they would like to continue using the device for the other untreated side and whether they would like to treat additional anatomical areas. All participants answered YES to these two questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
After the completion of the active treatment regimen, 93%, 96% and 100% of the study participants (according to agreement between at least 2 out of the 3 evaluators) have shown an improvement in overall cellulite appearance of the treated side at T8, FU1 and FU2, respectively. This improvement was manifested in an average reduction of -1.28. -1.59 and -1.78 in the Modified Neurenberg-Muller Cellulite Grading Scale, at T8, FU1 and FU2, respectively.
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.
DEN 150005
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
El Global Trade Ltd Yael Liebes-Peer RA/QA Manager Tzoran 8th St, P.O. Box 8242 Netanya, 4250608, Israel
Re: K170637
Trade/Device Name: sensiFirm Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: May 21, 2017 Received: May 31, 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.
Sincerelv.
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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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name sensiFirm
Indications for Use (Describe)
The sensiFirm device is intended for the following medical conditions using non thermal RF combined with massage:
Temporary reduction in the appearance of cellulite.
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
RD-12062 A0
DATE PREPARED: MAY 215T, 2016
510(K) OWNER NAME 1.
EL Global Trade Ltd. Tzoran 8th st, P.O.Box 8242, Netanya 425068, Israel. Phone: +972-9-7889069, Fax: +972-9-7734831.
Contact person name: Dr. Yael Liebes-Peer, RA/ QA Manager (E mail: Yael@sensica.com) and Martin Gurovich, CEO (E mail: Martin@elglobalt.com). Phone: +972-9-7889069, Fax: +972-9-7734831.
2. DEVICE NAME
Common/Usual Name: OTC device for improvement in the appearance of cellulite
Proprietary/Trade name: sensiFirm
Classification: EL Global Trade Ltd.'s sensiFirm device has been classified as Class II device under the following classification names:
| Device Category | Product
Code | Regulation
Number | Panel |
|---------------------------------------------------------|-----------------|----------------------|--------------------------------|
| Massager, Vacuum, Radio
Frequency Induced Heat | PBX | 878.4400 | General and Plastic
Surgery |
| Electrosurgical, Cutting &
Coagulation & Accessories | GEI | 878.4400 | General and Plastic
Surgery |
3. PREDICATE DEVICES
EL Global Trade Ltd.'s sensiFirm device is substantially equivalent to the following Predicate Devices:
- 3.1 InMode System MiniFX Handpiece by InMode MD Ltd. device, cleared under Premarket Notification K160329, dated August 19th, 2016.
- 3.2 V10 System, V-Form Handpiece by Viora Ltd. device,
cleared under Premarket Notification K150035, dated May 1st, 2015.
| EL Global Trade Ltd. 510(k) | July 13, 2017 |
|---|---|
| sensiFirm – K170637 | Page 1 of 15 |
4
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 | Fax: +972-9-7734831 |
|------------------------|-----------------------------------------------------------------------------|---------------------|
| conciFirm K170627/S001 | BD 12062 A0 | |
RD-12062 A0
DEVICE DESCRIPTION 4.
The sensiFirm is an OTC, home use device, designed to deliver non-thermal RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the non-thermal RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a noninvasive, non-ablative device and it is supplied as non-sterile.
The sensiFirm device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes a vibration motor, four Bi-polar (2 pairs) electrodes and two redundant temperature sensors. The PLC (on the PCBA) is specially configured software combined with hardware circuits that provides the operational and safety function of the system.
The sensiFirm device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the non-thermal RF energy together with mechanical massage over the entire treatment area.
Device specifications:
- Maximal power output: 10±1 Watt. .
- . Skin level power: 6±1, 8±1 and 10±1 Watt (energy levels 1-3).
- Frequency: 1±0.05 MHz. .
- Maximal temperature allowed: 41℃/ 105.8ºF. ●
5. INTENDED USE/ INDICATIONS FOR USE
The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage:
Temporary reduction in the appearance of cellulite.
5
RD-12062 A0
6. NON-CLINICAL (BENCH) PERFORMANCE DATA
The following performance data (bench tests) were provided in order to support the performance, safety and efficacy of the sensiFirm device as well as the substantial equivalence determination.
Safety Bench Tests and Verification & Validation (V&V) Summary
Bench testing was conducted according to IEC 60601 family of standards to demonstrate that the sensiFirm 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 (Verification and Validation):
- . Over-heating safety. The two redundant temperature sensors embedded in the device constantly measure the skin temperature and deactivate RF delivery when temperature exceeds 41ºC/ 105.8ºF. This temperature was determined to be acceptable, based on published information from the National Institute for for for Standard Technology (http://www.nist.gov/fire/fire_behavior.cfm), which states 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 150 Ω load, which is appropriate as the reference of the average load of the user, as well as on other impedance values and in overall relevant environmental conditions. The measured total power was within the
6
RD-12062 A0
predefined error margin, indicating that the device met the acceptance criteria.
- 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)
The sensiFirm device complies with the following recognized standards for Electrical Safety and EMC testing:
- IEC 60601-1:2012/EN 60601-1:2013, General safety standard: safety . requirements for medical electrical systems.
- IEC 60601-1-2:2014, Medical electrical equipment Part 1-2 General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- . 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.
- IEC 60601-1-11:2015, Medical electrical equipment Part 1-11 -. Requirements for the medical electrical equipment and medical electrical systems used in the home healthcare environment.
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 since inadvertent software errors could result in skin burns to the user.
7
RD-12062 A0
Human Factors Validation Testing
A human Factors Validation Testing was done to evaluate the HFE/ UE (Human Engineering/ Usability Engineering) concerns, including Label Factors 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 goal was to demonstrate that the typical OTC users can understand the device labeling (mainly the outer package) and correctly choose the sensiFirm device for themselves for its intended use. The study included three main questions regarding the intended use of the device, treatment areas and self-selection (the latter was acording to the contraindications), with possible answers: "Yes"or "No", followed by explenation and further validation by the moderator. A total of 47 participants, 5 men and 42 women, from age 24 to 71 years old (average 42 ± 12 years old) were enrolled to this study. Participants had different educational levels, as obtained by REALM testing with 26% below 9th grade level. All participants had met the inclusion/ exclusion criteria and signed ICF. 100% of the participants had made the correct descion regarding the intended use of the device, 98% had correctly identified the treatment areas and 96% had reported correct answers, as further validated by the moderator (K=0.91). Therfore, the success criteria of the primary enpoint was met.
Usability/ User Interface Study goal was to demonstrate the intended OTC user can correctly use the device, based on the labeling material for the intended aesthetic puspose. The study included four use scenarios including 21 relevant tasks: "getting to know the device and device set up" (7 tasks). "self-preparation" (4 tasks), "device usage" (7 tasks) and "after usage" (3 tasks). None of the participants required assistance from the moderator while performing the tasks.
8
RD-12062 A0
Altogether, all tasks were completed by 100% of the participants, and the success rate (pass criteria) was 100% per each task scenario, demonstrating rhe sucess criteria of the primary enpoint was met.
Furthermore, 62% of the participants (16 out of 26) had additionally commented that the device instructions are clear and that the use is easy and comfortable.
Participants were also asked regarding their user experience and satisfaction after this study, and high satisfaction was obtained, with an average result of 1.95±0.51, using a 1-5 discrete scale (when 1 represent best and 5 worst).
The human Factors Validation Testing , including both Labeling Comprehension/ Self-Selection Study and Usability/ User Interface Study, demonstrates that the potential 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
8. CLEANING, STERILIZATION, SHELF LIFE AND BIOCOMPATIBILITY
The sensiFirm is a non-sterile, reusable device, intended for a single user. The device cleaning instructions are based on the cleaning instructions of the predicate devices due to the fact that both devices are made from the same materials are used similarly.
The shelf-life expectancy of the device is 5 years, similarly to the predicate device.
The biocompatibility evaluation for the sensiFirm device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International
9
RD-12062 A0
Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
EL Global has categorized its sensiFirm 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.
9. CLINICAL PERFORMANCE DATA
The sensiFirm safety and efficacy for non-invasive temporary reduction in cellulite appearance, was examined in an open label, prospective, interventional single arm clinical study, in a home use environment.
33 women, age ranging between 29 to 63 years (average age 46 ± 9 years), fulfilling the inclusion criteria, were enrolled to the study by the Principle Investigator (PI). Participants treated one to three treatment areas, according to participants own preference and the PI's approval: 27 participants chose to treat the cellulite (buttocks, including one participant treated the inner thigh area), and 8 and 4 chose to treat the abdomen and arms regions, respectively resulting in total of 39 areas that had completed 8 sensiFirm treatments according to the instructions for use and appeared to the 3 months after treatments last follow-up (FU2).
10
RD-12062 A0
The cellulite appearance was assessed using the Modified Neurenberg-Muller Cellulite Grading Scale and improvement was defined as decrease of at least one score in the Scale. This assessment was conducted by 3 evaluators (3 board certified dermatologists and plastic surgeons) at the end of the active treatment regimen (T8), as well as one and three months after the last treatment (follow-up regimen FU1 and FU2, respectively). A participant was considered a success if at least 2 out of the 3 independent evaluators agreed that the participant had shown at least one degree of improvement in the cellulite appearance (one score reduction in the Modified Neurenberg-Muller Cellulite Grading Scale) when comparing the score obtained at each time point (T8, FU1 and FU2) to the baseline score ("subject as her own control"). In addition, a concurrent control was used, and only one side of the body (e.g. left buttocks) was treated to allow comparison to the other untreated side (e.g. right buttocks).
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, 93%, 96% and 100% of the study participants (according to agreement between at least 2 out of the 3 evaluators) have shown an improvement in overall cellulite appearance of the treated side at T8, FU1 and FU2, respectively. This improvement was manifested in an average reduction of -1.28. -1.59 and -1.78 in the Modified Neurenberg-Muller Cellulite Grading Scale, at T8, FU1 and FU2, respectively. In contrast, the untreated (control) side remained unchanged during the course of the study.
Effectiveness was also assessed according to the participants' satisfaction as recorded by the satisfaction questionnaire which was filled by all the participants at each follow-up visit. 95% of the participants (average value for after the last active treatment and follow-ups) were generally satisfied with the device. 94%
11
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 | Fax: +972-9-7734831 |
| --------------------- | ----------------------------------------------------------------------------- | --------------------- |
|---|
RD-12062 A0
had reported on improvement in their skin's appearance, 89% had reported on improvement in cellulite appearance and skin tightening and 90% had reported on skin texture improvement. In addition, the participants found the device easy to use, with 82% stating using sensiFirm was clear and simple, 93% and 89% stating that reaching the treatment areas and holding the device was comfortable, respectively, and 96% replied that a regime of total of 8 treatments was reasonable (all percentages refer to T8 visit). All participants found the device to be painless or discomfort less. At the last follow-up (FU2), participants were also asked whether they would like to continue using the device for the other untreated side and whether they would like to treat additional anatomical areas. All participants answered YES to these two questions.
To summarize, these results demonstrate that the device is safe and effective for the intended use under anticipated conditions of use (home environment).
10. SUBSTANTIAL EQUIVALENCE
The indications for use and technological characteristics of the sensiFirm device are substantially equivalent to the indications for use and technological characteristics of the predicate device. A detailed comparison between the sensiFirm 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.
| Feature | EL Global
sensiFirm
New Device | InMode MD
MiniFX/ InMode
[K160329]
Predicate Device #1 | Viora
V-FORM/ V10
[K150035]
Predicate Device #2 | Characteristics
comparison
(similarity) |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory classification | | | | |
| Device
Class | Class II | Class II | Class II | Same |
| Classificatio
n Panel | General and Plastic
Surgery | General and Plastic
Surgery | General and Plastic
Surgery | Same |
| Feature | EL Global
sensiFirm
New Device | InMode MD
MiniFX/ InMode
[K160329]
Predicate Device #1 | Viora
V-FORM/ V10
[K150035]
Predicate Device #2 | Characteristics
comparison
(similarity) |
| Product
code | PBX, GEI | PBX, GEI | PBX, ISA | Same as
Predicate
Device #1 |
| Regulation
number | • 21 CFR 878.4400
• 21 CFR 878.4400 | • 21 CFR 878.4400
• 21 CFR 878.4400 | • 21 CFR 878.4400
• 21 CFR 890.5660 | Same as
Predicate
Device #1 |
| Device
Category | • Massager, Vacuum,
Radio Frequency
Induced heat
• Electrosurgical,
Cutting & Coagulation
& Accessories | • Massager, Vacuum,
Radio Frequency
Induced heat
• Electrosurgical,
Cutting & Coagulation
& Accessories | • Massager, Vacuum,
Radio Frequency
Induced heat
• Massager, Therapeutic,
Electric | Same as
Predicate
Device #1 |
| Regulation
description | • Electrosurgical cutting
and coagulation device
and accessories
• Electrosurgical cutting
and coagulation device
and accessories | • Electrosurgical cutting
and coagulation device
and accessories
• Electrosurgical cutting
and coagulation device
and accessories | • Electrosurgical cutting
and coagulation device
and accessories
• Therapeutic massager | Same as
Predicate
Device #1 |
| Intended
use | The sensiFirm device is
intended for delivering
non thermal RF
combined with massage
for temporary reduction
in the appearance of
cellulite | The InMode System
(with MiniFX
Handpiece) is intended
for delivering non
thermal RF combined
with massage for
temporary reduction in
the appearance of
cellulite | The V-Form Handpiece
(with BC and FC
applicators) is indicated
for delivering non
thermal RF combined
with massage for
temporary reduction in
the appearance of
cellulite | Same |
| Device Characteristics | | | | |
| Mode of
operation | Mechanical (vibration)
massage combined
with RF energy
emitted from Bi-polar
electrodes via a delivery
Handpiece | Mechanical vacuum
massage combined
with RF energy
emitted from Bi-polar
electrodes via a delivery
Handpiece | Mechanical vacuum
massage combined
with RF energy
emitted from Bipolar
electrodes via a delivery
Handpiece | Similar.
Note No. 1. |
| Energy
Source | RF (Bi-polar), 1 MHz | RF (Bi-polar), 1 MHz | RF (Bi-polar), 0.8, 1.7,
and/ 2.45 MHz | Same as
Predicate
Device #1.
Note No. 2. |
| Number of
electrodes | 4 electrodes (2 pairs) | 2 electrodes (1 pair) | 6 or 4 electrodes (3 or 2
pairs, for BC or FC
applicators, respectively) | Note No. 2. |
| Massage | Vibrational massage
(1000 rpm, 1.5 [g])
assisted by manual
manipulation | Mechanical vacuum
massage, with pulsed
vacuum ( 300 - 500
mbar) | Mechanical vacuum
massage, with pulsed
vacuum (up to 500 mbar) | Different
mechanism,
since vacuum
technology |
| Feature | EL Global
sensiFirm
New Device | InMode MD
MiniFX/InMode
[K160329]
Predicate Device #1 | Viora
V-FORM/V10
[K150035]
Predicate Device #2 | Characteristics
comparison
(similarity) |
| Treatment
areas | Cellulite areas (buttocks,
thigh, upper legs) | Cellulite areas (buttocks,
thigh, upper legs) | Cellulite areas (buttocks,
thigh, upper legs) | Same |
| Treatment
regimen | 20 minutes per each area,
1 time per week, for 8
weeks | 1 time per week, for 6
weeks.
- Information according
to reference #17, see
Appendix F, VOL 003. | 20minutes per each area,
1 time per week for 8
weeks. - Information according
to reference #5, see
Appendix F, VOL 003. | Similar.
Treatment
regimen was
validated via
clinical Trial.
Note No.3. |
| Intended
population | Adult people who desire
to improve their body
appearance | Adult people who desire
to improve their body
appearance | Adult people who desire
to improve their body
appearance | Same |
| Use
Environment | Home Use, self-operation
by an untrained user. | Aesthetic Clinic | Aesthetic Clinic | Validated in a
Human Factors
tests and in a
Clinical Trial.
Same as
auxiliary
device.
Note No. 4. |
| Device Features | | | | |
| Hand piece
Dimensions | 146 X 74 X 63 mm3/
5.7 X 2.9 X2.5 inch3 | Unknown | 230 X 230 X 95 mm3/
9.1 X 9.1 X 3.7 inch3 or
230 X 230 X 65 mm3/
9.1 X 9.1 X 2.6 inch3,
BC or FC applicators,
respectively | Similar.
Note No. 4. |
| Weight | 192 gr/ 0.42 lb | Unknown | 930 gr/ 2.05 lb or 750 gr/
1.65 lb, BC or FC
applicators, respectively) | Similar.
Note No. 4. |
| Electrodes
treatment
area [mm²] | ~2000 (calculated
according to: 2×33×30),
where
• 2- numbers of electrodes
pairs
• 33 - average distance
between electrodes is 33 mm
• electrodes length 30 mm | Unknown.
Distance between
electrodes is 25 mm. | 6200 or 450 (BC or FC
applicators, respectively) | Similar.
Note No. 2. |
| Device main
components | Power adaptor, hand-held
handpiece | Console, MiniFX
handpiece | Console, V-FORM
handpiece | Similar.
Note No. 4. |
| User
interface | • 4 LEDs:
• 3 green LEDs for
visualizing the RF
energy level | • Touch screen (main
console)
• Different audible
beeping | • Touch screen (main
console)
• Audible sound
indications at various | Different.
Note No. 4. |
| | | InMode MD | Viora | |
| | EL Global
sensiFirm | MiniFX/ InMode
[K160329] | V-FORM/ V10
[K150035] | Characteristics
comparison
(similarity) |
| Feature | | Predicate Device #1 | Predicate Device #2 | |
| | New Device | | | |
| | • 1 green/ orange/ red
LED reflecting the
device status
• Button for energy level
selection
• The massage achieved
by the vibration motor
makes audible sound
and the sensation of
massage itself make the
user aware of treatment
being delivered. | sounds when the
suction is adequately
coupled and the RF is
being administered and
according to different
temperature measured | points of the treatments | |
| Energy
levels
(maximal
and user
selectable) | Up to 10 Watts.
3 energy levels (software
and hardware limited): 6,
8 or 10 Watts, depending
on the user selection. | 10-25 Watts | Up to 25 or 50 Watts (for
FC or BC handpiece,
respectively).
4 energy levels | Similar.
Note No. 2. |
| Safety
mechanism | • 2 redundant thermal
sensors for skin
temperature
measurements.
Automatically stop
delivering RF when
temperature of 41°C/
105.8°F is detected,
until temperature
lowers to 40.5°C/
104.9°F (hysteresis).
• Device automatic test
for proper skin contact
prior to release a pulse
(using a short and low
energy pulse)
• The vibrational
massage being
delivered reflects to the
user the device is active
• A steady LED when
the device is active | • Integrated IR
thermometer, with
maximal temperature
(skin surface 41°C/
105.8°F ) | • Integrated IR
thermometer
• Default treatment
parameters
automatically
suggested
• A trigger requires
pressing prior to
emitting energy
• Device automatic test
for proper coupling
prior to release a pulse
(using a short sub-
pulse)
• Proper connection of
the handpiece,
otherwise alert | Similar to
auxiliary
device.
Usefulness of
all safety
mechanisms
was validated in
clinical trial and
usability study.
Note No. 4. |
| Electrical
requiremen
ts | 100-240 V
50-60 Hz | 100-240 V
50-60 Hz | 100-240 V
50-60 Hz | Same |
| Safety standards | | | | |
| Safety/
EMC | • IEC 60601-1:2012/EN
60601-1:2013
• IEC 60601-1-2: 2014 | • IEC 60601-1:1988
(Am. 1 1991 + Am. 2
• IEC 60601-1-2: 2001 | • IEC 60601-1
• EC 60601-1-2 | Same, with
additional
safety standard
(60601-1-11) |
| Feature | EL Global
sensiFirm
New Device | InMode MD
MiniFX/ InMode
[K160329]
Predicate Device #1 | Viora
V-FORM/ V10
[K150035]
Predicate Device #2 | Characteristics
comparison
(similarity) |
| | • IEC 60601-2-2: 2009
• IEC 60601-1-11:2015 | • IEC 60601-2-2: 2006 | • IEC 60601-2-2 | for home use
environment |
| Biocompatibility | All parts that are in
contact with user comply
with the requirements of
ISO-10993-1. | All parts that are in
contact with user comply
with the requirements of
ISO-10993-1. | All parts that are in
contact with user comply
with the requirements of
ISO-10993-1. | Same |
| Software | The software was
verified and validated
according to the FDA
guidance. | The software was
verified and validated
according to the FDA
guidance. | The software was
verified and validated
according to the FDA
guidance. | Same |
Table 1. Substantial Equivalence of EL Global's sensiFirm with Predicate Device.
12
sensiFirm – K170637/ S001
RD-12062 A0
13
sensiFirm – K170637/ S001
RD-12062 A0
14
sensiFirm – K170637/ S001
RD-12062 A0
15
sensiFirm — K170637/ S001
RD-12062 A0
Note No. 1. The massage Type
There are several methods commonly used for massaging, including: manual massage, pressuring, vibrations, rollers assisted, vacuum assisted etc. Vibration assisted massage offers safe and localized treatment with similar therapeutic effect. Such devices are classified as class I devices and are 510(K) exempt (product code IRO or ISA).
Note No. 2 - The Energy Delivered and Electrodes Architecture
Treatment with all of the devices (sensiFirm and both predicate devices) utilizes the same technology of Bi-polar RF, on the same anatomical sites and for the same purpose. Generally, safety and efficacy of the device for the intended use is affected by the method of RF delivery, power energy output and the configuration/ area of the treatment electrodes. All these factors were taken into account when designing the treatment protocol, which has been validated in a clinical trial.
Note No. 3 - The Treatment Regimen
The treatment regimen of the sensiFirm was especially planned to achieve its intended use in a safe and effective manner. Both sensiFirm and its predicate devices are designed for the exact same anatomical sites, with similar treatment
16
RD-12062 A0
protocols. Though the treatment protocols are different, the total exposure to the sensiFirm device throughout the entire treatment regimen is identical to predicate device #2 and similar to predicate device #1. Therefore, no issues in means of safety for the user are raised. Furthermore, the efficacy was validated in a clinical trial.
Note No. 4 - Applicability to Home Use Environment
While the sensiFirm was designed for OTC home use, both predicate devices are prescription devices, to be used in a clinic by a professional operator. Auxiliary device (Newa by EndyMed Medical Ltd.. cleared under DEN 150005) supports the OTC home use environment. Several device's features, all related to its design and usability elements, were specially tailored for the home use environment, which was tested in a Human Factors Test study and further validated in a clinical trial.
11. CONCLUSIONS
Due to these identical clauses and high similarities, the sensiFirm device is at least as safe and as effective as the predicate device. The differences between the sensiFirm device and the predicate device do not raise new safety or effectiveness issues or questions, as detailed above.
The performance specifications of the sensiFirm (i.e., RF frequency and RF power) are substantially equivalent to those of the predicate devices. The safety features and compliance with safety standards of both are similar. The minor differences in the technological characteristics do not raise new safety or effectiveness concerns and are demonstrated to be substantially equivalent through relevant performance tests. Furthermore, the sensiFirm device has qualified with varied performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2, compatibility as medical electrical equipment for home healthcare environment according to
17
RD-12062 A0
60601-1-11, and high frequency of surgical equipment according to IEC 60601-2-
- The performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Based on the performance testing and comparison to predicate devices, the sensiFirm device is substantially equivalent to the previously cleared predicate devices.
. . . . . . . . . . .