InMode System with Fractora3D/3D-90 Applicators
Device Facts
| Record ID | K180189 |
|---|---|
| Device Name | InMode System with Fractora3D/3D-90 Applicators |
| Applicant | Inmode MD , Ltd. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jun 1, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis. At higher energy levels greater than 62 m./pin, use of the FRF applicator is limited to Skin Types I-IV.
Device Story
InMode System uses fractional radiofrequency (RF) multi-electrode technology for electrocoagulation and hemostasis. Device consists of console with AC/DC power supply, RF generator, controller, and LCD touch screen; connected to handpiece with disposable 24-pin electrode tip. Physician operates device in clinical setting. Foot switch activates energy delivery to skin via pin array. System monitors RF parameters to enhance safety. Output affects tissue via thermal effects, facilitating coagulation. Benefits include controlled dermatological/surgical treatment. Device platform builds upon previously cleared InMode FRF technology.
Clinical Evidence
No clinical data. Evidence includes bench performance testing comparing RF output parameters to predicate and a preclinical porcine study evaluating thermal effects and tissue healing via histology at 0, 7, 14, and 21 days post-treatment.
Technological Characteristics
RF-based electrosurgical device. Max output 65W, 1 MHz frequency. 24-pin disposable electrode tip. Console includes AC/DC power supply, RF generator, controller, LCD interface. Complies with AAMI/ANSI 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Biocompatible patient-contact materials.
Indications for Use
Indicated for dermatological and general surgical procedures requiring electrocoagulation and hemostasis. At energy levels >62 mJ/pin, use is limited to Skin Types I-IV.
Regulatory Classification
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.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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June 1, 2018
InMode MD Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 44425 Israel
Re: K180189
Trade/Device Name: InMode System with Fractora3D/3D-90 Applicators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 1, 2018 Received: May 4, 2018
Dear Amit Goren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
> Sincerely. Jennifer R. Stevenson -S3 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180189
Device Name
InMode System with the Fractora3D/3D-90 Applicators
Indications for Use (Describe)
The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.
At higher energy levels greater than 62 m./pin, use of the FRF applicator is limited to Skin Types I-IV.
Type of Use (Select one or both, as applicable)
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(K) SUMMARY INMODE SYSTEM WITH THE FRACTORA3D/3D-90 APPLICATORS
## 510(k) Number K180189
### Applicant Name:
| Company Name: | InMode MD Ltd. |
|---------------|----------------------------------------------------------|
| Address: | Tabor Building, Shaar Yokneam<br>Yokneam 20692<br>Israel |
| | Tel: +972-4-9097470 |
| | Fax: +972-4-9097471 |
| | E-mail: amit@asteinrac.com |
#### Contact Person:
Official Correspondent: Amit Goren
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
|----------------------|---------------------------------------------------------|
| Address: | 20 Hata'as Str., Suite 102<br>Kfar Saba 44425<br>Israel |
| Tel: | +972-9-7670002 |
| Fax: | +972-9-7668534 |
| E-mail: | amit@asteinrac.com |
| Date Prepared: | April 29, 2018 |
| Trade Name: | InMode System with the Fractora3D/3D-90 Applicators |
| Classification Name: | CFR Classification section 878.4400; (Product code GEI) |
| Classification: | Class II Medical Device |
#### Predicate Device:
The InMode System with the Fractora3D/3D-90 Applicators is substantially equivalent to the following predicate device;
| Manufacturer | Device | 510(k) No. |
|----------------------|-----------------------|------------|
| EndyMed Medical Ltd. | Intensif Applicator | K130501 |
| InMode MD Ltd. | InMode FRF Applicator | K151273 |
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Fractora3D/3D-90 Applicators 510(k) file Section 5 - 510(k) Summary
Page 2 of 5
#### Device Description:
The InMode System with the Fractora3D/3D-90 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.
The device platform is basically constituted on the same system platform as FDA cleared for InMode FRF Applicator (K151273). The InMode System with the Fractora3D/3D-90 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Fractora3D/3D-90 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.
The InMode System with the Fractora3D/3D-90 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Fractora3D/3D-90 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a disposable, single use, 24 electrode pins tip.
Following are the InMode System with the Fractora3D/3D-90 Applicators specifications:
RF Max Output Power: 65 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 46cm W x 46cm D x 100cm H (18.2'' W x 18.2'' D x 40'' H) Weight: 30 Kg (66 lbs.) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC
#### Intended Use/Indication for Use:
The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatologic and General Surgical procedures for Electrocoagulation and Hemostasis. At higher energy levels greater than 62 m]/pin, use of the FRF applicator is limited to Skin Types I-IV. Performance Standards:
The InMode System with the Fractora3D/3D-90 Applicators has been tested and complies with the following voluntary recognized standards:
- AAMI/ANSI 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And ● A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, Mod).
- IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: ● General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
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Fractora3D/3D-90 Applicators 510(k) file Section 5 - 510(k) Summary
- IEC 60601-2-2 Edition 5.0 2009-02, 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.
#### Non-Clinical (Bench) Performance Data:
Performance bench tests were performed to measure the accuracy and consistency of the RF output parameters of the InMode System and compare them to the specific design requirements and to the RF output parameters of the predicate device. The results of the bench tests demonstrate that the InMode System complies with the design requirements and consists of similar RF output specifications as the predicate device and therefore, is substantially equivalent to the predicate device.
#### Animal Performance Data / Histology Data:
The thermal effects of the InMode System with the Fractora3D/3D-90 Applicators and tissue healing process were evaluated in a preclinical study. The study was conducted on porcine model and included a single RF treatment followed by histology analysis performed immediately, 7, 14 and 21 days post treatment. The animal study results show that the InMode System with the Fractora3D/3D-90 Applicators are safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis.
#### Clinical Performance Data:
Not Applicable
#### Biocompatibility
All device materials which come in direct contact with the patient skin are biocompatible. The following 510(k)s were mentioned as reference devices for Biocompatibility determination: K102461, K082451, K142438, K151019 and K081365.
#### Substantial Equivalence:
A comparison table is provided below comparing the intended use and basic technological characteristics of the InMode System with the Fractora3D/3D-90 Applicators to the intended use and basic technological characteristics of the predicate devices.
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| Fractora3D/3D-90 Applicators 510(k) file |
|------------------------------------------|
| Section 5 - 510(k) Summary |
| Technological<br>Characteristic | InMode System<br>with the<br>Fractora3D/3D-<br>90 Applicators<br>InMode MD Ltd.<br>(Subject Device) | Intensif<br>Applicator<br>EndyMed<br>Medical Ltd.<br>K130501<br>(Main Predicate) | InMode FRF<br>Applicator<br>InMode MD Ltd.<br>K151273<br>(Reference<br>Predicate) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Dimensions | 46cm W x 46cm D<br>x 100cm H | 30cm W x 19cm D<br>x 115cm H | 46cm W x 46cm D<br>x 100cm H |
| | [18.2" W x 18.2"<br>D x 40" H] | [12" W x 8" D x<br>45" H] | [18.2" W x 18.2"<br>D x 40" H] |
| Weight<br>Platform weight<br>Applicator weight | 30 Kg (70.4 lbs.)<br>0.4 Kg (0.88 lbs.)<br>Tip weight - 0.02<br>Kg | 33 Kg (72.6 lbs.)<br>0.28 Kg (0.62 lbs.) | 30 Kg (70.4 lbs.)<br>0.22 Kg (0.5 lbs.)<br>Tip weight - 0.02<br>Kg |
| Applicator<br>Dimensions: | Applicator<br>Footprint Area:<br>1.6cm x 1.2cm | Applicator<br>Footprint Area:<br>1.1cm x 1.1cm | Applicator<br>Footprint Area:<br>1.6cm x 1.2cm |
| | Applicator needles<br>field area:<br>0.95cm X 1.1 cm | | Applicator needles<br>field area:<br>0.9cm X 1.2 cm |
| | Maximum volume<br>of treatment :<br>16mm x 12mm x<br>4.0mm | Maximum volume<br>of treatment :<br>11mm x 11mm x<br>3.5mm | Maximum volume<br>of treatment:<br>16mm x 12mm x<br>2.5mm |
| Number of pins | 24 pins | 25 pins | 24 pins |
| Maximal Treatment<br>depth | 4.0mm | 3.5mm | 2.5mm |
| Cable Dimensions: | 250 cm | idem | idem |
| Performance | Frequency: 1 MHz<br>Maximal RF<br>output power:<br>65W<br>Maximal pulse<br>duration: up to<br>74msec | Frequency: 1 MHz<br>Maximal RF<br>output power: 25W<br>Maximal pulse<br>duration: up to<br>200msec | Frequency: 1 MHz<br>Maximal RF<br>output power: 65W<br>Maximal pulse<br>duration: up to<br>74msec |
| Standards Met | IEC 60601-1<br>IEC 60601-1-2 | idem | idem |
| Technological<br>Characteristic | InMode System<br>with the<br>Fractora3D/3D-<br>90 Applicators<br>InMode MD Ltd.<br>(Subject Device) | Intensif<br>Applicator<br>EndyMed<br>Medical Ltd.<br>K130501<br>(Main Predicate) | InMode FRF<br>Applicator<br>InMode MD Ltd.<br>K151273<br>(Reference<br>Predicate) |
| | ANSI AAMI<br>60601-2-2 for<br>safety of high<br>frequency surgical<br>equipment | | |
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Fractora3D/3D-90 Applicators 510(k) file Section 5 - 510(k) Summary
### Comparison Discussion:
The indications for use and technological characteristics of the InMode System with the Fractora3D/3D-90 Applicators are substantially equivalent to the indications for use and technological characteristics of the EndyMed Intensif Applicator.
The design and components in the InMode System, including the console (with power supply, RF generator, controller and display panel) and the hand piece Applicator (with cable, connector to console, handle and tip) are similar to the design and components found in the predicate Endymed Intensif System. The performance specifications (including RF frequency, pulse duration and RF energy per pin) of the InMode System were shown to be similar and yielded similar RF energy per pin values to those of the EndyMed Intensif Applicator. The safety features and compliance with safety standards in the InMode System with the Fractora3D/3D-90 Applicators are similar to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are also similar. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new InMode System with the Fractora3D/3D-90 Applicators underwent performance testing, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 and IEC 60601-2-2, comparative bench testing and animal preclinical testing to evaluate the thermal effect of the device and the tissue healing process. These performance tests demonstrated that the minor differences in the device design and specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the InMode System with the Fractora3D/3D-90 Applicators are substantially equivalent to the predicate EndyMed Intensif Applicator, FDA cleared in 510(k) K130501, and therefore, may be legally marketed in the USA.
