InMode System with the Morhpeus8 Applicators

K200947 · InMode , Ltd. · GEI · Jul 2, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200947
• Device Name: InMode System with the Morhpeus8 Applicators
• Applicant: InMode , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.

Device Story

Computerized RF-based system for dermatological electrocoagulation and hemostasis; utilizes fractional RF multi-electrode technology. System comprises AC/DC power supply, RF generator, controller, and LCD touch screen interface. Applicators feature handle and detachable, single-use, gamma-sterilized pin tips (12, 24, 40 pin, and T tip). Operated in hospital or clinic settings by clinicians. Foot switch activates energy delivery; RF energy delivered via pin array to dermis/sub-dermis to trigger coagulation, collagen regeneration, and fibroblast proliferation. Monitoring of RF parameters enhances safety. Output provides thermal coagulation necrosis in target tissues. Benefits include localized tissue treatment for dermatological indications.

Clinical Evidence

No clinical data. Bench testing included ex-vivo porcine tissue study (muscle and fat) using 40-pin tip head to evaluate coagulation necrosis patterns at depths up to 7mm. Biopsy and TTC staining confirmed safety and effectiveness in achieving specified indications.

Technological Characteristics

Fractional RF system; 1 MHz frequency; 65W max output. Components: console, RF generator, LCD interface, footswitch, and disposable multi-pin tips (12, 24, 40, T-tip). Biocompatible materials. Sterilization: Gamma (tips). Standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2. Dimensions: 46cm x 46cm x 100cm; Weight: 30kg.

Indications for Use

Indicated for adults requiring dermatological procedures for 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

• InMode System with the Morpheus8 Applicators (K192695)

Submission Summary (Full Text)

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July 2, 2020

InMode Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba. Israel 4442520

Re: K200947/S001

Trade/Device Name: InMode System with the Morhpeus8 Applicators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 10, 2020 Received: June 12, 2020

Dear Amit Goren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200947

Device Name

InMode System with the Morpheus8 Applicators

Indications for Use (Describe)

The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis.

At higher energy levels greater than 62 m./pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------|---------------------------------------------------------|
| \$\bigotimes\$ Prescription Use (Part 21 CFR 801 Subpart D) | \$\square\$ Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(K) SUMMARY

# INMODE SYSTEM WITH THE MORPHEUS8 APPLICATORS

# 510(k) Number K200947

# Applicant Name:

| Company Name: | InMode MD Ltd. |
|---------------|-------------------------------|
| Address: | Tabor Building, Shaar Yokneam |
| | Yokneam 20692 |
| | Israel |
| | Tel: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |

#### 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<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | July 02, 2020 |
| Trade Name: | InMode System with the Morpheus8 Applicators |
| Classification Name: | CFR Classification section 878.4400; (Product code GEI) |
| Classification: | Class II Medical Device |

# Predicate Device:

The InMode System with the Morpheus8 Applicators is substantially equivalent to the following predicate device;

| Manufacturer | Device | 510(k) No. |
|--------------|-------------------------------------------------|------------|
| InMode Ltd. | InMode System with the Morpheus8<br>Applicators | K192695 |

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## Device Description:

The InMode System with the Morpheus8 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 InMode System with the Morpheus8 Applicators (K192695). The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.

The InMode System with the Morpheus8 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus8 Applicator comprises handle and detachable, sterilized, disposable, single use 12, 24, 40 pin and T tip head accessory.

Following are the InMode System with the Morpheus8 Applicators specifications:

| RF Max Output Power: | 65 Watt |
|--------------------------------|-----------------------------|
| RF Output Frequency: | 1[MHz] |
| Dimension: | 46cm W x 46cm D x 100cm H |
| | (18.2" W x 18.2" D x 40" H) |
| Weight: | 30 Kg (70.4 lbs.) |
| Main Line Frequency (nominal): | 50-60 Hz |
| Input Voltage (nominal): | 100-240 VAC |

#### Intended Use/Indication for Use:

The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis.

At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.

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#### Performance Standards:

The InMode System with the Morpheus8 Applicators has been tested and complies with the following voluntary recognized standards:

- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment Part 2-2: ● Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.

## Non-Clinical (Bench) Performance Data:

The performance and safety of the InMode System with the Morpheus8 Applicators treatment in dermatological procedures requiring electrocoagulation and hemostasis in deeper tissues of up to 5, 6 and 7 mm was evaluated in an ex-vivo tissue study. The study was conducted on a porcine animal model and included a single treatment of two different harvested porcine tissues: muscle and fat utilizing the InMode System with the Morpheus8 applicator 40 pin tip head. Treatment was followed by biopsy sampling of slices trimmed along the pin's penetration path and collection immediately stained by TTC staining to visualize the tissue coagulation necrosis pattern. The ex-vivo study results show that the Morpheus8 Applicators is safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis.

#### Animal Performance Data / Histology Data:

Not Applicable

## Clinical Performance Data:

Not Applicable

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# Substantial Equivalence:

A comparison table is provided below comparing the intended use and basic technological characteristics of the subject device to the intended use and basic technological characteristics of the predicate device.

| Technological<br>Characteristic | InMode System with the<br>Morpheus8 Applicators<br>InMode Ltd.<br>K200947<br>(Subject Device) | InMode System with the<br>Morpheus8 Applicators<br>InMode Ltd.<br>K192695<br>(Predicate Device) |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,<br>Class | GEI<br>Class II | GEI<br>Class II |
| Indications for<br>Use | The InMode System with<br>the Morpheus8<br>Applicators is intended for<br>use in dermatological and<br>general surgical<br>procedures for<br>electrocoagulation and<br>hemostasis.<br>At higher energy levels<br>greater than 62 mJ/pin, use<br>of these Applicators is<br>limited to Skin Types I-IV. | The InMode System with<br>the Morpheus8<br>Applicators is intended<br>for use in dermatological<br>procedures for<br>electrocoagulation and<br>hemostasis.<br>At higher energy levels<br>greater than 62 mJ/pin,<br>use of these Applicators<br>is limited to Skin Types<br>I-IV. |
| Anatomical<br>Sites | Body parts requiring<br>treatment as specified in<br>the indication for use | idem |
| Target<br>Population | Adults requiring treatment<br>as specified in the<br>indication for use | idem |
| Environment<br>Used | Hospital or Clinic setting | idem |
| Energy Used /<br>Delivered | RF energy | idem |
| Design: | Fractional RF: Use of RF<br>energy delivered through a<br>matrix of multiple pin<br>electrodes allocated on the<br>applicator tip | idem |
| - Mechanism of<br>Action | Treatment is based on<br>fractional RF technology<br>for localized dermis and | idem |
| Technological<br>Characteristic | InMode System with the<br>Morpheus8 Applicators<br>InMode Ltd.<br>K200947<br>(Subject Device) | InMode System with the<br>Morpheus8 Applicators<br>InMode Ltd.<br>K192695<br>(Predicate Device) |
| | sub dermis coagulation<br>triggering slow collagen<br>regeneration and fibroblast<br>cells' proliferation. | |
| - Components | The InMode Morpheus8<br>Applicators are add-on<br>applicators to the FDA<br>cleared InMode System<br>(K192695).<br>The system consists of the<br>following components:<br>- Console, including a<br>power supply, RF<br>generator, controller, and<br>touch screen control and<br>display panel.<br>- Applicator connected to<br>the console via a cable,<br>with tip including 12, 24,<br>40 & T tip heads.<br>- Footswitch | idem |
| - System<br>Dimensions | 46cm W x 46cm D x<br>100cm H<br>[18.2" W x 18.2" D x<br>40" H] | idem |
| - Weight<br>Platform weight | 30 Kg (70.4 lbs.) | idem |
| Applicator<br>weight | Applicator - 0.4 Kg (0.88<br>lbs.)<br>Tip - 0.02 Kg | |
| Number of pins | 12, 24 and 40 pins | idem |
| Maximal<br>Treatment depth | 0.5mm (for T tip head)<br>4.0mm (for 12 pin tip<br>head)<br>7.0mm (for 24 and 40 pin<br>tip heads) | 0.5mm (for T tip head)<br>4.0mm (for 12 pin tip<br>head)<br>4.0mm (for 24 and 40 pin<br>tip heads) |
| Technological<br>Characteristic | InMode System with the<br>Morpheus8 Applicators<br>InMode Ltd.<br>K200947<br>(Subject Device) | InMode System with the<br>Morpheus8 Applicators<br>InMode Ltd.<br>K192695<br>(Predicate Device) |
| RF energy level | 5-30 (for 24 tip head up to<br>1 mm)<br>5-30 (for T tip head and<br>for 12 tip head)<br>5-60 (for 24 and 40 in the<br>range of 2-7mm) | 5-30 (for 24 tip head up<br>to 1 mm)<br>5-30 (for T tip head and<br>for 12 tip head up to 1<br>mm)<br>5-60 (for 12 tip head in<br>the range of 2-4mm)<br>5-60 (for 24 and 40 in the<br>range of 2-4mm) |
| Cable<br>Dimensions: | 270 cm | idem |
| Performance | Frequency: 1 MHz<br>Maximal RF output<br>power: 65W<br>Maximal pulse duration:<br>up to 74msec | idem |
| Standards Met | AAMI/ANSI ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 | idem |
| Biocompatibility | All materials are<br>biocompatible | idem |
| Compatibility<br>with<br>Environment<br>and Other<br>Devices | InMode System with the<br>Morpheus8 Applicators is<br>compliant with the IEC<br>60601-1-2 (EMC Safety)<br>standard | idem |
| Sterility | The 12, 24, 40 and T tip<br>head are Gamma sterilized<br>and for single use.<br>The Morpheus8<br>Applicator handle is for<br>multiple use | idem |
| Technological<br>Characteristic | InMode System with the<br>Morpheus8 Applicators<br>InMode Ltd.<br>K200947<br>(Subject Device) | InMode System with the<br>Morpheus8 Applicators<br>InMode Ltd.<br>K192695<br>(Predicate Device) |
| | 100-240 VAC 50-60 Hz<br>The InMode System with<br>the Morpheus8<br>Applicators is compliant<br>with the IEC 60601-1<br>standard. | |
| Mechanical<br>Safety | The InMode System with<br>the Morpheus8 Applicator<br>is compliant with the IEC<br>60601-1 standard. | idem |
| Chemical Safety | Not Applicable | Not Applicable |
| Thermal Safety | The InMode System with<br>the Morpheus8<br>Applicators is compliant<br>with the IEC 60601-1<br>standard. | idem |
| Radiation Safety | The InMode System with<br>the Morpheus8<br>Applicators is compliant<br>with the IEC 60601-1-2<br>(EMC Safety) standard. | idem |

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The indications for use and technological characteristics of the InMode System with the Morpheus8 Applicators are substantially equivalent to the indications for use and technological characteristics of the FDA-Cleared InMode System with the Morpheus8 Applicators (K192695).

The design and components in the InMode System, including the console (with power supply, RF generator, controller and display panel) and the Applicator (with cable, connector to console, handle and tip) are similar to the design and components found in the predicate. The performance specifications (including RF frequency, pulse duration and RF energy per pin) of the subject device were shown to be identical and yielded the same RF energy per pin values to those of the predicate device. The safety features and compliance with safety standards in the InMode System with the Morpheus8 Applicators are identical to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are also identical. Any minor differences in the technological characteristics do not raise new safety or effectiveness

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concerns. Furthermore, the new InMode System with the Morpheus8 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 ex-vivo tissue testing to evaluate and compare the fractional coagulation necrosis pattern of target tissues, formed by thermal effect of the InMode System with the Morpheus8 Applicators 24 and 40 pin tip heads in different tissue depths. 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 Morpheus8 Applicators are substantially equivalent to the predicate InMode System with the Morpheus8 Applicators, FDA-Cleared in 510(k) K192695, and therefore, may be legally marketed in the USA.