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.

AI/ML Overview

This document describes a 510(k) premarket notification for the InMode System with the Morpheus8 Applicators. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared device (K192695). As such, the "acceptance criteria" and "study" described are primarily focused on demonstrating this equivalence rather than a de-novo clinical trial for a new performance claim.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate device (K192695). The reported device performance is largely a direct comparison of technological characteristics and safety standards adherence.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (InMode System with Morpheus8 Applicators, K200947)
Intended Use/Indications for Use: Substantially equivalent to predicate.	Indications for Use: The InMode System with the Morpheus8 Applicators is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of these Applicators is limited to Skin Types I-IV. (Slight expansion to "general surgical procedures" compared to predicate's "dermatological procedures" but deemed substantially equivalent).
Product Code, Class: Identical to predicate.	Product Code, Class: GEI, Class II (Identical to predicate).
Anatomical Sites: Identical to predicate.	Anatomical Sites: Body parts requiring treatment as specified in the indication for use (Identical to predicate).
Target Population: Identical to predicate.	Target Population: Adults requiring treatment as specified in the indication for use (Identical to predicate).
Environment Used: Identical to predicate.	Environment Used: Hospital or Clinic setting (Identical to predicate).
Energy Used/Delivered: Identical to predicate.	Energy Used/Delivered: RF energy (Identical to predicate).
Design/Mechanism of Action: Substantially equivalent to predicate.	Design/Mechanism of Action: Fractional RF technology for localized dermis and sub-dermis coagulation triggering slow collagen regeneration and fibroblast cells' proliferation (Identical to predicate).
Components: Substantially equivalent to predicate.	Components: Console (power supply, RF generator, controller, touch screen), Applicator (cable, handle, 12, 24, 40 & T tip heads), Footswitch. (Similar to predicate).
System Dimensions: Identical to predicate.	System Dimensions: 46cm W x 46cm D x 100cm H (Identical to predicate).
Weight (Platform): Identical to predicate.	Weight (Platform): 30 Kg (70.4 lbs.) (Identical to predicate).
Applicator Weight: Similar, minor difference noted but not impacting equivalence.	Applicator Weight: Applicator - 0.4 Kg (0.88 lbs.), Tip - 0.02 Kg. (The predicate's applicator weight is not explicitly stated in the table but "idem" is used for other characteristics suggesting substantial similarity).
Number of pins: Identical to predicate.	Number of pins: 12, 24 and 40 pins (Identical to predicate).
Maximal Treatment depth: Similar, with increased depth for some tips in the subject device, justified by testing.	Maximal Treatment depth: 0.5mm (T tip head), 4.0mm (12 pin tip head), 7.0mm (24 and 40 pin tip heads). (Predicate had 4.0mm for 24 and 40 pin tips, subject device showed increased depth).
RF energy level: Similar, with increased range for some tips in the subject device, justified by testing.	RF energy level: 5-30 (24 tip head up to 1 mm), 5-30 (T tip head and 12 tip head), 5-60 (24 and 40 in the range of 2-7mm). (Predicate had 5-60 for 12, 24, and 40 in 2-4mm range, subject had increased range for some tips).
Cable Dimensions: Identical to predicate.	Cable Dimensions: 270 cm (Identical to predicate).
Performance (Frequency, Max Output Power, Max Pulse Duration): Identical to predicate.	Performance: Frequency: 1 MHz, Maximal RF output power: 65W, Maximal pulse duration: up to 74msec (Identical to predicate).
Standards Met: Compliant with recognized standards.	Standards Met: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2 (Identical to predicate and evaluated for compliance).
Biocompatibility: Identical to predicate.	Biocompatibility: All materials are biocompatible (Identical to predicate).
Compatibility with Environment and Other Devices: Compliant with EMC safety standard.	Compatibility with Environment and Other Devices: Compliant with IEC 60601-1-2 (EMC Safety) standard (Identical to predicate).
Sterility: Identical to predicate.	Sterility: 12, 24, 40 and T tip head are Gamma sterilized and for single use. Morpheus8 Applicator handle is for multiple use (Identical to predicate).
Mechanical Safety: Compliant with IEC 60601-1 standard.	Mechanical Safety: Compliant with IEC 60601-1 standard (Identical to predicate).
Thermal Safety: Compliant with IEC 60601-1 standard.	Thermal Safety: Compliant with IEC 60601-1 standard (Identical to predicate).
Radiation Safety: Compliant with EMC safety standard.	Radiation Safety: Compliant with IEC 60601-1-2 (EMC Safety) standard (Identical to predicate).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The primary test set mentioned is an ex-vivo tissue study on a porcine animal model. The sample size is not explicitly stated as a number of animals or tissue samples, but it indicates "a single treatment of two different harvested porcine tissues: muscle and fat."

Sample size: Not explicitly quantified. Refers to "a single treatment of two different harvested porcine tissues."
Provenance: Ex-vivo tissue study on a porcine animal model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The ex-vivo study describes TTC staining to visualize coagulation necrosis, which is typically evaluated by pathologists or scientists with expertise in tissue histology, but no specific number or qualifications are given for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. The ex-vivo study focused on an objective measurement of coagulation necrosis visualized by TTC staining, rather than a subjective interpretation that would typically require an adjudication method.

5. 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 was done. This device is an electrocoagulation and hemostasis device, not an AI diagnostic or assistance tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical instrument (hardware-based) for dermatological procedures, not an algorithm, and it requires human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the ex-vivo tissue study, the type of "ground truth" used was visualization of tissue coagulation necrosis pattern immediately stained by TTC staining. This is a direct pathological/histological assessment marker for the intended effect of electrocoagulation.

8. The sample size for the training set

Not applicable. This device is hardware-based and does not involve AI or machine learning models that require a "training set."

9. How the ground truth for the training set was established

Not applicable. As stated above, there is no AI/ML training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +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 102Kfar Saba 44425IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: amit@asteinrac.com
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 Morpheus8Applicators	K192695

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Device Description:

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.

TechnologicalCharacteristic	InMode System with theMorpheus8 ApplicatorsInMode Ltd.K200947(Subject Device)	InMode System with theMorpheus8 ApplicatorsInMode Ltd.K192695(Predicate Device)
Product Code,Class	GEIClass II	GEIClass II
Indications forUse	The InMode System withthe Morpheus8Applicators is intended foruse in dermatological andgeneral surgicalprocedures forelectrocoagulation andhemostasis.At higher energy levelsgreater than 62 mJ/pin, useof these Applicators islimited to Skin Types I-IV.	The InMode System withthe Morpheus8Applicators is intendedfor use in dermatologicalprocedures forelectrocoagulation andhemostasis.At higher energy levelsgreater than 62 mJ/pin,use of these Applicatorsis limited to Skin TypesI-IV.
AnatomicalSites	Body parts requiringtreatment as specified inthe indication for use	idem
TargetPopulation	Adults requiring treatmentas specified in theindication for use	idem
EnvironmentUsed	Hospital or Clinic setting	idem
Energy Used /Delivered	RF energy	idem
Design:	Fractional RF: Use of RFenergy delivered through amatrix of multiple pinelectrodes allocated on theapplicator tip	idem
- Mechanism ofAction	Treatment is based onfractional RF technologyfor localized dermis and	idem
TechnologicalCharacteristic	InMode System with theMorpheus8 ApplicatorsInMode Ltd.K200947(Subject Device)	InMode System with theMorpheus8 ApplicatorsInMode Ltd.K192695(Predicate Device)
	sub dermis coagulationtriggering slow collagenregeneration and fibroblastcells' proliferation.
- Components	The InMode Morpheus8Applicators are add-onapplicators to the FDAcleared InMode System(K192695).The system consists of thefollowing components:- Console, including apower supply, RFgenerator, controller, andtouch screen control anddisplay panel.- Applicator connected tothe console via a cable,with tip including 12, 24,40 & T tip heads.- Footswitch	idem
- SystemDimensions	46cm W x 46cm D x100cm H[18.2" W x 18.2" D x40" H]	idem
- WeightPlatform weight	30 Kg (70.4 lbs.)	idem
Applicatorweight	Applicator - 0.4 Kg (0.88lbs.)Tip - 0.02 Kg
Number of pins	12, 24 and 40 pins	idem
MaximalTreatment depth	0.5mm (for T tip head)4.0mm (for 12 pin tiphead)7.0mm (for 24 and 40 pintip heads)	0.5mm (for T tip head)4.0mm (for 12 pin tiphead)4.0mm (for 24 and 40 pintip heads)
TechnologicalCharacteristic	InMode System with theMorpheus8 ApplicatorsInMode Ltd.K200947(Subject Device)	InMode System with theMorpheus8 ApplicatorsInMode Ltd.K192695(Predicate Device)
RF energy level	5-30 (for 24 tip head up to1 mm)5-30 (for T tip head andfor 12 tip head)5-60 (for 24 and 40 in therange of 2-7mm)	5-30 (for 24 tip head upto 1 mm)5-30 (for T tip head andfor 12 tip head up to 1mm)5-60 (for 12 tip head inthe range of 2-4mm)5-60 (for 24 and 40 in therange of 2-4mm)
CableDimensions:	270 cm	idem
Performance	Frequency: 1 MHzMaximal RF outputpower: 65WMaximal pulse duration:up to 74msec	idem
Standards Met	AAMI/ANSI ES 60601-1IEC 60601-1-2IEC 60601-2-2	idem
Biocompatibility	All materials arebiocompatible	idem
CompatibilitywithEnvironmentand OtherDevices	InMode System with theMorpheus8 Applicators iscompliant with the IEC60601-1-2 (EMC Safety)standard	idem
Sterility	The 12, 24, 40 and T tiphead are Gamma sterilizedand for single use.The Morpheus8Applicator handle is formultiple use	idem
TechnologicalCharacteristic	InMode System with theMorpheus8 ApplicatorsInMode Ltd.K200947(Subject Device)	InMode System with theMorpheus8 ApplicatorsInMode Ltd.K192695(Predicate Device)
	100-240 VAC 50-60 HzThe InMode System withthe Morpheus8Applicators is compliantwith the IEC 60601-1standard.
MechanicalSafety	The InMode System withthe Morpheus8 Applicatoris compliant with the IEC60601-1 standard.	idem
Chemical Safety	Not Applicable	Not Applicable
Thermal Safety	The InMode System withthe Morpheus8Applicators is compliantwith the IEC 60601-1standard.	idem
Radiation Safety	The InMode System withthe Morpheus8Applicators is compliantwith the IEC 60601-1-2(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.

Regulation Number and Section

§ 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.